CLSI QMS14 A : 1ED 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES
Hardcopy , PDF
26-10-2024
English
25-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Vision for Quality
5 Making the Case for a Quality Management System
6 Committing to Quality and Good Professional Practice
7 Creating and Maintaining an Organizational
Structure to Ensure Quality
8 Effectively Implementing the Quality
Management System
9 Managing Resources
10 Planning for Quality
11 Management Review
12 Communicating Quality-Related Information
13 Conclusion
References
Additional References
Appendix A - Force Field Analysis Template
Appendix B - Force Field Analysis - Culture
Assessment Example
Appendix C - Laboratory Director delegation of
Duties Template
Appendix D - Examples of Laboratory Personnel
Responsibilities in a Quality
Management System
Appendix E - Basic Organisational Chart Example
Appendix F - Complex Oragnisational Structure Example
Appendix G - Quality Committee Structure Example
Appendix H - Committee Charter Template
Appendix I - Prioritization Matrix for Quality
Management System Implementation Example
Appendix J - Quality Management System
Implementation Plan Template
Appendix K - Internal Audit Program
Implementation Timeline Example
Appendix L - Meeting Agenda Template
Appendix M - Meeting Record Template
Appendix N - Change Announcement Example
Appendix O - Quality System Essential Policy
Statement - Single Document Example
Appendix P - Sample Quality System Essential
Policy Statement: Organisation
Appendix Q - Basic Organisation of a Quality
Manual Chapter (With Document Titles)
Appendix R - Implementation Plan for Laboratory
Instrumentation Template
Appendix S - Excerpt From a Quality Plan Example
Appendix T - Quality Report Template by Quality
System Essential
Appendix U - Sample Quality Report
Appendix V - Management Review Meeting Agenda Example
Appendix W - Sample Management Review Agenda Template
Appendix X - Management Review Meeting Record Example
Appendix Y - Communication Program Overview Example
Appendix Z - Communication Plan for Quality
Management System Implementation Example
Appendix AA - Sample Communication Plan Template
Appendix AB - Staff Meeting Planning Template
The Quality Management System Approach
Related CLSI Reference Materials
This guideline is intended to assist laboratories in meeting the leadership-based requirements for their QMS, as represented by quality system essential (QSE) Organization.
DevelopmentNote |
Formerly CLSI GP38 A. (07/2013)
|
DocumentType |
Miscellaneous Product
|
ISBN |
1-56238-861-4
|
Pages |
170
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
CLSI QMS16 : 2015 | LABORATORY PERSONNEL MANAGEMENT |
CLSI QMS11 : 2ED 2015 | NONCONFORMING EVENT MANAGEMENT |
CLSI QMS15 A : 1ED 2013 | ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM |
CLSI QMS17 : 2017 | EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY |
CLSI QMS19 : 2017 | CUSTOMER FOCUS IN A QUALITY MANAGEMENT SYSTEM |
CLSI GP48 : 1ED 2017 | ESSENTIAL ELEMENTS OF A PHLEBOTOMY TRAINING PROGRAM |
CLSI QMS25:1ED 2017 | Handbook for Developing a Laboratory Quality Manual |
CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
CLSI QMS12 A : 1ED 2010 | DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY |
CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.