Standard Document
First Edition
Quality Management Systems

CLSI QMS13A

Quality Management System: Equipment

CLSI QMS13A provides expert guidance for creating effective equipment management processes, covering everything from selection to decommissioning, to ensure optimal performace and reliability in laboratory operations.

This document is exclusively available in the electronic format for your convenience and accessibility.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of March 2017.

August 22, 2011
Susan Blonshine, RRT, RPFT, FAARC

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Abstract

Clinical and Laboratory Standards Institute document QMS13-A—Quality Management System: Equipment; Approved Guideline provides recommendations for establishing criteria and methods for all aspects of managing laboratory equipment including selection, identification, validation, reverification, use, and decommission of equipment required for the provision of laboratory services. This guideline focuses on general and service-specific equipment, instruments, and analytical systems. This guideline is intended for individuals and laboratories that perform medical testing.

Scope

This guideline is intended for individuals and laboratories that perform medical testing and focuses on general and service-specific equipment, instruments, and analytical systems. Recommendations for establishing criteria and methods for all aspects of equipment operation—including selection, identification, validation, reverification, use, and decommission of equipment—are provided. 

Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents and CLSI documents AUTO08, AUTO11, and GP19. 

A detailed description of acquisition options is beyond the scope of this document.

Product Details
QMS13AE
1-56238-763-4
72
Additional Details

This document is available in electronic format only.

Authors
Susan Blonshine, RRT, RPFT, FAARC
Dorothy J. Ball, PhD
Christine Flaherty, MHA, CLS, CPHQ
Jason Majorowicz, BS
David Manalan, F(ASQ), CSQE, CBA, CQA
Caroline Satyadi, MS, MBA, DLM(ASCP), SM; SLS, CLS
Diane I. Szamosi, MA, MT(ASCP)SH
Abstract

Clinical and Laboratory Standards Institute document QMS13-A—Quality Management System: Equipment; Approved Guideline provides recommendations for establishing criteria and methods for all aspects of managing laboratory equipment including selection, identification, validation, reverification, use, and decommission of equipment required for the provision of laboratory services. This guideline focuses on general and service-specific equipment, instruments, and analytical systems. This guideline is intended for individuals and laboratories that perform medical testing.

Scope

This guideline is intended for individuals and laboratories that perform medical testing and focuses on general and service-specific equipment, instruments, and analytical systems. Recommendations for establishing criteria and methods for all aspects of equipment operation—including selection, identification, validation, reverification, use, and decommission of equipment—are provided. 

Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents and CLSI documents AUTO08, AUTO11, and GP19. 

A detailed description of acquisition options is beyond the scope of this document.

Additional Details

This document is available in electronic format only.

Authors
Susan Blonshine, RRT, RPFT, FAARC
Dorothy J. Ball, PhD
Christine Flaherty, MHA, CLS, CPHQ
Jason Majorowicz, BS
David Manalan, F(ASQ), CSQE, CBA, CQA
Caroline Satyadi, MS, MBA, DLM(ASCP), SM; SLS, CLS
Diane I. Szamosi, MA, MT(ASCP)SH