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DD CEN/TS 15224:2005

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Health services. Quality management systems. Guide for the use of EN ISO 9001:2000
Available format(s)

Hardcopy , PDF

Superseded date

11-30-2012

Language(s)

English

Published date

04-28-2006

Foreword
0 Introduction
  0.1 General
  0.2 Process approach
  0.3 Relationship with ISO 9004
  0.4 Compatibility with other management systems
1 Scope
  1.1 General
  1.2 Application
2 Normative reference
3 Terms and definitions
4 Quality management system
  4.1 General requirements
  4.2 Documentation requirements
5 Management responsibility
  5.1 Management commitment
  5.2 Customer focus
  5.3 Quality policy
  5.4 Planning
  5.5 Responsibility, authority and communication
  5.6 Management review
6 Resource management
  6.1 Provision of resources
  6.2 Human resources
  6.3 Infrastructure
  6.4 Work environment
7 Product realisation
  7.1 Planning of product realisation
  7.2 Customer-related processes
  7.3 Design and development
  7.4 Purchasing
  7.5 Production and service provision
  7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
  8.1 General
  8.2 Monitoring and measurement
  8.3 Control of non-conforming product
  8.4 Analysis of data
  8.5 Improvement
Annex A (informative) Practical guide for the implementation of
        EN ISO 9001:2000 in health care organisations
Bibliography

Applies to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards (including professional standards) may complement the guide or be used in parallel.

Committee
CH/100/-/2
DocumentType
Standard
Pages
68
PublisherName
British Standards Institution
RevisionOf
Status
Superseded
SupersededBy

Standards Relationship
CEN/TS 15224:2005 Identical

EN ISO 19011:2011 COR 2011 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
ISO/TR 10014:1998 Guidelines for managing the economics of quality
ISO 10011-3:1991 Guidelines for auditing quality systems Part 3: Management of audit programmes
ISO 10015:1999 Quality management Guidelines for training
ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
ISO 10011-1:1990 Guidelines for auditing quality systems Part 1: Auditing
ISO 10012-2:1997 Quality assurance for measuring equipment Part 2: Guidelines for control of measurement processes
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10013:1995 Guidelines for developing quality manuals
ISO 10005:2005 Quality management systems Guidelines for quality plans
ISO 10006:2003 Quality management systems Guidelines for quality management in projects
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 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 10007:2017 Quality management — Guidelines for configuration management
ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
UNE 66174:2010 Guide for the assessment of management system standard for the sustained success of an organization according to UNE-EN ISO 9004:2009
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
ISO 10011-2:1991 Guidelines for auditing quality systems — Part 2: Qualification criteria for quality systems auditors

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