CLSI QMS11 : 2ED 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NONCONFORMING EVENT MANAGEMENT
Hardcopy , PDF
English
25-08-2018
28-11-2019
Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Nonconforming Event Management
Chapter 3 - Path of Workflow and Quality System Essentials
Chapter 4 - Conclusion
Chapter 5 - Supplemental Information
References
Appendix A1 - Data Collection Tools
Appendix A2 - Investigation and Data Reporting Tools
Appendix B - Potential Components of an Internal
Nonconforming Event Report
Appendix C1 - Nonconforming Event Report Form (Example 1)
Appendix C2 - Nonconforming Event Report Form (Example 2)
Appendix C3 - Nonconforming Event Report Form (Example 3)
Appendix C4 - Nonconforming Event Report Form (Example 4)
Appendix D - Risk Classification Example
Appendix E - Information to Consider When Conducting Root
Cause Analysis
Appendix F1 - Root Cause Analysis Process (Example 1)
Appendix F2 - Root Cause Analysis Process (Example 2)
Appendix G1 - Nonconforming Event Case Study
Example - The Process
Appendix G2 - Nonconforming Event Case Study
Example - The Report
Appendix G3 - Nonconforming Event Case Study
Example - The process Map
Appendix G4 - Nonconforming Event Case Study
Example - The Cause and Effect Diagram
and 5 Whys Analysis
Appendix H - Nonconforming Event log
Appendix I - Application of Data Analysis: A
Laboratory Example
Appendix J - Management Review Agenda Template
Appendix K1 - Quality Report Example
Appendix K2 - Quality Report by Quality System Essential
The Quality Management System Approach
Related CLSI References Materials
Gives an outline and content for developing a program to manage a laboratory's nonconforming events.
| DevelopmentNote |
Supersedes CLSI QMS11 A. (09/2015)
|
| DocumentType |
Miscellaneous Product
|
| ISBN |
1-56238-909-2
|
| Pages |
128
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI QMS25 : 1ED 2016 | HANDBOOK FOR DEVELOPING A LABORATORY QUALITY MANUAL |
| CLSI QMS17 : 2017 | EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY |
| CLSI QMS19 : 2017 | CUSTOMER FOCUS IN A QUALITY MANAGEMENT SYSTEM |
| CLSI QMS24 : 3ED 2016 | USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY |
| 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 GP49 : 2017 | DEVELOPING AND MANAGING A MEDICAL LABORATORY (TEST) UTILIZATION MANAGEMENT PROGRAM |
| CLSI GP41 : 7ED 2017 | COLLECTION OF DIAGNOSTIC VENOUS BLOOD SPECIMENS |
| CLSI QMS21 : 1ED 2016 | PURCHASING AND INVENTORY MANAGEMENT |
| CLSI QMS12 A : 1ED 2010 | DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY |
| CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI QMS20 R : 1ED 2014 | UNDERSTANDING THE COST OF QUALITY IN THE LABORATORY |
| CLSI QMS14 A : 1ED 2012 | QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES |
| CLSI QMS06 A3 : 3ED 2011 | QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT |
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