1. Decision making process 2014 Seminars

2. Introduction • Background to CPA decision making • Current approach due to recent changes • Differences under UKAS • How CPA accreditation be maintained • How ISO 15189 accreditation be granted

3. Background • Nonconformities left with the lab by team – CNC/NCNC • Recommendation left with lab • Reports written and sent to Decision Maker (DM) • DM reviews and status is confirmed • Lab receives report 2-8 weeks after visit (included receipt of Clearance Review Form) • Classification or content of findings could have changed. Clauses could have been added/removed • Findings to be cleared within a defined timescale

4. Current approach • As of March 2013 a single CNC did not automatically mean Conditional status • Guidance of eight weeks to submit evidence rather than just state 12 weeks to clear • As of 1 August 2013, Conditional status disappeared: • Applicant • Accredited • Suspended (Partial/Total) • Withdrawn (Partial/Total)

5. UKAS approach • Nonconformities, Executive Summary and Recommendation left with lab • Improvement Action Summary Form (IASF) left with lab at visit (equivalent to Clearance Review Form). • Assessment Report provided to the lab within five working days (equivalent to Overview). • DM reviews documentation but nothing is changed – questions are asked of the Assessment Manager if necessary – Provisional Decision • DM prepares package of correspondence

6. DM correspondence with lab • Positive Provisional Decision: • Draft Schedule of Accreditation • Offer of accreditation letter • Estimate of effort for the four year cycle of accreditation

8. Schedule of accreditation • Defines the breadth of activities a lab is accredited for • By discipline • By matrix • By site • By individual analyte • Benefits the Accreditation Body and the lab

9. Final Decision • Evidence reviewed and findings cleared • Offer of accreditation letter signed and returned • DM reviews package of information • Production of Grant of Accreditation letter and Certificate of Accreditation for lab

10. Transition process • Some findings raised will apply to CPA and ISO 15189 • Some findings will be ISO 15189-only • Labs must clear findings that would apply to CPA Standards to ensure maintenance of accreditation • 15189-related findings are not as time-critical • There will still be a requirement to clear CPA-related findings within 12 weeks and so an eight week deadline for submission of evidence will be given.

11. Summary • Labs will receive documentation at, or very soon after the visit • Content and classification of findings will not be changed • Scope will be defined on a Schedule of Accreditation • Timescales to submit evidence will be defined at the visit • Any findings that would have been raised at a CPA Main Visit will have to be cleared within 12 weeks to maintain accreditation • Once all findings are cleared, laboratory will transition to ISO 15189 accreditation under UKAS

12. Decision making process 2014 Seminars