BS 70000:2017

Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Annexes
Annex A (informative) - Medical physics, clinical
        engineering and associated science services
        in healthcare
Bibliography

Describes requirements for quality, safety and competence in medical physics, clinical engineering and associated science services, including the development and manufacture of associated products, in healthcare, which include: a) the optimization and delivery of diagnostic and therapeutic procedures; b) provision of expert professional advice; c) project management; d) provision of scientific and technical support for the procurement, governance and life cycle management of medical devices; e) the repair, maintenance, testing, metrological confirmation and quality assurance of equipment and facilities within a healthcare environment; f) design and manufacture of devices and patient aids; g) radiopharmaceutical production; h) healthcare science education and training; and i) innovation, research and development.

This British Standard specifies requirements for quality, safety and competence in medical physics, clinical engineering and associated science services, including the development and manufacture of associated products, in healthcare, which include: the optimization and delivery of diagnostic and therapeutic procedures; provision of expert professional advice; project management; provision of scientific and technical support for the procurement, governance and life cycle management of medical devices; the repair, maintenance, testing, metrological confirmation and quality assurance of equipment and facilities within a healthcare environment; design and manufacture of devices and patient aids; NOTE See “Further reading?? in the Bibliography for standards covering the design and manufacture of devices. radiopharmaceutical production; healthcare science education and training; and innovation, research and development. It specifies a framework for good practice in service delivery, training and innovation research and development, including the roles, responsibilities, activities, facilities and equipment that are required for the delivery of such healthcare science services and associated products for the benefit of patients. This British Standard can be used: by service providers in developing their quality management systems and assessing the performance of their service and the competence of their staff; and for confirming or recognizing the competence of these professional services by service users (including patients), regulating authorities and accreditation bodies. Services for the maintenance of buildings and environmental conditions of healthcare facilities are not covered by this British Standard, although its main principles can be used to improve the provision of such services.