ukiaf.org FILE/AF-5-3... · Web viewPolicy formulation, process and/or procedure development, proceedings of safeguarding impartiality committee/scheme committee, application &

UK International Acreditation Forum Limited

UKIAF Application form for Accreditation(All applicants shall fill part 1 & part 3 while part 2 will be filled according to each of their specific scheme ex. ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024, UAE.S 2255-2)

Part 1. General Information: Initial accreditation Re-accreditation (re-assessment)Extension of accreditation

I wish this application to be processed now (which may require an extra visit by UKIAF)

I wish this application to be processed with my next assessment/reassessment visit.Instructions:

1. Your application cannot be processed unless attached with the required document in Soft or/and Hard copies.

2. Aapplicant understand and accept that an assessment fee will normally be charged in accordance to UKIAF.(which published in UKIAF website www.ukiaf.org ).

3. This application must be completed in full and returned to UKIAF with a copy of each of the following:

Information / Documentation

Required forInitial

Application

Extension

Application

Renewal of

Accrediattion

1. Fully filled signed application form. Yes Yes Yes2. CAB legal entity evidence (please enclose proof of structure and

legal status, e.g. certificate of registration, commercial register) Yes Yes Yes3. Signed agreement (2 original copies). Yes No Yes4. UKIAF relevant assessment checklist report. Yes Yes Yes5. Standard (international / national /in house / non standard) used by

laboratory. Yes Yes Yes6. The applicant’s quality system documentation and (quality manual

if any). Yes Yes Yes7. Copy of the relevant associated method(s). Yes Yes Yes8. Procedure for validation/verification of methods and validation

data for tests requiring accreditation. Yes Yes Yes9. Detailed job description of applicant personnel seeking

accreditation. Yes Yes Yes10. Risk analisis for confedentiality , impartiality & technical activities. Yes Yes Yes

Note: Incomplete applications cannot be processed by UKIAF4. Additional information may be provided on additional copies of the applicable sheets where the spaces

provided are insufficient.5. Additional advice or information may be obtained by contacting the relevant UKIAF accreditation

manager as displayed on UKIAF website.6. Granting accreditation will be subject to the applicant entity fully complying with the accreditation

criteria, UKIAF accreditation requirements and UKIAF regulation.7. The applicant is specifically advised to read relevant UKIAF information pack. before applying for

accreditation.8. UKIAF will issue an invoice once this application form is processed. Evidence of payment will be required

prior to proceeding with evaluation of application.

1 | 2 4website: www.ukiaf.org

AF-5-3_Application Form Rev-02 Issue 01 01st Jan 2020

CAB Id.

http://www.ukiaf.org/



9. If the applicant does not receive an acknowledgement of receipt of this form within 1 month of dispatch,

please contact UKIAF relevant accreditation manager.10. For initial applicant, its application remains valid for 6 months from the date of receipt of the

application if there is no response or no ongoing response during the accreditation process from this applicant.

11. Applications for renewal of accreditation (re-assessment) should submitted to UKIAF at least six (6) months prior to the expiry of accreditation certificate.

Information about CAB:CAB NameCAB OrganizationCAB Address (in English)

City & CountryPO box / Code

Website E-MailTelephone FaxContact person Name TitlePosition E-MailTel./Mob. FaxParent OrganizationAddress

City& CountryPO box / Code

Website E-MailTelephone FaxAddress where invoice to be sent (if different from CAB address)Fax

PO box / Code E-Mail

Information about ownership (Legal status of your organization): please tick the appropriate box

Owned by an individual Part of an academic institution Owned by a private company/ partnership Part of learned / technical institutionOwned by a public body / nationalized industry Owned by public limited companyNational / governmental organization Other (Please describe):

Description of the main activities of the organization seeking accreditation:Total no. of employeesNumber of employees involved in area(s) seeking accreditation





(*) Attach an organization chart indicating the structure of the areas to be accredited and their relation to the rest of the organization.

