INTERNATIONAL STANDARD ISO/IEC 17025

STANDARD INTERNATIONAL ISO/IEC 17025

GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND

CALIBRATION LABORATORIES

CERINTE GENERALE CU PRIVIRE LA COMPETENTA LABORATOARELOR DE

INCERCARE SI ETALONARE

FOREWORD

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.

International Standard ISO/IEC 17025 was prepared by ISO/CASCO, Committee on Conformity Assessment.

This first edition of ISO/IEC 17025 cancels and replaces ISO/IEC Guide 25:1990.

Annexes A and B of this International Standard are for information only.

INTRODUCTION This International Standard has been produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it now replaces. It contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results.

Accreditation bodies that recognize the competence of testing and calibration laboratories should use this

International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound management. Clause 5 specifies the requirements for technical competence for the type of tests and/or calibrations the laboratory

CUVANT INAINTE

ISO (Organizatia Internationala pentru Standardizare) si IEC (Comisia Electrotehnica Internationala) formeaza sistemul specializat pentru standardizare la nivel mondial. Organismele nationale membre ISO sau IEC participa la dezvoltarea standardelor internationale prin intermediul unor comisii tehnice stabilite de organizatia respectiva pentru a se ocupa de zonele specifice de activitate tehnica. Comisiile tehnice ISO si IEC colaboreaza in domeniile de interes reciproc. De asemenea in activitatea generala sunt implicate si alte organizatii internationale, guvernamentale si neguvernamentale, aflate in legaturi cu ISO si IEC. Standardele internationale sunt emise ca draft in acord cu regulile prezentate de Directivele ISO/IEC, Partea 3. Standardele internationale in draft sunt adoptate de comisiile tehnice si trimise organismelor membre pentru votare. Publicarea ca si standard international necesita aprobarea a cel putin 75% dintre organismele membre care voteaza. Se acorda de asemeni atentie posibilitatii ca unele din elementele standardului de fata sa fie supuse dreptului de autor. ISO si IEC nu vor fi trase la raspundere la identificarea unora sau tuturor acestor drepturi de autor. Standardul international ISO/IEC 17025 a fost pregatit de Comisia ISO/CASCO de Evaluare a Conformitatii. Prima editie din ISO/IEC 17025 anuleaza si inlocuieste ISO/IEC Ghid 25:1990. Anexele A si B ale standardului de fata sunt destinate doar informarii.

INTRODUCEREAcest standard a fost produs ca rezultat al vastei

experiente a implementarii ISO/IEC Ghid 25 si EN 45001, inlocuindu-le acum pe amandoua. El contine toate cerintele pe care laboratoarele de incercare si etalonare trebuie sa le indeplineasca daca vor sa demonstreze ca lucreaza dupa un sistem al calitatii, ca sunt competente tehnic si capabile sa furnizeze rezultate validate tehnic.

Organismele de acreditare care recunosc competenta laboratoarelor de incercare si etalonare vor utiliza acest standard ca baza pentru acreditarea lor.

Clauza 4 precizeaza cerintele de management al sunetului. Clauza 5 precizeaza cerintele privind competenta tehnica pentru tipul de incercari si/sau etalonari pe care le intreprinde laboratorul.

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undertakes.The growth in use of quality systems generally has

increased the need to ensure that laboratories which form part of larger organizations or offer other services can operate to a quality system that is seen as compliant with ISO 9001 or ISO 9002 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 and ISO 9002 that are relevant to the scope of testing and calibration services that are covered by the laboratory's quality system.

Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001 and ISO 9002.

Certification against ISO 9001 and ISO 9002 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results.

The acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this International Standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this International Standard.

The use of this International Standard will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures.

1. SCOPE1.1 This International Standard specifies the general

requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

1.2 This International Standard is applicable to all organizations performing tests and/or calibrations. They include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

This International Standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by this International Standard, such as sampling and the design/development of new methods, requirements of those clauses do not apply.

1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard.

1.4 This International Standard is for use by laboratories in developing their quality, administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.

1.5 Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this International Standard.

1.6 If testing and calibration laboratories comply with the requirements of this International Standard they will operate a quality system for their testing and calibration activities that

Cresterea utilizarii sistemelor de calitate a sporit in general nevoia de a asigura ca laboratoarele care fac parte din organizatii mari sau ofera alte servicii pot opera dupa un sistem al calitatii care este considerat ca fiind in acord cu ISO 9001 sau ISO 9002, ca si cu acest standard. Prin urmare s-a ajuns cu grija la incorporarea in acest standard a tuturor cerintelor din ISO 9001 si ISO 9002 care sunt relevante pentru scopul serviciilor de incercare si etalonare acoperite de sistemul de calitate al laboratorului.

Laboratoarele de incercare si etalonare care se supun regulilor din acest standard vor fi asadar capabile sa opereze in conformitate cu ISO 9001 sau ISO 9002.

Certificarea pentru ISO 9001 sau ISO 9002 nu demonstreaza de la sine competenta laboratorului de a produce rezultate si date valide tehnic.

Acceptarea intre tari a rezultatelor de incercare si etalonare trebuie facilitata daca laboratoarele se conformeaza acestui standard si daca obtin acreditarea din partea unor organisme ce au intrat in acord de recunoastere reciproca cu organisme asemanatoare din alte tari ce utilizeaza acest standard.

Utilizarea acestui standard va facilita cooperarea dintre laboratoare si alte organisme, ajutand la schimbul de informatii si experienta, si la armonizarea standardelor si procedurilor.

1. SCOP1.1 Acest standard prezinta cerintele generale pe care

laboratorul trebuie sa le indeplineasca pentru a fi recunoscut ca fiind competent sa execute incercari si etalonari, inclusiv esantionare. Acest standard acopera incercarile si etalonarile care se executa utilizand metode standardizate, metode ne-standardizate si metode dezvoltate de laboratoare.

1.2 El este aplicabil tuturor organizatiilor care executa incercari si/sau etalonari. Acestea includ, de exemplu, laboratoare de prima, de secunda si terta parte si laboratoare in care incercarile si/sau etalonarile fac parte din inspectie si certificare. Acest standard este aplicabil tuturor laboratoarelor indiferent de numarul de personal si de extinderea domeniului activitatilor de calibrare si/sau etalonare. Cand un laborator nu preia una sau mai multe activitati acoperite de acest Standard International, precum esantionarea si proiectarea/dezvoltarea de metode noi, cerintele acestor clauze nu se aplica.

1.3 Notele contin clarificari ale textului, exemple si indicatii. Ele nu contin cerinte si nu formeaza o parte integranta a acestui Standard.

1.4 Acest Standard este destinat utilizarii de catre laboratoarele in dezvoltarea sistemelor de calitate, administrative si tehnice proprii, pe care se bazeaza functionarea lor. De asemenea el poate fi utilizat de catre clienti, autoritatile reglementare si organisme de acreditare in confirmarea sau recunoasterea competentei laboratoarelor.

1.5 Conformitatea cu cerintele de reglementare si de siguranta cu privire la functionarea laboratoarelor nu este acoperita de acest standard.

1.6 Daca laboratoarele de incercare si calibrare satisfac cerintele acestui Standard ele vor opera cu un sistem al calitatii pentru activitatile de incercare si etalonare, sistem care de asemenea satisface cerintele din ISO 9001 cand ele se ocupa de proiectarea/dezvoltarea unor metode noi si/sau dezvoltarea de

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also meets the requirements of ISO 9001 when they engage in the design/development of new methods, and/or develop test programmes combining standard and non-standard test and calibration methods, and ISO 9002 when they only use standard methods. Annex A provides nominal cross-references between this International Standard and ISO 9001 and ISO 9002. ISO/IEC 17025 covers several technical competence requirements that are not covered by ISO 9001 and ISO 9002.Note 1: it might be necessary to explain or interpret certain

requirements in this International Standard to ensure that requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially accreditation bodies (see ISO/IEC Guide 58:1993, 4.1.3) is given in Annex B.

Note 2: if a laboratory wishes accreditation for part or all of its testing and calibration activities, it should select an accreditation body that operates in accordance with ISO/IEC Guide 58.

2 NORMATIVE REFERENCES

The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.ISO 9001:1994, Quality systems - Model for quality assurance in design, development, production, installation and servicingISO 9002:1994, Quality systems - Model for quality assurance in production, installation and servicingISO/IEC Guide 2, General terms and their definitions concerning standardization and related activitiesVIM, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML.Note 1: further related standards, guides etc. on subjects

included in this International Standard are given in the bibliography.

Note 2: it should be noted that when this International Standard was being developed, the revisions of ISO 9001 and ISO 9002 were anticipated to be published in late 2000 as a merged ISO 9001:2000. This is no longer the case.

3. TERMS AND DEFINITIONSFor the purposes of this International Standard, the

relevant terms and definitions given in ISO/IEC Guide 2 and VIM apply.Note: general definitions related to quality are given in ISO

8402, whereas ISO/IEC Guide 2 gives definitions specifically related to standardization, certification and laboratory accreditation. Where different definitions are given in ISO 8402, the definitions in ISO/IEC Guide 2 and VIM are preferred.

4. MANAGEMENT REQUIREMENTS

4.1 ORGANIZATION

programe de incercare prin combinarea metodelor standard si ne-standard de incercare si etalonare, si ISO 9002 cand utilizeaza numai metode standardizate. Anexa A furnizeaza corespondente dintre acest standard si ISO 9001 si ISO 9002. ISO/IEC 17025 acopera mai multe cerinte privind competenta tehnica neacoperite de ISO 9001 si ISO 9002.

Nota 1: ar putea fi necesara explicarea si interpretarea anumitor cerinte ale acestui standard pentru a se asigura aplicarea cerintelor intr-o maniera consistenta. Indicatii pentru a se stabili aplicarea in diverse domenii, mai ales in cel al organismelor de acreditare (vezi ISO/IEC Ghid 58:1993, 4.1.3) sunt date in cadrul Anexei B.

Nota 2: daca un laborator doreste acreditare pentru o parte sau pentru toate activitatile sale de incercare si etalonare, ar trebui sa aleaga un organism de acreditare ce functioneaza in acord cu cu ISO/IEC Ghid 58.

2 REFERINTE NORMATIVE

Urmatoarele documente normative contin prevederi care, datorita referintelor din acest text, constituie prevederi ale acestui standard. Pentru referinte datate, amendamente ulterioare sau revizii de orice fel nu se aplica nici una din aceste publicatii. In orice caz, partile la acordurile bazate pe acest standard sunt incurajate a investiga posibilitatea aplicarii celor mai recente editii a documentelor normative indicate mai jos. Pentru referinte nedatate se va aplica ultima editie a documentului normativ citat. Membrii ISO si IEC pastreaza cataloage cu standardele internationale valabile in mod curent.

ISO 9001:1994, Sisteme ale calitatii - model pentru asigurarea calitatii in proiectare, dezvoltare, productie, instalare si serviceISO 9002:1994, Sisteme ale calitatii - model pentru asigurarea calitatii in productie, instalare si service ISO/IEC Guide 2, Termeni generali si definitiile lor referitoare la standardizare si activitatile conexeVIM, Vocabular international de termeni generali si de baza in metrologie, editat de BIPM, IEC, IFCC, ISO, IUPAC, IUPAP si OIML.Nota 1: standarde asociate suplimentare, ghiduri, etc., pe teme

incluse in acest Standard se gasesc la bibliografie.Nota 2: trebuie observat ca la elaborarea acestui standard, se

anticipa publicarea reviziilor la ISO 9001 si ISO 9002 spre sfarsitul anului 2000 ca un ISO 9001:2000 unificat. Nu mai e cazul.

3. TERMENI SI DEFINITIIPentru scopul acestui standard se utilizeaza definitiile

relevante din ISO/IEC- Ghid 2 si VIM.

Nota: ISO 8402 prezinta definitiile generale referitoare la calitate, in timp ce ISO/IEC Ghid 2 prezinta definitii referitoare in mod specific la standardizare, certificare si acreditare a laboratoarelor. Daca in ISO 8402 sunt date definitii diferite, se prefera cele din ISO/CEI Ghid 2 si VIM.

4. CERINTE PRIVIND SISTEMUL DE MANAGEMENT

4.1 ORGANIZARE4.1.1 Laboratorul sau organizatia din care acesta face

parte va fi o entitate si trebuie sa poata fi tras(a) in mod legal la 3

4.1.1 The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.

4.1.2 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the client, the regulatory authorities or organizations providing recognition. 4.1.3 The laboratory management system shall cover work carried out in the laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities. 4.1.4 If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

Note 1: where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard.

Note 2: if the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.

4.1.5 The laboratory shalla. have managerial and technical personnel with the authority

and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also 5.2)

b. have arrangements to ensure that its management and personnel are free from any undue internal or external commercial, financial and other pressures and influences that may adversely affect the quality of their work

c. have policies and procedures to ensure the protection of its clients' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results

d. have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity

e. define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services

f. specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations

g. provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and

raspundere.4.1.2 Este responsabilitatea laboratorului sa-si

efectueze activitatile de incercare si etalonare astfel incat sa satisfaca cerintele acestui standard si sa satisfaca necesitatile clientului, a autoritatilor reglementare sau a organizatiilor ce se ocupa de recunoastere.

4.1.3 Sistemul de management al laboratorului va acoperi activitatile executate in localurile permanente ale acestuia, in localuri exterioare sau in localuri asociate temporare sau mobile.

4.1.4 Daca laboratorul face parte dintr-o organizatie efectuand si alte activitati in afara de incercare si/sau etalonare, responsabilitatile tuturor cadrelor de conducere din organizatie care au implicare sau o influenta asupra activitatilor de incercare si/sau etalonare ale laboratorului, trebuie definite astfel incat sa se identifice conflictele de interese potentiale.Nota 1: acolo unde laboratorul este o parte a unei organizatii

mai mari, planul organizatiei trebuie sa fie incat departamentele avand conflicte de interese ca de pilda productia, comercialul sau financiarul sa nu influenteze negativ acordul laboratorului cu cerintele acestui Standard.

Nota 2: daca laboratorul doreste recunoastere ca laborator de terta parte el trebuie sa poata demonstra ca este impartial si ca el personalul sau nu se afla sub vreo forma de presiune inoportuna de natura comerciala, financiara etc. care Ie-ar putea influenta judecata in zona tehnica. Laboratoarele de incercare sau etalonare de terta parte nu trebuie sa se angajeze in vreo activitate ce ar putea periclita increderea in independenta sa de judecata si integritatea sa in raport cu activitatile sale de incercare sau etalonare.4.1.5 Laboratorul trebuie:

a. sa aiba personal de conducere sustinut de personal tehnic, avand autoritatea si resursele necesare realizarii sarcinilor si identificarii aparitiei de abateri de la sistemul de management al calitatii sau de la procedurile de efectuare a incercarilor si/sau etalonarilor, ca si initierii de actiuni pentru prevenirea sau minimizarea unor astfel de abateri (vezi si 5.2)

b. sa ia masuri prin care sa asigure ca managementul si personalul sau nu sunt supusi in nici unui fel la presiuni interne sau externe, de natura comerciala, financiara sau de alta natura, care le-ar afecta negativ calitatea activitatii

c. sa aiba politici si proceduri care sa asigure protectia informatiilor cofidentiale si drepturile de proprietate ale clientilor sai, inclusiv proceduri de protectie a transmiterii si stocarii electronice a rezultatelor

d. sa aiba politici si proceduri, pentru a evita implicarea in orice activitate care ar diminua increderea in competenta sa, in impartialitatea, aprecierile sau integritatea sa functionala

e. sa defineasca organizarea si structura managementului laboratorului, locul sau in orice organizatie tutelara si relatiile intre functiile tehnice, serviciile auxiliare si sistemul de management al calitatii

f. sa specifice responsabilitatea, autoritatea si interrelatiile tuturor persoanelor care conduc, efectueaza sau verifica lucrari afectand calitatea incercarilor si/sau etalonarilor

g. sa asigure o supervizare adecvata a personalului de incercare si etalonare, inclusiv a personalului in curs de instruire, din partea unor persoane cunoscand metodele si procedurile, scopul fiecarei incercari si/sau etalonari, si evaluarea rezultatelor incercarilor sau etalonarilor

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with the assessment of the test or calibration resultsh. have technical management which has overall

responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations

i. appoint a member or staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the quality system is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources

j. appoint deputies for key managerial personnel (see note).Note: individuals may have more than one function and it may

be impractical to appoint deputies for every function.

