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CSA Z15189 : 2003

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
Available format(s)

Hardcopy , PDF

Withdrawn date

07-01-2008

Language(s)

English

Published date

01-01-2003

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
  4.1 Organization and management
  4.2 Quality management system
  4.3 Document control
  4.4 Review of contracts
  4.5 Examination by referral laboratories
  4.6 External services and supplies
  4.7 Advisory services
  4.8 Resolution of complaints
  4.9 Identification and control of nonconformities
  4.10 Corrective action
  4.11 Preventive action
  4.12 Continual improvement
  4.13 Quality and technical records
  4.14 Internal audits
  4.15 Management review
5 Technical requirements
  5.1 Personnel
  5.2 Accommodation and environmental conditions
  5.3 Laboratory equipment
  5.4 Pre-examination procedures
  5.5 Examination procedures
  5.6 Assuring quality of examination procedures
  5.7 Post-examination procedures
  5.8 Reporting of results
Annex A (normative) - Correlation with ISO 9001:2001 and
                        ISO/IEC 17025:1999
Annex B (informative) - Recommendations for protection of
                        laboratory information systems (LIS)
Annex C (informative) - Ethics in laboratory medicine
Bibliography

Defines requirements for quality and competence particular to medical laboratories.

DocumentType
Standard
Pages
62
PublisherName
Canadian Standards Association
Status
Withdrawn

Standards Relationship
ISO 15189:2012 Identical

CSA Z22870 : 2007 : R2013 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE
CSA Z22870:2007 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO/IEC Guide 58:1993 Calibration and testing laboratory accreditation systems General requirements for operation and recognition
ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
CLSI M29 A2 : 2ED 2001 PROTECTION OF LABORATORY WORKERS FROM OCCUPATIONALLY ACQUIRED INFECTIONS
EN 1614 : 2006 HEALTH INFORMATICS - REPRESENTATION OF DEDICATED KINDS OF PROPERTY IN LABORATORY MEDICINE
ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
CLSI GP16 A2 : 2ED 2001 ROUTINE URINALYSIS AND COLLECTION, TRANSPORTATION, AND PRESERVATION OF URINE SPECIMENS
CLSI GP2 A4 : 4ED 2002 CLINICAL LABORATORY TECHNICAL PROCEDURE MANUALS
CLSI H51 A : 1ED 2002 ASSAYS OF VONWILLEBRAND FACTOR ANTIGEN AND RISTOCETIN COFACTOR ACTIVITY
ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
ISO 15190:2003 Medical laboratories Requirements for safety
ISO Guide 30:2015 Reference materials Selected terms and definitions
ISO 9001:2015 Quality management systems — Requirements
CLSI H3 A4 : 4ED 98 PROCEDURE FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
CLSI C3 A3 : 3ED 97 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
EN 12435 : 2006 HEALTH INFORMATICS - EXPRESSION OF RESULTS OF MEASUREMENTS IN HEALTH SCIENCES
CLSI GP5 A2 : 2ED 2002 CLINICAL LABORATORY WASTE MANAGEMENT
CLSI GP17 A : 1ED 96 CLINICAL LABORATORY SAFETY
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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