Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management responsibility in preventive and corrective
actions, and continual improvement
5 Identification of potential and actual laboratory
non-conformities, errors and incidents
6 Classification of laboratory non-conformities, errors and
incidents
7 Preventive action and corrective actions
8 Assessment of risk arising from actual and potential
laboratory non-conformities
9 Review of collected laboratory non-conformities, errors and
incidents
10 Preventive action and corrective action plans
11 Preventive action and corrective action plan files
12 Continual improvement plan
Annex A (informative) - Failure modes and effects analysis
Annex B (informative) - Model for assessing risk of harm
Annex C (informative) - Ranking of severity levels
Bibliography