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  • 16/30334735 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-02-2017

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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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

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

    Comment Closes On
    Committee ²CH/100/-/2
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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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