4.2 QUALITY SYSTEM4.2.1 The laboratory shall establish, implement and

maintain a quality system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.

4.2.2 The laboratory's quality system policies and objectives shall be defined in a quality manual (however named). The overall objectives shall be documented in a quality policy statement. The quality policy statement shall be issued under the authority of the chief executive. It shall include at least the following:a. the laboratory management's commitment to good

professional practice and to the quality of its testing and calibration in servicing its clients

b. the management's statement of the laboratory's standard of service

c. the objectives of the quality systemd. a requirement that all personnel concerned with testing and

calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work

e. the laboratory management's commitment to compliance with this International Standard.

Note: the quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and clients' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.

4.2.3 The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the quality system.

4.2.4 The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.

4.3 DOCUMENT CONTROL4.3.1 GeneralThe laboratory shall establish and maintain procedures

to control all documents that form part of its quality system (internally generated or from external sources), such as

h. sa dispuna de un management tehnic, avand responsabilitatea generala pentru activitatea tehnica si furnizarea resurselor necesare pentru asigurarea calitatii cerute a activitatii laboratorului

i. sa numeasca un membru al staff-ului ca manager al calitatii (oricum ar fi acesta definit), care, indiferent de alte sarcini si responsabilitati, sa aiba definite responsabilitatea si autoritatea pentru a asigura ca cerintele sistemului calitatii sunt implementate si urmarite in orice moment; managerul calitatii trebuie sa aiba acces direct la cel mai inalt nivel al managementului, la care se iau deciziile privind politica sau resursele laboratorului;

j. sa numeasca loctiitori pentru principalele functii de conducere (vezi nota).

Nota: anumite persoane pot avea mai multe functii si poate fi nepractic sa se numeasca loctiitori pentru fiecare functie in parte.

4.2 SISTEMUL CALITATII4.2.1 Laboratorul trebuie sa stabileasca, implementeze si

sa mentina un sistem de management al calitatii corespunzator obiectului sau de activitate. Laboratorul trebuie sa-si documenteze politicile, sistemele, programele, procedurile si instructiunile in extinderea necesara pentru a asigura calitatea rezultatelor incercarilor si/sau etalonarilor. Toate documentele folosite in acest sistem de management al calitatii trebuie transmise, intelese, disponibile si implementate, de catre tot personalul implicat.

4.2.2. Laboratorul trebuie sa identifice si sa demonstreze politicile si obiectivele de realizat in domeniul calitatii intr-un manual al calitatii (indiferent cum este numit). Declaratia de politica a calitatii trebuie sa fie emisa sub autoritatea sefului executiv. Ea va include cel putin urmatoarele:a. angajarea managementului laboratorului pe linia unei bune

practici profesionale si a calitatii incercarilor si etalonarilor in slujba clientilor

b. o declaratie a intentiilor laboratorului, referitoare la standardul serviciilor pe care le va oferi

c. scopul sistemului calitatiid. o cerinta ca tot personalul implicat in activitatile de

incercare si etalonare din laborator sa fie familiarizat cu documentatia privind calitatea si sa implementeze politicile si procedurile in permanenta in munca lor

e. angajamentul conducerii laboratorului privind acordul cu acest Standard.

Nota: declaratia de politica a calitatii trebuie sa fie concisa si poate include cerinta ca incercarile si/sau etalonarile sa fie intotdeauna efectuate conform metodelor stabilite si cerintelor clientilor. Atunci cand laboratorul de incercare si/sau etalonare face parte dintr-o organizatie mai mare, unele elemente ale politicii privind calitatea se pot afla in alte documente.

4.2.3. Manualul calitatii trebuie sa includa sau sa faca referinte la procedurile de sprijin, inclusiv proceduri tehnice. El va contura structura documentatiei utilizate in cadrul sistemului calitatii.

4.2.4 Manualul calitatii trebuie sa defineasca rolurile si responsabilitatile personalului tehnic si managerului calitatii, inclusiv responsabilitatea de asigurare a conformitatii cu prezentul standard.

4.3 CONTROLUL DOCUMENTELOR4.3.1 Generalitati

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regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.Note 1: in this context "document" could be policy statements,

procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written.

Note 2: the control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.12.

4.3.2 Document approval and issue 4.3.2.1 All documents issued to personnel in the laboratory as part of the quality system shall be reviewed and approved for use by authorized personnel prior to issue. A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the quality system shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

4.3.2.2 The procedure(s) adopted shall ensure that:a. authorized editions of appropriate documents are available

at all locations where operations essential to the effective functioning of the laboratory are performed

b. documents are periodically reviewed and, where necessary, revised to ensure continuing suitably and compliance with applicable requirements

c. invalid or obsolete documents are promptly removed from all points of issue for use, or otherwise assured against unintended use

d. obsolete documents retained for either legal or knowledge preservation purposes are suitably marked

4.3.2.3 Quality system documents generated by the laboratory shall be uniquely identified. Such identification shall include the date of issue and/or identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority(s).

4.3.3 Document changes4.3.3.1 Changes to documents shall be reviewed and

approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval.

4.3.3.2 Where practicable, the altered or new text shall be identified in the document or appropriate attachments. 4.3.3.3 If the laboratory's documentation control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined. Amendments shall be clearly marked, initialed and dated. A revised document shall be formally re-issued as soon as practicable.

4.3.3.4 Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.

4.4. REVIEW OF REQUESTS, TENDERS AND CONTRACTS

4.4.1 The laboratory shall established and maintain procedures for the review of requests, tenders and contracts. The policies and procedures for these reviews leading to a

Laboratorul trebuie sa stabileasca si sa mentina proceduri pentru controlul tuturor documentelor (generate intern sau din surse externe) ce fac parte din documentatia calitatii, ca de ex. reguli, standarde, alte documente normative, metode de incercare si/sau etalonare, desene, software, specificatii, instructiuni si manuale.Nota 1: in acest context “document” poate insemna declaratii de

politica, proceduri, specificatii, tabele de etalonare, diagrame, manuale, postere, notite, insemnari, soft-uri, planuri, desene, etc. Acestea pot fi pe diverse suporturi, fie hard copy, fie electronic, iar informatiile pot fi digitale, analogice, fotografice sau scrise.

Nota 2: controlul datelor care se refera la incercare/calibrare este acoperit de 5.4.7. Controlul inregistrarilor este acoperit de 4.12.

4.3.2 Aprobarea si difuzarea documentelor 4.3.2.1. Toate documentele difuzate personalului in laborator ca parte a sistemului calitatii trebuie sa fie analizate si aprobate pentru folosire de catre un personal autorizat in acest sens, inainte de difuzare. O lista centralizatoare sau o procedura echivalenta de control al documentelor, indentificand situatia curenta a reviziilor documentelor din sistemul calitatii trebuie sa fie intocmit si usor disponibil, pentru a se impiedica folosirea de documente nevalabile sau anulate.

4.3.2.2. Procedurile adoptate trebuie sa asigure, de asemenea, ca : a. editiile autorizate ale documentelor corespunzatoare sunt

disponibile peste tot unde se efectueaza operatii esentiale pentru functionarea efectiva a laboratorului

b. documentele sunt revazute in mod periodic si, unde este necesar, revizuite pentru a se asigura un caracter adecvat si conformitatea cu cerintele aplicabile

c. documentele nevalabile sau anulate sunt sterse promt de peste tot unde pot fi folosite sau sunt asigurate in alt mod impotriva utilizarii lor neintentionate

d. documente anulate retinute in scopuri legale sau pastrarea informatiilor sunt corespunzator marcate

4.3.2.3 Documentele sistemului de calitate generate de laborator trebuie sa fie unic identificate, aceasta identificare incluzand data editarii si/sau ID-ul, numerotarea paginilor, numarul total de pagini sau un marcaj semnificand sfarsitul documentului, precum si autoritatea emitenta.

4.3.3 Modificarile documentului4.3.3.1 Modificarile documentelor trebuie sa fie

analizate si aprobate de aceleasi functii care au efectuat revizuirea initiala, exceptand cazul in care s-a decis altfel. Personalul desemnat trebuie sa aiba acces la informatiile de baza adecvate, pe care sa-si bazeze analiza si aprobarea.

4.3.3.2 Unde este realizabil, textul modificat sau nou va fi identificat in cadrul documentului sau al anexelor corespunzatoare.

4.3.3.3 Daca sistemul de control al documentelor laboratorului permite modificarea de mana a documentelor, pana la reeditarea acestora, trebuie definite procedurile si autoritatile pentru aceste modificari si trebuie sa se asigure ca modificarile sunt vizate, notate si datate cu claritate. Un document revizuit va fi re-editat in mod formal cat mai rapid posibil.

4.3.3.4 Trebuie stabilite proceduri care sa descrie cum se realizeaza si se controleaza modificari in documentele pastrate in sisteme computerizate.

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contract for testing and/or calibration shall ensure that:

a. the requirements, including the methods to be used, are adequately defined, documented and understood (see 5.4.2)

b. the laboratory has the capability and resources to meet the requirements

c. the appropriate test and/or calibration method is selected and capable of meeting the clients' requirements (see 5.4.2).

Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and the client.Note 1: the request, tender and contract review should be

conducted in a practical and efficient manner and effect of financial, legal and time schedule aspects should be taken into account. For internal clients, reviews of requests, tenders and contracts can be performed in a simplified way.

Note 2: the review of capability should established that the laboratory possesses the necessary physical, personnel and information resources and that the laboratory's personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also encompass results of earlier participation in the inter-laboratory and comparisons of proficiency testing and/or the running of trial test or calibration programmes using samples or items of known value in order to determine uncertainties of measurement, limits of detection, confidence limits etc.

Note 3: a contract may be any written and oral agreement to provide a client with testing and/or calibration services.

4.4.2 Records of reviews, including any significant changes, shall be maintained. Records shall also be maintained of pertinent discussions with a client relating to the client's requirements or the results of the work during the period of execution of the contract.Note: for the review of routine and other simple tasks, the date

and the identification (e.g. the initials) of the person and the laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks, the review need be made only at the initial inquiry stage or on granting of the contract for on-going routine work performed under a general agreement, provided that the clients' requirements remain unchanged. For new, complex or advanced testing and/or calibration tasks, a more comprehensive record should be maintained.4.4.3 The review shall also cover any work that is

subcontracted by the laboratory.4.4.4 The client shall be informed of any deviation

from the contract.4.4.5 If a contract needs to be amended after work has

commenced, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel.

4.5 SUBCONTRACTING OF TESTS AND CALIBRATIONS4.5.1 When a laboratory subcontracts work whether

because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent

4.4 . ANALIZA COMENZII, OFERTEI SAU CONTRACTULUI

4.4.1 Laboratorul trebuie sa stabileasca si sa mentina proceduri pentru analiza comenzilor, ofertelor sau contractelor. Politicile si procedurile pentru analiza fiecarui contract, comanda sau oferta conducand la un contract pentru incercare si/sau etalonare vor asigura ca:a. cerintele, inclusiv metodele ce trebuie folosite sunt adecvat

definite, documentate si intelese (vezi 5.4.2.)b. laboratorul are capacitatea si resursele sa satisfaca cerintelec. metoda potrivita de incercare si/sau etalonare este selectata

si capabila sa satisfaca cerintele clientilor (vezi 5.4.2).

Orice diferenta intre cerinta sau oferta si contract trebuie sa fie rezolvata inainte de inceperea oricarei lucrari. Fiecare contract trebuie sa fie acceptat atat de laborator cat si de client.Nota 1: analiza fiecarei comenzi, oferte sau contract ar trebui

intr-un mod practic si eficient, luandu-se in considerare aspectele financiar, legal si de termen. Pentru clienti interni, analiza comenzilor, ofertelor si contractelor se poate realiza de o maniera simplificata.

Nota 2: analiza capabilitatii trebuie sa demonstreze ca laboratorul poseda resursele umane, fizice si de informatie si ca personalul laboratorului are calificarea si experienta necesare pentru efectuarea incercarilor si etalonarilor in cauza. Analiza capabilitatii poate include rezultatele unor participari anterioare la comparatii interlaboratoare sau incercari de aptitudine si/sau desfasurarea de incercari de verificare sau programe de etalonare folosind esantioane sau obiecte de valoare cunoscuta, pentru a determina incertitudinea masurarii, limitele de detectie si limitele de incredere, etc.

Nota 3: un contract poate fi orice acord scris sau verbal pentru furnizarea catre un client de servicii de incercare si/sau etalonare.

4.4.2 Trebuie mentinute inregistrari ale acestor analize, inclusiv ale oricaror modificari. Inregistrarile trebuie de asemenea sa mentioneze discutiile utile cu clientii referitor la cerintele acestora sau a rezultatelor lucrarii pe perioada executarii contractului. Nota: pentru sarcini de rutina si alte chestiuni simple sunt

considerate adecvate data si initialele persoanei si laboratorului responsabile pentru executarea contractului. Pentru sarcini de rutina repetitive, analiza trebuie facuta numai pentru stadiul initial de ancheta sau la aprobarea contractului pentru lucrari de rutina in desfasurare efectuate pa baza unui acord general cu clientul, in conditiile in care cerintele clientului raman neschimbate. Pentru sarcini de incercare si/sau etalonare noi, complexe si avansate trebuie mentinuta o inregistrare mai cuprinzatoare.

4.4.3.Analiza trebuie sa includa orice lucrare ce trebuie sa fie subcontractata de catre laborator.

4.4.4 Clientul va fi informat in legatura cu orice abatere de la contract.

4.4.5 Daca un contract necesita corectari dupa ce s-a inceput lucrarea, procesul analizei aceluiasi contract trebuie sa se repete si orice amendamente trebuie communicate tutror persoanelor afectate.

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subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.

4.5.2 The laboratory shall advise the client of the arrangement in writing and, when appropriate, gain the approval of the client, preferably in writing.

4.5.3 The laboratory is responsible to the client for the subcontractor's work, excepting the case where the client or a regulatory authority specifies which subcontractor is to be used.

4.5.4 The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of evidence of compliance with this International Standard for the work in question.

4.6 PURCHASING SERVICES AND SUPPLIES4.6.1 The laboratory shall have a policy and

procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations.

4.6.2 The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used shall comply with

specified requirements. Records of action taken to check compliance shall be maintained.

4.6.3 Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered. These purchasing documents shall be reviewed and approved for technical content prior to release.Note: the description may include type, class, grade, precise

identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the quality system standard under which they were made.4.6.4 The laboratory shall evaluate suppliers of critical

consumables, supplies and services which affect the quality of testing and calibration, and shall maintain records of these evaluations and list those approved.

4.7 SERVICE TO THE CLIENTThe laboratory shall afford clients or their

representatives cooperation to clarify the client's request and to monitor the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other clients.

Note 1: such cooperation may include:a. providing the client or the client's representative

reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the client

b. preparation, packaging and dispatch of test and/or calibration items needed by the client for verification purposes.

Note 2: clients value the maintenance of good communication,

4.5 SUBCONTRACTAREA INCERCARILOR SI ETALONARILOR

4.5.1 Cand un laborator contracteaza lucrari, fie datorita unor circumstante neprevazute (de ex. volum de lucru, necesitatea unei noi expertize sau incapacitate temporara), fie pe baza de continuitate (de ex. subcontractare permanenta, aranjamente de agentie sau prioritati), subcontractarea se va realiza cu un subcontractant eficient. Acesta este acela care, de ex, se conformeaza acestui standard in privinta lucrarii in discutie.

4.5.2 Laboratorul trebuie sa avizeze in scris clientul si, cand este cazul, sa ceara aprobarea acestuia, preferabil in scris.

