CPA is a UKAS
company
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
CPA is a UKAS
company
Background
CPA is a UKAS
company
• 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
CPA is a UKAS
company
• 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• Withdrawn (Partial/Total)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
CPA is a UKAS
company
• 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
CPA is a UKAS
company
CPA is a UKAS
company
Schedule of accreditation
CPA is a UKAS
company
• 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
CPA is a UKAS
company
• 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
CPA is a UKAS
company
• 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
CPA is a UKAS
company
• 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
CPA is a UKAS
company
Decision making process
2014 Seminars