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United Kingdom Accreditation Service. Background and Introduction 2014 Seminars. UKAS – who we are. The national accreditation body Established in 1995 by Ministers as a private company limited by guarantee UKAS appointed as national accreditation body by The Accreditation Regulations 2009.
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United Kingdom Accreditation Service Background and Introduction 2014 Seminars
UKAS – who we are • The national accreditation body • Established in 1995 by Ministers as a private company limited by guarantee • UKAS appointed as national accreditation body by The Accreditation Regulations 2009
UKAS – mandate • EU Regulation 765/2008 provides legal framework for accreditation • Operates under an MoU with BIS • Accreditation recognised as a public authority activity • Duty to act in the public interest: commercially aware, but not commercially driven
UKAS – what we do • Accreditation – the recognition of competence of organisations to perform specific tasks • UKAS assesses for compliance against criteria of competence (international standards)
UKAS and CPA UKAS CPA Chief Executive Business Development Director Finance Director Technical Director UKAS CPA Accreditation Manager UKAS CPA Transition Project Manager UKAS/CPA Assessment Managers
UKAS and CPA • Clinical Pathology Accreditation (UK) • Private company, wholly owned by UKAS • CPA is a non-profit distributing organisation that acts in the public interest.
Requirements for MLA/MRA • Compliance with: • EC Regulation 765/2008 • ISO/IEC 17011:2004 • European cooperation for Accreditation requirements EA 2/02:2011 • International Accreditation Forum and International Laboratory Accreditation Cooperation IAF/ILAC A2:2010
EA, ILAC/IAF requirements • Requirements and mandatory documents • Applicable IAF and ILAC guidance documents • Relevant supplementary requirements • Applicable requirements of Regional Group
Supplementary requirements • Experience of assessment • Experience of operating an accreditation body • Access to technical expertise • Acceptable routes for traceability • Relevant requirements for proficiency testing • Abide by/promote regional/international arrangement(s) • Contribute resources for peer evaluations • Implement a cross frontier accreditation policy • Only subcontract to other signatories
Impact on laboratories • Pathology laboratories complying with ISO 15189 • Point of care testing complying with ISO 22870 • Withdrawal of CPA Standards
United Kingdom Accreditation Service Background and Introduction 2014 Seminars