4.5.3 Laboratorul este de asemenea responsabil fata de clientii sai pentru executarea lucrarii subcontractantului, cu exceptia cazului in care clientul sau o autoritate reglementara specifica ce subcontractor va fi utilizat. 4.5.4 Laboratorul trebuie sa mentina un registru al subcontractantilor pe care ii foloseste pentru incercari si/sau etalonari si o inregistrare a dovezilor de conformitate cu standardul de fata in privinta lucrarilor in discutie.

4.6 APROVIZIONAREA CU SERVICII SI FURNITURI4.6.1 Laboratorul trebuie sa aiba politici si proceduri

pentru selectarea si procurarea serviciilor si furniturilor utilizate care afecteaza calitatea incercarilor si/sau etalonarilor. Trebuie sa existe proceduri pentru achizitionarea, primirea si depozitarea reactivilor si materialelor consumabile relevante pentru incercari si etalonari.

4.6.2 Laboratorul trebuie sa se asigure ca echipamentul aprovizionat, reactivii si materialele consumabile care afecteaza calitatea incercarilor si/sau etalonarilor nu sunt utilizate pana cand nu au fost inspectate sau altcumva verificate ca sunt conforme cu specificatiile standardelor sau cu cerintele definite in metodele de incercare si/sau etalonare implicate.

Serviciile si furniturile utilizate trebuie sa satisfaca cerintele specificate. Inregistrarile actiunilor intreprinse trebuie sa verifice conformitatea si sa o mentina.

4.6.3 Documentele achizitionate pentru elementele ce afecteaza calitatea iesirilor laboratorului vor contine date despre serviciile si furniturile comandate. Aceste documente vor fi analizate si aprobate ca si continut tehnic inaintea editarii.Nota: prezentarea poate cuprinde tipul, clasa, gradul,

identificarea precisa, specificatii, desene, instructiuni de inspectie, alte date tehnice inclusiv aprobarea rezultatelor de incercare, calitatea ceruta si standardul sistemului calitatii in lumina caruia au fost realizate.

4.6.4 Laboratorul va evalua furnizorii de consumabile, furnituri si servicii importante ce afecteaza calitatea incercarii si etalonarii si va pastra inregistrari ale acestor evaluari, listandu-le pe cele aprobate.

4.7 SERVICIUL CATRE CLIENTILaboratorul trebuie sa asigure clientului sau

reprezentantului sau o cooperare care sa-i permita acestuia sa clarifice cerintele clientului si sa monitorizeze performanta laboratorului relativ la lucrarea efectuata, cu conditia ca laboratorul sa asigure confidentialitate fata de alti clienti.Nota 1: aceasta cooperare poate include:

a. asigurarea accesului clientului sau reprezentantului sau in zonele relevante ale laboratorului, pentru a asista la incercarile si/sau etalonarile efectuate pentru client

b. pregatirea, ambalarea si expedierea obiectelor incercate sau etalonate necesare clientului pentru scopuri de verificare.

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advice and guidance in technical matters, and opinions and interpretations based on results. Communication with the client, especially in large assignments, should be maintained throughout the work. The laboratory should inform the client of any delays or major deviations in the performance of the tests and/or calibrations.

Note 3: laboratories are encouraged to obtain other feedback, both positive and negative, from their clients (e.g. client surveys). The feedback should be used to improve the quality system, testing and calibration activities and client service.

4.8 COMPLAINTSThe laboratory shall have a policy and procedure for

the resolution of complaints received from clients or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.10).

4.9 CONTROL OF NONCONFORMING TESTING AND/OR CALIBRATION WORK

4.9.1 The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the client. The policy and procedures shall

ensure that:a. the responsibilities and authorities for the management of

nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified

b. an evaluation of the significance of the nonconforming work is made

c. corrective actions are taken immediately, together with any decision about the acceptability of the nonconforming work

d. where necessary, the client is notified and work is recallede. the responsibility for authorizing the resumption of work is

defined.Note: identification of nonconforming work or problems with

the quality system or with testing and/or calibration activities can occur at various places within the quality system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits.

4.9.2 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.10 shall be promptly followed.

4.10 CORRECTIVE ACTION4.10.1 GeneralThe laboratory shall establish a policy and procedure

and shall designate appropriate authorities for implementing corrective action when nonconforming work of departures from the policies and procedures in the quality system or technical operations have been identified.

Nota 2: clientii apreciaza mentinerea unei bune comunicari, sfatuirea si indrumarea in zona tehnica, interpretari si recomandari bazate pe rezultate. Trebuie mentinuta pe timpul lucrarii comunicarea cu clientul, in special la sarcini mari. Laboratorul trebuie sa informeze clientii de orice intarziere sau abatere majora in efectuarea incercarilor si/sau etalonarilor.

Nota 3: laboratoarele sunt incurajate sa obtina si alte comunicari, pozitive si negative, cu clientii (de ex. supravegherea clientului). Acestea trebuie utilizate pentru imbunatatirea sistemului calitatii, a activitatilor de incercare si etalonare si a serviciilor catre client.

4.8 RECLAMATIILaboratorul trebuie sa aiba o politica si proceduri

pentru rezolvarea reclamatiilor primite de clienti sau din alte parti. Trebuie mentinute inregistrari ale tuturor reclamatiilor, investigatiilor si actiunilor corective intreprinse de laborator (vezi de asemeni 4.10).

4.9 CONTROLUL LUCRARILOR DE INCERCARE SI ETALONARE NECONFORME

4.9.1 Laboratorul trebuie sa aiba o politica si proceduri ce trebuie implementate cand se stabileste ca anumite aspecte ale lucrarilor de incercare si/sau etalonare sau rezultatele acestor lucrari nu sunt conforme cu procedurile proprii sau cu cerintele convenite cu clientul.

Politica si procedurile trebuie sa se asigure ca:a. au fost desemnate responsabilitatile si autoritatile pentru

managementul lucrarilor neconforme si sunt definite si intreprinse actiuni (inclusiv oprirea lucrului si stoparea rapoartelor de incercare si certificatelor de etalonare, dupa cum e necesar) cand se identifica o lucrare neconforma

b. se face o evaluare a semnificatiei lucrarii neconformec. actiunile de remediere sunt intreprinse imediat, impreuna cu

orice decizii legate de acceptabilitatea lucrarii neconformed. daca este necesar, clientul este avertizat si se repeta

procedurae. este definita responsabilitatea autorizarii reluarii lucrarii.

Nota: identificarea lucrarii neconforme sau problemelor cu sistemul de management al calitatii sau activitatile de incercare si/sau etalonare pot aparea in diferite locuri ale sistemului management al calitatii; cum ar fi: reclamatiile clientilor, controlul calitatii, etalonarea aparatelor, verificarea materialelor consumabile, observatiile sau supervizarea personalului, verificarea rapoartelor de verificare si a certificatelor de etalonare, analizele managementului si auditurile interne sau externe.

4.9.2 Daca evaluarea indica faptul ca lucrarea neconforma poate sa reapara sau ca exista dubii privind conformitatea laboratorului cu propriile sale politici si proceduri, trebuie urmate prompt procedurile actiunilor corective date la pct. 4.10.

4.10 ACTIUNI CORECTIVE4.10.1 GeneralitatiLaboratorul trebuie sa stabileasca o politica si

proceduri si sa desemneze autoritatile corespunzatoare pentru implementarea actiunii corective, atunci cand au fost identificate lucrari neconforme sau abateri de la politici, proceduri ale sistemului calitatii.

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Note: a problem with the quality system or with the technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, feedback from clients or staff observations.

4.10.2 Cause analysisThe procedure for corrective action shall start with an

investigation to determine the root cause(s) of the problem.Note: cause analysis is the key and sometimes the most difficult

part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include client requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.

4.10.3 Selection and implementation of corrective actions

Where corrective action is needed, the laboratory shall identify potential corrective actions. It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence.

Corrective actions shall be to a degree appropriate to the magnitude and the risk of the problem.

The laboratory shall document and implement any required changes resulting from corrective action investigations.

4.10.4 Monitoring of corrective actionsThe laboratory shall monitor the results to ensure that

the corrective actions taken have been effective.

4.10.5 Additional auditsWhere the identification of nonconformances or

departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.13 as soon as possible.Note: such additional audits often follow the implementation of

the corrective actions to confirm their effectiveness. An additional audit should be necessary only when a serious issue or risk to the business is identified.

4.11 PREVENTIVE ACTION4.11.1 Needed improvements and potential sources of

nonconformances, either technical or concerning the quality system, shall be identified. If preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of nonconformances and to take advantage of the opportunities for improvement.

4.11.2 Procedures for preventive actions shall include the initiation of such actions and application of controls to ensure that they are effective.Note 1: preventive action is a pro-active process to identify

opportunities for improvement rather than a reaction to the identification of problems or complaints.

Note 2: apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.

4.12 CONTROL OF RECORDS

Nota: o problema cu sistemul calitatii sau cu operatiile tehnice ale laboratorului pot fi identificate printr-o varietate de actiuni: controlul actiunilor neconforme, audituri interne sau externe, analizele managementului, feedback de la clienti sau observatii ale personalului.

4.10.2 Analiza cauzelorProcedura de actiuni corective va incepe cu o

investigare pentru a determina cauza (cauzele) problemei.

Nota: aceasta este uneori cel mai dificil, dar este partea cheie a procedurii de actiuni corective. Adesea, cauzele nu sunt evidente si atunci se cere o analiza atenta a tuturor cauzelor potentiale ale problemei. Cauzele potentiale pot include, intre altele, esantioane, specificatii ale esantionului, cerintele clientului, metodele si procedurile, calificarea si experienta personalului, materialele consumabile sau echipamentul si etalonarea sa.

4.10.3 Selectarea si implementarea actiunilor corective

Unde sunt necesare astfel de actiuni, laboratorul trebuie sa identifice actiunile corective potentiale. El trebuie sa aleaga si sa implementeze actiunea (actiunile) cele mai probabile de a elimina problema si a preveni repetarea

acesteia.Orice actiune corectiva trebuie sa fie de un nivel

corespunzator marimii problemelor si riscului implicat.Laboratorul va documenta si implementa orice

modificari cerute ce rezulta din investigarea actiunilor corective.4.10.4 Monitorizarea actiunilor corectiveLaboratorul trebuie sa monitorizeze rezultatele, pentru

a se asigura ca actiunile corective intreprinse au fost eficiente.4.10.5 Audituri suplimentareAtunci cand identificarea neconformitatilor sau

abaterilor arunca dubii asupra conformitatii laboratorului cu propriile politici si proceduri sau asupra conformitatii cu acest standard, laboratorul trebuie sa se asigure ca zonele corespunzatoare de activitate sunt promt auditate, in concordanta cu clauza 4.13, si asta cat mai rapid.Nota: astfel de audituri suplimentare urmeaza adeseori

implementarii actiunilor corective, pentru a le confirma acestora eficienta. Un audit suplimentar este necesar doar cand a fost identificata o sursa serioasa de risc.

4.11 ACTIUNI PREVENTIVE4.11.1 Imbunatatirile necesare si sursele potentiale ale

neconformitatilor, fie tehnice, fie in sistemul de management al calitatii, trebuie identificate. Daca e necesara o actiune de tip preventiv trebuie intocmite, implementate si urmarite planuri de actiune pentru reducerea probabilitatilor de aparitie a unor astfel de neconformitati si obtinerea avantajelor oportunitatilor de imbunatatire.

4.11.2 Procedurile de actiune preventiva vor cuprinde initierea de astfel de actiuni si aplicarea de controale in scopul asigurarii eficientei.

Nota 1: actiunea preventiva este mai degraba un proces de identificare a oportunitatilor de imbunatatire a calitatii decat o relatie de identificare de probleme sau reclamatii.

Nota 2: separat de analiza procedurilor operationale, actiunea preventiva poate cuprinde analiza datelor, incluzand analizele de tendinte si riscuri analizelor si rezultatele testarii competentei.

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4.12.1 General4.12.1.1 The laboratory shall establish and maintain

procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.

4.12.1.2 All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of records shall be established.Note: records may be in any media, such as hard copy or

electronic media.4.12.1.3 All records shall be held secure and in

confidence.4.12.1.4 The laboratory shall have procedures to

protect and back-up records stored electronically and to

prevent unauthorized access to or amendment of these records.4.12.2 Technical records4.12.2.1 The laboratory shall retain records of original

observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.

Note 1: in certain fields it may be impossible or impractical to retain records of all original observations.

Note 2: technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, clients' notes, papers and feedback.

4.12.2.2 Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.

4.12.2.3 When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data.

4.13 INTERNAL AUDITS4.13.1 The laboratory shall periodically, and in

accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the quality system and this International Standard. The internal audit programme shall address all elements of the quality system, including the testing and/or calibration activities. It is

4.12 INREGISTRARI 4.12.1 Generalitati

4.12.1.1 Laboratorul trebuie sa stabileasca si sa mentina proceduri de identificare, colectare, indexare, acces, completare, depozitare, mentenanta si folosire a inregistrarilor tehnice si de calitate. Inregistrarile calitatii trebuie sa includa rapoartele auditurilor interne si analizele managementului ca si inregistrarile actiunilor corective si preventive.

4.12.1.2 Toate inregistrarile trebuie sa fie lizibile, depozitate si mentinute astfel incat sa fie promt regasibile, in incaperi ce asigura un mediu adecvat pentru prevenirea deteriorarilor si pierderilor. Trebuie stabilita si durata de pastrare a inregistrarilor.Nota: inregistrarile pot fi sub forma oricarui tip de suport, cum

ar fi hard copy sau suport electronic.4.12.1.3 Toate inregistrarile trebuie sa se pastreze in

securitate si confidentialitate.4.12.1.4 Laboratorul trebuie sa aiba proceduri pentru

protectia si salvarea datelor stocate in computere si

pentru prevenirea accesului neautorizat sau a modificarii acestor date.

4.12.2 Inregistrari tehnice4.12.2.1 Laboratorul trebuie sa pastreze observatiile

inregistrate in original, datele derivate si informatie suficienta pentru a stabili un traseu de audit, inregistrari de etalonare, inregistrari de personal si copii dupa fiecare raport de incercare sau certificat de etalonare eliberat, pentru o perioada definita. Inregistrarile pentru fiecare incercare si/sau etalonare trebuie sa contina suficiente informatii care sa faciliteze, daca este posibil, identificarea factorilor care afecteaza incertitudinea si sa permita ca incercarea sau etalonarea sa se repete sub conditii cat mai apropiate posibil de cele initiale. Inregistrarile trebuie sa includa identitatea personalului responsabil pentru esantionare, indeplinirea fiecarei incercari si/sau etalonari si verificarea rezultatelor.Nota 1: in anumite domenii este imposibil sau nepractic sa se

retina inregistrarile tuturor observatiilor initiale.Nota 2: inregistrarile tehnice sunt acumulari de date (vezi 5.4.7)

si informtii ce rezulta din desfasurarea procedurilor de incercare si etalonare si care indica care din parametrii specificati ai calitatii sau procesului au fost realizati. Ele pot cuprinde formulare, contracte, foi de lucru, carti de lucru, foi de verificare, note de lucru, grafice de control, rapoarte de incercare si certificate de etalonare interne si externe, note ale clientilor, acte si feedback.4.12.2.2 Observatiile, datele si calculele trebuie sa fie

inregistrate in momentul colectarii si vor fi identificabila per sarcina.

4.12.2.3 Cand apar greseli in inregistrari, fiecare greseala trebuie taiata, nu stearsa sau facuta ilizibila, iar valoarea corecta trebuie inscrisa alaturi. Toate aceste modificari ale inregistrarilor trebuie semnate bsau marcate cu initiale de catre persoana care a facut corectia. In cazul datelor stocate in calculator, trebuie luate masuri similare, pentru a evita modicarea sau pierderea datelor originale.

4.13 AUDITURI INTERNE

4.13.1 Laboratorul trebuie sa efectueze periodic si conform unei planificari si proceduri dinainte stabilite, audituri interne ale activitatilor sale, pentru a verifica daca functionarea sa continua sa satisfaca cerintele sistemului calitatii si pe cele ale acestui standard. Programul de audit intern trebuie sa cuprinda toate elementele sistemului calitatii, inclusiv 11

the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management. Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.Note: the cycle for internal auditing should normally be completed in one year.

