When a clinical laboratory is selected to perform an analysis in the health sector, we need to be sure that it can provide correct results that we can trust; in other words, we must choose a technically competent laboratory.
For the users that require this service (clinicians and patients), choosing a laboratory that can provide total technical competence is essential for ensuring clinical decisions based on reliable results, minimising risks and improving diagnostic quality.
All ENAC documentation relative to accreditation criteria and procedures for clinical laboratories is available in the DOCUMENTS section.
Technical competence, more than just quality management
Unlike ISO 9001 certification, which is the confirmation that a company has set up a quality management system in accordance with certain requirements, accreditation under the UNE-EN ISO 15189 standard confirms the technical competence of the laboratory and ensures the reliability of test results.
Only accreditation can generate confidence both in the laboratory's competence for issuing reliable results – with the necessary human and material resources and experience – and its ability to provide a service adapted to the needs of its users, since the UNE-EN ISO/IEC 15189 standard requires the laboratory to have a quality management system defined in the standard itself, in addition to technical competence requirements.
See the joint IAF-ILAC-ISO communiqué on the UNE-EN ISO 15189 standard here.
Associations with which ENAC collaborates
- AEBM (Spanish Association of Medical Biopathology)
- AECNE (Spanish Association of Neonatal Screening)
- AEDP (Spanish Association of Prenatal Diagnostics)
- AEFA (Spanish Association of Pharmaceutical Analysts)
- AEGH (Spanish Association of Human Genetics)
- SEAP (Spanish Society of Anatomical Pathology)
- SEHH (Spanish Society of Haematology and Haemotherapy)
- SEI (Spanish Society of Immunology)
- SEIMC (Spanish Society of Infectious Diseases and Clinical Microbiology)
- SEQC (Spanish Society of Clinical Biochemistry and Molecular Pathology)
Accredited clinical laboratories provide this guarantee to users in:
- Anatomical pathology
- Clinical toxicology