Quality and safety are key when it comes to providing health and health and social care services, as well as for the demanded guarantees from society in order to choose these services safely.
Accreditation generates confidence among patients, prescribers and health and community health and social care service managers because the assessment is performed impartially, independently and competently, in accordance with internationally recognised standards.
Diagnosis is a critical stage of health care. As a result, all parties involved – especially the patient and the clinical physicians – benefit from access to reliable and competent diagnostic services, covering everything from national centres of reference to routine and emergency hospital laboratories, both public and private. The safety and reliability of the services provided by these laboratories benefit the patient, both in the diagnosis and in the prognosis and treatment of the disease.
Clinical laboratories demonstrate their technical competence through compliance with the requirements of UNE-EN ISO/15189.
- Pathological anatomy: plays a central role in cancer diagnosis, including cytology, biopsies and, increasingly, molecular basis studies focusing on the selection of specific anti-tumour drugs.
- Clinical laboratories in the different disciplines: biochemistry, haematology, immunology, microbiology, genetics, toxicology, etc.
- Immunogenetics-Transplants: laboratories that conduct histocompatibility tests for transplants receive dual accreditation from ENAC and the European Federation for Immunogenetics (EFI).
Health Care services:
- Assessment of acute in-patient centres in Catalonia.
- Certification of the quality standards applicable to the different health services (hospitals, primary care centres, haemodialysis units, pharmacies, etc.) in certain Spanish regions.
- Certification of the quality and safety requirements of blood transfusion services and centres.
Population ageing has led to the dramatic growth of health and social care (HSC) services, which underlines the importance of offering services to users and their families that have been competently and independently assessed and which offer guarantees in terms of their provision.
Health and Social Care services:
- Inspection of social, health and HSC centres for compliance with requirements to eliminate the use of restraints.
- Certification in residential services and day care services.
- Inspection of risk facilities: cooling towers, spas and hydrothermal circuits, etc. to verify compliance with the legionellosis prevention programme.
- Legionella water testing.
Medicines and Heath Products
- The microbiological, chemical and development tests required to provide users with quality and safety guarantees for medicines of chemical or biological origin derived from medicinal plants and their raw materials.
- Studies on the sterility of medical devices such as dressings, bandages, syringes, etc.
- Effectiveness studies (bactericidal, fungicidal, virucidal, etc.) required to register antiseptics and disinfectants with the Ministry of Health.
- Microbiological testing in cosmetics.
- Inspection of compliance with correct manufacturing standards for raw materials (active ingredients and excipients) and standards on the correct distribution of medicines.
- Certification of quality management systems for medical devices under UNE-EN ISO 13485, in the voluntary sector.
Testing of biological samples for doping control in athletes based on the requirements of the World Anti-Doping Agency (WADA) set out in its International Standard for Laboratories (ISL) and related technical documents, and the UNE-EN ISO/IEC 17025 accreditation standard.