Decision making process
Decision making process. 2014 Seminars. 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. Background.
Decision making process
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Presentation Transcript
Decision making process 2014 Seminars
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
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
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to clear • As of 1 August 2013, Conditional status disappeared: • Applicant • Accredited • Suspended (Partial/Total) • Withdrawn (Partial/Total)
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
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
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
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
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.
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
Decision making process 2014 Seminars
