S.R. CEN TR 15592:2007
Current
The latest, up-to-date edition.
HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9004:2000 IN HEALTH SERVICES FOR PERFORMANCE IMPROVEMENT
Hardcopy , PDF
English
01-01-2007
Foreword
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with EN ISO 9001
0.4 Compatibility with other management systems
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 Managing systems and processes
4.2 Documentation
4.3 Use of quality management principles
5 Management responsibility
5.1 General guidance
5.1.1 Introduction
5.1.2 Issues to be considered
5.2 Needs and expectations of interested parties
5.2.1 General
5.2.2 Needs and expectations
5.2.3 Statutory and regulatory plans
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 General guidance
6.1.2 Issues to be considered
6.2 Human resources
6.2.3 Involvement of people
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
6.5 Information
6.6 Suppliers and partnerships
6.7 Natural resources
6.8 Financial resources
7 Product realisation
7.1 General guidance
7.1.1 Introduction
7.1.2 Issues to be considered
7.1.3. Managing processes
7.2 Process related to interested parties
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development input and output
7.3.3 Design and development review
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Supplier control process
7.5 Production and service operations
7.5.1 Operation and realization
7.5.2 Identification and traceability
7.5.3 Customer property
7.5.4 Preservation of product
7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8.1 General guidance
8.1.1 Introduction
8.1.2 Issues to be considered
8.2 Measurement and monitoring
8.2.1 Measurement and monitoring of system
performance
8.2.2 Measurement and monitoring of processes
8.2.3 Measurement and monitoring of products
8.2.4 Measurement and monitoring the
satisfaction of interested parties
8.3 Control of non-conformity
8.3.1 General
8.3.2 Nonconformity review and disposition
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Loss prevention
8.5.4 Continual improvement of the organisation
Annex A (informative) Guidelines for self-assessment
A.1 Introduction
A.2 Performance maturity levels
A.3 Self-assessment questions
A.4 Documentation of self-assessment
results
A.5 Linking potential benefits of ISO 9004
to self-assessment
Annex B (informative) Process for continual improvement
Bibliography
Provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization.
DocumentType |
Standard
|
Pages |
93
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
CEN/TR 15592:2007 | Identical |
ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
ISO/TR 10014:1998 | Guidelines for managing the economics of quality |
ISO 19011:2011 | Guidelines for auditing management systems |
ISO 10015:1999 | Quality management Guidelines for training |
IWA 1:2005 | Quality management systems Guidelines for process improvements in health service organizations |
ISO/TR 10017:2003 | Guidance on statistical techniques for ISO 9001:2000 |
ISO 10014:2006 | Quality management Guidelines for realizing financial and economic benefits |
ISO 10576-1:2003 | Statistical methods — Guidelines for the evaluation of conformity with specified requirements — Part 1: General principles |
ISO 10005:2005 | Quality management systems Guidelines for quality plans |
ISO 10006:2003 | Quality management systems Guidelines for quality management in projects |
ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
ISO 14004:2016 | Environmental management systems General guidelines on implementation |
ISO/TR 13425:2006 | Guidelines for the selection of statistical methods in standardization and specification |
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/IEC Guide 73:2002 | Risk management Vocabulary Guidelines for use in standards |
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 |
ISO 9001:2015 | Quality management systems — Requirements |
ENV 13940 : DRAFT 2001 | HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE |
ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
ISO 10007:2017 | Quality management — Guidelines for configuration management |
CEN/TS 15224:2005 | Health services - Quality management systems - Guide for the use of EN ISO 9001:2000 |
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 |
EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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