4.13.2 When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory shall take timely corrective action, and shall notify clients in writing if investigations show that the laboratory results may have been affected.

4.13.3 The area of activity audited, the audit findings and corrective actions that arise from them shall be

recorded.4.13.4 Follow-up audit activities shall verify and

record the implementation and effectiveness of the corrective action taken.

4.14 MANAGEMENT REVIEWS4.14.1 In accordance with a predetermined schedule

and procedure, the laboratory's executive management shall periodically conduct a review of the laboratory's quality system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements.

The review shall take account of:- the suitability of policies and procedures- reports from managerial and supervisory personnel- the outcome of recent internal audits- corrective and preventive actions- assessments by external bodies- the results of inter-laboratory comparisons or proficiency

tests- changes in the volume and type of the work- client feedback - complaints- other relevant factors, such as quality control activities,

resources and staff training.

Note 1: a typical period for conducting a management review is once every 12 months.

Note 2: results should feed into the laboratory planning system and should include the goals, objectives and action plans for the coming year.

Note 3: a management review includes consideration of related subjects at regular management meetings.

4.14.2 Findings from management reviews and the actions that arise from them shall be recorded. The management shall ensure that those actions are carried out within an appropriate and agreed timescale.

5 TECHNICAL REQUIREMENTS

5.1 GENERAL5.1.1 Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:

activitatile de etalonare si/sau incercare. Managerul calitatii are responsabilitatea planificarii si organizarii auditurilor, asa cum este cerut de planificare si impus de management. Astfel de audituri trebuie efectuate de un personal instruit si calificat, care este – cand resursele o permit – independent de activitatile auditate. Nota: planificarea pentru auditurile interne trebuie in mod normal sa fie completa intr-un an.

4.13.2 Cand constatarile auditului conduc la dubii asupra efectivitatii functionarii sau asupra corectitudinii sau validitatii rezultatelor incercarilor sau etalonarilor laboratorului, laboratorul trebuie sa intreprinda la timp actiuni corective si sa-si anunte in scris clientii daca investigatiile indica faptul ca rezultatele laboratorului s-ar putea sa fi fost afectate.

4.13.3 Zona de activitate supusa auditarii, constatarile auditului si actiunile corective care deriva din

aceasta trebuie inregistrate. 4.13.4 Activitatile de auditare realizate in continuare

vor verifica si inregistra implementarea si eficienta actiunii corective intreprinse.

4.14 ANALIZA EFECTUATA DE CATRE CONDUCERE4.14.1 Conform unui program si unei proceduri

prestabilite, conducerea la varf a laboratorului trebuie sa efectueze periodic o analiza a sistemului propriu de management al calitatii si activitatilor de incercare si/sau etalonare, pentru a le asigura continua adecvare si eficienta si pentru a efectua orice modificare sau imbunatatire necesara. Analiza trebuie sa tina cont de:- adecvarea politicilor si procedurilor- rapoartele primite de la personalul managerial si de

supervizare- rezultatele auditurilor interne recente- actiunile corective si preventive- evaluarile de catre organismele externe- de rezultatele comparatiilor inter-laboratoare sau ale

incercarilor de aptitudine- modificari in volumul si tipul lucrarilor- feedback-ul de la clienti.- reclamatii- alti factori relevanti, precum activitatile de control al calitatii,

resursele si pregatirea personalului.Nota 1: o perioada tipica pentru efectuarea unei analize a

conducerii este considerata a fi o data la 12 luni.Nota 2: rezultatele trebuie sa fie cuprinse in sistemul de

planificare al laboratorului si trebuie sa includa: scopurile obiectivele si planurile de actiuni pentru anul urmator.

Nota 3: analiza managementului cuprinde considerarea subiectelor descrise la intalniri regulate ale conducerii.4.14.2 Constatarile rezultate in urma analizei efectuate

de catre conducere si actiunile ce decurg din aceasta trebuie sa fie inregistrate. Managerul trebuie sa asigure ca aceste actiuni vor fi realizate intr-un interval de timp corespunzator si acceptat.

5 CERINTE TEHNICE

5.1 GENERALITATI5.1.1 Multi factori determina corectitudinea si

increderea incercarilor si/sau etalonarilor efectuate de un laborator. Acesti factori includ contributia:- factorul uman (5.2)- localurile si conditiile de mediu (5.3)12

- human factors (5.2)- accommodation and environmental conditions (5.3)- test and calibration methods and method validation (5.4)- equipment (5.5)- measurement traceability (5.6)- sampling (5.7)- the handling of test and calibration items (5.8).

5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations. The laboratory shall take account of these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

5.2 PERSONNEL5.2.1 The laboratory management shall ensure the

competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. When using staff who are undergoing training, appropriate supervision shall be provided. Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required.

Note 1: in some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the client.

Note 2: the personnel responsible for the opinions and interpretation included in test reports should, in addition to the appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have:- relevant knowledge of the technology used for the

manufacturing of the items, materials, products etc. tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service

- knowledge of the general requirements expressed in the legislation and standards

- an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned.

5.2.2 The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated tasks of the laboratory.

5.2.3 The laboratory shall use personnel who are employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory’s quality system.

5.2.4 The laboratory shall maintain current job

- metodele de incercare si etalonare si validarea metodelor (5.4)

- echipamentul (5.5)- trasabilitatea masurarii (5.6)- prelevarea (5.7)- manipularea obiectelor de incercare si etalonare (5.8).

5.1.2 Masura in care factorii contribuie la incertitudinea totala de masurare difera considerabil de la (tipuri de) incercare la incercare si de la (tipuri de) etalonare la etalonare. Laboratorul trebuie sa tina cont de acesti factori in dezvoltarea metodelor si procedurilor de incercare si etalonare, in instruirea si calificarea personalului si in alegerea si etalonarea echipamentelor pe care le utilizeaza.

5.2 PERSONALUL5.2.1 Conducerea laboratorului trebuie sa se asigure de

competenta intregului personal ce deserveste echipamentele specifice, care efecturaza incercari si/sau etalonari, evalueaza rezultatele si semneaza rapoarte de incercare si certificate de etalonare. Daca se utilizeaza personal in curs de instruire, trebuie asigurata o supervizare corespunzatoare. Personalul care executa sarcini specifice trebuie sa fie calificat pe baza unei formari adecvate, a instruirii, experientei si/sau priceperii demonstrate, dupa cum se cere.Nota 1: in anumite domenii tehnice (cum ar fi incercarile

nedustructive) este necesar ca personalul care indeplineste anumite sarcini sa aiba o certificare de personal. Laboratorul este responsabil pentru indeplinirea cerintelor de certificare a personalului. Cerintele de certificare a personalului pot fi reglementare sau pot fi cuprinse in standarde pentru domenii tehnice specifice sau cerute de catre client.

Nota 2: personalul responsabil cu pozitiile si interpretarea din rapoartele de incercare mai trebuie, pe langa calificarea corespunzatoare, instruire, experienta si cunostinte satisfacatoare cu privire la incercarile efectuate, sa mai detina:

- cunostinte relevante despre tehnologia utilizata la fabricarea elementelor, materiale, produse etc. testate, sau despre modul in care acestea sunt folosite sau se intentioneaza utilizarea lor, precum si despre defectele sau defectiunile ce ar putea interveni in timpul lucrului

- cunostinte adecvate cu privire la cerintele generale din legislatie si standarde

- o intelegere a semnificatiei abaterilor descoperite in raport cu utilizarea normala a elementelor, materiale, produse etc. in discutie.

5.2.2 Conducerea laboratorului trebuie sa formuleze scopurile, tinand cont de educatia si priceperea personalului laboratorului. Laboratorul trebuie sa aiba o politica si proceduri pentru identificarea necesitatilor de instruire si asigurarea instruirii personalului. Programul de instruire trebuie sa fie relevant pentru perioada de aplicare si sa anticipeze sarcinile laboratorului. 5.2.3 Laboratorul trebuie sa foloseasca personal care este angajat permanent sau pe baza de contract cu laboratorul. Cand se utilizeaza personal tehnic si de sprijin important, cu contract si suplimentar, laboratorul trebuie sa asigure ca acest personal este supervizat si competent si ca lucrarile pe care acesta le executa sunt in concordanta cu sistemul calitatii laboratorului. 5.2.4 Laboratorul trebuie sa pastreze fise ale postului pentru personalul managerial, tehnic si de sprijin important implicat in incercari si/sau etalonari.Nota: fisa postului poate fi definita in diverse moduri. In mod

obligatoriu, aceasta trebuie sa defineasca 13

descriptions for managerial, technical and key support personnel involved in tests and/or calibrations. Note: job descriptions can be defined in many ways. As a

minimum, the following should be defined:- the responsibilities with respect to performing tests

and/or calibrations- the responsibilities with respect to the planning of

tests and/or calibrations and evaluation of results- the responsibilities for reporting opinions and

interpretations- the responsibilities with respect to method

modification and development and validation of new methods

- expertise and experience required- qualifications and training programmes- managerial duties. 5.2.5 The management shall authorize specific

personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment. The laboratory shall maintain records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or competence is confirmed.

5.3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS

5.3.1 Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations.

The laboratory shall ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement. Particular care shall be taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility. The technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations shall be documented.

5.3.2 The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.

5.3.3 There shall be effective separation between neighbouring areas in which there are incompatible activities. Measures shall be taken to prevent cross-contamination.

5.3.4 Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled. The laboratory shall determine the extent of control based on its particular circumstances.

5.3.5 Measures shall be taken to ensure good housekeeping in the laboratory. Special procedures shall be prepared where necessary.

responsabilitatile privind:- efectuarea incercarilor si/sau etalonarilor- planificarea incercarilor si/sau etalonarilor si evaluarea rezultatelor- modificarea metodelor, dezvoltarea si validarea de noi metode- cunostinte de specialitate si experienta- calificari si programe de instruire- obligatii manageriale.

5.2.5 Conducerea trebuie sa autorizeze un personal specific pentru efectuarea unor tipuri particulare de prelevari, incercari si/sau etalonari, sa autorizeze emiterea rapoartelor de incercare si a certificatelor de etalonare, sa emita opinii si interpretari si sa deserveasca tipuri particulare de echipament. Laboratorul trebuie sa pastreze inregistrari ale unor autorizari relevante, ale competentei, calificarii educationale si profesionale, ale instruirii si experientei intregului personal tehnic, inclusiv cel cu contract. Aceste informatii trebuie sa poata deveni imediat disponibile si sa mentioneze data la care este confirmata autorizatia si/sau competenta.

5.3 LOCALURI SI CONDITII DE MEDIU 5.3.1 Instalatiile laboratorului pentru incercare si/sau etalonare, incluzand, dar nefiind limitate la surse de energie, iluminat si conditii de mediu trebuie sa fie astfel incat sa faciliteze efectuarea corecta a incercarilor si/sau etalonarilor. Laboratorul trebuie sa se asigure ca mediul ambiant nu invalideaza rezultatele sau afecteaza negativ calitatea ceruta a oricarei masurari. Trebuie acordata o atentie deosebita situatiilor in care esantionarea, incercarea si/sau etalonarea sunt efectuate in alte locuri decat siturile permanente ale laboratorului. Cerintele tehnice privind localurile si conditiile de mediu ce pot afecta rezultatele incercarilor si etalonarilor vor fi documentate.

5.3.2 Laboratorul trebuie sa monitorizeze, sa controleze si sa inregistreze conditiile ambientale, asa cum e cerut de specificatiile relevante, metode si proceduri sau atunci cand acestea influenteaza calitatea rezultatelor. Trebuie acordata o atentie corespunzatoare, de exemplu, sterilizarii biologice, prafului, interferentelor electromagnetice, radiatiilor, umiditatii, alimentarii electrice, temperaturii, nivelului sunetului si vibratiilor, dupa cum este adecvat la activitatile tehnice in cauza. Incercarile si etalonarile trebuie oprite, daca conditiile de mediu afecteaza (invalideaza) rezultatele incercarilor si/sau etalonarilor. 5.3.3 Trebuie sa existe o separatie efectiva intre zonele invecinate, in care se desfasoara activitati incompatibile. Trebuie luate masuri pentru prevenirea contaminarilor incrucisate. 5.3.4 Trebuie controlat accesul si folosirea zonelor afectand calitatea incercarilor si/sau etalonarilor. Laboratorul va determina dimensiunile controlului pe baza circumstantelor. 5.3.5 Trebuie luate masuri pentru a asigura curatenia in laborator. In caz de nevoie, se vor pregati proceduri speciale.

5.4 METODE DE INCERCARE SI ETALONARE SI VALIDAREA METODELOR

5.4.1 Generalitati Laboratorul trebuie sa foloseasca metode si proceduri adecvate pentru toate incercarile si/sau etalonarile din domeniul 14

5.4 TEST AND CALIBRATION METHODS AND METHOD VALIDATION

5.4.1 General The laboratory shall use appropriate methods and

procedures for all tests and/or calibrations within its scope. These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of

test and/or calibration data. The laboratory shall have instructions on the use and

operation of all relevant equipment and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel (see 4.3). Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the client.

Note: international, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details.

5.4.2 Selection of methods The laboratory shall use test and/or calibration

methods, including methods for sampling, which meet the needs of the client and which are appropriate for the tests and/or calibrations it undertakes. Methods published in international, regional or national standards shall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. When necessary, the standard shall be supplemented with additional details to ensure consistent application.

When the client does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and it they are validated. The client shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. If the standard method changes, the confirmation shall be repeated.

The laboratory shall inform the client when the method proposed by the client is considered to be inappropriate or out of date.

5.4.3 Laboratory-developed methodsThe introduction of test and calibration methods

developed by the laboratory for its own use-shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.

Plans shall be updated as development proceeds and

sau, pentru esantionare, manipulare, transport, depozitare si pregatirea elementelor (obiectelor) pentru incercare si/sau etalonare si, atunci cand este cazul, o estimare a incertitudinii de masurare, ca si tehnici statistice

de analiza a datelor de incercare si/sau etalonare. Laboratorul trebuie sa aiba instructiuni privind functionarea si utilizarea tuturor echipamentelor mai importante si pentru manipularea si pregatirea obiectelor pentru incercare si/sau etalonare – sau ambele - atunci cand absenta acestor instructiuni ar putea periclita rezultatele incercarilor si/sau etalonarilor. Toate instructiunile, standardele, manualele si datele de referinta relevante pentru activitatea laboratorului trebuie mentinute la zi si trebuie sa fie usor accesibile personalului (vezi 4.3). Abaterile de la metodele de incercare si/sau etalonare pot surveni numai daca abaterea a fost documentata, justificata tehnic, autorizata si acceptata de client.Nota: standardele internationale, regionale sau nationale sau alte

specificatii recunoscute ce contin informatii suficiente si concise privind efectuarea incercarilor si/sau etalonarilor nu este necesar sa fie amendate sau rescrise ca si proceduri interne daca aceste standarde au fost scrise intr-un mod in care pot fi utilizate asa cum au fost publicate, de catre personalul operativ al laboratorului. S-ar putea sa fie necesara o documentatie suplimentara pentru fazele optionale ale metodei, sau detalii suplimentare.

5.4.2 Alegerea metodelor Laboratorul trebuie sa foloseasca metode de incercare si/sau etalonare, inclusiv pentru esantionare, care satisfac nevoile clientului si care sunt corespunzatoare incercarilor si/sau etalonarilor pe care le efectueaza. Sunt preferabile metodele publicate in standarde nationale, regionale sau internationale. Laboratorul trebuie sa se asigure ca utilizeaza ultima editie valida a standardului, cu exceptia cazului cand nu este corespunzator sau posibil sa procedeze astfel. Atunci cand este necesar, standardul trebuie sa fie suplimentat cu detalii pentru a se asigura o aplicare consistenta. Cand clientul nu specifica metoda care trebuie utilizata, laboratorul trebuie sa aleaga metodele corespunzatoare care au fost publicate fie in standardele internationale, regionale sau nationale, fie de catre organizatii tehnice reputate sau in texte si publicatii stiintifice relevante, sau dupa specificatiile producatorului echipamentului. Pot fi utilizate si metode proprii sau adoptate de laboratorul in cauza, daca acestea sunt corespunzatoare utilizarii dorite si daca sunt validate. Clientul trebuie informat de metoda aleasa. Laboratorul va confirma ca poate opera corespunzator cu metode standard inaintea inceperii incercarilor si etalonarilor. Daca metoda standard se modifica, confirmarea se va repeta. Laboratorul trebuie sa-l informeze pe client, atunci cand metoda propusa de acesta este considerata ca fiind inadecvata sau depasita.

