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Cancer Screening, Diagnosis and Care

European quality assurance scheme for breast cancer services

The European quality assurance scheme defines a common set of both quality and safety requirements for breast cancer services wishing to improve the quality of care offered to women.

The scheme is designed to be implemented on a voluntary basis and covers all the relevant care processes from screening until end-of-life care. Services compliant with the requirements can apply for certification.

Manuals have been developed for each main actor involved in the European quality assurance (QA) scheme implementation process.

The current versions of the manuals have been used to assess its feasibility in real settings and to pilot the certification process. A final version of the QA scheme will be prepared based on the outcomes obtained.

Scheme owner

This manual sets out how the QA scheme is organised, managed and maintained and how the certification process is carried out. The aim is to provide full details on scheme owner requirements for breast cancer services and certification bodies participating in the QA scheme.

Separate checklists have been prepared for each of the modules described in the manual to facilitate the auditing process.

Scheme Owner Manual
(624.6 kB - PDF)
Corrected page 48 - Scheme Owner Manual
(576 kB - PDF)

Breast cancer services

This manual describes all requirements of the QA scheme. It provides details on how to meet these requirements and how to calculate the indicators that will be used to verify the quantitative requirements.

This manual also specifies how compliance with a given requirement has to be demonstrated by breast cancer services.

Manual for Breast Cancer Services
(1.5 MB - PDF)
Errata - Manual for Breast Cancer Services
(350 kB - PDF)

Certification bodies

This manual intends to facilitate the process for piloting of the certification body audit process of breast cancer services for the European QA scheme. It describes the requirements for certification bodies, including how to perform the auditing process and when to offer certification.

Manual for Certification Bodies
(1.43 MB - PDF)

Implementation of the scheme

The revised versions of the European QA scheme manuals will be submitted to the EA to obtain the formal validation of the European QA scheme for distribution to the National Accreditation Bodies, thus ready-for-use. 

Information on how the accredited certification process for the breast cancer initiative will be operated at EU level and how interested breast cancer services will be able to apply for certification will be made available by the EC. Meanwhile, the Scheme Owner Manual explains in detail the type of certification process the European QA scheme shall follow and already allows breast cancer services to start preparing for reaching compliance with the European requirements.

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