RINA Services has obtained ACCREDIA accreditation for certification according to ISO 13485:2016, the international standard for quality management systems in the medical devices sector.
The revision of the standard was published on 1 March 2016 and covers all organisations involved on one or more phases of the life cycle of medical devices, including supply and distribution companies. The transition period will run over 3 years, until 28 February 2019, until when the certifications issued in relation to both standards will be valid.
The certification procedure will be as follows:
These organisations can request launching of the transition process at the time of a surveillance audit or a renewal audit, or on a date between the two audits already planned. This applies to organisations already certified by RINA Services and those certified by other companies, who do not wish to transfer their certificate.
Organisations not yet certified can request their first certification directly, according to the requirements laid down on the new revision. This also applies to any organisation who has a negative outcome of an ISO 13485:2012 certification process, and who has implemented the management system according to the new requirements.