Determine the field of the organization seeking accreditation:Testing Laboratory ISO/IEC 17025 (Fill section 2.1)

Inspection Body ISO/IEC 17020 (Fill section 2.2)

MS Certification Body ISO/IEC 17021 (Fill section 2.3)

Product Certification BodyISO/IEC 17065 (Fill section 2.4)

Person Certification Body ISO/IEC 17024 (Fill section 2.5)

Halal Certification BodyUAE.S 2055-2 (Fill section 2.6)

Internal Audit and Management ReviewLast internal audit reportLast management review report

Information on Senior StaffName and position (Director level) of person authorizing this application

NamePosition Title

Technical/Scheme ManagerNameTechnical QualificationsRelevant ExperiencePosition within the organization

Quality Manager:NameQualificationsRelevant ExperiencePosition within the organization

Other Accreditation / Certifications: (including UKIAF accreditation)Name & address of

Accreditation / certification Scope of accreditation /

certificationPeriod of

accreditation/certification





body Start date Expiry date

Applicant outside UK:

Applicants from outside UK will be processed according to UKIAF policy.

Is there a local accreditation body? Yes NoIs the local accreditation body a signatory to the arrangement of UKIAF? Yes NoDoes the local accreditation body offer the required scope? Yes NoDo you permit:That UKIAF informs the local accreditation body about your application and the development of the accreditation process? Yes NoThat the local accreditation body may send an observer to join the assessment? Yes NoThat the local accreditation body may send (an) assessor/s (joint assessment for a dual accreditation)? Yes No

Considering the questions above, what are the reasons for choosing UKIAF instead of the local accreditation body?





Part 2. Filled individually for each scheme applicant:Section 2.1: For Testing Laboratory Applicant:

Field for which accreditation is sought: (Please tick the appropriate boxes)Chemical Analysis Microbiology, Hydrobiology & ToxicityCivil Engineering and Materials Testing Electrical & ElectronicsEnvironmental including Ambient Air Monitoring Heat & TemperatureMechanical Non-destructiveOptics and Radiometry VeterinaryPharmaceutical Others*

* For others: Please, write the field: ………….................................................................................................................................

Scope of testing for which accreditation is sought: Materials / Product Tested Types of test

/propertiesMeasuredRange of Measurement

Standard Specifications / Techniques used

List the major items of equipment currently used for the types of test:Description of equipment

(Include Manufacturer, Model & Serial number / Code number)

Range / Capacity of equipment and other relevant information

Please indicate the type of calibration for the testing lab equipment:

External Calibration Internal Calibration* In case of internal calibration for equipment used, please fill in the following two tables for the scope of the internal calibration:

Please indicate the type of calibration sitesCustomers premisesMobil facilitiesThe locations of temporary sitesCollection sites (premises that only collect

sample)Other .................................................................

Measured QuantityRange

Calibration & Measurement Capability (±) Uncertainity

Brief Description of Measurement and Equipment Used





Section 2.2: For Inspection Body Applicant: Field for which accreditation is sought: (Please tick the appropriate boxes)

Glass and ceramics industries

Health care technology

Natural sciences ServicesMechanical systems& components

Metrology and measurement

Environment. Safety

TestingFluid systems& components

Manufacturing Engineering

Energy and heat transfer

Electrical EngineeringGeneralities. Standardization. Documentation

Domestic and commercial equipment. Entertainment. Sports

Information technology. Office machines

Image technology

Construction materials and building

Road vehicles engineering

Railway Engineering

Paper technologyMaterial handling equipment

Packaging and distribution of goods

Textile and leather technology

Clothing industryAgriculture Food Technology Chemical

technologyMetallurgy

Petroleum and related technologies

Telecommunications. Audio and video

Wood technology ElectronicsRubber and plastic industries

Shipbuilding& marine structure

Paint and color industries

JewelleryCivil engineering Mining and minerals Other (please describe):

……………………….......

Scope of inspection for which accreditation is sought: Field of Inspection

such as :product design, products (specified as materials or equipment)

Installations, plant, premises, processes, services and surveys

Type and Range of Inspection e.g. In-service inspection or inspection

of new products

Methods and Proceduressuch as: EC directives, regulations, standards, specifications, internal

procedures

For whom does the inspection body undertake inspection?Own organizationParent organizationOther organization

What do you consider to be the type of your Inspection Body, as defined in ISO/IEC 17020?

