Description
Table of contents Page
Introduction……………………………………………………………………………………………………………………………………………….. v
1 Scope. ………………………………………………………………………………………………………………………………………………………1
2 Normative references. ………………………………………………………………………………………………………………………………..1
3 Terms and definitions. …………………………………………………………………………………………………………………………………1
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
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

