I.S. EN 15224:2016
Current
The latest, up-to-date edition.
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
Hardcopy , PDF
English
01-01-2016
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National Foreword
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) - Other International Standards on
quality management and quality management systems
developed by ISO/TC 176
Annex C (informative) - Correlation matrix EN 15224:2012
to EN ISO 9001:2015 to EN 15224:2016
Annex D (informative) - Quality requirements and quality
characteristics in healthcare
Annex E (informative) - Guidance for process approach in
Healthcare
Bibliography
Defines requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
| DevelopmentNote |
Supersedes I.S. CEN TS 15224. (11/2012)
|
| DocumentType |
Standard
|
| Pages |
90
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 15224:2016 | Identical |
| ISO 10001:2007 | Quality management Customer satisfaction Guidelines for codes of conduct for organizations |
| EN ISO 19011:2011 COR 2011 | GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011) |
| 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 |
| ISO 13940:2015 | Health informatics — System of concepts to support continuity of care |
| 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 |
| EN ISO 13940:2016 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
| 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 |
| 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 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 |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 61160:2005 | Design review |
| 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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