Type AType B Type C

Do you perform inspection outside UK ?NoYes

If yes state the countries in which

inspections performed

Please indicate the type of calibration for the inspection body equipment: External Calibration Internal Calibration

* In case of internal calibration for equipment used, please fill in the following two table for the scope of the internal calibration:

Please indicate the type of calibration sitesCustomers premisesMobil facilitiesThe locations of temporary sitesCollection sites (premises that only collect





sample)Other .................................................................

Measured QuantityRange

Calibration & Measurement Capability (±) Uncertainity

Brief Description of Measurement and Equipment Used

Section 2.3: For Management Systems Certification Body Applicant: Identify the management system certification scheme(s) for which accreditation is sought:

StandardScope

(according to IAF Codes, FSMS subcatagory and Energy Technical area )

Geographical Areas(countries)

QMS- ISO 9001EMS- ISO 14001OH &SMS - ISO 45001FSMS - ISO 22000EnMS - ISO 50001ISMS – ISO 27001ITSMS – ISO 20000BCMS – ISO 22301ABMS – ISO 37001

Other StandardScopeGeographical Areas

StandardScope

Geographical Areas(countries)

Main Technical

Areas

Technical

Areas

Product Categories Covered by the Technical Areas

Medical Devices QMS - ISO 13485





Scope of Accreditation (Please see Annex A for detailed code descriptions)

ISO 9001:2015

(Quality Management

Systems)

ISO 14001:2015

(Environmental Management

Systems)

OHSAS 18001:2007(Occupational

Health and Safety Management

Systems)

ISO 45001:2017(Occupational

Health and Safety Management

Systems)Codes Select boxes Codes Select boxes Codes Select boxes Codes Select Boxes

1 1 1 12 2 2 23 3 3 34 4 4 45 5 5 56 6 6 67 7 7 78 8 8 89 9 9 910 10 10 1011 11 11 1112 12 12 1213 13 13 1314 14 14 1415 15 15 1516 16 16 1617 17 17 1718 18 18 1819 19 19 1920 20 20 2021 21 21 2122 22 22 2223 23 23 2324 24 24 2425 25 25 2526 26 26 2627 27 27 2728 28 28 2829 29 29 2930 30 30 3031 31 31 3132 32 32 32





33 33 33 3334 34 34 3435 35 35 3536 36 36 3637 37 37 3738 38 38 3839 39 39 39





Scope of Accreditation (Please see Annex B for detailed code descriptions)

ISO 22000:2005 and 2018(Food Safety Management Systems)

ISO 50001:2011(Energy Management Systems)

Cluster Category Select Boxes

Types of Organizations Select Boxes

FarmingA A. Commercial

Buildings

B B. Light to Medium Industry

Food and Feed Processing C C. Heavy Industry

DD. Transportation

Catering E E. Building ComplexEnergy Use

Retail, Transport and StorageF

F. Energy SupplyG

G. Mining

Auxiliary ServiceH

H. OtherI

J

Biochemical K





Scope of Accreditation (Please see Annex C for detailed code descriptions)

ISO 13485:2016(Medical Device Quality Management Systems)

Main Technical Area Technical Area Select Box

A. NON-ACTIVE MEDICAL DEVICES

General non-active, non-implantable medical devicesNon-active implants

Devices for wound careNon-active dental devices and accessories

Non-active medical devices other than specified above

B. ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES

General active medical devicesDevices for imagingMonitoring devices

Devices for radiation therapy and thermo-therapyActive (non-implantable) medical devices other than

specified aboveB. ACTIVE (IMPLANTABLE)

MEDICAL DEVICESGeneral active implantable medical devices

Implantable medical devices other than specified above

C. IN-VITRO DIAGNOSTIC MEDICAL DEVICES (IVD)

Reagents and reagent products, calibrators and control materials for:

- Clinical Chemistry- Immunochemistry (Immunology)

- Hematology/Hemostasis/Immunohematology- Microbiology

- Infectious Immunology- Histology/Cytology

- Genetic TestingIn-Vitro diagnostic instruments and software

IVD medical devices other than specified above

D. STERILIZATION METHODS FOR MEDICAL DEVICES

Ethylene oxide gas sterilization (EOG)Moist heat

Aseptic processingRadiation sterilization (e.g. gamma, x-ray, electron beam)

