Description
This standard gives guidance on the application of SZNS ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care.
TABLE OF CONTENTS
| Contents | Page |
| Introduction | v |
| 1 Scope | 1 |
| 2 Normative references | 1 |
| 3 Terms and definitions | 1 |
| 4 Management responsibility in preventive and corrective actions, and continual improvement | 2 |
| 4.1 General | 2 |
| 4.2 Management responsibility in preventive actions | 2 |
| 4.3 Management responsibility in corrective actions | 3 |
| 4.4 Management responsibility in continuous improvement | 3 |
| 5 Identification of potential and actual laboratory non-conformities, errors and incidents | 3 |
| 6 Classification of laboratory non-conformities, errors and incidents | 3 |
| 7 Preventive action and corrective actions | 4 |
| 8 Assessment of risk arising from actual and potential laboratory non-conformities | 5 |
| 9 Review of collected laboratory non-conformities, errors and incidents | 6 |
| 10 Preventive action and corrective action plans | 6 |
| 11 Preventive action and corrective action plan files | 6 |
| 12 Continual improvement plan | 6 |
| Annex A (informative) Failure modes and effects analysis | 7 |
| Annex B (informative) Model for assessing risk of harm | 8 |
| Annex C (informative) Ranking of severity levels | 9 |
| Bibliography | 10 |