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CLSI QMS17 : 2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY

Available format(s)

Hardcopy , PDF

Superseded date

09-28-2023

Language(s)

English

Published date

08-28-2017

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Laboratory External Assessment Process
Chapter 3 - Conclusion
Chapter 4 - Supplemental Information
References
Appendix A - Example of Laboratory External Assessment
             Organizations
Appendix B - Example of Decision matrix for identification
             and selection of Potential Assessment
             Organizations
Appendix C - Example of a Tracking Tool for Noncompliance With
             Requirements and Action Taken
Appendix D - Example of Tracer Audit Checklist
Appendix E - Example of a Notification plan for Assessment Visit
Appendix F - Examples of Prepared Group Communication
Appendix G - Assessment Visit preparation Checklist
Appendix H - External Assessment Executive Summary
Appendix I - Examples of Requirements and Responses
The quality Management System Approach
Related CLSI References Materials

Gives recommendations for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external organization.

DocumentType
Miscellaneous Product
ISBN
1-56238-822-3
Pages
94
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

CLSI QMS12 A : 1ED 2010 DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY
CLSI QMS15 A : 1ED 2013 ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM
CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
CLSI QMS24 : 3ED 2016 USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY
CLSI GP17 A3 : 3ED 2012 CLINICAL LABORATORY SAFETY
CLSI QMS14 A : 1ED 2012 QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES
CLSI QMS11 : 2ED 2015 NONCONFORMING EVENT MANAGEMENT
CLSI QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
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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