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Chapter 12 - Quality Management and Accreditation
David Mortimer, Lars Björndahl, Karolinska Institutet, Stockholm, Christopher L. R. Barratt, University of Dundee, José Antonio Castilla, Roelof Menkveld, Stellenbosch University, South Africa, Ulrik Kvist, Karolinska Institutet, Stockholm, Juan G. Alvarez, Trine B. Haugen
Book:

A Practical Guide to Basic Laboratory Andrology

Published online:

16 February 2022

Print publication:

10 March 2022, pp 262-289
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Summary

Following an overview of Quality Management concepts and the creation of a Quality Management System (QMS) there is a discussion of the principles of Accreditation and Accreditation schemes. The importance of training is emphasized, and the goal-orientated reiterative assessments apporach described, including defining criteria for competence as the endpoint of training. There are also discussion on quality control, measurement uncertainty, test method selection and comparison,laboratory equipment monitoring, and External Quality Assurance (EQA). A section on regulatory aspects includes a comparison between Standards (including the new ISO 23162) and guidelines. A final section describes a framework for validating new test methods.