5.4.3 Metode dezvoltate in laborator Introducerea metodelor de incercare si etalonare dezvoltate in laborator pentru folosinta proprie va fi o activitate planificata si repartizata unui personal calificat, echipat cu resurse adecvate. Planurile vor fi actualizate pe masura dezvoltarii si se va asigura o comunicare eficienta intre toti membrii personalului implicati.

5.4.4 Metode nestandadrizate Atunci cand este necesar sa se foloseasca metode neacoperite de specificatii ale standardelor, trebuie sa existe un acord cu clientul si se va avea in vedere o specificatie clara a cerintelor clientului si a obiectivelor incercarii si/sau15

effective communication amongst all personnel involved shall be ensured.

5.4.4 Non-standard methods When it is necessary to use methods not covered by

standard methods, these shall be subject to agreement with the client and shall include a clear specification of the client’s requirements and the purpose of the test and/or

calibration. The method developed shall have been validated appropriately before use. Note: for new test and/or calibration methods, procedures

should be developed prior to the tests and/or calibrations being performed and should contain at least the following information:a. appropriate identificationb. scopec. description of the type of item to be tested or

calibratedd. parameters or quantities and ranges to be

determinede. apparatus and equipment, including technical

performance requirementsf. reference standards and reference materials

requiredg. environmental conditions required and any

stabilization period neededh. description of the procedure, including

-affixing of identification marks, handling, transporting, storing and preparation of items

-checks to be made before the work is started-checks that the equipment is working properly

and, where required, calibration and adjustment of the equipment before each use

-the method of recording the observations and results

-any safety measures to be observedi. criteria and/or requirements for approval/rejectionj. data to be recorded and method of analysis and

presentationk. the uncertainty or the procedure for estimating

uncertainty. 5.4.5 Validation of methods5.4.5.1 Validation is the confirmation by examination

and the provision of objective evidence that the partlcular requirements for a specific intended use are fulfilled.

5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use.

Note 1: validation may include procedures for sampling, handling and transportation.

Note 2: the techniques used for the determination of the performance of a method should be one of, or a combination of the following:- calibration using reference standards or reference materials- comparison of results achieved with other methods

etalonarii. Metoda dezvoltata trebuie sa fi fost validata in mod corespunzator inainte de folosire.Nota: in cazul metodelor noi de incercare si/sau etalonare,

procedurile trebuie dezvoltate anterior lucrarilor si trebuie sa contina cel putin urmatoarele informatii:a. o identificare corespunzatoareb. obiectulc. descrierea tipului obiectului care trebuie incercat sau

etalonatd. parametrii sau marimile si intervalele care vor fi

determinatee. aparatele si echipamentele, inclusiv cerinte de

functionare tehnicaf. standardele de referinta si materialele de referinta

ceruteg. conditiile de mediu cerute si perioada de stabilizare

necesarah. descrierea procedurii, incluzand:- aplicarea de marcaje de identificare, manipularea, transportul, depozitarea si pregatirea obiectelor- verificarile ce trebuie efectuate inaintea inceperii lucrarii- verificarea ca echipamentele functioneaza corect si, unde se cere, etalonarea sau ajustarea echipamentului inainte de fiecare utilizare- metoda de inregistrare a observatiilor si rezultatelor- masurile de securitate care trebuie respectatei. criteriile si/sau cerintele de acceptare/respingerej. datele care se inregistreaza si metoda de analiza si

prezentarek. incertitudinea sau procedura de estimare a ei.

5.4.5 Validarea metodelor 5.4.5.1 Validarea este confirmarea prin examinare si furnizarea de dovezi obiective ca cerintele particulare cu privire la o utilizare specifica intentionata sunt toate indeplinite. 5.4.5.2. Laboratorul trebuie sa valideze metodele de incercare si/sau etalonare nestandardizate, metode dezvoltate/elaborate in laborator, metode standard utilizate in afara domeniului pentru care au fost proiectate, precum si amplificari si modificari de metode standard, pentru a confirma ca metodele sunt adecvate pentru utilizarea avuta in vedere. Validarea trebuie sa fie extinsa atat cat este necesar pentru a indeplini necesitatile aplicatiei sau domeniului de aplicare dat. Laboratorul trebuie sa inregistreze rezultatele obtinute, procedura folosita pentru validare si o declaratie daca metoda este potrivita sau nu pentru intentia de utilizare.Nota 1: validarea poate cuprinde proceduri de esantionare,

manuire si transport.Nota 2: tehnicile utilizate pentru determinarea functionarii unei

metode trebuie sa fie una dintre sau o combinatie intre urmatoarele:

- etalonare cu standarde de referinta sau materiale de referinta- comparare de rezultate obtinute prin alte metode- comparare intre laboratoare- evaluare sistematica a factorilor ce influenteaza rezultatul

- evaluare a incertitudinii rezultatelor pe baza intelegerii stiintifice a principiilor teoretice ale

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- inter-laboratory comparisons- systematic assessment of the factors influencing the result

- assessment of the uncertainly of the results based on scientific understanding of the theoretical principles of the method and practical experience.

Note 3: when some changes are made in the validated non-standard methods, the influence of such changes should be documented and, if appropriate, a new validation should be carried out.

5.4.5.3 The range and accuracy of the values obtainable from validated methods, e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross-sensitivity against interference from the matrix of the sample/test objects as assessed for the intended use, shall be relevant to the clients’ needs.Note 1: validation includes specification of the requirements,

determination of the characteristics of the methods, a check that the requirements can be fulfilled by using the method, and a statement on the validity.

Note 2: as method-development proceeds, regular review should be carried out to verify that the needs of the client are still being fulfilled. Any change in requirements requiring modifications to the development plan should be approved and authorized.

Note 3: validation is always a balance between costs, risks and technical possibilities. There are many cases in which the range and uncertainty of the values (e.g. accuracy, detection limit, selectivity, linearity, repeatability, reproducibility, robustness and cross-sensitivity) can only be given in a simplified way due to lack of information.

5.4.6 Estimation of uncertainty of measurement5.4.6.1 A calibration laboratory, or a testing laboratory

performing its own calibrations, shall have and apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations.

5.4.6.2 Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. In certain cases the nature of the test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these cases the laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data.Note 1: the degree of rigor needed in an estimation of

uncertainty of measurement depends on factors such as:- the requirements of the test method- the requirements of the client- the existence of narrow limits on which decisions on

conformance to a specification are based.Note 2: in those cases where a well-recognized test method

specifies limits to the values of the major sources of uncertainty of measurement and specifies the form

metodei si pe baza experientei practice.

Nota 3: cand se fac schimbari in metodele nestandardizate validate, influenta acestor schimbari trebuie documentata si, daca e cazul, efectuata o noua validare.

5.4.5.3 Domeniul si acuratetea valorilor ce pot fi obtinute prin metode validate, de ex. incertitudinea rezultatelor, limita de detectie, selectivitatea metodei, liniaritatea, limita de repetabilitate si/sau reproductibilatate, robustetea fata de influentele exterioare si/sau sensibilitatea incrucisata fata de interferenta din partea matricei obiectelor pentru esantion/testare asa cum s-a evaluat pentru utilizarea dorita, trebuie sa fie relevant pentru necesitatile clientului.Nota 1: validarea cuprinde specificarea cerintelor, determinarea

caracteristicilor metodelor, verificarea daca cerintele pot fi indeplinite cu ajutorul acelei metode, precum si o precizare in legatura cu validitatea.

Nota 2: pe masura progresului dezvoltarii de metoda vor fi necesare revizii regulate care sa verifice daca necesitatile clientului sunt inca indeplinite. Orice modificare a cerintelor legate de modificarea planului de dezvoltare va trebui aprobata si autorizata.

Nota 3: validarea este intotdeauna un echilibru intre costuri, riscuri si posibilitati tehnice. Exista numeroase cazuri in care intervalul si incertitudinea valorilor (de ex. precizia, limita de detectie, selectivitatea, liniaritatea, fidelitatea, reproductibilitatea, robustetea si finetea incrucisata) se pot da doar intr-o forma simplificata, din cauza lipsei de informatii.

5.4.6 Estimarea incertitudinii in masurare5.4.6.1 Un laborator de etalonare sau unul de incercare

care-si realizeaza singur etalonarile trebuie sa aiba si sa aplice o procedura de estimare a incertitudinii masurarii pentru toate etalonarile si tipurile de etalonari. 5.4.6.2 Laboratoarele de incercare vor detine si aplica proceduri de estimare a incertitudinii in masurare. In anumite cazuri, natura metodei de incercare poate exclude o calculare riguroasa, valida din punct de vedere metrologic si statistic, a incertitudinii. In aceste cazuri laboratorul va incerca macar sa identifice toate componentele incertitudinii si sa realizeze o estimare rezonabila, precum si sa se asigure ca forma de prezentare a rezultatului nu da o impresie gresita despre incertitudine. O estimare rezonabila se va axa pe cunoasterea performantelor metodei precum si pe campul masurarii si va folosi, spre ex, experienta anterioara si datele cu privire la validare.

Nota 1: gradul de rigoare necesar la estimarea incertitudinii in masurare depinde de factori precum:

- cerintele metodei de incercare- cerintele clientului- existenta unor limite inguste pe care se

fundamenteaza deciziile asupra conformitatii la o specificatie.

Nota 2: in cazurile in care o metoda de incercare recunoscuta specifica limite pentru valorile surselor majore de incertitudine in masurare, precum si

forma de prezentare a rezultatelor calculate, se considera ca laboratorul a satisfacut aceasta clauza prin respectarea metodei de incercare si prezentarea instructiunilor (vezi 5.10).

5.4.6.3 Cand se estimeaza incertitudinea trebuie luate in considerare toate componentele incertitudinii care sunt

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of presentation of calculated results, the laboratory is considered to have satisfied this clause by following the test method and reporting instructions (see 5.10).5.4.6.3 When estimating the uncertainty of

measurement, all uncertainty components which are of importance in the given situation shall be taken into account using appropriate methods of analysis.Note 1: sources contributing to the uncertainty include, but are

not necessarily limited to, the reference standards and reference materials used, methods and equipment used, environmental conditions, properties and condition of the item being tested or calibrated, and the operator.

Note 2: the predicted long-term behaviour of the tested and/or calibrated item is not normally taken into account when estimating the measurement uncertainty.

Note 3: for further information, see ISO 5725 and the Guide to the Expression of Uncertainty in Measurement (see bibliography).5.4.7 Control of data5.4.7.1 Calculations and data transfers shall be subject

to appropriate checks in a systematic manner.5.4.7.2 When computers or automated equipment are

used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that:a. computer software developed by the user is documented in

sufficient detail and is suitably validated as being adequate for use

b. procedures are established and implemented for protecting the data; such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing

c. computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.

Note: commercial off-the-shelf software (e.g. word processing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/ modifications should be validated as in 5.4.7.2 a).

5.5 EQUIPMENT5.5.1 The laboratory shall be furnished with all items

of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data). In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.

5.5.2 Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned. Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results. Before

being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications. It shall be checked

importante in situatia data, folosindu-se metode acceptate de analiza.Nota 1: sursele contribuind la incertitudine cuprind, dar nu sunt

limitate neaparat la standardele de referinta si materialele de referinta folosite, la metodele si echipamentele utilizate, la conditiile de mediu, la proprietatile si starea obiectului incercat sau etalonat sau la operator.

Nota 2: comportarea prezisa pe termen lung a obiectului incercat si/sau etalonat nu este in mod normal luata in considerare atunci cand se estimeaza incertitudinea masurarii.

Nota 3: pentru informatii suplimentare, vezi ISO 5725 si "Ghidul de exprimare a incertitudinii in masurare" (vezi bibliografia).

5.4.7 Controlul datelor 5.4.7.1 Calculele si transferul de date trebuie sa fie supuse unor verificari corespunzatoare, in mod sistematic. 5.4.7.2 Daca se folosesc calculatoare sau echipament automat pentru achizitia, procesarea, inregistrarea, prezentarea, stocarea sau recuperarea datelor de incercare sau etalonare, laboratorul trebuie sa se asigure ca:a. soft-ul calculatorului dezvoltat de utilizator este documentat

suficient de detaliat si validat corespunzator ca fiind adecvat pentru utilizare

b. sunt stabilite si implementate proceduri pentru protectia datelor; aceste proceduri trebuie sa cuprinda, fara insa a se limita la acestea, integritatea si caracterul confidential ale intrarii sau colectarii de date, stocarea de date, transmisia de date si procesarea de date

c. calculatoarele si echipamentul automat trebuie intretinute, pentru a se asigura functionarea corecta si ca dispun de conditiile de functionare si de mediu necesare mentinerii integritatii datelor de incercare si etalonare.

Nota: softurile comerciale neoficiale (de ex. de procesare texte, baze de date si programe de statistica), pentru o utilizare generala in cadrul intervalului proiectat de aplicare, pot fi considerate ca fiind suficient validate. Totusi, modificarile/configuratiile soft-urilor de laborator trebuie validate conform cu 5.4.7.2 a).

5.5 ECHIPAMENTUL 5.5.1 Laboratorul trebuie sa fie dotat cu toate echipamentele de prelevare, masurare si incercare cerute pentru efectuarea corecta a incercarilor si/sau etalonarilor (inclusiv prelevarea, pregatirea obiectelor de incercare si/sau etalonare, procesare si analiza datelor de incercare si/sau etalonare). In cazurile in care laboratorul trebuie sa utilizeze echipament din afara controlului sau permanent, el trebuie sa se asigure ca sunt indeplinite cerintele prezentului Standard. 5.5.2 Echipamentul si soft-ul sau, utilizat pentru incercare, etalonare si prelevare trebuie sa fie capabil sa obtina exactitatea ceruta si sa fie conform cu specificatiile relevante pentru incercarile si/sau etalonarile respective. Trebuie sa se intocmeasca programe de etalonare pentru marimile sau valorile -cheie ale instrumentelor atunci cand aceste proprietati au un efect semnificativ asupra

rezultatelor. Inainte de plasarea in serviciu, echipamentul (inclusiv cel de prelevare), trebuie etalonat sau verificat pentru a se stabili daca indeplineste cerintele din specificatiile laboratorului si se conformeaza specificatiilor standardelor relevante. El va fi verificat si/sau etalonat inainte de utilizare (vezi 5.6). 5.5.3 Echipamentul trebuie operat de catre personal 18

and/or calibrated before use (see 5.6).

5.5.3 Equipment shall be operated by authorized personnel. Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use by the appropriate laboratory personnel.

5.5.4 Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified.

5.5.5 Records shall be maintained of each item of equipment and its software significant to the tests and/or calibrations performed. The records shall include at least the following:a. the identity of the item of equipment and its softwareb. the manufacturer's name, type identification, and serial

number or other unique identificationc. checks that the equipment complies with the specification

(see 5.5.2)d. the current location, where appropriatee. the manufacturer's instructions, if available, or reference to

their location

f. dates, results and copies of reports and certificates of all calibrations, adjustments, acceptable criteria, and the due date of next calibration

g. the maintenance plan, where appropriate, and maintenance carried out to date

h. any damage, malfunction, modification or repair to the equipment.

5.5.6 The laboratory shall have procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.

Note: additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests, calibrations or sampling.

5.5.7 Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service. It shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly. The laboratory shall examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and shall institute the "Control of non-conforming work" procedure (see 4.9).

5.5.8 Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when re-calibration is due.

5.5.9 When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory

shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.