Sterilization method other than specified above

E. DEVICES INCORPORATING/UTILIZING

SPECIFIC SUBSTANCES/TECHNOLOGIES

Medical devices incorporating medicinal substancesMedical devices utilizing tissues of animal origin

Medical devices incorporating derivatives of human bloodMedical devices utilizing micromechanicsMedical devices utilizing nanomaterials

Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed





ISO 55001:2014 ISO 29990:2010 ISO 20121:2012 ISO 39001:2012(Asset Management Systems)

(Learning Services – Non formal education & training)

(Event Sustainability Management Systems)

(Road Traffic Safety Management Systems)

AMS is non-sector specific

Select Box LSET is non-sector specific

Select Box ESMS is non-sector specific

Select Box RTSMS isnon-sector specific

Select Box

ISO 27001:2013 ISO/IEC 20000-1:2011 ISO 22301:2012 ISO 37001:2016(Information Security (Information (Business Continuity (Anti-BriberyManagement Technology Service Management ManagementSystems) Management Systems) Systems) Systems)ISMS is non-sector specific

Select Box ITSMS isnon-sector specific

Select Box BCMS is non-sector specific

Select Box ABMS is non-sector specific

Select Box





Section 2.4: For Product Certification Body Applicant:

Conformity evaluation in the field (product, process and/or service groups):

The certification schemes, standards or normative documents:

Scope of product, process and/or service groups for which accreditation is sought (conformity assessment procedures to be accredited):Product (s) / Product Group (s) Certification Standard / Scheme

General information Is the certification body already accredited by another accreditation body (including abroad)? Yes NoHas an application for accreditation been made to another accreditation body? Yes No

If the answer is yes fill the following:Name of the accreditation bodyDate of applicationFields of conformity evaluation which are accredited or for which accreditation has been applied:

Approvals and other recognitions of the certification body:

Documented structure to safeguard impartiality Yes NoWho are the stakeholders represented in this structure (committee)?

Staff of the certification bodyNumber of Staff Other staff (part-time workers)

Persons with university educationPersons with technical school educationPersons trained in quality management

Certification procedures What are the rules and procedures of certification for the fields of conformity listed in the application?





Are the proposed certification systems for accreditation described by own procedure and administration rules?

Does the certification body have special departments, groups or technical committees responsible for determined fields of certification? Yes NoInformation on the special field (name, address):

Does the certification body itself carry out tests of products, processes and services in the fields of certification applied for? Yes NoIs there an accreditation of the testing laboratories of the certification body? Yes NoBy which accreditation bodies?

Fields of testing:

Does the certification body itself carry out the surveillance of products, processes and services in the fields of certification applied for? Yes No

Who are the subcontractors for surveillance visits?

Which testing laboratories work for the certification body?Name / Identification Test fields Accredited by

In the case of non-accredited subcontractors, in which way does the certification body make sure that it complies with the requirements of the concerning international documents (e.g. ISO/IEC 17025)?

Quality systemDoes the certification body have a quality manual? Yes NoHas a quality manager been appointed Yes NoIf yes, nameTo ensure the compliance with the criteria of the standard ISO/IEC 17065, are there Internal audits and repetitive checks? Yes NoWhere are they documented?

Which arrangements are made to ensure confidentiality?

Is there a procedure for handling of complaints against decisions of the certification body? Yes No





Section 2.5: For Person Certification Body Applicant:

Does the applying organization / certification body operate additional locations / test centres: Yes No

Locations of the applicant organization / certification body:

Address

PO box / Code:

City

Address

PO box / Code:

City

Address

PO box / Code:

City

Address

PO box / Code:

City

* Org. chart/s: Please attach the organisational structure of the certification body and, where relevant, the structure within an organisation.Identify the certification scheme for persons for which accreditation is sought:

General information Is the certification body already accredited by another accreditation body (including abroad)? Yes NoHas an application for accreditation been submitted to another accreditation body? Yes NoName of the accreditation bodyDate of applicationFields of conformity evaluation which are accredited or for which accreditation has been applied for:

