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PREN 15224 : DRAFT 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
Superseded date

01-12-2016

Published date

08-03-2016

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

Describes 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.

Committee
TC 362
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
16/30334735 DC : 0 Identical

DIN EN 16224:2015-03 HEALTHCARE PROVISION BY CHIROPRACTORS
BS EN 16224 : 2012 HEALTHCARE PROVISION BY CHIROPRACTORS
EN 16224:2012+A1:2014 Healthcare provision by chiropractors
UNI EN 16224 : 2014 HEALTHCARE PROVISION BY CHIROPRACTORS

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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