5.5.10 When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined

autorizat. Instructiunile actualizate de utilizare si intretinere a echipamentului (inclusiv orice manuale relevante furnizate de fabricant) trebuie sa fie usor accesibile pentru utilizare de catre personalul corespunzator din laborator.

5.5.4 Fiecare echipament si soft-ul sau, utilizat pentru incercare si etalonare si semnificativ pentru rezultat trebuie sa fie, dupa caz, unic identificat. 5.5.5 Trebuie pastrate inregistrari pentru fiecare echipament in parte si soft-ul sau (semnificative pentru incercarile si/sau etalonarile efectuate). Inregistrarile vor contine cel putin urmatoarele:a. identificarea echipamentului si soft-ului saub. numele fabricantului, identificarea tipului si nr de serie sau

alta identificare unica

c. verificarea daca echipamentul satisface specificatia (vezi 5.5.2)

d. amplasarea curenta, unde este cazule. instructiunile fabricantului, daca sunt disponibile, sau o

referire despre unde pot fi gasitef. date, rezultate si copii ale rapoartelor si certificatelor

tuturor etalonarilor, reglarilor, criterii acceptabile si data corespunzatoare a urmatoarei etalonari

g. planul de intretinere, unde este cazul, si mentenanta efectuata pana la data respectiva

h. defectari, functionari defectuase, modificari sau reparatii ale echipamentului.

5.5.6 Laboratorul va detine proceduri de manuire, transport, depozitare, utilizare si intretinere planificata sigure pentru echipamentul de masurare pentru a asigura functionarea corespunzatoare si a evita contaminarea sau deteriorarea. Nota: ar putea fi necesare proceduri suplimentare atunci cand

echipamentul este utilizat in afara incintei permanente a laboratorului pentru incercari, etalonari sau prelevari.

5.5.7 Echipamentul care a fost supus la suprasarcini sau manipulare gresita, care da rezultate suspecte sau despre care s-a constat la verificari ca este defect sau iese din limitele specificate, trebuie scos din serviciu. Aceste echipamente vor fi izolate pentru a nu fi folosite sau etichetate ori marcate in mod clar ca nefiind disponibile, pana cand sunt reparate si se demonstreza prin etalonare sau incercare ca functioneaza corect. Laboratorul va examina efectul la nivelul defectarii sau abaterii de la limitele specificate la incercarile si/sau etalonarile anterioare si va institui procedura denumita ”Controlul lucrarilor neconforme”(vezi 4.9). 5.5.8 Intotdeauna cand este posibil, toate echipamentele tinute sub control de laborator si necesitand etalonare vor fi etichetate, codate sau altfel identificate pentru a indica situatia etalonarii, inclusiv data ultimei etalonari precum si data sau conditiile expirarii, atunci cand se impune re-etalonarea. 5.5.9 Cand, indiferent din ce motiv, echipamentul iese de sub controlul direct al laboratorului, acesta trebuie sa se

asigure ca functionarea si situatia etalonarii echipamentului sunt verificate si se arata a fi satisfacatoare, inainte ca echipamentul sa se reintoarca in serviciu. 5.5.10 Cand sunt necesare verificari intermediare pentru a se mentine increderea in starea de etalonare a echipamentului, acestea vor fi efectuate conform unei proceduri definite. 5.5.11 Cand etalonarile conduc la aparitia unui set de factori de corectie, laboratorul trebuie sa aiba proceduri pentru a asigura ca orice copie (de ex. in calculator) este corect actualizata.

5.5.12 Echipamentul de incercare si etalonare, 19

procedure. 5.5.11 Where calibrations give rise to a set of

correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.

5.5.12 Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results.

5.6 MEASUREMENT TRACEABILITY5.6.1 General All equipment used for tests and/or calibrations,

including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test, calibration or sampling shall be calibrated before being put into service. The laboratory shall have an established programme and procedure for the calibration of its equipment. Note: such a programme should include a system for selecting,

using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform tests and calibrations.

5.6.2 Specific requirements 5.6.2.1 Calibration 5.6.2.1.1 For calibration laboratories, the programme

for calibration of equipment shall be designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (Sl) (Systeme intemational d’unites).

A calibration laboratory establishes traceability of its own measurement standards and measuring instruments to the Sl by means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards of the Sl units of measurement. The link to Sl units may be achieved by reference to national measurement standards. National measurement standards may be primary standards, which are primary realizations of the Sl units or agreed representations of Sl units based on fundamental physical constants, or they may be secondary standards which are standards calibrated by another national metrology institute. When using external calibration services, traceability of measurement shall be assured by the use of calibration services from laboratories that can demonstrate competence, measurement capability and traceability. The calibration certificates issued by these laboratories shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification (see also 5.10.4.2). Note 1: calibration laboratories fulfilling the requirements of

this International Standard are considered to be competent. A calibration certificate bearing an

accreditation body logo from a calibration Iaboratory accredited to this International Standard, for the calibration concerned, is sufficient evidence of traceability of the calibration data reported.

Note 2: traceability to Sl units of measurement may be achieved by reference to an appropriate primary standard (see VIM: 1993, 6.4) or by reference to a natural constant, the value of which in terms of the relevant Sl unit is

incluzand atat hard cat si soft, trebuie aparat de reglaje ce ar putea invalida rezultatele incercarii si/sau etalonarii.

5.6 TRASABILITATEA MASURARII 5.6.1 Generalitati

Toate echipamentele folosite pentru incercari si/sau etalonari, inclusiv cel pentru masurari subsidiare (de ex. pentru conditiile de mediu), si care au un efect semnificativ asupra acuratetii sau validitatii rezultatului incercarii, etalonarii sau esantionarii trebuie etalonate inainte de a fi plasate in serviciu. Laboratorul trebuie sa aiba stabilite un program si o procedura de etalonare a echipamentului sau.Nota: un astfel de program trebuie sa cuprinda un sistem pentru

selectarea, utilizarea, etalonarea, verificarea, controlarea si mentinerea etaloanelor, a celor de referinta ca si a etaloanelor si a echipamentului de masurare si incercare utilizat la efectuarea incercarilor si etalonarilor.

5.6.2 Cerinte specifice 5.6.2.1 Etalonarea 5.6.2.1.1 Pentru laboratoarele de etalonare, programul de etalonare a echipamentului trebuie conceput si derulat astfel incat sa asigure ca etalonarile si masurarile efectuate de laborator sunt trasabile la Sistemul International de Unitati (SI). Un laborator de etalonare stabileste trasabilitatea la SI a etaloanelor si aparatelor de masura proprii prin intermediul unui lant neintrerupt de etalonari sau comparatii care le leaga de etaloanele primare relevante ale unitatilor de masura SI. Legatura cu unitatile SI poate fi obtinuta prin referinta la etaloanele nationale. Acestea pot fi etaloane primare, adica realizari primare ale unitatilor SI sau reprezentari prin conventie ale acestor unitati, pe baza unor constante fizice fundamentale, sau etaloane secundare, adica etaloane etalonate la randul lor de un alt institut national de metrologie. In cazul utilizarii serviciilor externe de etalonare, trasabilitatea masurarii se va asigura cu ajutorul serviciilor de etalonare din partea unor laboratoare care pot sa-si demonstreze competenta, capabilitatile de masurare si trasabilitatea. Certificatele de etalonare emise de aceste laboratoare trebuie sa contina rezultatele masurarilor, inclusiv incertitudinea de masurare si/sau o declaratie a acordului cu o specificatie metrologica identificata (vezi de asemeni 5.10.4.2.).

Nota 1: laboratoarele de etalonare care indeplinesc cerintele acestui Standard sunt considerate a fi competente. Un certificat de etalonare purtand marca unui organism de acreditare, emis de un laborator de

etalonare acreditat in raport acest Standard International, pentru etalonarea in discutie, reprezinta o garantie suficienta a trasabilitatii datelor de etalonare prezentate.

Nota 2: trasabilitatea la unitatile de masura SI se poate obtine prin referinta la un etalon primar potrivit (vezi VIM: 1993, 6.4.) sau prin referinta la o constanta universala a carei valoare, in termenii unitatilor relevante SI, este cunoscuta si recomandata de Conferinta Generala pentru Greutati si Masurari (CGGM) si Comitetul International pentru Masuri si Greutati (CIPM).

Nota 3: laboratoarele de etalonare care-si mentin propriul etalon primar sau reprezentare a unitatilor SI pe baza unor constante fizice fundamentale pot pretinde trasabilitate

20

known and recommended by the General Conference of Weights and Measures (CGPM) and the International Committee for Weights and Measures (CIPM).

Note 3: calibration laboratories that maintain their own primary standard or representation of Sl units based on fundamental physical constants can claim traceability to the Sl system only after these standards have been compared, directly or indirectly, with other similar standards of a national metrology institute.

Note 4: the term "identified metrological specification" means that it must be clear from the calibration certificate which specification the measurements have been compared with, by including the specification or by giving an unambiguous reference to the specification.

Note 5: when the terms "International standard" or "national standard" are used in connection with traceability, it is assumed that these standards fulfil the properties of primary standards for the realization of Sl units.

Note 6: traceability to national measurement standards does not necessarily requires the use of the national metrology institute of the country in which the laboratory is located.

Note 7: if a calibration laboratory wishes or needs to obtain traceability from a national metrology institute other than in its own country, this laboratory should select a national metrology institute that actively participates in the activities of BIPM either directly or through regional groups.

Note 8: the unbroken chain of calibrations or comparisons may be achieved in several steps carried out by different laboratories that can demonstrate traceability.

5.6.2.1.2 There are certain calibrations that currently cannot be strictly made in Sl units. In these cases calibration shall provide confidence in measurements by establishing traceability to appropriate measurement standards such as: - the use of certified reference materials provided by a

competent supplier to give a reliable physical or chemical characterization of a material

- the use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned.

Participation in a suitable programme of inter-laboratory comparisons is required where possible.

5.6.2.2 Testing 5.6.2.2.1 For testing laboratories, the requirements

given in 5.6.2.1 apply for measuring and test equipment with measuring functions used unless it has been established that the associated contribution from the calibration contributes little to the total uncertainty of the test result. When this situation arises, the laboratory shall ensure that the equipment used can provide the uncertainty of measurement needed. Note: the extent to which the requirements in 5.6.2.1 should be

followed depends on the relative contribution of the calibration uncertainty to the total uncertainty. If calibration is the dominant factor, the requirements should be strictly followed. 5.6.2.2.2 Where traceability of measurements to Sl

units is not possible and/or not relevant, the same requirements

la sistemul SI numai dupa ce aceste etaloane au fost comparate, direct sau indirect, cu alte etaloane asemanatoare ale unui institut national de metrologie.

Nota 4: termenul “specificatie metrologica identificata” inseamna ca trebuie sa reiasa clar din certificatul de etalonare cu ce specificatie au fost comparate masurarile, prin includerea specificatiei sau prin acordarea unei referinte neambigue la specificatie.

Nota 5: cand termenii “etalon international” sau “etalon national” sunt folositi in legatura cu trasabilitatea, se presupune ca aceste etaloane indeplinesc proprietatile etaloanelor primare pentru realizarea unitatilor SI.

Nota 6: trasabilitatea la etaloanele nationale nu necesita in mod necesar folosirea institutului national de metrologie al tarii in care se afla laboratorul.

Nota 7: daca un laborator de etalonare doreste sau are nevoie de trasabilitate de la un institut national de metrologie, altul decat cel din tara in care se afla, el trebuie sa aleaga un institut care participa in mod activ la activitatile BIPM fie direct, fie prin grupuri regionale.

Nota 8: lantul neintrerupt de etalonari sau comparatii se poate obtine in mai multe etape efectuate de laboratoare diferita care-si pot demonstra trasabilitatea.

5.6.2.1.2 Exista unele etalonari ce nu se pot realiza in mod curent strict in unitati SI. In aceste cazuri etalonarea va furniza incredere in masurari prin stabilirea trasabilitatii la etaloane adecvate precum:

- utilizarea materialelor de referinta certificate asigurate de un furnizor competent pentru a oferi o caracterizare de incredere a materialului, din punct de vedere fizic si chimic

- utilizarea de metode specificate si/sau etaloane prin consens care sunt descrise si intelese in mod clar la fel de catre toate partile implicate.

Participarea la un program corespunzator de comparatii inter-laboratoare este necesara acolo unde este posibila.

5.6.2.2 Incercarea 5.6.2.2.1 Pentru laboratoarele de incercare, cerintele cuprinse in 5.6.2.1. se aplica pentru echipamentul de masurare si incercare cu functiile de masurare utilizate, cu exceptia cazului in care s-a stabilit ca incertitudinea de masurare asociata etalonarii contribuie foarte putin la incertitudinea totala a rezultatului incercarii. Cand apare aceasta situatie, laboratorul se va asigura ca echipamentul folosit poate asigura incertitudinea de masurare necesara.Nota: masura in care trebuie urmate cerintele 5.6.2.1. depinde

de contributia relativa a incertitudinii etalonarii, in incertitudinea totala. Daca etalonarea este un factor dominant, cerintele trebuie sa fie strict respectate.

5.6.2.2.2 Daca trasabilitatea masurarilor nu este posibila si/sau relevanta la unitatile SI, atunci trebuie aplicate aceleasi cerinte de trasabilitate la, de ex, materiale de referinta certificate, aceleasi metode in consens si/sau etaloane de consens ca pentru laboratoarele de etalonare (vezi 5.6.2.12).

5.6.3 Etaloane de referinta si materiale de referinta5.6.3.1 Etaloane de referinta

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for traceability to, for example, certified reference materials, agreed methods and/or consensus standards are required as for calibration laboratories (see 5.6.2.12).

5.6.3 Reference standards and reference materials 5.6.3.1 Reference standards The laboratory shall have a programme and procedure

for the calibration of its reference standards. Reference standards shall be calibrated by a body that can provide traceability as described in 5.6.2.1. Such reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated. Reference standards shall be calibrated before and after any adjustment.

5.6.3.2 Reference materials Reference materials shall, where possible, be traceable

to Sl units of measurement, or to certified reference materials. Internal reference materials shall be checked as far as is technically and economically practicable.

5.6.3.3 Intermediate checks Checks needed to maintain confidence in the

calibration status of reference, primary, transfer or working standards and reference materials shall be carried out according to defined procedures and schedules.

5.6.3.4 Transport and storage The laboratory shall have procedures for safe handling,

transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity. Note: additional procedures may be necessary when reference

standards and reference materials are used outside the permanent laboratory for tests, calibrations or sampling.

5.7 SAMPLING5.7.1 The laboratory shall have a sampling plan and

procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken. Sampling plans shall, whenever reasonable, be based on appropriate statistical methods. The sampling process shall address the factors to be controlled to ensure

the validity of the test and calibration results.

Note 1: sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of a representative sample of the whole. Sampling may also be required by the appropriate specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis), the sample may not be representative but is determined by availability.

Note 2: sampling procedures should describe the selection, sampling plan, withdrawal and preparation of a sample or samples from a substance, material or product to yield the required information.

5.7.2 Where the client requires deviations, additions or exclusions from the documented sampling procedure, these

Laboratorul trebuie sa aiba un program si o procedura pentru etalonarea etaloanelor sale de referinta. Etaloanele de referinta de masura trebuie etalonate de catre un organism care poate asigura trasabilitatea, conform cu 5.6.2.1. Astfel de etaloane de referinta detinute de laborator trebuie sa fie utilizate numai pentru etalonare si nu in alte scopuri, in afara cazului in care se poate demonstra ca performanta lor ca etaloane de referinta nu va fi invalidata. Aceste etaloane vor fi etalonate inainte si dupa orice reglaj.

5.6.3.2 Materiale de referintaMaterialele de referinta trebuie, atunci cand este posibil,

sa fie trasabile la unitati SI sau la materialele de referinta certificate. Materialele de referinta interne trebuie verificate pe cat este posibil, tehnic si economic vorbind.

5.6.3.3 Verificari intermediare Verificarile necesare mentinerii increderii in situatia de etalonare a etaloanelor de referinta, primare, de transfer sau de lucru si a materialelor de referinta vor fi realizate in conformitate cu planificarile si procedurile definite.