Approvals and other recognitions of the certification body :

Has UKIAF already sent a quotation to the certification body? Yes NoIf yes, indicate the reference number (if available)

Documented structure to safeguard impartiality Yes NoPlease provide details of the membership of the governing board / impartiality committee and the interests they represent:

Staff of the applying organisation / certification bodyNumber of: Staff Other staff (part-time employees)

Persons with university educationPersons with technical school educationPersons trained in quality management

Certification Scheme15 | 2 4

website: www.ukiaf.org AF-5-3_Application Form Rev-02 Issue 01 01st Jan 2020



Accepted personal certification scheme including quality procedures for verification and certification, quality manual:

Owner / authors of the personal certification scheme (if different form applicant organization/ certification body):

Interested parties represented in the scheme (scheme committee):

Is the scheme nationally / internationally accepted within the industry?

Quality systemDo the applicant organization / the certification body comply with any standard for quality system? Yes NoIf yes, which oneHas a quality manager been appointed Yes NoIf yes, nameIs there a documented system for internal quality audits to ensure the compliance with ISO 17024? Yes NoReference documentAre there documented procedures to ensure confidentiality? Yes NoReference document Are there procedures regarding the misuse of certificates? Yes NoReference documentIs a description of the certification system available in published form? Yes NoReference document

Scope of applicationNo.

Certification Scheme for

Persons

Product Sector

Industrial Sector

Method & Level

Scheme based on......

Scheme Owner





Section 2.6: For Halal Certification Body Applicant:

Does CB has any other critical location(s) other than the main / head office or branches where *key activities takes place then please specify the names of cities & countries where critical locations or branches are situated.

Yes No

NO.Location Type (such as Regional

office, Branch, outsourced Location etc)

City & Country *Key Activities carried out at this location

Note: *Key activities include: Policy formulation, process and/or procedure development, proceedings of safeguarding impartiality committee/scheme committee, application & contract review, (approval of, selection of, handling of contractual agreements with & monitoring of auditors/examiners/inspectors), (planning of and review/approval & decision on the results of audits/examinations/inspections) and preparation, release & control of certificates, Final decision on appeals and complaints.* Please attach the organizational structure that shows these locations.

Please list down the type, name(s) & location(s) of establishments under supervision of the organization (i.e. slaughterhouses, manufacturers, service providers,…etc.) which come under the scope of Halal certification: No. Type of Establishment * Name of Establishments Location/Address

* Type of establishment: for example, slaughterhouse, manufacturer, restaurant or other service providers,etc

List the names of the authorized persons for signing the Halal certificates:No. Name of the authorized

persons for signing the halal certificates

Signature Contact Details

Insert stamp & logo used on halal certificatesStamp Logo

Islamic Affairs ExpertNameMobile No. E-mailTechnical QualificationsRelevant ExperiencePosition within the organization

Scope of accreditation & Geographical scope: Please indicate the standard against which you are applying for UKIAF Accreditation of Halal product/service

categories





UAE.S 2055-2Other (Please state):

……………………………………………………………………………….....................................................

Identify the Halal product/service categories for which accreditation is sought:Kindly state the scope of accreditation for Halal product/service categories according to Table A.1 of UAE.S 2055-2. For the 'Geographical Areas' please state your intended working geographical areas (countries).

Category Codes(Select the required

code)Categories

Specific Type of Product &

Geographical AreasA Farming 1 (Animals)

Examples: Animals; fish; egg production; milk production; beekeeping; fishing; hunting; trapping

B Farming 2 (Plants)Example: Fruits; vegetables; grain; spices; horticultural products

C Processing 1 (Perishable animal products)including all activities after farming, e.g. slaughteringExamples: Meat, poultry, eggs, dairy and fish products

D Processing 2 (Perishable vegetal products)Examples: Fresh fruits and fresh juices; preserved fruits; fresh vegetables; preserved vegetables

E Processing 3 (Products with long shelf life at ambient temperature)Examples: Canned products; biscuits; snacks; oil; drinking water; beverages; pasta; flour; sugar; salt

F Feed productionExamples: Animal feed; fish feed

G CateringExamples: Hotels; restaurants

H DistributionExamples: Retail outlets; shops; wholesalers

I ServicesExamples: Water supply; cleaning; sewage; waste disposal; development of product, process and equipment; veterinary services

J Transport and storageExamples: Transport and storage

K Equipment manufacturingExamples: Process equipment; vending machines

L (Bio)chemical manufacturingExamples: Additives; vitamins; pesticides; drugs; fertilizers; cleaning agents; biocultures

M Packaging material manufacturingExample: Packaging material





Part 3. Declaration by the applicantDeclaration:- I declare that I am authorized, on behalf of the organization, to submit this

application, and that the information contained herein is both correct and accurate to the best of my knowledge and belief.

