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 an...