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  • DIN EN 15224:2016-04 (Draft)

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  07-03-2021

    Language(s):  German

    Published date:  01-01-2016

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

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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.

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

    Comment Closes On
    Development Note Supersedes DIN CEN/TS 15224. (12/2012)
    Document Type Draft
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

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

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

    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)
    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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