SZNS ISO/TS 22367:2008 Medical laboratories – Reduction of error through risk management and continual improvement

E146.03

This standard gives guidance on the application of SZNS 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.

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Description

This standard gives guidance on the application of SZNS 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.

TABLE OF CONTENTS

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
5 Identification of potential and actual laboratory non-conformities, errors and incidents 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

Additional information

Format

PDF, Hardcopy