CLSI QMS02

Developing and Managing Laboratory Documents, 7th Edition

CLSI QMS02 provides guidance on the processes needed for documents management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments.

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

Date of Publication: March 11, 2024

Order Code PDF: CLSI QMS02Ed7E
ISBN Number: 978-1-68440-205-2

Order Code Print: CLSI QMS02Ed7
ISBN Number: 978-1-68440-204-5

Edition: Seventh

Pages: 122

CLSI QMS02 Additional Details

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

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CLSI QMS02 Abstract

Clinical and Laboratory Standards Institute document QMS02—Developing and Managing Laboratory Documents presents the important components of a program for documents management, including creating, reviewing, approving, maintaining, assessing, changing, and retiring documents used in the laboratory environment. This guideline describes the components of a documents management program, whether paper-based or electronic, and the related processes for creating and managing laboratory documents. Key features of electronic document management systems are also described. Several examples of process and procedure documents for quality management and preexamination, examination, and postexamination laboratory activities are included.