This Technical Report provides assistance on how the 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 EN ISO 9004:2000 promotes a better understanding of the 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 organisation.
An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing
the performance of the organisation with the 290 individual “should” performance improvement guideline statements of the standard. These statements can be used to create a check list for evaluators (see A.3).
Using the EN ISO 9004:2000 criteria, organisations can assess the maturity of their quality management system (see A.2) 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 organisational waste are carried out consistently and in a controlled manner