CSA PLUS 15189 : 2010

Withdrawn

THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES

Available format(s)

Hardcopy , PDF

Withdrawn date

04-23-2014

Language(s)

English

Published date

01-01-2010

Publisher

Canadian Standards Association

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Status	Withdrawn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