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Mar 31 2022 management systems - Part 3: Competence requirements for auditing and certification of quality management system. UNI CEI ISO/IEC TS 17021-.
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Page 1 of 26
Schedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationUnited Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
United House
4 Hinton Road
Bournemouth
Dorset
BH1 2EE
Contact: Mr D Riggs
Tel: +44 (0)1202 552 153
Fax: +44 (0)1202 290 716
E-Mail: info@urs-holdings.com
Website: www.urs-holdings.com/
SUMMARY OF ACCREDITED SCOPE
Accredited to provide certification of the following Management Systems Standards and related SectorSchemes as detailed in this schedule:
Quality Management Systems (QMS) to ISO 9001: 2015 Medical Devices - Quality Management Systems (MD-QMS) to ISO 13485: 2016 Environmental Management Systems (EMS) ISO 14001: 2015 Information Technology Service Management Systems (ITSMS) to ISO/IEC 20000-1: 2011 and ISO/IEC20000-1: 2018
Food Safety Management Systems (FSMS) to ISO 22000: 2005 and ISO 22000: 2018 Business Continuity Management Systems (BCMS) to ISO 22301: 2012 and ISO 22301: 2019 Information Security Management Systems (ISMS) to ISO/IEC 27001: 2013 Health and Safety Management Systems (HSMS) to BS OHSAS 18001: 2007 and ISO 45001: 2018 Energy Management Systems (EnMS) to ISO 50001: 2018 Anti-Bribery Management Systems (ABMS) to ISO 37001: 2016 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 2 of 26
KEY LOCATION ADDRESS QMS
MD -QMS EMS ITSMS FSMS BCMS ISMS HSMS EnMS ABMSUnited House
4 Hinton Road
Bournemouth
BH1 2EE
United Kingdom
Lead Office for EN 9104-001:2013
Aerospace Sector Scheme
F 3Sector 6
Noida 201301
IndiaThis Certification Body has demonstrated to UKAS that it has the systems and processes in place to provide the
competence and capability, including understanding of local requirements, to manage and issue accredited
management systems certification in the country in which it is established and in any other country, for the standards
and scopes detailed on this schedule, unless specifically detailed in the individual Management System scope table
(denoted by *). 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 3 of 26
QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 9001: 2015 Certification
Accreditation Scope Reference
(as defined in IAF ID 1)Full / Limited
Accreditation Extent of Scope
IAF 1 Agriculture, forestry and fishing Limited
Growing of crops (non animal feed); market
gardening; horticultureRaising of (non diary) cattle and buffaloes
Raising of swine/pigs
Including HACCP in accordance with the
principles of Codex Alimentarius (URS document AN 34) in association withISO 9001for a limited scope associated with
food chain related activity. IAF 3 Food products, beverages and tobacco Full Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association withISO 9001
IAF 4 Textiles and textile products Full
IAF 5 Leather and leather products Full
IAF 6 Wood and wood products Full
IAF 7 Pulp, paper and paper products Full
IAF 8 Publishing companies Full
IAF 9 Printing companies Full
IAF 12 Chemicals, chemical products and fibres LimitedManufacture of chemicals, chemical
products and fibres excluding explosives 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 4 of 26
QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 9001: 2015 Certification
Accreditation Scope Reference
(as defined in IAF ID 1)Full / Limited
Accreditation Extent of Scope
IAF 13 Pharmaceuticals Limited Manufacture of botanical products.Compounding, supply and delivery of
medically prescribed treatment, including pharmaceutical, medical and ancillary products and servicesIAF 14 Rubber and plastic products Full
IAF 15 Non-metallic mineral products Full
IAF 16 Concrete, cement, lime, plaster etc Full
IAF 17 Basic metals and fabricated metal
products FullIAF 18 Machinery and equipment Full
IAF 19 Electrical and optical equipment Full
IAF 21 Aerospace Full
IAF 22 Other transport equipment Limited
Manufacture of motor vehicles, trailers and
semi-trailersManufacture of invalid carriages.
