16/30334735 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
Hardcopy , PDF
English
28-02-2017
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement
Annex A (informative) - Clarification of new structure,
terminology and concepts
Annex B (informative) - Correlation matrix EN 15224:2012 to
EN ISO 9001:2015 to EN 15224:2016
Annex C (informative) - Quality characteristics and
quality requirements in healthcare
Annex D (informative) - Guidance for clinical process approach
Bibliography
BS EN 15224.
| Committee |
²CH/100/-/2
|
| DocumentType |
Draft
|
| Pages |
76
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 15224 : DRAFT 2016 | Identical |
| ISO 10001:2007 | Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 10015:1999 | Quality management — Guidelines for training |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO/TR 10017:2003 | Guidance on statistical techniques for ISO 9001:2000 |
| EN 60300-1:2014 | Dependability management - Part 1: Guidance for management and application |
| ISO 31000:2009 | Risk management — Principles and guidelines |
| IEC 61160:2005 | Design review |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 10019:2005 | Guidelines for the selection of quality management system consultants and use of their services |
| ISO 10004:2012 | Quality management — Customer satisfaction — Guidelines for monitoring and measuring |
| ISO 10014:2006 | Quality management — Guidelines for realizing financial and economic benefits |
| ISO 860:2007 | Terminology work — Harmonization of concepts and terms |
| ISO 10005:2005 | Quality management systems — Guidelines for quality plans |
| ISO 10008:2013 | Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions |
| ISO 10003:2007 | Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations |
| ISO 10006:2003 | Quality management systems — Guidelines for quality management in projects |
| EN 13940-1:2007 | Health informatics - System of concepts to support continuity of care - Part 1: Basic concepts |
| ISO 10018:2012 | Quality management — Guidelines on people involvement and competence |
| ISO 10002:2014 | Quality management — Customer satisfaction — Guidelines for complaints handling in organizations |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO 9004:2009 | Managing for the sustained success of an organization — A quality management approach |
| ISO/TR 10013:2001 | Guidelines for quality management system documentation |
| IEC 60300-1:2014 | Dependability management - Part 1: Guidance for management and application |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| EN ISO 14001:2015 | Environmental management systems - Requirements with guidance for use (ISO 14001:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 37500:2014 | Guidance on outsourcing |
| EN 61160:2005 | Design review |
| PREN 13940-2 : DRAFT 2010 | HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE - PART 2: HEALTH CARE PROCESS AND WORKFLOW |
| EN ISO 10012:2003 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
| ISO/IEC 90003:2014 | Software engineering — Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 704:2009 | Terminology work — Principles and methods |
| ISO/IEC 27000:2016 | Information technology — Security techniques — Information security management systems — Overview and vocabulary |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| ISO Guide 73:2009 | Risk management — Vocabulary |
| ISO/TR 20514:2005 | Health informatics — Electronic health record — Definition, scope and context |
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