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 2
Notifying Bodies - UK 3
Nando (New Approach Notified and Notifying Bodies - UK Designated Organisations) Information System 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) 4
Medicines and Healthcare products Regulatory Agency (MHRA) MHRA is the designating and competen t 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 or more Notified Bodies, to act as independent third party assessors of the manufacturer’s compliance. 5
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. 6
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 ). 7
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 . 8
System Responsibility Type of notified Tasks type body System 1+ Notified body Product certification Initial Inspection of the fpc system body 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 Initial Inspection of the fpc system C body Continuous Surveillance of the fpc system Determination of product type P Manufacturer Factory Production Control and further R testing of samples System 2+ Notified body Factory production Initial Inspection of the fpc system control certification Continuous Surveillance of the fpc body 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 Factory Production Control involvement Determination of product type 9
Notified Bodies - UK . UK National Standards Body Notified body for nearly all Notified Body for the Medical Notified Body for products EU product safety directives , Devices Directive (93/42/EEC). requiring CE marking Notified Body for the CE marking of products under the EU Directives on personal protective equipment, toys, medical devices and construction products . 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 10
UK Notified Bodies for medical devices 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) 11
UK Market Surveillance 12
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