Description
Table of 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
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