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CLSI QMS15 A : 1ED 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM

Superseded date

28-03-2023

Superseded by

CLSI QMS15 : 2022

Published date

25-08-2018

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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

Specifies guidance for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement.

DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

CLSI QMS25:1ED 2017 Handbook for Developing a Laboratory Quality Manual
CLSI QMS18 : 1ED 2015 PROCESS MANAGEMENT
CLSI QMS17 : 2017 EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY
CLSI POCT4 : 3ED 2016 ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM
CLSI GP47 : 1ED 2015 MANAGEMENT OF CRITICAL- AND SIGNIFICANT-RISK RESULTS
CLSI QMS20 R : 1ED 2014 UNDERSTANDING THE COST OF QUALITY IN THE LABORATORY

CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI QMS14 A : 1ED 2012 QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES
CLSI QMS11 A : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
CLSI QMS02 A6 : 6ED 2013 QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT

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