CLSI QMS18 : 1ED 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PROCESS MANAGEMENT
Hardcopy , PDF
24-06-2023
English
10-03-2015
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Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Workflow of Process Management
Chapter 3 - Quality system Essentials and process Management
Chapter 4 - Conclusion
Chapter 5 - Supplemental information
References
Appendix A1 - Process Definition Document Example
Appendix A2 - Sample of a Completed Process Definition
Document
Appendix B - Example of a stakeholder Analysis for the Critical
Value Reporting Process
Appendix C - How to Constructa a Process Flow Chart
Appendix D - Sample Postexamination Process: 'Critical
Value Handling Process'
Appendix E - Sample Quality Implementation plan for
New Laboratory Bar Codes
Appendix F - Example of a Generic Day-of-implementation
Checklist
Appendix G - Example of Document Inventory for the Critical
Value Handling process
Appendix H1 - Example Outline for a Validation plan
Appendix H2 - Sample Acceptance Criteria for the Critical
Value Reporting process
Appendix I1 - Example of a Learner Responsibilities Form
Appendix I2 - Example of a Training Schedule Form
Appendix I3 - Example of Training Schedule Form
Appendix I4 - Example of Training Schedule Form
Appendix 15 - Example of Training Guide Form
Appendix 16 - Sample Written Assessment Form
Appendix I7 - Preparing a Direct Observation Checklist
Appendix I8 - Sample Learner Evaluation Form
Appendix J1 - Communication Plan Template
Appendix J2 - Sample Communication Plan for Changing the
Critical Value Reporting Process
Appendix K1 - Change Announcement Template
Appendix K2 - Sample Change Announcement for New
Bar Code Labels
Appendix L - Project Management Tool Template
The Quality Management System Approach
Related CLSI References Materials
This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.
| DocumentType |
Standard
|
| ISBN |
1-56238-994-7
|
| Pages |
132
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI QMS25:1ED 2017 | Handbook for Developing a Laboratory Quality Manual |
| CLSI GP47 : 1ED 2015 | MANAGEMENT OF CRITICAL- AND SIGNIFICANT-RISK RESULTS |
| CLSI GP27 A2 : 2ED 2007 | USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY |
| 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 QMS11 A : 1ED 2007 | MANAGEMENT OF NONCONFORMING LABORATORY EVENTS |
| 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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