5.6.3.4 Transport si depozitare Laboratorul trebuie sa aiba proceduri pentru siguranta manipularii, transportului, depozitarii si utilizarii etaloanelor de referinta si materialelor de referinta, pentru a preveni contaminarea sau deteriorarea acestora in scopul protectiei integritatii lor.Nota: pot fi necesare proceduri suplimentare atunci cand

etaloanele de referinta si materialele de referinta sunt folosite in afara incintei permanente a laboratorului pentru incercari, etalonari sau prelevari.

5.7 ESANTIONAREA/PRELEVAREA 5.7.1 Laboratorul trebuie sa aiba un plan si proceduri de esantionare atunci cand efectueaza prelevarea de substante, materiale sau produse in scopul incercarii sau etalonarii ulterioare. Planul si procedura de esantionare trebuie sa fie disponibile in locul in care se desfasoara esantionarea. Planurile de esantionare se vor baza, acolo unde este cazul, pe metode statistice corespunzatoare. Procesul de esantionare va tine cont de factorii care trebuie

controlati pentru a se asigura validitatea rezultatelor de incercare si etalonare. Nota 1: prelevarea este o procedura definita prin care o parte

dintr-o substanta, material sau produs este luata pentru a asigura incercarea sau etalonarea unui esantion reprezentativ pentru intreg. Esantionarea poate fi de asemeni solicitata de specificatii corespunzatoare conform carora trebuie sa fie etalonate sau incercate substanta, materialul sau produsul. In anumite cazuri (ca de ex. analizele medico-legale, esantionul ar putea sa nu fie reprezentativ, fiind determinat insa prin disponibilitate.

Nota 2: procedurile de esantionare trebuie sa prezinte selectarea, planul de prelevare, retragerea si pregatirea unui esantion/esantioane dintr-o substanta, material sau produs, in scopul de a se obtine informatiile cerute.

5.7.2 Cand clientul impune abateri, adaugiri sau omisiuni din procedura de esantionare documentata, acestea trebuie inregistrate in detaliu, cu datele corespunzatoare de esantionare, fiind incluse in toate documentele continand rezultatele incercarii si/sau etalonarii si communicate personalului corespunzator.

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shall be recorded in detail with the appropriate sampling data and shall be included in all documents containing the test and/or calibration results, and shall be communicated to the appropriate personnel.

5.7.3 The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken. These records shall include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

5.8 HANDLING OF TEST AND CALIBRATION ITEMS

5.8.1 The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the client.

5.8.2 The laboratory shall have a system for identifying test and/or calibration items. The identification shall be retained throughout the life of the item in the laboratory. The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents. The system shall, If appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory.

5.8.3 Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded. When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the client for further instructions before proceeding and shall record the discussion.

5.8.4 The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage,

handling and preparation. Handling instructions provided with the item shall be followed. When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded. Where a test or calibration item or a portion of an item is to be held secure, the laboratory shall have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.

Note 1: where test items are to be returned into service after testing, special care is required to ensure that they are not damaged or injured during the handling, testing or storing/waiting processes.

Note 2: a sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, should be provided by those responsible for taking and transporting the samples.

Note 3: reasons for keeping a test or calibration item secure can be for reasons of record, safety or value, or to enable

5.7.3 Laboratorul trebuie sa aiba proceduri pentru inregistrarea datelor relevante si a operatiilor legate de esantionare parte a incercarii sau etalonarii efectuate. Aceste inregistrari vor cuprinde procedura de esantionare folosita, identificarea celui care preleveaza, conditiile de mediu (daca sunt relevante), precum si schite sau alte modalitati echivalente destinate identificarii locatiei esantionarii daca este necesar si, daca e cazul, statisticile pe care se axeaza procedurile de prelevare.

5.8 MANIPULAREA OBIECTELOR DE INCERCARE SI ETALONARE

5.8.1 Laboratorul trebuie sa aiba proceduri pentru transportul, primirea, manipularea, protectia, depozitarea, retinerea sau eliberarea obiectelor de incercare si/sau etalonare, inclusiv toate prevederile necesare protejarii integritatii obiectelor destinate incercarii sau etalonarii, precum si a intereselor laboratorului si clientului. 5.8.2 Laboratorul trebuie sa aiba un sistem de identificare a obiectelor de incercare si/sau etalonare. Identificarea trebuie pastrata pe toata durata existentei obiectului in laborator. Sistemul trebuie conceput si aplicat astfel incat sa asigure ca obiectul nu poate fi confundat fizic sau in referintele din inregistrari sau alte documente. Sistemul, daca este cazul, va organiza o subdiviziune de grupuri de obiecte si transferul obiectelor in si din laborator. 5.8.3 La receptia obiectului de incercare sau etalonare trebuie sa fie inregistrate orice anormalitate sau abatere de la conditiile normale sau specificate descrise in metoda de incercare si/sau etalonare. Atunci cand exista dubii cu privire la adecvarea unui obiect pentru incercare sau etalonare, sau atunci cand un obiect nu este conform cu descrierea furnizata, sau cand incercarea sau etalonarea cerute nu sunt specificate in suficiente detalii, laboratorul trebuie sa consulte clientul pentru alte instructiuni inainte de a actiona si sa inregistreze rezultatul discutiei. 5.8.4 Laboratorul trebuie sa aiba proceduri si amenajari corespunzatoare pentru a evita deteriorarea, pierderea sau defectarea obiectelor de incercare sau

etalonare in timpul depozitarii, manipularii si pregatirii. Trebuie urmate instructiunile de manipulare primite odata cu obiectul. Atunci cand obiectele trebuie depozitate sau restranse la conditii de mediu specificate, aceste conditii trebuie mentinute, monitorizate si inregistrate. Cand un obiect de incercare sau etalonare sau o portiune a acestuia trebuie pastrate in siguranta, laboratorul trebuie sa dispuna de aranjamente pentru depozitare si securitate, care sa protejeze starea si integritatea obiectelor sau partilor in discutie.Nota 1: cand obiectele pentru incercare trebuie sa se intoarca

imediat in serviciu se cere atentie ca sa nu se strice sau sa fie afectate in timpul manipularii, incercarii sau proceselor de depozitare/asteptare.

Nota 2: o procedura de esantionare, precum si informatiile despre depozitarea si transportul esantioanelor, inclusiv date cu privire la factorii de esantionare cu influenta asupra rezultatului incercarii sau etalonarii, toate acestea trebuie furnizate de cei responsabili cu preluarea si transportarea esantioanelor.

Nota 3: motivele pentru a securiza un obiect de incercare sau etalonare pot fi legate de inregistrare, siguranta sau valoare, sau pentru a se permite efectuarea ulterioara a unor incercari si/sau etalonari complementare.

5.9 ASIGURAREA CALITATII REZULTATELOR DE 23

complementary tests and/or calibrations to be performed later.

5.9 ASSURING THE QUALITY OF TEST AND CALIBRATION RESULTS

The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following: a. regular use of certified reference materials and/or internal

quality control using secondary reference materialsb. participation in inter-laboratory comparison or proficiency-

testing programmesc. replicate tests or calibrations using the same or different

methodsd. re-testing or re-calibration of retained itemse. correlation of results for different characteristics of an item. Note: the selected methods should be appropriate for the type

and volume of the work undertaken.

5.10 REPORTING THE RESULTS 5.10.1 General The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.

The results shall be reported, usually in a test report or a calibration certificate (see note 1), and shall include all the information requested by the client and necessary for the interpretation of the test or calibration and all information required by the method used. This information is normally that required by 5.10.2 and 5.10.3 or 5.10.4.

In the case of tests or calibrations performed for internal clients, or in the case of a written agreement with the client, the results may be reported in a simplified way. Any information listed in 5.10.2 to 5.10.4 which is not reported to the client shall be readily available in the laboratory which carried out the tests and/or calibrations. Note 1: test reports and calibration certificates are sometimes

called test certificates and calibration reports, respectively.

Note 2: the test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met.

5.10.2 Test reports and calibration certificatesEach test report or calibration certificate shall include

at least the following information, unless the laboratory has valid reasons for not doing so:

a. a title (e.g. "Test Report" or "Calibration Certificate")b. the name and address of the laboratory, and the location

where the tests and/or calibrations were carried out, if different from the address of the laboratory

c. unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a

INCERCARE SI ETALONARE Laboratorul trebuie sa detina proceduri de control al calitatii pentru a monitoriza validitatea incercarilor si etalonarilor efectuate. Datele ce rezulta vor fi inregistrate astfel incat eventualele tendinte sa fie detectabile si, unde se poate, la revizuirea rezultatelor vor fi aplicate tehnici statistice. Monitorizarea va fi planificata si revizuita si poate include, fara a se limita insa la, urmatoarele:

a. utilizarea regulata de materiale de referinta certificate si/sau controlul intern al calitatii folosindu-se materiale de referinta secundare

b. participarea la programe de comparatii interlaboratoare sau de testare a competentei

c. repetarea incercarilor sau etalonarilor, folosind aceleasi metode sau metode diferite

d. re-incercarea sau re-etalonarea obiectelor retinutee. corelarea rezultatelor pentru diferite caracteristici ale unui

obiect.Nota: metodele alese trebuie sa fie corespunzatoare tipului si

volumului lucrarilor efectuate.

5.10 PREZENTAREA REZULTATELOR 5.10.1 Generalitati Rezultatele fiecarei incercari, etalonari sau serii de incercari sau etalonari efectuate de laborator trebuie prezentate precis, clar, neambiguu si obiectiv, in conformitate cu oricare instructiuni specifice ale metodelor de incercare si etalonare.

Rezultatele vor fi communicate de obicei intr-un raport de incercare sau un certificat de etalonare (vezi nota 1) si trebuie sa includa toate informatiile solicitate de client si necesare pentru interpretarea incercarii sau etalonarii, precum si toate informatiile cerute de metoda folosita. Aceste informatii sunt in mod normal cele cerute de 5.10.2 si 5.10.3 sau 5.10.4.

In situatia in care incercarile sau etalonarile se executa pentru clienti interni, sau in cazul unei intelegeri scrise cu clientul, rezultatele pot fi prezentate in mod simplificat. Informatia de la 5.10.2-5.10.4 neprezentata clientului, trebuie sa fie usor disponibila in laboratorul care a realizat incercarile si/sau etalonarile.Nota 1: rapoartele de incercare sau certificatele de etalonare

sunt uneori denumite certificate de incercare, respectiv rapoarte de etalonare.

Nota 2: rapoartele de incercare sau certificatele de etalonare pot fi eliberate ca “hard copy” sau prin transfer electronic de date, cu conditia respectarii cerintelor acestui Standard International.

5.10.2 Rapoarte de incercare si certificate de etalonare Fiecare raport de incecare sau certificat de etalonare trebuie sa cuprinda cel putin urmatoarele informatii, cu exceptia cazului in care laboratorul are motive valide sa nu procedeze astfel:a. un titlu (de ex. ”raport de incercare” sau “certificat de

etalonare”)b. numele si adresa laboratorului si locul de desfasurare,

atunci cand incercarile si/sau etalonarile se efectueaza in alta parte decat la adresa laboratorului

c. identificarea unica a raportului de incercare sau a certificatului de etalonare (cum ar fi seria) si, pe fiecare pagina, o identificare care sa ateste faptul ca pagina e recunoscuta ca parte a raportului sau certificatului, precum si o identificare clara a finalului documentului

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clear identification of the end of the test report or calibration certificate

d. the name and address of the cliente. identification of the method usedf. a description of, the condition of, and unambiguous

identification of the item(s) tested or calibratedg. the date of receipt of the test or calibration item(s) where

this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration

h. reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results

i. the test or calibration results with, where appropriate, the units of measurement

j. the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate

k. where relevant, a statement to the effect that the results relate only to the items tested or calibrated.

Note 1: hard copies of test reports and calibration certificates should also include the page number and total number of pages.

Note 2: it is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory.

5.10.3 Test reports5.10.3.1 In addition to the requirements listed in 5.10.2,

test reports shall, where necessary for the interpretation of the test results, include the following:

a. deviations from, additions to, or exclusions from the test method, and information on specific test conditions,

such as environmental conditionsb. where relevant, a statement of compliance/non-compliance

with reqirements and/or specificationsc. where applicable, a statement on the estimated uncertainty

of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a client's instruction so requires, or when the uncertainty affects compliance to a specification limit

d. where appropriate and needed, opinions and interpretations (see 5.10.5)

e. additional information which may be required by specific methods, clients or groups of clients.

5.10.3.2 In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results sampling shall include the following, where necessary for the interpretation of test results:a. the date of samplingb. unambiguous identification of the substance, material or

product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate)

c. the location of sampling, including any diagrams, sketches or photographs

d. a reference to the sampling plan and procedures usede. details of any environmental conditions during sampling

that may affect the interpretation of the test results

d. numele si adresa clientuluie. identificarea metodei utilizatef. descierea, situatia si identificarea neambigua a obiectului

(obiectelor) incercat(e) sau etalonat(e)g. data primirii obiectului (obiectelor) de incercat sau etalonat

- acolo unde aspectul este esential pentru validitatea si aplicarea rezultatelor, precum si data (datele) efectuarii incercarii sau etalonarii

h. referire la planul de esantionare si la procedurile folosite de laborator sau de alte organisme, daca acestea au relevanta pentru validitatea sau utilizarea rezultatelor

i. rezultatele de incercare sau etalonare cu (unde este cazul) unitatile de masura

j. numele, titlul (titlurile) si semnatura (semnaturile) sau o identificare echivalenta a persoanei (persoanelor) care autorizeaza raportul de incercare sau certificatul de etalonare

k. daca este cazul, o declaratie privind faptul ca rezultatele se refera numai la obiectele incercate sau etalonate.

Nota 1: copiile hard ale rapoartelor de incercare si certificatelor de etalonare trebuie sa cuprinda de asemenea nr paginii si nr total al paginilor.

Nota 2: li se recomanda laboratoarelor sa includa o declaratie specificand faptul ca raportul de incercare sau certificatul de etalonare nu trebuie reproduse, decat in totalitate, fara aprobarea scrisa a laboratorului.

5.10.3 Rapoartele de incercari 5.10.3.1 Pe langa cerintele de la 5.10.2, rapoartele de incercare vor cuprinde, acolo unde este necesar pentru interpretarea rezultatelor incercarii, sa cuprinda urmatoarele:a. abaterile, suplimentarile sau omisiunile din metoda de

incercare si informatii despre conditiile specifice de

incercare, cum ar fi conditiile de mediub. unde este relevant, o declaratie de

conformitate/neconformitate cu cerintele si/sau specificatiile

c. unde se aplica, o declaratie asupra incertitudinii estimate a masurarii; informatiile despre incertitudine sunt necesare in rapoartele de incercari cand sunt relevante pentru validarea sau utilitatea rezultatelor incercarii, cand o cere o instructiune a clientului sau cand incertitudinea afecteaza conformitatea cu o limita specificata

d. unde este potrivit si necesar, opinii si interpretari (vezi 5.10.5)

e. informatii suplimentare ce ar putea fi cerute de metode, clientela sau grupuri de clientela specifice.

5.10.3.2 Suplimentar fata de cerintele de la 5.10.2 si 5.10.3.1, rapoartele de incercare continand rezultatele esantionarii trebuie sa includa, unde este necesar pentru interpretarea rezultatelor de incercare, urmatoarele:a. data esantionariib. identificarea neambigua a substantei, rocii, materialului sau

produsului prelevat (inclusiv numele fabricantului, modelul sau tipul de desemnare si seriile, dupa cum este cazul)

c. locul esantionarii, inclusiv orice diagrame, schite sau fotografii

d. referirea la planul de esantionare si procedurile folositee. detalii ale orcaror conditii de mediu din timpul esantionarii

care ar putea afecta interpretarea rezultatelor incercariif. standardul sau alta specificatie pentru metoda sau

procedura de esantionare, precum si abaterile, adaugirile sau eliminarile din specificatia in discutie.

5.10.4 Certificate de etalonare25

f. any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned.

