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16/30334735 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
Available format(s)

Hardcopy , PDF

Superseded date

28-02-2017

Language(s)

English

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Superseded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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