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DIN EN 15224:2016-04 (Draft)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
Available format(s)

Hardcopy , PDF

Superseded date

03-07-2021

Language(s)

German

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
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 aspects; 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 DIN CEN/TS 15224. (12/2012)
DocumentType
Draft
Pages
158
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
Supersedes

Standards Relationship
EN 15224:2016 Identical

DIN HDBK 469 : 2ED 2013 QUALITAETS- UND RISIKOMANAGEMENTSYSTEME IM GESUNDHEITSWESEN UND KONFORMITAETSBEWERTUNG VON ZERTIFIZIERUNGSSTELLEN - NORMEN UND SPEZIFIKATIONEN

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
DIN ISO 31000:2011-01 (Draft) RISK MANAGEMENT - PRINCIPLES AND GUIDELINES
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
DIN ISO 10007:2004-12 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR CONFIGURATION MANAGEMENT
IEC 61160:2005 Design review
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
DIN ISO 10001:2008-07 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR CODES OF CONDUCT FOR ORGANIZATIONS
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
DIN ISO/IEC 27000:2015-12 (Draft) INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
ISO 10006:2003 Quality management systems Guidelines for quality management in projects
DIN-Fachbericht ISO 10006:2004 QUALITAETSMANAGEMENTSYSTEME - LEITFADEN FUER QUALITAETSMANAGEMENT IN PROJEKTEN
DIN ISO/IEC 27001 : 2017 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO/IEC 27001:2013 + COR. 1:2014)
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
DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
DIN ISO 10003:2008-07 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS
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
DIN ISO 37500:2015-08 GUIDANCE ON OUTSOURCING (ISO 37500:2014)
DIN ISO 10008:2015-01 Quality management - Customer satisfaction - Guidelines for business-to-consumer electronic commerce transactions (ISO 10008:2013); Text in German, English and French
ISO 37500:2014 Guidance on outsourcing
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
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
DIN ISO 10004:2015-01 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR MONITORING AND MEASURING (ISO 10004:2012)
ISO/TR 20514:2005 Health informatics Electronic health record Definition, scope and context

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PDF - German
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