CSA Z15189 : 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
01-07-2008
English
01-01-2003
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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Withdrawn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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