DD CEN/TS 15224:2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Health services. Quality management systems. Guide for the use of EN ISO 9001:2000
Hardcopy , PDF
30-11-2012
English
28-04-2006
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Superseded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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