CLSI QMS15 A : 1ED 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM
28-03-2023
25-08-2018
Abstract
Committee Membership
Foreword
Chapter 1: Introduction
Chapter 2: Rationale for a Laboratory Internal
Audit Program
Chapter 3: Development of the Laboratory Internal
Audit Program
Chapter 4: Structure of the Internal Audit Process
Chapter 5: Conclusion
Chapter 6: Supplemental Information
References
Appendix A1: Laboratory Internal Auditor Training Guide
Appendix A2: Laboratory Internal Audit Trainer
Responsibilities
Appendix A3: Laboratory Internal Auditing Learner
Responsibilities
Appendix A4: Training Checklist for the Laboratory Internal
Auditing Process
Appendix B - Annual Audit Schedule
Appendix C - Laboratory Internal Audit Plan
Appendix D - Example (Excerpt) of an abbreviated
Internal Audit Tool
Appendix E - Sample Laboratory Product Management Audit
Appendix F - Sample Audit Sheet
Appendix G1 - Assessment Tool for Verifying the Effectiveness
of Document Control (Formant 1)
Appendix G2 - Assessment Tool for Verifying the Effectiveness
of Document Control (Formant 2)
Appendix H1 - Example of an Audit Findings Report
Appendix H2 - Sample Audit Report
Appendix H3 - Example of a Quality Assessment Audit
Findings Report
Appendix H4 - Assessment Findings and Quality Action Form
Appendix I - Audit Evaluation Example
Appendix J - Sample Internal Audit Feedback Form
The Quality Management System Approach
Related CLSI References Materials
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