- Upon accreditation the organization agrees to comply with UKIAF requirements.- I enclose a copy of the quality manual (if any), UKIAF relevant Assessment Checklist

Report ,relevant procedures, the application fees, and any needed documentation- I understand the manner by which the accreditation system operates and functions.- I agree to cooperate with the visit assessment team appointed by UKIAF for

examination of all relevant documents by them and their visits to those parts of the CAB which are part of the scope of the accreditation.

- I agree to comply with the accreditation procedures, pay all the costs for pre-assessment (if any), initial assessment, sequential assessment and re-assessment.

Position Name Date Signe

Aplicant Representive ............................................................

UKIAF Relative Accreditation Manager

UKIAF Relative Accreditation Director





Annex AQuality (ISO 9001), Environmental (ISO 14001) and Occupational Health and Safety (OHSAS

18001) Management System Certification Scopes

Codes Description of Sector (bolded) and Subsectors (non-bolded)1 Agriculture, Hunting, Forestry & Fishing

Growing of non-perennial crops, Growing of perennial crops, Plant propagationAnimal productionMixed farming, Support activities to agriculture and post-harvest crop activities, Hunting, trapping and relatedservice activitiesForestry and loggingFishing and aquaculture

2 Mining and QuarryingMining of coal and ligniteExtraction of crude petroleum and natural gas, Support activities for petroleum and natural gas extractionMining of iron oresMining of non-ferrous metal oresOther mining and quarrying, Other mining and quarrying n.e.c.

3 Food Products, Beverages and TobaccoProcessing and preserving of meat and production of meat products, Processing and preserving of fish, crustaceans and mollusksProcessing and preserving of fruit and vegetables, Manufacture of vegetable and animal oils and fats, Manufacture of dairy products, Manufacture of grain mill products, starches and starch products, Manufacture of bakery and farinaceous products, Manufacture of other food products, Manufacture ofprepared animal feedsManufacture of beverages except of the manufacture of soft drinksManufacture of soft drinks; production of mineral waters and other bottled watersManufacture of tobacco products

4 Textiles and Textile ProductsManufacture of textiles, Manufacture of wearing apparel

5 Leather and Leather ProductsManufacture of leather and related products

6 Wood and Wood ProductsManufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials

7 Pulp, Paper and Paper ProductsManufacture of paper and paper products

8 Publishing CompaniesPublishing of books, periodicals and other publishing activities, Sound recording and music publishing activities

9 Printing CompaniesPrinting and service activities related to printing





Reproduction of recorded media10 Coke and Refined Petroleum Products

Manufacture of coke and refined petroleum products11 Nuclear Fuel

Processing of nuclear fuel, Manufacture of other inorganic basic chemicals12 Chemicals, Chemical Products and Fibres

Manufacture of chemicals and chemical productsManufacture of industrial gasesManufacture of explosives

13 PharmaceuticalsManufacture of basic pharmaceutical products and pharmaceutical preparations

14 Rubber and Plastic ProductsManufacture of rubber and plastic products

15 Non-metallic Mineral ProductsManufacture of other non-metallic mineral products

16 Concrete, Cement, Lime, Plaster, etc.Manufacture of cement, lime and plaster, Manufacture of cement, lime and plaster

17 Basic Metals and Fabricated Metal ProductsManufacture of basic metalsManufacture of fabricated metal products, except machinery and equipmentManufacture of steam generators, except central heating hot water boilers

18 Machinery and EquipmentManufacture of machinery and equipment n.e.c., Manufacture of military fighting vehicles, Repair ofmachinery, Installation of industrial machinery and equipmentManufacture of weapons and ammunition

