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IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
The National Safety and Quality Health Service Standards (NSQHS Standards) are Australia's principal health care standards, and apply to all health services including inpatient, outpatient, and community care. [5] There are 8 standards: Clinical governance; Partnering with consumers; Preventing and controlling infections; Medication safety
ISO/IEC/IEEE 12207 Systems and software engineering – Software life cycle processes [1] is an international standard for software lifecycle processes. First introduced in 1995, it aims to be a primary standard that defines all the processes required for developing and maintaining software systems, including the outcomes and/or activities of each process.
A systems development life cycle is composed of distinct work phases that are used by systems engineers and systems developers to deliver information systems.Like anything that is manufactured on an assembly line, an SDLC aims to produce high-quality systems that meet or exceed expectations, based on requirements, by delivering systems within scheduled time frames and cost estimates. [3]
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Ministries of health in several sub-Saharan African countries, including Zambia, Uganda, and South African, were reported to have begun planning health system reform including hospital accreditation before 2002. However, most hospitals in Africa are administered by local health ministries or missionary organizations without accreditation programs.
CHKS Ltd is a specialist provider of healthcare accreditation programmes to UK and international healthcare providers, based in the UK and accredited to ISQua and ISO 17021:2015 standards. The Council for Health Service Accreditation of Southern Africa; Malaysian Society for Quality in Health ( MSQH) - based in Malaysia
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.