Accreditation Authority and Notified Bodies United Kingdom - - PowerPoint PPT Presentation

United Kingdom Accreditation Authority and Notified Bodies

United Kingdom Accreditation Service [UKAS]

• UKAS has an annual turnover in excess of £26M.
• Employs 230 permanent staff
• UKAS currently accredits:
• Around 1500 Laboratories
• Over 150 Certification Bodies
• Over 250 Inspection Bodies
• Around 20 Proficiency Testing and Reference Material providers
• Medical Laboratories and Departments

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Notifying Bodies - UK

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Notifying Bodies - UK

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• Department for Business, Innovation and Skills (BIS)
• Department for Business, Innovation and Skills

 National Measurement Regulation Office

• Department for Communities and Local Government
• Department for Environment, Food & Rural Affairs (DEFRA)

 Climate & Energy: Households & Markets Division

• Department for Transport (DfT) - Buses and Taxis Division
• Department for Transport (DfT) - Rail Group
• Department for Transport (DfT) - Regional and Local Major Projects Division
• Department of Health Medicines and Healthcare Products Regulatory Agency (MHRA)
• Health and Safety Executive (HSE)
• Maritime and Coastguard Agency
• Vehicle Certification Agency (VCA)

Nando (New Approach Notified and Designated Organisations) Information System

Medicines and Healthcare products Regulatory Agency (MHRA)

• MHRA is the designating and competent authority in the UK
• The Competent Authority is a body with authority to act on

behalf of the government of the member state to ensure that the requirements of the Medical Device Directives are transposed into National Law and are applied.

• The Designating Authority is responsible for specifying one
• r more Notified Bodies, to act as independent third party

assessors of the manufacturer’s compliance.

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Construction Products Regulation

 Article 40.1 of the CP Regulation requires Member States to

designate a notifying authority.

 In the UK this is the Department for Communities and Local

Government.

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Construction Products Regulation (EU) No 305/2011

• Harmonises
• the methods of assessment and test,
• the means of declaration of product performance; and
• the system of conformity assessment of construction products, but
• NOT national building regulations.
• The choice of required values for the particular intended use is left to

the regulators and public / private sector procurers at the national level.

• Products covered by a harmonised European standard (hEN) or a

European Technical Assessment (ETA).

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Construction Products Regulation (EU) No 305/2011

• Assessment and verification of constancy of

performance [AVCP]

• AVCP is the term applied to define the degree of involvement of third

parties in assessing the conformity of the product according to the relevant technical specification(s).

• For each product family, the system of AVCP is decided collectively by

the Member States and the European Commission.

• They do so on the basis of the implications of the product on health

and safety and on the particular nature and production process for the product itself.

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System type Responsibility Type of notified body Tasks System 1+ Notified body Product certification body Initial Inspection of the fpc system Continuous Surveillance of the fpc system Determination of product type Audit testing Manufacturer Factory Production Control and further testing of samples System 1 Notified body Product certification body Initial Inspection of the fpc system Continuous Surveillance of the fpc system Determination of product type Manufacturer Factory Production Control and further testing of samples System 2+ Notified body Factory production control certification body Initial Inspection of the fpc system Continuous Surveillance of the fpc system Manufacturer Factory Production Control and further testing of samples Determination of product type System 3 Notified body Test Laboratory Determination of product type Manufacturer Factory Production Control System 4 Manufacturer No independent involvement Factory Production Control Determination of product type

C P R

Notified Bodies - UK

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.

TÜV UK Ltd is:

• UKAS accredited Type A Third Party Inspection Organisation (UKAS Accreditation No 033)
• Certification Body (UKAS Accreditation Number 065) and
• Notified Body (0879) for services according to the European Pressure Equipment Directive

Notified Body for the CE marking of products under the EU Directives on personal protective equipment, toys, medical devices and construction products.

Notified Body for the Medical Devices Directive (93/42/EEC). Notified body for nearly all EU product safety directives, UK National Standards Body Notified Body for products requiring CE marking

UK Notified Bodies for medical devices

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• Amtac Certification Services Ltd (0473)
• BSI Healthcare (0086)
• Lloyd’s Register Quality Assurance Ltd (0088
• SGS United Kingdom Ltd (0120)
• UL International (UK) Ltd (0843)

UK Market Surveillance

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