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Accreditation: Underpinning quality and confidence in health and social care provision, and providing consistency in the delivery of healthcare services to patients and commissioners alike.
Accreditation within the health and social care sector provides reassurance to patients, commissioners and the health and social care providers that the service that is being provided has been independently evaluated against recognised standards. It seeks to validate and recognise success, as well as drive up the quality and consistency of service by aspiring towards excellence and the sharing of good practice with quality patient outcomes at its core. Indeed commissioners recognise there is a need to drive up the quality of care for patients, whilst delivering efficiency and productivity.
Following a submission to the Care Quality Commission (CQC) third party peer review and accreditation scheme panel, three UKAS healthcare accreditation schemes are approved for use within the CQC hospital inspection methodology. Clinical Pathology Accreditation (CPA), the Imaging Services Accreditation Scheme (ISAS), and Physiological Services (IQIPS) are now formally recognised as part of the CQC inspection programme.
Imaging Services Accreditation Scheme (ISAS) is a patient-focused assessment and accreditation programme that is designed to help diagnostic imaging services ensure that their patients consistently receive high quality services, delivered by competent staff working in safe environments.
IQIPS is a professionally-led assessment and accreditation programme designed to improve services, care and safety for patients undergoing physiological science service tests, examinations and procedures.
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. This includes the development of their quality management system, and demonstrates that the specific activities performed by the medical laboratory meet the criteria set out in the standard. Independent accreditation verifies their integrity, impartiality and competence.
Point of Care Testing
Point of Care Testing (POCT) is often carried out at a patient’s bedside to allow results to be available sooner and therefore, is outside of the controlled and regulated environment of a medical laboratory. As the outcome can trigger immediate decisions about a patient’s care, accreditation means that patients can trust that the results are reliable, and should any decisions be made as a direct consequence of testing, they can be assured that they are still following the correct patient care pathway. POCT services are accredited against the requirements of ISO 22870, which is used in conjunction with ISO 15189 accreditation.
Quality Assurance of Dental Providers
Accreditation to ISO/IEC 17065 ensures that patients receive high standards and quality of care in dentistry, which is supportive of current NHS and overall government healthcare objectives.
Inspection of health and social care services.
UKAS assesses the competence, impartiality and the performance capability of companies that provide the inspection of residential care homes using the internationally recognised inspection standard ISO/IEC 17020 (Conformity assessment – Requirements for the operation of various types of bodies performing inspection).
UKAS also accredits organisations that carry out peer review of health and social care services against quality standards developed from National guidance.
Traceability of Results via Medical Reference Materials
Accurate measurements are vitally important as they will often influence the patient pathway. A crucial element of providing accurate measurements is reliable reference materials. ISO Guide 34 (and ISO 17034) sets out the management system requirements, in accordance with which reference materials should be produced. It ensures that reference material providers are competent to manufacture their products to a given quality, and that the measurement procedures are controlled, allowing laboratories to verify their ability to measure accurately. In addition, the accuracy and traceability of some measurements in medical laboratories is demonstrated via the use of ISO 15195, in conjunction with ISO/IEC 17025, an international standard dedicated to medical reference measurement laboratories.
Medical Device Certification (ISO 13485)
UKAS accredits certification bodies to certify the manufacturers of medical devices to ISO 13485 to ensure excellence in the provision of medical devices. The primary objective of this standard is to facilitate harmonized medical device regulatory requirements by providing an effective solution to meet the comprehensive requirements for a quality management system (QMS). ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities, as well as demonstrating a commitment to the safety and quality of medical devices.
Accredited certification is used to assess conformity of medical devises against this standard.
Management System Certification of Medical Facilities
UKAS accredited certification bodies certify the management systems of healthcare providers to ISO 9001 to continuously support quality or to ISO/IEC 27001, which gives patients confidence in those organisations handling their personal data.
UKAS also accredits certification bodies to certify Healthcare Services Quality Management Systems to BS EN 15224:2012, which is based on the requirements of ISO 9001.
Accredited Reference Material Producers
UKAS accredits Reference Material Producers (RMP) to ISO Guide 34 (currently in the process of being replaced by ISO 17034) for a number of materials including, whole blood, serum and freeze dried serum and freeze dried urine.
Medical Physics and Clinical Engineering (MPACE) (In Development)
A project is underway to develop an accreditation scheme which will provide an external assurance of quality and competence and to drive improvement in standards of medical physics and clinical engineering science services (MPCE). Accreditation will provide confidence to all service users, including patients and commissioners, with the aim of promoting delivery of better quality services and quality outcomes.
- Directory of accredited organisations
- The benefits of accreditation
- Route to accreditation
- Apply for ISAS accreditation
- Apply for IQIPS accreditation
- CPA Transition to ISO 15189
UKAS Recognition within Health and Social Care Sector
The Department for Business, Energy & Industrial Strategy (BEIS) and the Department of Health released a joint policy agreement on accreditation formally recognising UKAS and its role within the health and social care sector.
The policy agreement highlights that “Accreditation increases trust in conformity assessment and thus reinforces the mutual recognition of products, processes, services, systems, persons and bodies across the EU”. It goes on to state that where new quality assurance schemes are planned in the NHS or social care, particularly where there is interest in schemes awarding certification or accreditation, their initiators should work with UKAS from an early stage to ensure that the schemes are sufficiently rigorous to meet EU and UK accreditation requirements.
For further details please visit: https://www.gov.uk/accreditation-and-conformity-assessment-guidance-for-business-and-government-departments