Quality and safety are essential elements in the provision of health and socio-health services and a demand from society, who needs to have the necessary guarantees to make an appropriate choice of those services.
How to increase confidence in diagnostic services?
Medical laboratories, anatomical pathology services, diagnostic imaging studies (x-rays, ultrasonography, etc.) point-of-care testing (POCT) and other diagnostic tests are key in the healthcare system and must hold the necessary guarantees of technical competence.
Accreditation under UNE-EN ISO 15189 standard is the internationally recognised tool for diagnostic services to demonstrate their quality and technical competence.
Accreditation, confidence in diagnostic services
Document including information regarding accredited diagnostic services and their benefits for laboratories, medical professionals and patients
Check the document (in Spanish)
Other accredited services
- Certification of the quality standards applicable to health services (hospitals, primary healthcare centres, haemodialysis units, pharmacies…)
- Certification of quality and safety requirements of blood establishments.
- Inspection of compliance with the requirements and indicators established for health services (speciality care and primary care) in some Spanish autonomous regions
Inspection of social, health and HSC centres for compliance with requirements to eliminate the use of restraints.
Certification of residential services and day-care services.
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.
- Inspection of risk installations (cooling towers, spas and hydrothermal circuits…) required to verify compliance with the legionellosis prevention program.
- Legionella water testing
Ongoing collaboration with scientific-medical societies
- Federación de Asociaciones Científico Médicas (FACME)
- Asociación Española de Biopatología Médica (AEBM-ML)
- Sociedad Española de Hematología y Hemoterapia (SEHH)
- Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC)
- Sociedad Española de Medicina de Laboratorio (SEQC-ML)
- Sociedad Española de Inmunología (SEI)
- Sociedad Española de Anatomía Patológica (SEAP)
- Sociedad Ibérica de Citometría (SIC)
- Asociación Española de Diagnóstico Prenatal (AEDP)
- Asociación Española de Genética Humana (AEGH)
- Asociación Española de Laboratorio Clínico (AEFA)
- Asociación Española de Técnicos de Laboratorio (AETEL)
- Sociedad Española de Técnicos Superiores Sanitarios (SETSS)
Among the main objectives of the scientific-medical societies in general and their federation (FACME) in particular are the care quality improvement and the drive towards the evaluation of health outcomes. Thus, we need tools guaranteeing the quality of processes and procedures, crucial to have reliable and rigorous accreditation systems aligned with European standards”.
Dra. Pilar Garrido López
FACME President (Federation of Spanish Medical-Scientific Associations)