CEN ISO/TS 22367:2010

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

ISO/TS 22367:2008 characterizes the application of 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. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.