Description
This standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care.
TABLE OF CONTENTS
| Contents | Page |
| 1 Scope | 1 |
| 2 Normative references | 1 |
| 3 Terms and definitions | 1 |
| 4 Management requirements | 1 |
| 4.1 Organization and management | 1 |
| 4.2 Quality management system | 2 |
| 4.3 Document control | 3 |
| 4.4 Review of contracts | 3 |
| 4.5 Examination by referral laboratories | 3 |
| 4.6 External services and supplies | 3 |
| 4.7 Advisory services | 3 |
| 4.8 Resolution of complaints | 3 |
| 4.9 Identification and control of nonconformities | 3 |
| 4.10 Corrective action | 4 |
| 4.11 Preventive action | 4 |
| 4.12 Continual improvement | 5 |
| 4.13 Quality and technical records | 5 |
| 4.14 Internal audits | 5 |
| 4.15 Management review | 5 |
| 5 Technical requirements | 5 |
| 5.1 Personnel | 5 |
| 5.2 Accommodation and environmental conditions | 7 |
| 5.3 Laboratory equipment | 7 |
| 5.4 Pre-examination procedures | 7 |
| 5.5 Examination procedures | 7 |
| 5.6 Assuring the quality of examination procedures | 8 |
| 5.7 Post-examination procedure | 8 |
| 5.8 Reporting of results | 8 |
| Bibliography | 10 |