CLSI QMS02 A6 : 6ED 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
Hardcopy , PDF
14-03-2024
English
28-02-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Need for New Document
5 Document Type is Determined
6 Document Is Drafted
7 Draft Is Evaluated, Edited as Needed, and Verified
8 Approval
9 Training Requirements Determined and Training Verified
10 Document Is Distributed and Implemented
11 Document Maintenance
12 Control of Reference Documents
13 Procedures Manuals
14 Key Features of Electronics Document Management System
15 How to Get Started
16 Conclusion
References
Appendix A - Sample Policy: "Quality System Essential
Facilities and Safety Policy"
Appendix B - Sample Policy: "Quality System Essential
Nonconforming Event Management policy"
Appendix C - Sample Quality Process for Quality System
Essential Assessments: "Unannounced
Inspection Day Process"
Appendix D - Sample Preexamination Process: "Blood
Sample Collection Process"
Appendix E1 - Sample Examination Process: "Analyzer
Setup and Run Process"
Appendix E2 - Sample Examination Process: "Surgical
Pathology Process"
Appendix F - Sample Postexamination Process: "Critical
Value Handling Process"
Appendix G1 - Sample Quality Procedure: "Correcting
a Laboratory Paper Record Procedure"
Appendix G2 - Sample Preexamination Procedure: "Identifying
the Patient for Sample Collection Procedure"
Appendix G3 - Sample Microbiology Examination Procedure:
"Urine Culture: Reading and Interpreting
Procedure"
Appendix G4 - Sample Transfusion Medicine Examination
Procedure: "Weak D (D[u]) Determination
Procedure"
Appendix G5 - Sample Histology Examination Procedure:
"Hematoxylin and Eosin Staining Procedure:
Manual Method"
Appendix G6 - Sample Postexamination Procedure:
"Critical Values Reporting Procedure"
Appendix H1 - Sample Job Aid: "Shared Testing Job Aid"
Appendix H2 - Sample Job Aid: "Draw Tubes and Minimum Fill"
Appendix I1 - Sample Form: "Document Management Form"
Appendix I2 - sample Form: "ABO/Rh Discrepancy Worksheet"
Appendix J - Suggested Contents of Templates for Laboratory
Documents
Appendix K1 - How to Construct a Process Flow Chart
Appendix K2 - Sample Process Flow Chart: "Laboratory Sample
Receiving Process"
Appendix K3 - Sample Process Flow Chart: "Bacteriology
Culture Process"
Appendix K4 - Table Format for the Document Management Process
Appendix L1 - Sample Attributes for a Single Analyte on a
Single Analyzer
Appendix L2 - Attributes for Multiple Analytes on a Single
Analyzer
Appendix L3 - Attributes for a Single Analyte on a Multiple
Analyzers
Appendix M - Sample Checklist: Document Review Checklist
Appendix N - Sample Form: "Group Training Record"
Appendix O1 - Sample Procedures Manual Table of Contents:
"Transfusion Reaction Investigation Process"
Appendix O2 - Sample Procedures Manual Table of Contents:
"Automated Analyzer Operations Process"
Appendix P - Ten Rules for Laboratory Document Management
The Quality Management System Approach
Related CLSI Reference Materials
Specifies guidance on the processes needed for document management, including creating, controlling, changing, and retiring a laboratory's policy, process, procedure, and form documents in both paper and electronic environments.
DevelopmentNote |
Supersedes CLSI GP2 A5. (04/2013)
|
DocumentType |
Miscellaneous Product
|
ISBN |
1-56238-869-X
|
Pages |
106
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
This guideline presents evidence-based suggestions for preparing different types of laboratory documents. In addition, a process is described for how laboratory documents can be managed and controlled from the time a need is recognized for a new or revised document, through the document’s use and control, until the time it is retired.This guideline is applicable to documents used by medical laboratories of any size, complexity, or specialty, including point-of-care testing.QMS02 is intended for use by the following: · Administrative and technical personnel who develop laboratory documents · Manufacturers · Educators · Regulatory and accreditation organizations QMS02 is a guideline for how to implement requirements established in international standards, and by regulatory and accrediting organizations for laboratory documents and procedures manuals. QMS02 is not a standard; that is, this guideline does not set requirements for laboratory documents and procedures. Instead, this guideline describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards2-13 for documents and document management, and provides suggestions and examples for fulfilling the requirements.
CLSI MM23 : 1ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS) |
CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
CLSI MM7 A2 : 2ED 2013 | FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES |
CLSI NBS07 : 1ED 2017 | NEWBORN BLOOD SPOT SCREENING FOR POMPE DISEASE BY LYSOSOMAL ACID A-GLUCOSIDASE ACTIVITY ASSAYS |
CLSI MM9 A2 : 2ED 2014 | NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
CLSI QMS25 : 1ED 2016 | HANDBOOK FOR DEVELOPING A LABORATORY QUALITY MANUAL |
CLSI QMS20 R : 1ED 2014 | UNDERSTANDING THE COST OF QUALITY IN THE LABORATORY |
CLSI NBS06 A : 1ED 2013 | NEWBORN BLOOD SPOT SCREENING FOR SEVERE COMBINED IMMUNODEFICIENCY BY MEASUREMENT OF T-CELL RECEPTOR EXCISION CIRCLES |
CLSI QMS15 A : 1ED 2013 | ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM |
CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
CLSI QMS17 : 2017 | EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY |
CLSI GP36-A : 2014 | PLANNING FOR LABORATORY OPERATIONS DURING A DISASTER |
CLSI MM21 : 1ED 2015 | GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS |
CLSI QMS18 : 1ED 2015 | PROCESS MANAGEMENT |
CLSI GP41 : 7ED 2017 | COLLECTION OF DIAGNOSTIC VENOUS BLOOD SPECIMENS |
CLSI POCT4 : 3ED 2016 | ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM |
CLSI GP23 A2 : 2ED 2014 | NONGYNECOLOGICAL CYTOLOGY SPECIMENS: PREEXAMINATION, EXAMINATION, AND POSTEXAMINATION PROCESSES |
CLSI GP47 : 1ED 2015 | MANAGEMENT OF CRITICAL- AND SIGNIFICANT-RISK RESULTS |
CLSI I/LA26 A2 : 2ED 2013 | PERFORMANCE OF SINGLE CELL IMMUNE RESPONSE ASSAYS |
CLSI GP39 A6 : 6ED 2010 | TUBES AND ADDITIVES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
CLSI GP41 A6 : 6ED 2007 | PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE |
CLSI QMS03 A3 : 3ED 2009 | TRAINING AND COMPETENCE ASSESSMENT |
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.