CSA PLUS 15189 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES
Hardcopy , PDF
23-04-2014
English
01-01-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Preface
How to use this handbook
Introduction
4 Management requirements
5 Technical Requirements
Annexes
A (informative) - Correlation with ISO 9001:2000 and
ISO/IEC 17025:2005
B (informative) - Recommendations for protection of
laboratory information systems (LIS)
C (informative) - Ethics in laboratory medicine
Glossary
Reference publications
Provides guidance on the implementation of the second edition of ISO 15189, Medical laboratories - Particular requirements for quality and competence, published in 2007.
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO/IEC Guide 43-1:1997 | Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO/IEC Guide 25:1990 | General requirements for the competence of calibration and testing laboratories |
| ISO/IEC 17011:2004 | Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO 15190:2003 | Medical laboratories Requirements for safety |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 9000-1:1994 | Quality management and quality assurance standards — Part 1: Guidelines for selection and use |
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