DD ISO/TS 22367 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
Hardcopy , PDF
04-30-2010
English
01-01-2008
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management responsibility in preventive and
corrective actions, and continual improvement
4.1 General
4.2 Management responsibility in preventive actions
4.3 Management responsibility in corrective actions
4.4 Management responsibility in continuous 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
Describes 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.
| Committee |
CH/212
|
| DevelopmentNote |
Renumbered and superseded by DD CEN ISO/TS 22367. (04/2010)
|
| DocumentType |
Draft
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 22367:2008 | Identical |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO/IEC Guide 73:2002 | Risk management Vocabulary Guidelines for use in standards |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| CLSI GP22 A2 : 2ED 2004 | CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| MIL-STD-1629 Revision A:1980 | PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS |
| CLSI EP18 A : 1ED 2002 | QUALITY MANAGEMENT FOR UNIT-USE TESTING |
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