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ELENCO NORME E DOCUMENTI DI RIFERIMENTO PER L

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Page 1 of 26

Schedule of Accreditation

issued by

United Kingdom Accreditation Service

2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

United 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 Sector

Schemes 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/IEC

20000-1: 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 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 ABMS

United House

4 Hinton Road

Bournemouth

BH1 2EE

United Kingdom

Lead Office for EN 9104-001:2013

Aerospace Sector Scheme

F 3

Sector 6

Noida 201301

India

This 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 *). 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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; horticulture

Raising 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 with

ISO 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 with

ISO 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 Limited

Manufacture of chemicals, chemical

products and fibres excluding explosives 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 services

IAF 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 Full

IAF 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-trailers

Manufacture of invalid carriages.

IAF 23 Manufacturing not elsewhere classified Full IAF 24 Recycling Limited Recycling of non-hazardous materials 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 treatment

IAF 28 Construction Full

IAF 29 Wholesale and retail trade; Repair of

motor vehicles, motorcycles and personal and household goods

Full Including HACCP in accordance with the

principles of Codex Alimentarius (URS document AN 34) in association with ISO

9001 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 ISO

9001 associated with food and food chain

related activities only

IAF 31 Transport, storage and communication Full

IAF 32 Financial intermediation; real estate;

renting Full

IAF 33 Information technology Full

IAF 34 Engineering services Full

IAF 35 Other services Full

IAF 36 Public administration Full

0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 activities

Sporting activities

Other personal service activities

membership organisations, and of professional membership organisations

Travel agency, tour operator reservation

service and related activities

Radio broadcasting

Television programming and broadcasting

activities

Waste collection, treatment and disposal

END

ISO 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 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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

0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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) 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 blood

Medical devices utilising micromechanics

Medical devices utilising nanomaterials

Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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

0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 0043

Accredited to

ISO/IEC 17021-1: 2015

to provide management systems certification

Schedule of Accreditation

issued by

United 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 Agriculture

IAF 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 stationery

IAF 8 Publishing companies Full

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