CLSI QMS25 : 1ED 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
HANDBOOK FOR DEVELOPING A LABORATORY QUALITY MANUAL
01-04-2023
23-01-2017
Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Answer to Question About a Quality Manual
Chapter 3 - Guidance for Contents of a Quality Manual
Chapter 4 - Getting Started
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Additional Resources
Appendix A - Structure and Contents of a Template for a Quality
System Essential-Based Policy
Appendix B1 - Organization and Leadership
Appendix B2 - Customer Focus
Appendix B3 - Facilities and Safety Management
Appendix B4 - Personnel Management
Appendix B5 - Supplier and Inventory Management
Appendix B6 - Equipment Management
Appendix B7 - Process Management
Appendix B8 - Documents and Records Management
Appendix B9 - Information Management
Appendix B10 - Nonconforming Event Management
Appendix B11 - External and Internal Assessments
Appendix B12 - Continual Improvement
Appendix C -Crosswalk of Quality System Essential to Related
Clauses of ISO 15189:2012 and ISO 17025
Appendix D1 - Example Quality Process Flow Chart: ?Document
Management Process
Appendix D2 - Example Quality Process Flow Chart: ?Training
and Competence Assessment Process
Appendix D3 - Example Quality Process Flow Chart: ?Nonconforming
Event Response Process
Appendix D4 - Example Quality Process Flow Chart: ?The Audit
Process
Appendix D5 - Example Quality Process Flow Chart: ?Process
Management Process
Appendix E1 - Example Quality Procedure: ?Correcting a Laboratory
Paper Record Procedure
Appendix E2 - Example Quality Procedure: ?Electronic Reporting
of a Laboratory Nonconforming Event Procedure
Appendix F1 - Example of a Quality Manual Table of Contents
With Process and Other Supporting Documents
Included in the Supporting Documents Section
Appendix F2 - Example of a Quality Manual Table of Contents With
Process and Other Supporting Documents Included in the
Applicable QSE Section
The Quality Management System Approach
Related CLSI References Materials
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