PD CEN/TR 15592:2007 is a Technical Report that provides assistance on how the BS EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.
Even though BS EN ISO 9004:2000 promotes a better understanding of the BS EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.
To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organization. An important value of BS EN ISO 9004:2000 is that it can be used for self-assessment comparing the performance of the organization with the 290 individual “should” performance improvement guideline statements of the standard. These statements can be used to create a check list for evaluators.
Using the BS EN ISO 9004:2000 criteria, organizations can assess the maturity of their quality management system and identify opportunities for improvement.
This Technical Report ensures that those health system activities that are necessary for continuous improvement, risk management and reduction of variation and organizational waste are carried out consistently and in a controlled manner. It addresses any health system or health care organization involved in the provision of health services to the population including prevention, care and rehabilitation, regardless of the type and size of the system/organization and the product or service provided.
Contents
Foreword
Introduction General
Process approach
Relationship with EN ISO 9001
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
6.2.2 Competence, awareness and training
6.2.3 Involvement of people
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)
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