The Spanish accreditation system grows by 3%, reinforcing its progress in the health sector

The National Accreditation Entity (ENAC) has presented the 2025 Activity Report during the meeting of its General Assembly, in which José Manuel Prieto, president of the entity, highlighted the role of accreditation as "an essential tool to guarantee the correct application of public policies, strengthen the competitiveness and provide confidence in an international context characterized by technological acceleration, the transition to more sustainable models and the evolution of European regulation ". 

For her part, Beatriz Rivera, general director of ENAC, has reported below the positive evolution of the Spanish accreditation system, with a growth in activity and expansion to new areas, exceeding the 2,000 accredited entities and the 2,500 accreditations in force, which represents an increase of close to 3% compared to the previous year. 

Thus, 2025 has ended with 1,197 accreditations of test laboratories, 167 of calibration laboratories, 135 of clinical laboratories and other diagnostic services, 528 of inspection entities, 256 of product certification bodies, 136 management systems certification bodies, 37 people certification bodies, 27 validation and verification bodies, among others. 

Accreditation of clinical laboratories continues to rise 

Among the areas with the highest growth, validation and verification activity stands out, which has experienced an increase of more than 20%, driven especially for regulatory developments linked to sustainability, energy efficiency and the management of public funds. The suppliers of aptitude tests have also registered a growth of close to 12%, while the certification of management systems and people, as well as clinical laboratories, have shown increases of close to 9%. It is also important to note that almost 40% of laboratories have expanded their specialties, which translates into an increasingly complete and reliable diagnostic offer for the health system. 

Among the new services accredited in this sector in the last year is the first accreditation to the Spanish Society of Cytology (SEC) for the organization of aptitude tests for laboratories that carry out two types of tests to detect cervical cancer. Likewise, the Niño Jesús University Children's Hospital and the Virgen de la Arrixaca University Hospital have obtained accreditation for the quantification of CAR-T cells, a fundamental test in the follow-up of patients with oncohematological malignancies treated with CAR-T therapy. 

It also highlights the first accreditation to the biobank of the Public Health System of Andalusia under the ISO 20387 standard for the activity it carries out as a Node of Granada of the National Bank of Cell Lines (BNLC). Specifically, this accreditation supports the biobank's activity related to the custody and distribution of human pluripotent cell lines. 

Accreditation, a tool at the service of the regulator 

In this context, José Manuel Prieto stressed that "there continues to be an increasing integration of accreditation in European and national regulatory developments, with nearly 400 provisions that incorporate accreditation requirements as a mechanism to guarantee technical competence, optimize public resources and support simplification processes administrative". 

For her part, Beatriz Rivera stressed that ENAC's collaboration with public administrations, both at European and national, regional and local levels, has continued to be a central element of the activity: "Throughout the year, we have worked closely with different ministries, such as Industry and Tourism; Agriculture, Fisheries and Food; Transition Ecological and Demographic Challenge; Defense or Health, as well as with organizations such as the National Cryptological Center (CCN-CERT), the Center for Technological Development and Innovation (CDTI), the Spanish Agency for Medicines and Health Products (AEMPS), the Spanish Agency for Data Protection (AEPD), the State Agency for Railway Safety (AESF) or the State Administration Agency Tax (AEAT), among others. Likewise, cooperation with the Autonomous Communities and local entities has been strengthened, favoring a homogeneous application of the requirements and supporting the effectiveness of public policies. "

The growing international commitment to administrative simplification and improving regulatory quality has highlighted the value of accreditation as a tool to support Public Administrations. "This is reflected in the reports published in 2025 by the OECD and the World Bank and echoed in ENAC's report, which highlight its contribution to reducing administrative burdens, eliminating duplications and improving regulatory efficiency. These recommendations are fully in line with the vision driven by the European Commission, which identifies administrative simplification as a priority to strengthen European competitiveness, "said the director general of ENAC. 

In this context, ENAC has prepared a document addressed to Public Administrations in which it shows how accreditation can contribute to optimizing resources and improving the effectiveness of evaluation and control at the service of public policies. 

Source: PharmaMarket