EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”

EN ISO/IEC 17025

1 Saxony-Anhalt EU Twinning RO 04/IB/EN/09State Environmental Protection Agency Wolfgang Garche Bukarest 23.05.2007

EN ISO/IEC 17025 “General requirements for the competence of testing

and calibration laboratories”

Dr. Wolfgang Garche

Saxony-Anhalt Environmental Protection AgencyDepartment Air Quality Monitoring, Information, Assessment

EN ISO/IEC 17025


What means accreditation in accordance to EN ISO/IEC 17025

Confirmation of competence of a testing or calibration laboratory by an independent third party, the accreditation body, to carry out specific tests and/or calibrations.

Usually there are national regulations for one or several accreditation bodies in each country.

The accreditation bodies cooperate in international organisations:

Europe: European Accreditation Cooperation (EA)

Worldwide: International Laboratory Accreditation Cooperation (ILAC)

EN ISO/IEC 17025


A laboratory may apply quality assurance procedures according to EN ISO 17025 to all or a part of its operations.

Quality management is supported by a clear statement of activities, which ideally should define the range of work, without restricting the laboratory's operation.

The scope is typically defined in terms of: range of products, materials or sample types measurements (or types of measurements) specification or method/equipment/technique concentration range and uncertainty

Scope of accreditation

EN ISO/IEC 17025


organisation quality system document control review of requests, tenders and contracts subcontracting of tests and calibrations purchasing services and supplies service to the client complaints control of nonconforming testing and /or calibration work corrective action preventive action internal audits management reviews

Management requirements

EN ISO/IEC 17025


personnel accommodation and environmental conditions test and calibration methods and method validation equipment measurement traceability sampling complaints handling of test calibration items assuring the quality of test and calibration items reporting the results

Technical requirements

EN ISO/IEC 17025


legal responsibility meeting the requirements of this International Standard, satisfying the

needs of the client, the regulatory authorities or organisations providing recognition

The management system shall cover work carried out in all facilities:- laboratory's permanent facilities,- at sites away from its permanent facilities,- or in associated temporary or mobile facilities

Responsibilities of key personnel shall be defined in order to identify potential conflicts of interest

managerial and technical personnel with the authority and resources needed to carry out their duties

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

technical management with overall responsibility for the technical operations

appoint a member of staff as quality manager

Organisation

EN ISO/IEC 17025


Quality System

Establishing, implementing and maintaining a quality system appropriate to the scope of its activities.

Documenting 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.

Quality manual

The laboratory's quality system policies and objectives shall be defined in a quality manual (however named).

Quality policy statement

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.

EN ISO/IEC 17025


Documentation

QMH

Procedureinstructions

Standard OperationProcedures (SOP‘s)

Forms, Lists, Control Charts

• description of organisation• quality policy statement• range of services, quality objectives, responsibilities• general statements that requirements of EN ISO 17025 are complied

• descriptions of the applied procedures for fulfilment of the requirements of EN ISO 17025

• descriptions of special procedures used for specific operating processes

• detailed guidelines for the execution of single works

• formal templates and working tools for the creation of test records and for the documentation of measurements, tests, audits, etc.

EN ISO/IEC 17025


Management Reviews

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

Review shall take into account:the suitability of policies and proceduresreports from managerial and surveyor personnelthe outcome of recent internal auditscorrective and preventive actionsassessments by external bodiesthe results of interlaboratory comparisons or proficiency testschanges in the volume and type of the workclient feedbackcomplaintsother relevant factors, such as quality control activities, resources and staff training

EN ISO/IEC 17025


Technical Requirements

Factors which determine the correctness and reliability of the tests and/or calibrations performed by a laboratory:

human factorsaccommodation and environmental conditionstest and calibration methods and method validation equipment)measurement traceabilitysamplingthe handling of test and calibration items

General

EN ISO/IEC 17025


Personnel

Requirements for personnel:Ensuring the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. Personnel certification: the laboratory is responsible for fulfilling specified personnel certification requirements.Training programmeSupervising additional personnelAuthorization

EN ISO/IEC 17025


Accommodation and Environmental Conditions

Laboratory facilities Monitoring the environmental conditions

Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.

Preventing cross-contamination Access to the laboratory Good housekeeping

EN ISO/IEC 17025


Test and Calibration Methods and Method Validation

Using appropriate methods and procedures for all tests and/or calibrations within its scope.

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,

shall be kept up to date and shall be available for the personnel

Selection of methods Laboratory developed methodsNon-standard methodsValidation of methodsEstimation of uncertainty of

measurementControl of data

EN ISO/IEC 17025


Equipment

Records of Equipment shall include at least the following:the identity of the item of equipment and its softwarethe manufacturer's name, type identification, and serial number or other

unique identificationchecks that equipment complies with the specificationthe current location, where appropriatethe manufacturer's instructions, if available, or reference to their locationdates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the date of next calibrationthe maintenance plan, where appropriate, and maintenance carried out to

dateany damage, malfunction, modification or repair to the equipment

EN ISO/IEC 17025


Measurement Traceability

The laboratory shall have an established programme and procedure for the calibration of its equipment.

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.

Specific requirements for calibration laboratories:

- traceable to the International System of Units (SI) (Systeme international d'unites).

TestingReference standards and reference materials

EN ISO/IEC 17025


Further Requirements

Sampling Handling of test and calibration itemsAssuring the quality of test and calibration results

EN ISO/IEC 17025


Reporting the Results

Results shall be reported accurately, clearly, unambiguously objectively in accordance with any specific instructions in the test or

calibration methods.

EN ISO/IEC 17025


Test Reports and Calibration Certificates

A test report or calibration certificate shall include at least the following information:

a title (e.g. "Test Report" or "Calibration Certificate") the name and address of the laboratory unique identification of the test report or calibration certificate (such as the serial

number), the name and address of the client identification of the method used a description of and unambiguous identification of the item(s) tested or calibrated 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

the test or calibration results the name(s), function(s) and signature(s) or equivalent identification of person(s)

authorizing the test report or calibration certificate

EN ISO/IEC 17025


Calibration Certificates

shall include:the conditions (e.g. environmental) under which the calibrations were

made that have an influence an the measurement resultsthe uncertainty of measurement and/or a statement of compliance with an identified metrological specificationevidence that the measurements are traceable

EN ISO/IEC 17025


Many Thanks for your Attention!

Documents

EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”