DIN EN 15224 E : 2017

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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

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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.

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Published
Document Type	Standard
Status	Current
Publisher	German Institute for Standardisation (Deutsches Institut für Normung)
Pages
ISBN

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN 15224 : 2016	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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)
DIN ISO/IEC 27001 E : 2015	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO/IEC 27001:2013 + COR. 1:2014)
ISO 10015 : 1999(R2005)	QUALITY MANAGEMENT - GUIDELINES FOR TRAINING
ISO/IEC 27001 : 2013	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS
DIN ISO 31000 : DRAFT 2011	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 (IEC 60300-1:2014)
ISO 31000 : 2009	RISK MANAGEMENT - GUIDELINES
DIN ISO 10007 : 2004	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR CONFIGURATION MANAGEMENT
IEC 61160 : 2.0	DESIGN REVIEW
ISO 13485 : 2016	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
DIN ISO 10001 : 2008	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(R2015)	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(R2016)	TERMINOLOGY WORK - HARMONIZATION OF CONCEPTS AND TERMS
ISO 10005 : 2005	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
ISO 10008 : 2013(R2019)	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 37500 E : 2015	GUIDANCE ON OUTSOURCING (ISO 37500:2014)
ISO 10006 : 2003	QUALITY MANAGEMENT - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
DIN ISO 10002 : 2010	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS
DIN-FACHBERICHT ISO 10006 : 2004	QUALITAETSMANAGEMENTSYSTEME - LEITFADEN FUER QUALITAETSMANAGEMENT IN PROJEKTEN
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	QUALITY MANAGEMENT - QUALITY OF AN ORGANIZATION - GUIDANCE TO ACHIEVE SUSTAINED SUCCESS
ISO TR 10013 : 2001(R2007)	GUIDELINES FOR QUALITY MANAGEMENT SYSTEM DOCUMENTATION
DIN EN ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
DIN ISO 10003 : 2008	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS
ISO 10012 : 2003(R2015)	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 10008 : 2015	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS (ISO 10008:2013)
ISO 37500 : 2014	GUIDANCE ON OUTSOURCING
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
DIN ISO/IEC 27000 E : 2011	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
EN 61160 : 2005	DESIGN REVIEW
EN ISO 10012 : 2003	MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
ISO/IEC 90003 : 2014	SOFTWARE ENGINEERING - GUIDELINES FOR THE APPLICATION OF ISO 9001:2008 TO COMPUTER SOFTWARE
ISO 704 : 2009(R2017)	TERMINOLOGY WORK - PRINCIPLES AND METHODS
DIN EN ISO 9001 E : 1994	QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING
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(R2016)	RISK MANAGEMENT - VOCABULARY
DIN ISO 10004 : 2015	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR MONITORING AND MEASURING (ISO 10004:2012)
DIN ISO 10005 : 2009	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
ISO TR 20514 : 2005	HEALTH INFORMATICS - ELECTRONIC HEALTH RECORD - DEFINITION, SCOPE AND CONTEXT

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