NZS/ISO 15189:2007
Medical laboratories - Particular requirements for quality and competence
Provides requirements for competence and quality that are particular to medical laboratories. Medical laboratory services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work. Bodies engaged in the recognition of the competence of medical laboratories will also be able to use this Standard as the basis for their activities. Demonstrated conformity to this Standard does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is not intended to be used for the purposes of certification. Identical to and adopted from ISO 15189:2007.
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Committee Representation
Acknowledgement
Copyright
Contents
Foreword
Introduction
SECTION
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
5.7 Post-examination procedures
5.8 Reporting of results
Annex A Correlation with ISO 9001:2000 and ISO/IEC 17025:2005
Annex B Recommendations for protection of laboratory information systems (LIS)
Annex C Ethics in laboratory medicine
Bibliography
Table
A.1 — Correlation between ISO 9001:2000 and this International Standard
A.2 — Correlation between ISO/IEC 17025:2005 and this International Standard
STANDARDS COUNCIL APPROVAL
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Committee Representation
Acknowledgement
Copyright
Contents
Foreword
Introduction
SECTION
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
5.7 Post-examination procedures
5.8 Reporting of results
Annex A Correlation with ISO 9001:2000 and ISO/IEC 17025:2005
Annex B Recommendations for protection of laboratory information systems (LIS)
Annex C Ethics in laboratory medicine
Bibliography
Table
A.1 — Correlation between ISO 9001:2000 and this International Standard
A.2 — Correlation between ISO/IEC 17025:2005 and this International Standard
STANDARDS COUNCIL APPROVAL
Previous versions
NZS/ISO 15189:2007
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.