ConCAss Open Day: 3 Dec 08
Implementing the accreditation aspects of Regulation 765/08
John Mortimer
What I am going to talk about today
• DIUS’ role and responsibility
• What is accreditation and scope of Regulation
• ImplementationWhat has to be implemented
DIUS’ approach to implementation
Where we currently stand
• Article 7 – Cross Border
DIUS role and responsibility
• Innovation Group leads on all aspects of standardisation policyAccreditation & conformity assessment
• UKAS a DIUS Delivery PartnerDIUS 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
What is accreditation?
Attests Meet
Harmonisedstandards
Additional Requirements
RelevantSectoralSchemes
+
+NABNAB
ConformityAssessment
Bodies
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
De
live
rs
Government recognises UKAS as the UK National
Accreditation Body
Conformity Assessment
(testing & calibration labs,certification and inspection bodiesor any independent evaluation)
Business
(people, management systems, equipmentorganisations, products, etc)
UKASAccreditation
CONSUMERS PURCHASERS
Confidence Trust AssuranceDe
live
rs
De
live
rs
Harmonised standards
ISO/IEC 17011 - Requirements for Accreditation Bodies for accreditation of:
Standards for accreditation
Manufacturer
Certification bodies – for certification of: Laboratories Inspection bodies
ProductsEN 45011
for PersonsISO / 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
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;
And?
• Additional requirements ….. Including
• Those set out in sectoral schemes
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
What has to be implemented?
• This Regulation is directly applicable law
Implementation
Appointmentof UK NAB
Commission
Who NAB is
Scope
DIUS
Monitoring
Utmost account of peer
evaluations
Public authorityactivity
Not for profit
Not provide service that
CABs do or have interest in
Member of EA
Regularly peer evaluated
Appeals
DIUS’ approach
• Light touch
• Administrative measures wherever possible
• Letter of appointment or possibly Statutory Instrument
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
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?