CLSI QMS17 : 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY
Hardcopy , PDF
28-09-2023
English
28-08-2017
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Superseded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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