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Quality Issues
12.1 Can you name three differences between IQC and EQA?
IQC:
Nature: Concurrent and continuous
Performed by: Laboratory staff
Objective: Release of reliable results on day to day basis
EQA:
Nature: Retrospective and periodic
Performed by: Independent agency
Objective: Ensure inter-laboratory comparability
12.2 (a) What standards are used for medical laboratory accreditation? (b) What standards are used by the MHRA to assess compliance to the BSQR?
(a) CPA use their own standards based on ISO 15189.
(b) MHRA use GMP based on the UK Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as the ‘Orange Book’.