CLSI QMS02 A6 : 6ED 2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Need for New Document
5 Document Type is Determined
6 Document Is Drafted
7 Draft Is Evaluated, Edited as Needed, and Verified
8 Approval
9 Training Requirements Determined and Training Verified
10 Document Is Distributed and Implemented
11 Document Maintenance
12 Control of Reference Documents
13 Procedures Manuals
14 Key Features of Electronics Document Management System
15 How to Get Started
16 Conclusion
References
Appendix A - Sample Policy: "Quality System Essential
             Facilities and Safety Policy"
Appendix B - Sample Policy: "Quality System Essential
             Nonconforming Event Management policy"
Appendix C - Sample Quality Process for Quality System
             Essential Assessments: "Unannounced
             Inspection Day Process"
Appendix D - Sample Preexamination Process: "Blood
             Sample Collection Process"
Appendix E1 - Sample Examination Process: "Analyzer
              Setup and Run Process"
Appendix E2 - Sample Examination Process: "Surgical
              Pathology Process"
Appendix F - Sample Postexamination Process: "Critical
             Value Handling Process"
Appendix G1 - Sample Quality Procedure: "Correcting
              a Laboratory Paper Record Procedure"
Appendix G2 - Sample Preexamination Procedure: "Identifying
              the Patient for Sample Collection Procedure"
Appendix G3 - Sample Microbiology Examination Procedure:
              "Urine Culture: Reading and Interpreting
              Procedure"
Appendix G4 - Sample Transfusion Medicine Examination
              Procedure: "Weak D (D[u]) Determination
              Procedure"
Appendix G5 - Sample Histology Examination Procedure:
              "Hematoxylin and Eosin Staining Procedure:
              Manual Method"
Appendix G6 - Sample Postexamination Procedure:
              "Critical Values Reporting Procedure"
Appendix H1 - Sample Job Aid: "Shared Testing Job Aid"
Appendix H2 - Sample Job Aid: "Draw Tubes and Minimum Fill"
Appendix I1 - Sample Form: "Document Management Form"
Appendix I2 - sample Form: "ABO/Rh Discrepancy Worksheet"
Appendix J - Suggested Contents of Templates for Laboratory
             Documents
Appendix K1 - How to Construct a Process Flow Chart
Appendix K2 - Sample Process Flow Chart: "Laboratory Sample
              Receiving Process"
Appendix K3 - Sample Process Flow Chart: "Bacteriology
              Culture Process"
Appendix K4 - Table Format for the Document Management Process
Appendix L1 - Sample Attributes for a Single Analyte on a
              Single Analyzer
Appendix L2 - Attributes for Multiple Analytes on a Single
              Analyzer
Appendix L3 - Attributes for a Single Analyte on a Multiple
              Analyzers
Appendix M - Sample Checklist: Document Review Checklist
Appendix N - Sample Form: "Group Training Record"
Appendix O1 - Sample Procedures Manual Table of Contents:
              "Transfusion Reaction Investigation Process"
Appendix O2 - Sample Procedures Manual Table of Contents:
              "Automated Analyzer Operations Process"
Appendix P - Ten Rules for Laboratory Document Management
The Quality Management System Approach
Related CLSI Reference Materials

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

This guideline presents evidence-based suggestions for preparing different types of laboratory documents. In addition, a process is described for how laboratory documents can be managed and controlled from the time a need is recognized for a new or revised document, through the document’s use and control, until the time it is retired.This guideline is applicable to documents used by medical laboratories of any size, complexity, or specialty, including point-of-care testing.QMS02 is intended for use by the following: · Administrative and technical personnel who develop laboratory documents · Manufacturers · Educators · Regulatory and accreditation organizations QMS02 is a guideline for how to implement requirements established in international standards, and by regulatory and accrediting organizations for laboratory documents and procedures manuals. QMS02 is not a standard; that is, this guideline does not set requirements for laboratory documents and procedures. Instead, this guideline describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards2-13 for documents and document management, and provides suggestions and examples for fulfilling the requirements.