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?

• Thank you

• John Mortimer

• john.mortimer@dius.gsi.gov.uk