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 |