UNI CEN ISO/TS 22367 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
07-27-2022
01-01-2010
Foreword
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
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