European Cancer Care Certification activity is based on what requested by the European regulation on Certification (UNI CEI EN 45011-1999; UNI EN ISO 19011/2003).
European Cancer Care Certification has created an online database, in order to make the procedure more structured.
European Cancer Care Certification has been appointed by Eusoma to carry out the voluntary process of Certification of Breast Units in Europe according to Eusoma document "The requirements of a Specialist Breast Unit".
The high level of expertise of the whole procedure is guaranteed by a team of international auditors and a Certification board made by specialists recognised as international experts in the field of cancer.
European Cancer Care Certification lasts 3 years:
1st year INITIAL AUDIT
The INITIAL AUDIT is carried out by a TEAM made up by 5 experts.
During the INITIAL AUDIT will be evaluated the capacity of the Unit to meet the recommendations of the EUSOMA Guidelines 'The Requirements of a Specialist Breast Unit' i.e. buildings, hardware, specialist team, protocols, service provision, data base and audit.
2nd and 3rd year SURVEILLANCE AUDIT
To maintain the Certification, each year a surveillance visit must take place.
The 2 SURVEILLANCE AUDITS are carried out usually by one visitor (plus European Cancer Care Certification Technical Director acting as Visit Manager).
The first surveillance audit is scheduled within twelve months following the date of the Initial audit and also the following one will be scheduled on a twelve month basis (this plan can be modified by European Cancer Care Certification depending on the evaluation of the outcomes).
During each Surveillance Audit, the Audit Team evaluates at least:
- the efficacy and fulfilment of those missing non-mandatory requirements at the time of certification, changes in the Breast Unit organisation; any lodgements of claims and contentious European Cancer Care Certification may receive regarding the Unit; use of certificate and logos.
This procedure is carried out in compliance with what foreseen for granting the Certification.
Following each 3-year period, if the Unit wishes to continue the whole procedure starts again with the RENEWAL PROCEDURE = RE-AUDIT
