1. ConCAss Open Day: 3 Dec 08 Implementing the accreditation aspects of Regulation 765/08 John Mortimer

2. What I am going to talk about today DIUS’ role and responsibility What is accreditation and scope of Regulation Implementation What has to be implemented DIUS’ approach to implementation Where we currently stand Article 7 – Cross Border

3. DIUS role and responsibility Innovation Group leads on all aspects of standardisation policy Accreditation & conformity assessment UKAS a DIUS Delivery Partner DIUS sponsors UKAS DIUS has a MoU with UKAS DIUS involved in negotiation of the Regulation DIUS responsible for implementing the accreditation aspects of the Regulation – EC 765/08 Accreditation and Market Surveillance BERR responsible for implementing the market surveillance aspects

4. What is accreditation? NAB Conformity Assessment Bodies

5. BSI helps develop and promote standards UKAS uses International standards to assess GOVERNMENT How the Standardisation Infrastructure operates CABs use standards / regulatory requirements / scheme criteria Delivers Government recognises UKAS as the UK National Accreditation Body Conformity Assessment (testing & calibration labs, certification and inspection bodies or any independent evaluation) Business ( people, management systems, equipment organisations, products, etc) UKAS Accreditation CONSUMERSPURCHASERS ConfidenceTrustAssurance Delivers

6. ISO/IEC 17011 - Requirements for Accreditation Bodies for accreditation of: Standards for accreditation Manufacturer Certification bodies – for certification of: Laboratories Inspection bodies Products EN 45011 for Persons ISO / IEC 17024 Products Persons Testing and Calibration Laboratories ISO / IEC 17025 ISO 15189 Testing and Calibration ISO/IEC 17020 Inspection Supplier, manufacturer Management systems ISO/IEC 17021 Environmental, Quality etc Management Systems

7. UKAS MoU appendix APPENDIX 1 The following are the activities for which UKAS is recognised by the Secretary of State as the sole national body under the terms of the memorandum: The accreditation to the International Standard ISO/IEC 17025 of laboratories carrying out tests and/or calibrations, including sampling; The accreditation of medical laboratories to ISO 15189; The accreditation of reference material producers to ISO Guide 34; The accreditation of providers of proficiency testing schemes to ISO/IEC Guide 43-1. The accreditation of inspection bodies to ISO/IEC 17020; The accreditation of certification bodies to ISO/IEC 17021 for the certification of management systems; The accreditation of certification bodies to the European Standard EN 45011 for the certification of products; The accreditation of certification bodies to ISO/IEC 17024 for the certification of persons; The accreditation of attestors and attestation bodies to EN 45503 for the assessment of contract award procedures of entities operating in the water, energy, transport and telecommunications sectors; The accreditation of environmental verifiers under EU Council Regulation (EC) No 761/2001 on an Eco- Management and Audit Scheme;

8. And? Additional requirements ….. Including Those set out in sectoral schemes

9. Scope Compulsory OR voluntary relating to conformity assessment Whether the assessment is compulsory or not Irrespective of the legal status of the body performing the accreditation

10. What has to be implemented? This Regulation is directly applicable law

11. Public authority activity Not for profit Not provide service that CABs do or have interest in Member of EA Regularly peer evaluated Appeals

12. DIUS’ approach Light touch Administrative measures wherever possible Letter of appointment or possibly Statutory Instrument

13. Implementation progress So far Decide what needed to be done Information gathering Analysis how should it be done Information/consultation exercise [Re-]appoint UKAS as UK NAB Interpretation of more difficult provisions To come Ministerial approval Formalities

14. Cross border Aim to support the UK interest Position as is stated in information pack – Annex C Have presented to Commission. Need to reconcile differing views. Anticipate SOGS [Senior Officials Group on Standardisation] will be one major vehicle HMG will use best endeavours to come to an agreement before the Regulation applies on 1 January 2010 Meanwhile ‘business as usual’ Your views?

15. Thank you John Mortimer john.mortimer@dius.gsi.gov.uk