SZNS ISO 15189: 2012 Medical Laboratories- Particular requirements for quality and competence

E619.09

This National Standard specifies requirements for quality and competence in medical laboratories. This standard can be used by medical laboratories in developing their quality management system and assessing their own competence. It can also be used for conforming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Supersedes SZNS ISO 15189: 2007 Medical Laboratories- Particular requirements for quality and competence

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Description

This National Standard specifies requirements for quality and competence in medical laboratories. This standard can be used by medical laboratories in developing their quality management system and assessing their own competence. It can also be used for conforming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Supersedes SZNS ISO 15189: 2007 Medical Laboratories- Particular requirements for quality and competence

TABLE OF CONTENTS

Content Page
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Management requirements 5
4.1   Organization and management responsibility 5
4.2   Quality management system 8
4.3   Service agreements 10
4.4   Examination by referral laboratories 11
4.5   External services and supplies 12
4.6   Advisory services 12
4.7   Resolution of complaints 12
4.8   Identification and control of nonconformities 12
4.9   Corrective action 13
4.10 Preventive action 13
4.11 Continual improvement 13
4.12 Control of records 14
4.13 Evaluation and audits 15
4.14 Management review 17
5   Technical requirements 18
5.1   Personnel 18
5.2   Accommodation and environmental conditions 19
5.3   Laboratory equipment, reagents, and consumables 21
5.4   Pre-examination processes 24
5.5   Examination processes 27
5.6   Ensuring quality of examination results 30
5.7   Post-examination processes 32
5.8   Reporting of results 32
5.9   Release of results 33
5.10 Laboratory information management 35
Annex A (informative) 37
Annex B (informative) 42
Bibliography 46

Additional information

Format

PDF, Hardcopy