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  • PREN 15224 : DRAFT 2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015

    Available format(s): 

    Superseded date:  01-12-2016

    Language(s): 

    Published date:  08-03-2016

    Publisher:  Comite Europeen de Normalisation

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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.

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

    Comment Closes On
    Committee TC 362
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

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

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

    DIN EN 16224:2015-03 HEALTHCARE PROVISION BY CHIROPRACTORS
    BS EN 16224 : 2012 HEALTHCARE PROVISION BY CHIROPRACTORS
    EN 16224:2012+A1:2014 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 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
    ISO 31000:2009 Risk management Principles and guidelines
    IEC 61160:2005 Design review
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    ISO 10006:2003 Quality management systems 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 Managing for the sustained success of an organization A quality management approach
    ISO/TR 10013:2001 Guidelines for quality management system documentation
    IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    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
    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 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
    ISO/TR 20514:2005 Health informatics Electronic health record Definition, scope and context
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