IAF 23 Manufacturing not elsewhere classified Full IAF 24 Recycling Limited Recycling of non-hazardous materials 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 5 of 26
QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 9001: 2015 Certification
Accreditation Scope Reference
(as defined in IAF ID 1)Full / Limited
Accreditation Extent of Scope
IAF 27 Water supply Limited Water collection and treatmentIAF 28 Construction Full
IAF 29 Wholesale and retail trade; Repair of
motor vehicles, motorcycles and personal and household goodsFull Including HACCP in accordance with the
principles of Codex Alimentarius (URS document AN 34) in association with ISO9001 for a limited scope associated with
food and food chain related products only IAF 30 Hotels and restaurants Full Including HACCP in accordance with the principles of Codex Alimentarius (URS document AN 34) in association with ISO9001 associated with food and food chain
related activities onlyIAF 31 Transport, storage and communication Full
IAF 32 Financial intermediation; real estate;
renting FullIAF 33 Information technology Full
IAF 34 Engineering services Full
IAF 35 Other services Full
IAF 36 Public administration Full
0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 6 of 26
QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 9001: 2015 Certification
Accreditation Scope Reference
(as defined in IAF ID 1)Full / Limited
Accreditation Extent of Scope
IAF 37 Education Full
IAF 38 Health and social work Full
IAF 39 Other social services Limited
Library, archives, museums and other
cultural activitiesSporting activities
Other personal service activities
membership organisations, and of professional membership organisationsTravel agency, tour operator reservation
service and related activitiesRadio broadcasting
Television programming and broadcasting
activitiesWaste collection, treatment and disposal
ENDISO 9001 Sector Scheme Accreditation
Aerospace Sector Certification Scheme
EN 9104-001:2013 for the certification of clients to:AS, EN or JISQ 9100 including the 2018 version
AS, EN or JISQ 9120 including the 2018 version
END 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 7 of 26
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 13485: 2016 Certification
IAF Mandatory Scopes of Accreditation
Scope Reference Technical Area
1.1 Non-active Medical Devices General non-active, non-implantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
1.2 Active Medical Devices (Non-
Implantable) General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
1.3 Active Implantable Medical Devices General active implantable medical devices
0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 8 of 26
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 13485: 2016 Certification
IAF Mandatory Scopes of Accreditation
Scope Reference Technical Area
1.4 In Vitro Diagnostic Medical Devices (IVD) Reagents and reagent products, calibrators and control materials
for:Clinical Chemistry
Immunochemistry (immunology)
Haematology /Haemostasis /Immunohematology
Microbiology
Infection Immunology
Histology/cytology
Genetic Testing
In vitro diagnostic instruments and software
1.5 Sterilisation Method for Medical Devices Ethylene oxide gas (EOG)
Moist heat
Aseptic processing
Radiation sterilisation (e.g. gamma, x-ray, electron beam) 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 9 of 26
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 13485: 2016 Certification
IAF Mandatory Scopes of Accreditation
Scope Reference Technical Area
1.6 Devices Incorporating/Utilising Specific
Substances/Technologies Medical devices incorporating medicinal substances Medical devices utilising tissues of animal origin Medical devices incorporating derivatives of human bloodMedical devices utilising micromechanics
Medical devices utilising nanomaterials
Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 10 of 26
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 13485: 2016 Certification
IAF Mandatory Scopes of Accreditation
Scope Reference Technical Area
1.7 Parts or Services Raw Materials
Components
Subassemblies
Calibration Services
Distribution Services
Maintenance Services
0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 11 of 26
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 13485: 2016 Certification
IAF Mandatory Scopes of Accreditation
Scope Reference Technical Area
Transportation Services
Other services
END 0043Accredited to
ISO/IEC 17021-1: 2015
to provide management systems certificationSchedule of Accreditation
issued byUnited Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
United Registrar of Systems Ltd
Issue No: 093 Issue date: 22 June 2021
Page 12 of 26
ENVIRONMENTAL MANAGEMENT SYSTEMS
In accordance with ISO/IEC 17021-1: 2015
ISO 14001: 2015 Certification
Accreditation Scope Reference
(as defined in IAF ID 1)Full / Limited
Accreditation Extent of Scope
IAF 1 Agriculture, forestry and fishing Limited AgricultureIAF 3 Food products, beverages and tobacco Full
IAF 4 Textiles and textile products Full
IAF 6 Wood and wood products Full
IAF 7 Pulp, paper and paper products Limited Manufacture of paper stationeryIAF 8 Publishing companies Full
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