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External Assessments, Audits, and Inspections of the Laboratory, 2nd Edition

This guideline provides recommendations for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external organization. This includes selecting and evaluating an external assessment organization, preparing for and undergoing a successful assessment, and sustaining ongoing readiness for assessment. 


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Chairholder: Lucia M. Berte, MA, MLS(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE

Date of Publication: September 29, 2023

Order Code PDF: CLSI QMS17Ed2E
ISBN Number: 978-1-68440-199-4

Order Code Print: CLSI QMS17Ed2
ISBN Number: 978-1-68440-198-7

Edition: Second

Pages: 78

CLSI QMS17 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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CLSI QMS17 Abstract

Clinical and Laboratory Standards Institute guideline QMS17—External Assessments, Audits, and Inspections of the Laboratory outlines the process of selecting an assessment organization, preparing the laboratory for assessment, undergoing the assessment, responding to any deficiencies, and sustaining the state of readiness in a logical, ongoing cycle. This guideline provides expert information from laboratory professionals, industry, and accreditation organization perspectives to assist laboratories in planning for and attaining successful external assessments. External assessments include on-site and virtual audits, inspections, site visits, and surveys of laboratories and can also apply to some laboratory industry settings.