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Chapter 12 - Quality Management and Accreditation

Published online by Cambridge University Press:  16 February 2022

David Mortimer ,
Lars Björndahl ,
Christopher L. R. Barratt ,
José Antonio Castilla ,
Roelof Menkveld ,
Ulrik Kvist ,
Juan G. Alvarez  and
Trine B. Haugen
David Mortimer
Affiliation:
Oozoa Biomedical Inc., Vancouver
Lars Björndahl
Affiliation:
Karolinska Institutet, Stockholm
Christopher L. R. Barratt
Affiliation:
University of Dundee
José Antonio Castilla
Affiliation:
HU Virgen de las Nieves, Granada
Roelof Menkveld
Affiliation:
Stellenbosch University, South Africa
Ulrik Kvist
Affiliation:
Karolinska Institutet, Stockholm
Juan G. Alvarez
Affiliation:
Centro ANDROGEN, La Coruña
Trine B. Haugen
Affiliation:
Oslo Metropolitan University
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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.

Keywords

accreditationlicensingquality managementquality controlquality assuranceEQAISOvalidationtrainingcompetencyBland and Altman plot
Type
Chapter
Information
A Practical Guide to Basic Laboratory Andrology , pp. 262 - 289
Publisher: Cambridge University Press
Print publication year: 2022

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