19 Electrical and Optical EquipmentManufacture of computer, electronic and optical products except irradiation, electro-medical, electrotherapeutic, optical instruments and photographic equipment, Repair of electronic and opticalequipment, Repair of electrical equipment, Repair of computers and communication equipmentManufacture of wiring and wiring devicesManufacture of irradiation, electro-medical and electrotherapeutic equipment, Manufacture of optical instruments and photographic equipment

20 ShipbuildingBuilding of ships and boats, Repair and maintenance of ships and boats

21 AerospaceManufacture of air and spacecraft and related machinery, Repair and maintenance of aircraft and spacecraft

22 Other Transport EquipmentManufacture of motor vehicles, trailers and semi-trailers, Manufacture of railway locomotives and rolling stock, Manufacture of motorcyclesManufacture of bicycles and invalid carriages, Manufacture of other transport equipment n.e.c., Repair and maintenance of other transport equipment

23 Manufacturing Not Elsewhere ClassifiedManufacture of furniture, Other manufacturing, Repair of other equipment

24 RecyclingMaterials recovery

25 Electricity SupplyElectric power generation, transmission and distribution

26 Gas SupplyManufacture of gas; distribution of gaseous fuels through mains

27 Water SupplySteam and air conditioning supply, Water collection, treatment and supply

28 ConstructionConstruction of buildings, Civil engineering, Specialized construction activities except Electrical, plumbing and other construction installation activities as well as building completion and finishingElectrical, plumbing and other construction installation activities, Building completion and finishing

29 Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personaland Household GoodsWholesale and retail trade and repair of motor vehicles and motorcyclesRetail sale of automotive fuel in specialized storesWholesale trade, except of motor vehicles and motorcycles, Retail trade, except of motor vehicles and motorcycles except retail sale of automotive fuel in specialized stores, Repair of personal and householdgoods

30 Hotels and RestaurantsAccommodation, Food and beverage service activities





31 Transport, Storage and CommunicationsLand transport and transport via pipelines, Water transport, Air transport except Space transportSpace transportWarehousing and support activities for transportationPostal and courier activitiesTelecommunications

32 Financial Intermediation, Real Estate, RentingFinancial service activities, except insurance and pension funding, Insurance, reinsurance and pensionfunding, except compulsory social security, Activities auxiliary to financial services and insurance activities, Real estate activities, Rental and leasing activities

33 Information TechnologySoftware publishing, Computer programming, consultancy and related activities, Data processing, hosting and related activities; web portals

34 Engineering ServicesArchitectural and engineering activities, Scientific research and development, Other professional, scientific and technical activitiesTechnical testing and analysis

35 Other ServicesLegal and accounting activities, Activities of head offices; management consultancy activities, Advertisingand market research, Translation and interpretation activities, Employment activities, Office administrative, office support and other business support activitiesSecurity and investigation activitiesServices to buildings and landscape activities

36 Public AdministrationPublic administration and defense; compulsory social security

37 EducationEducation except Higher educationHigher education

38 Health and Social WorkHuman health activities except Hospital activitiesHospital activitiesVeterinary activitiesResidential care activities, Social work activities without accommodation

39 Other Social ServicesSewerage, Waste collection, Waste treatment and disposal, Remediation activities and other waste management servicesMotion picture, video and television program activities, Programming and broadcasting activities, Other information service activities, Travel agency, tour operator and other reservation service and related activities, Creative, arts and entertainment activities, Libraries, archives, museums and other culturalactivities , Gambling and betting activities, Sports activities and amusement and recreation activities, Activities of membership organizations, Other personal service activities





Annex B

Food Safety Management System (ISO 22000) Certification Scopes

Cluster Category SubcategoryTick as

appropriate

Farming

A Farming of Animals

AI Farming of Animals for Meat/Milk/Eggs/Honey

AII Farming of Fish and Seafood

B Farming of Plants

BI Farming of Plants (other than grains and pulses)

BII Farming of Grains and Pulses

Food and feed processing

C Food Manufacturing

CI Processing of perishable animal products

CII Processing of perishable plant products

CIIIProcessing of perishable animal and plant products (mixed products)

