Breast cancer is the most common tumour in Western women. In Spain, according to data from the Spanish Society of Medical Oncology (SEOM), around 27,000 new cases of breast cancer are diagnosed each year. Although the breast cancer mortality rate has declined in recent years thanks to improved treatments and screening programmes, it remains the leading cause of cancer death in women in Spain.

Within Europe, there are significant disparities in the mortality figures between EU countries, therefore, the "European Commission Initiative on Breast Cancer" project (ECIBC) was set up, aimed at developing a voluntary patient-centred European breast cancer quality assurance scheme, covering all stages of the process. Particularly regarding analysis, anatomy pathology and diagnostic imaging activities, since the beginning of the project the Commission has considered it essential that such activities be carried out under National Accreditation Body's accreditation. Therefore, European Accreditation (EA) has signed a cooperation agreement with the Commission and set up a working group made up of representatives of ENAC and the Finnish, Danish and Italian accreditation bodies to work hard on defining the model.

In parallel to participating directly in this project, ENAC has developed various activities set up nationally and, as a first step, has collaborated with the most directly involved Scientific Societies: Spanish Society of Senology and breast disease (SESPM), Spanish Society of Anatomy Pathology (SEAP), Spanish Society for diagnostic breast imaging (SEDIM).

ENAC accreditation is a recognition of the quality and competence of accredited bodies and, above all, the guarantee of reliability in results and issued diagnostic reports. Therefore, ENAC carried out a rigorous evaluation process based on the international UNE-EN ISO 15189 standard and protocols, guidelines and recommendations of the national and international scientific societies.

All this provides surety that clinical decisions made for breast cancer patients will be based on guaranteed results. In recent years ENAC has granted accreditation to the international UNE-EN ISO 15189 standard in the following activities:

• Five accredited bodies to carry out fine breast anatomopathological diagnosis studies, prognoses and treatment choices.
• Five accredited bodies for axillary node metastasis detection.
• Two accredited bodies for carrying out studies of the molecular expression of tumours providing information about long-term risks of recurrence
• Two accredited bodies to carry out studies of genetic predisposition to hereditary breast cancer.