5.10.4 Calibration certificates 5.10.4.1 In addition to the requirements listed in

5.10.2, calibration certificates shall include the following, where necessary for the interpretation of calibration results:

a. the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results

b. the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof

c. evidence that the measurements are traceable (see note 2 In 5.6.2.1.1).

5.10.4.2 The calibration certificate shall relate only to quantities and the results of functional tests. If a statement of compliance with a specification is made, this shall identify which clauses of the specification are met or not met.

When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.

When statements of compliance are made, the uncertainty of measurement shall be taken into account.

5.10.4.3 When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair, if available, shall be reported.

5.10.4.4 A calibration certificate (or calibration label)

shall not contain any recommendation on the calibration interval except where this has been agreed with the client. This requirement may be superseded by legal regulations.

5.10.5 Opinions and interpretations When opinions and interpretations are included, the

laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations shall be dearly marked as such in a test report. Note 1: opinions and interpretations should not be confused

with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.

Note 2: opinions and interpretations included in a test report may comprise, but not be limited to, the following:

- an opinion on the statement of compliance/non-compliance of the results with requirements

- fulfilment of contractual requirements- recommendations on how to use the results- guidance to be used for improvements.

Note 3: in many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the client. Such dialogue should be written down.

5.10.6 Testing and calibration results obtained from subcontractors

When the test report contains results of tests performed by subcontractors, these results shall be clearly identified. The

5.10.4.1 Suplimentar fata de cerintele cuprinse de la 5.10.2, certificatele de etalonare vor contine, acolo unde este necesar pentru interpretarea rezultatelor de etalonare, urmatoarele:a. conditiile (de ex. de mediu) in care s-au desfasurat

etalonarile si care au o oarecare influenta asupra rezultatelor masurarii

b. incertitudinea de masurare si/sau o declaratie de conformitate cu o specificatie metrologica identificata sau clauzele din aceasta

c. proba ca masurarile sunt trasabile (vezi nota 2 de la 5.6.2.1.1).

5.10.4.2 Certificatul de etalonare trebuie sa se refere numai la marimi si la rezultatele incercarilor functionale. Daca se face o declaratie de conformitate cu o specificatie, ea va identifica ce clauze ale acelei specificatii sunt sau nu sunt indeplinite. Daca se face o declaratie de conformitate cu o specificatie omitandu-se rezultatele masurarilor si incertitudinile asociate, laboratorul trebuie sa inregistreze aceste rezultate si sa le pastreze pentru posibile referinte ulterioare. Atunci cand se fac declaratii de conformitate trebuie sa se tina cont de incertitudinea masurarii. 5.10.4.3 Cand un aparat pentru etalonare a fost reglat sau reparat se vor comunica rezultatele etalonarii (daca sunt disponibile) si pentru inainte si pentru dupa reglare sau reparatii.

5.10.4.4 Un certificat de etalonare (sau o marca de etalonare) nu trebuie sa contina nici o recomandare asupra intervalului de etalonare, cu excepti cazului in care acest lucru s-a stabilit prin acord cu clientul. Aceasta cerinta poate fi inlocuita de reglementari legale.

5.10.5 Opinii si interpretariCand opiniile si interpretarile sunt incluse in raport,

laboratorul va documenta fundamentul acestora. Ele trebuie sa fie clar marcate intr-un raport de incercare.

Nota 1: opiniile si interpretarile nu trebuie confundate cu inspectarile si certificarile de produs conform ISO/IEC 17020 si Ghidul ISO/IEC 65.

Nota 2: opiniile si interpretarile incluse intr-un raport de incercare pot cuprinde dar nu sunt limitate la urmatoarele:

- o opinie asupra declaratiei de conformitate/ neconformitate a rezultatelor cu cerintele- indeplinirea cerintelor contractuale- recomandari asupra modului in care sa fie utilizate

rezultatele- indicatii care sa fie utilizate pentru imnbunatatiri.

Nota 3: in multe cazuri poate fi mai bine sa se comunice opiniile si interpretarile prin dialog direct cu clientul. Un astfel de dialog trebuie scris.

5.10.6 Rezultate de incercare si etalonare obtinute de la subcontractanti

Atunci cand raportul de incercare contine rezultate ale unor incercari efectuate de subcontractanti, aceste rezultate trebuie sa fie clar identificate. Subcontractantul va prezenta rezultatele in scris sau electronic.

Daca a fost subcontractata o etalonare, laboratorul care

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subcontractor shall report the results in writing or electronically.When a calibration has been subcontracted, the

laboratory performing the work shall issue the calibration certificate to the contracting laboratory.

5.10.7 Electronic transmission of resultsIn the case of transmission of test or calibration results

by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met (see also 5.4.7).

5.10.8 Format of reports and certificatesThe format shall be designed to accommodate each

type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.

Note 1: attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the presentation of the test or calibration data and ease of assimilation by the reader.

Note 2: the headings should be standardized as far as possible.

5.10.9 Amendments to test reports and calibration certificates

Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: "Supplement to Test Report [or Calibration Certificate], serial number…[or as otherwise identified]",or an equivalent form of wording.

Such amendments shall meet all the requirements of this International Standard.

When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.

efectueaza lucrarea va emite certificatul de etalonare catre laboratorul care a subcontractat.

5.10.7 Transmiterea electronica a rezultatelorIn cazul transmiterii rezultatelor incercarii sau

etalonarii prin telefon, fax, telex sau prin alte mijloace electronice sau electromagnetice, cerintele prezentului Standard trebuiesc indeplinite (vezi de asemenea 5.4.7).

5.10.8 Formatul rapoartelor si certificatelorFormatul trebuie sa fie astfel conceput incat sa se poata

adapta fiecarui tip de incercare sau etalonare efectuat si sa minimalizeze posibilitatea de neintelegere sau utilizare gresita.Nota 1:trebuie acordata atentie prezentarii rapoartelor si

certificatelor, in special in ceea ce priveste prezentarea datelor de incercare sau etalonare si intelegerea usoara din partea cititorului.

Nota 2: capitolele trebuie sa fie, pe cat posibil, tipizate.

5.10.9 Amendamente la rapoarte si certificate

Amendamentele materiale la un raport de incercare sau certificat de etalonare dupa difuzare trebuie realizate numai sub forma unui alt document sau ca transfer de date, incluzand declaratia: “Supliment la raportul de incercare [sau certificatul de etalonare], seria…[sau alta identificare]”sau o modalitate echivalenta de formulare.

Astfel de amendamente se vor conforma tuturor cerintelor prezentului Standard. Cand este necesar sa se elaboreze un raport sau un certificat complet nou, acesta trebuie sa fie unic identificat si sa contina o referire la originalul pe care il inlocuieste.

ANNEX A (informative) NOMINAL CROSS-REFERENCES TO ISO 9001:1994 AND ISO 9002:1994ANEXA A (informativa) REFERINTE INCRUCISATE NOMINALE LA ISO 9001:1994 SI ISO 9002:1994

ISO 9001:1994 ISO 9002:1994 ISO/IEC 17025Clause 1 Clause 1 Clause 1Clause 2 Clause 2 Clause 2Clause 3 Clause 3 Clause 34.1.1 4.1.1 4.1.3 , 4.2.24.1.2.1 4.1.2.1 4.1.5 a), f), h) ; 4.2.4 ; 4.9.1 a) ;

4.10.1 ; 5.2.54.1.2.2 4.1.2.2 4.1.5 a), f), h) ; 5.5.14.1.2.3 4.1.2.3 4.1.5 j)4.1.3 4.1.3 4.144.2.1 ; 4.2.2 4.2.1 ; 4.2.2 4.2.1 ; 4.2.2 ; 4.2.34.2.3 4.2.3 4.2.1 ; 4.2.2 ; 4.144.3 4.3 4.44.4 4.4 (n.a.) 1.5 ; 5.4.2 ; 5.4.3 ; 5.4.4 ; 5.4.54.5 4.5 4.3 ; 5.4.7 ; 5.5.114.6.1 4.6.1 4.6 ; 5.5 ; 5.6.1 ; 5.6.2.1 ; 5.6.2.24.6.2 4.6.2 4.5 ; 4.64.6.3 4.6.3 4.64.6.4 4.6.4 4.5 ; 4.6.4 ; 4.7 ; 5.5.24.7 4.7 5.8 ; 5.10.64.8 4.8 5.5.4 ; 5.84.9 4.9 4.12 ; 5.3 ; 5.4 ; 5.5 ; 5.64.10.1 4.10.1 5.44.10.2 4.10.2 4.5 ; 4.6 ; 5.5.2 ; 5.84.10.3 4.10.3 4.9 ; 5.5.9 ; 5.8.3 ; 5.8.4 ; 5.94.10.4 4.10.4 5.4.7 ; 5.9 ; 5.10.1

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4.10.5 4.10.5 4.12.24.11.1 4.11.1 5.4 ; 5.5 ; 5.64.11.2 4.11.2 5.3 ; 5.4.1 ; 5.4.5 ; 5.5 ; 5.64.12 4.12 5.5.12 ; 5.8 ; 5.9.24.13 4.13 4.94.14 4.14.1 4.10 ; 4.114.15 4.15 5.94.16 4.16 4.124.17 4.17 4.10.5 ; 4.13 (4.12)4.18 4.18 5.2 ; 5.5.34.19 4.19 4.7 ; 5.2.1 ; 5.10.54.20 4.20 5.9n.a. = not applicable [ne-aplicabil]

ISO/IEC 17025 covers several technical competence requirements that are not covered by ISO 9001:1994 and ISO 9002:1994 [ISO/IEC 17025 acopera mai multe cerinte de competenta tehnica neacoperite de ISO 9001:1994 si ISO9002:1994].

ANNEX B (informative) GUIDELINES FOR ESTABLISHING APPLICATIONS FOR SPECIFIC

FIELDS

B.1 The requirements specified in this International Standard are stated in general terms and, while they are applicable to all test and calibration laboratories, explanations might be needed. Such explanations on applications are herein referred to as

applications. Applications should not include additional general requirements not included in this International Standard.

B.2 Applications can be thought of as an elaboration of the generally stated criteria (requirements) of this International Standard for specified fields of test and calibration, test technologies, products, materials or specific tests or calibrations. Accordingly, applications should be established by persons having appropriate technical knowledge and experience, and should address items that are essential or most important for the proper conduct of a test or calibration.

B.3 Depending on the application at hand, it may be necessary to establish applications for the technical requirements of this International Standard. Establishing applications may be accomplished by simply providing detail or adding extra information to the already generally stated requirements in each of the clauses (e.g. specific limitations to the temperature and humidity in the laboratory).

In some cases the applications will be quite limited, applying only to a given test or calibration method or to a group of calibration or test methods. In other cases the applications may be quite broad, applying to the testing or calibration of various products or items or to entire fields of testing or calibration.

B.4 If the applications apply to a group of test or calibration methods in an entire technical field, common wording should be used for all of the methods.

Alternatively, it may be necessary to develop a separate document of applications to supplement this

ANEXA B (informativa) LINII DIRECTOARE PENTRU STABILIREA APLICARII IN DOMENII

SPECIFICE

B.1 Cerintele stabilite in acest Standard sunt in termeni generali si, aplicandu-se in toate laboratoarele de incercari si etalonari, pot fi necesare unele explicatii. Astfel de explicatii in legatura cu aplicarea sunt denumite aici aplicatii.

Aplicatiile nu trebuie sa cuprinda cerinte generale suplimentare ce nu se gasesc in acest Standard International.

B.2 Aplicatiile pot fi gandite ca o elaborare a criteriilor (cerintelor) general stabilite ale acestui Standard pentru anumite domenii de incercare si etalonare, tehnologii de incercare, produse, materiale sau incercari sau etalonari specifice. In consecinta, trebuie stabilite aplicatii de catre persoane posedand cunostinte si experienta tehnica corespunzatoare si trebuie sa se refere la obiecte esentiale sau cele mai importante pentru desfasurarea corespunzatoare a unei incercari sau etalonari.

B.3 In functie de aplicatia la indemana, poate fi necesara stabilirea de aplicatii pentru cerintele tehnice ale prezentului Standard. Stabilirea aplicatiilor poate fi realizata prin simpla furnizare de detalii sau prin adaugarea de informatii noi cerintelor deja general stabilite la nivelul fiecareia dintre clauze (ca de ex. limitele specifice ale temperaturii si umiditatii din laborator).

In anumite cazuri, aplicatiile vor fi destul de limitate, aplicandu-se numai la o metoda de incercare sau etalonare data sau la un grup de metode de etalonare sau incercare. In celelalte situatii, aplicatiile pot fi chiar extinse, aplicandu-se la incercarea sau etalonarea diverselor produse sau obiecte sau la domenii integrale ale incercarii sau etalonarii.

B.4 Daca aplicatiile sunt valabile pentru un grup de metode de incercare sau etalonare pe un intreg domeniu tehnic, se va utiliza limbajul comun pentru toate metodele.

In mod alternativ, poate fi necesara dezvoltarea unui document separat al aplicatiilor in scopul suplimentarii acestui Standard International pentru tipuri

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International Standard for specific types or groups of tests or calibrations, products, materials or technical fields of tests or calibrations. Such a document should provide only the necessary supplementary information, while maintaining this International Standard as the governing document through reference. Applications which are too specific should be avoided in order to limit the proliferation of detailed documents.

B.5 The guidance in this annex should be used by accreditation bodies and other types of evaluation bodies when they develop applications for their own purposes (e.g. accreditation in specific areas).

specifice de grupuri de incercari sau etalonari, produse, materiale sau domenii tehnice de incercare sau etalonare. Un astfel de document trebuie sa furnizeze numai informatiile suplimentare necesare, mentinand Standardul de fata ca si document principal, de referinta. Trebuie evitate aplicatiile prea specifice, pentru a se limita proliferarea documentelor detaliate.

B.5 Precizarile din aceasta anexa trebuie utilizate de catre organismele de acreditare sau de alte tipuri de organisme de evaluare atunci cand acestea isi dezvolta aplicatii in scop propriu (de ex. acreditarea in domenii specifice).

BIBLIOGRAPHYBIBLIOGRAFIE

[1] ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions[2] ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method[3] ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method[4] ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results - Part 4: Basic methods for the determination of the trueness of a standard measurement method[5] ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values[6] ISO 8402, Quality management and quality assurance - Vocabulary[7] ISO 9000-1:1994, Quality management and quality assurance standards - Part 1: Guidelines for selection and use[8] ISO 9000-3:1997, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software[9] ISO 9004-1:1994, Quality management and quality system elements - Part 1: Guidelines[10] ISO 9004-4:1993, Quality management and quality system elements - Part 4: Guidelines for quality improvement[11] ISO 10011-1, Guidelines for auditing quality systems - Part 1: Auditing[12] ISO 10011-2, Guidelines for auditing quality systems - Part 2: Qualification criteria for quality system auditors[13] ISO 10011-3, Guidelines for auditing quality systems - Part 3: Management of audit programmes[14] ISO 10012-1, Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation for measuring equipment[15] ISO 10012-2, Quality assurance requirements for measuring equipment - Part 2: Guidelines for control of measurement processes[16] ISO/IEC 17020, General criteria for the operation of various types of bodies performing inspection[17] ISO Guide 30, Terms and definitions used in connection with reference materials[18] ISO Guide 31, Contents of certificates of reference materials[19] ISO Guide 32, Calibration in analytical chemistry and use of certified reference materials[20] ISO Guide 33, Uses of certified reference materials[21] ISO Guide 34, General requirements for the competence of reference material producers[22] ISO Guide 35, Certification of reference materials - General and statistical principles[23] ISO/IEC Guide 43-1, Proficiency testing by inter-laboratory comparisons - Part 1: Development and operation of proficiency testing schemes

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[24] ISO/IEC Guide 43-2, Proficiency testing by inter-laboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies[25] ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems - General requirements for operation and recognition[26] ISO/IEC Guide 65, General requirements for bodies operating product certification systems[27] Guide to the Expression of Uncertainty in Measurement, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML[28] Information and documents on laboratory accreditation can be found on the ILAC (International Laboratory Accreditation Cooperation): www.ilac.org

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