DIN EN 15224 E : 2017

Current

Current The latest, up-to-date edition.

QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE

Publisher: German Institute for Standardisation (Deutsches Institut für Normung)

Published:

Available Formats: PDF - English, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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)

DIN EN ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
EN 61160 : 2005	DESIGN REVIEW
ISO 10001 : 2007	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR CODES OF CONDUCT FOR ORGANIZATIONS
EN ISO 14001 : 2015	ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS WITH GUIDANCE FOR USE (ISO 14001:2015)
ISO 860 : 2007(R2016)	TERMINOLOGY WORK - HARMONIZATION OF CONCEPTS AND TERMS
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 10012 : 2003(R2015)	MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
DIN ISO 10003 : 2008	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS
ISO 10014 : 2006	QUALITY MANAGEMENT - GUIDELINES FOR REALIZING FINANCIAL AND ECONOMIC BENEFITS
EN ISO 10012 : 2003	MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
ISO 9004 : 2009	QUALITY MANAGEMENT - QUALITY OF AN ORGANIZATION - GUIDANCE TO ACHIEVE SUSTAINED SUCCESS
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
EN ISO 9001 : 2015	QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
EN ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
ISO 10015 : 1999(R2005)	QUALITY MANAGEMENT - GUIDELINES FOR TRAINING
DIN ISO 37500 E : 2015	GUIDANCE ON OUTSOURCING (ISO 37500:2014)
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 (IEC 60300-1:2014)
ISO 10006 : 2003	QUALITY MANAGEMENT - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
ISO 10003 : 2007	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR DISPUTE RESOLUTION EXTERNAL TO ORGANIZATIONS
ISO 10008 : 2013(R2019)	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS
EN ISO 19011:2011 COR 2011	GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
DIN ISO 10001 : 2008	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR CODES OF CONDUCT FOR ORGANIZATIONS
DIN EN ISO 9001 E : 1994	QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING
ISO 10018 : 2012	QUALITY MANAGEMENT - GUIDELINES ON PEOPLE INVOLVEMENT AND COMPETENCE
ISO 37500 : 2014	GUIDANCE ON OUTSOURCING
DIN ISO 10008 : 2015	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR BUSINESS-TO-CONSUMER ELECTRONIC COMMERCE TRANSACTIONS (ISO 10008:2013)
EN ISO 13940 : 2016	HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE (ISO 13940:2015)
ISO/IEC 27000 : 2016	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
DIN-FACHBERICHT ISO 10006 : 2004	QUALITAETSMANAGEMENTSYSTEME - LEITFADEN FUER QUALITAETSMANAGEMENT IN PROJEKTEN
DIN ISO 10004 : 2015	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR MONITORING AND MEASURING (ISO 10004:2012)
ISO GUIDE 73 : 2009(R2016)	RISK MANAGEMENT - VOCABULARY
ISO 10002 : 2014	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS
ISO 10007 : 2017	QUALITY MANAGEMENT - GUIDELINES FOR CONFIGURATION MANAGEMENT
DIN ISO 10002 : 2010	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR COMPLAINTS HANDLING IN ORGANIZATIONS
ISO/IEC 27001 : 2013	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO/IEC 90003 : 2014	SOFTWARE ENGINEERING - GUIDELINES FOR THE APPLICATION OF ISO 9001:2008 TO COMPUTER SOFTWARE
ISO 9001:2015	QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO TR 20514 : 2005	HEALTH INFORMATICS - ELECTRONIC HEALTH RECORD - DEFINITION, SCOPE AND CONTEXT
DIN ISO/IEC 27001 E : 2015	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO/IEC 27001:2013 + COR. 1:2014)
IEC 61160 : 2.0	DESIGN REVIEW
DIN ISO 31000 : DRAFT 2011	RISK MANAGEMENT - PRINCIPLES AND GUIDELINES
DIN ISO/IEC 27000 E : 2011	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
DIN ISO 10007 : 2004	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR CONFIGURATION MANAGEMENT
ISO 10019 : 2005(R2015)	GUIDELINES FOR THE SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS AND USE OF THEIR SERVICES
ISO TR 10013 : 2001(R2007)	GUIDELINES FOR QUALITY MANAGEMENT SYSTEM DOCUMENTATION
ISO 10005 : 2005	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
ISO 704 : 2009(R2017)	TERMINOLOGY WORK - PRINCIPLES AND METHODS
DIN ISO 10005 : 2009	QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
ISO 13940 : 2015	HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE
ISO 31000 : 2009	RISK MANAGEMENT - GUIDELINES
ISO 10004 : 2012	QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR MONITORING AND MEASURING

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DIN EN 15224 E : 2017

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

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

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

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