CIV Processing of ambient stable products

D

Animal Feed

Production

DI Production of Feed

DII Production of Pet Food

Catering E Catering

Retail, transport and storage

F Distribution

FI Retail/Wholesale

FII Food Broking/Trading

GProvision of Transport and Storage Services

GIProvision of Transport and Storage Services for Perishable Food and Feed

GIIProvision of Transport and Storage Services for Ambient Stable Food and Feed

Auxiliary services

H Services

I Production of Food Packaging and Packaging Material

J Equipment manufacturing

Biochemical K Production of (Bio) chemicals





Annex C

Medical Devices Quality Management System (ISO 13485) Certification Scopes

A. NON-ACTIVE MEDICAL DEVICES TECHNICAL AREA

Main Technical Areas Technical Areas Product Categories Covered by the Technical Areas

Non-active Medical Devices

General non-active, non-implantable medical devices

Non-active devices for anesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopedic and rehabilitation devices Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive medical devices Non-active medical devices for disinfecting, cleaning, rinsing Non-active devices for in vitro fertilization (IVF) and assisted reproductive

technologies (ART)

Non-active implants

Non-active cardiovascular implants Non-active orthopedic implants Non-active functional implants Non-active soft tissue implants

Devices for wound care

Bandages and wound dressings Suture material and clamps Other medical devices for wound care

Non-active dental devices and accessories

Non-active dental devices/ equipment and instruments Dental materials Dental implants

Non-active medicaldevices other than specified above

B. ACTIVE (IMPLANTABLE/NON-IMPLANTABLE) MEDICAL DEVICES

Main Technical Areas Technical Areas Product Categories Covered by the Technical Areas





Active Medical Devices(Non- Implantable)

General active medical devices

Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy,

inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilization Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Active devices for in vitro fertilization (IVF) and assisted reproductive

technologies (ART) Software

Devices for imaging Devices utilizing ionizing rays Devices utilizing non-ionizing rays

Monitoring devices Monitoring devices of non-vital physiological parameters Monitoring devices of vital

Devices for radiation therapy and thermo therapy

Devices utilizing ionizing radiation Devices utilizing non-ionizing radiation Devices for hyperthermia / hypothermia Devices for (extracorporal) shockwave therapy (lithotripsy)

Active (non-implantable) medical devices other than specified above

C. IN VITRO DIAGNOSTIC MEDICAL DEVICES

Main Technical Areas Technical Areas

In Vitro Diagnostic Medical Devices (IVD)

Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haematology/Haemostasis/Immunohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing

In Vitro Diagnostic Instruments and software

IVD medical devices other than specified above

D. STERILIZATION METHODS FOR MEDICAL DEVICES

Main TechnicalAreas Technical Areas

Sterilization Method for Medical Devices

Ethylene oxide gas sterilization (EOG)

Moist heatAseptic processingRadiation sterilization (e.g. gamma, x-ray, electron beam)Sterilization method other than specified above

E. DEVICES INCORPORATING/UTILIZING SPECIFIC SUBSTANCES/TECHNOLOGIES

Main TechnicalAreas Technical Areas

Devices Incorporating/Utilizing Specific

Medical devices incorporating medicinal substances

Medical devices utilizing tissues of animal origin





Substances/Technologies

Medical devices incorporating derivatives of human blood

Medical devices utilizing micromechanics

Medical devices utilizing nanomaterials

Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed

Annex D

Energy Management System (ISO 50001) Scopes

a) Commercial Buildingsb) Light to Medium Industryc) Heavy Industryd) Transportatione) Building Complex Energy Usef) Energy Supplyg) Miningh) Other

Annex E

ISO/IEC 27001 (Information Security Management System), ISO/IEC 20000-1 (Information Technology Service Management System),

ISO 22301 (Business Continuity Management System),ISO 37001:2016 (Anti-Bribery Management System)

For the above mentioned standards, no specific scoping is currently available. Therefore, specific sectors/areas for certification need not be defined.




Documents

ukiaf.org FILE/AF-5-3... · Web viewPolicy formulation, process and/or procedure development, proceedings of safeguarding impartiality committee/scheme committee, application &