PREN 15224 : DRAFT 2016

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

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

Abstract - (Show below) - (Hide below)

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.

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Published
Document Type	Draft
Status	Superseded
Publisher	Comite Europeen de Normalisation
Pages
ISBN
Committee	TC 362
Superseded By	EN 15224 : 2016
Comment Closes On

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
16/30334735 DC : 0	Identical
16/30334735 DC : 0	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

DIN EN 16224 E : 2015	HEALTHCARE PROVISION BY CHIROPRACTORS
DIN EN 16224 : 2015	HEALTHCARE PROVISION BY CHIROPRACTORS
BS EN 16224 : 2012	HEALTHCARE PROVISION BY CHIROPRACTORS
UNI EN 16224 : 2014	HEALTHCARE PROVISION BY CHIROPRACTORS

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

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(R2005)	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 (IEC 60300-1:2014)
ISO 31000 : 2009	RISK MANAGEMENT - GUIDELINES
IEC 61160 : 2.0	DESIGN REVIEW
ISO 13485 : 2016	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
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
ISO 10006 : 2003	QUALITY MANAGEMENT - 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	QUALITY MANAGEMENT - QUALITY OF AN ORGANIZATION - GUIDANCE TO ACHIEVE SUSTAINED SUCCESS
ISO TR 10013 : 2001(R2007)	GUIDELINES FOR QUALITY MANAGEMENT SYSTEM DOCUMENTATION
IEC 60300-1 : 3.0	DEPENDABILITY MANAGEMENT - PART 1: GUIDANCE FOR MANAGEMENT AND APPLICATION
ISO 14001:2015	ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS WITH GUIDANCE FOR USE
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
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/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
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
ISO TR 20514 : 2005	HEALTH INFORMATICS - ELECTRONIC HEALTH RECORD - DEFINITION, SCOPE AND CONTEXT

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