ISO 13485 Certification

ISO 13485:2016

ISO 13485:2016 is an international standard titled “Medical Devices – Quality Management Systems – Requirements for regulatory purposes.” In Europe, under EN ISO 13485:2016/A11:2021, the standard is harmonised with Regulation 745/2017(MDR) and Regulation 746/2017 (IVDR). 
Compliance with a harmonised standard provides a presumption of conformity with the essential requirements laid down in the European Union legislation (legislative acts), including the aforementioned Regulations. On a national level, in November 2021 UNI issued the UNI CEI EN ISO 13485:2021 standard, transposing the EN ISO 13485:2016/A11:2021 version. The standard is voluntary. 
The standard specifies requirements for Quality Management Systems allowing an organisation to demonstrate its ability to provide medical devices and related services that meet customer and applicable regulatory requirements.

ISO 13485:2016 CERTIFICATION (EN ISO 13485:2016/A11:2021 - UNI CEI EN ISO 13485:2021)

The requirements of this standard relate to the Quality Management System of an organisation involved in one or more stages of a medical device’s lifecycle, including design and development, production, storage and distribution, installation, servicing as well as final decommissioning and disposal of medical devices.

Suppliers and other external parties providing products to such organisations (e.g. raw materials, components, sub-assemblies, medical devices, sterilisation services, calibration services, distribution and maintenance services) can also apply the requirements of this International Standard.
Bureau Veritas is recognised as an accredited Certification Body and performs independent third-party audits to assess the management systems and provide certification services concerning the ISO 13485 standard. 

Our methodology

The key phases of the certification process include:

• Defining the certification scope;
• Preliminary verification (on request): gap analysis to assess the organisation's compliance with requirements;
• Certification audit, which ultimately results in the issuance of the certificate;
• Periodic surveillance audits, aimed at monitoring continuous improvement.

After each audit, the organisation receives a clear and comprehensive report detailing the results of the activity carried out, which it can use to enhance process improvement.

WHAT ARE THE MAIN BENEFITS OF CERTIFICATION?

ISO 13485 certification demonstrates and promotes organisations' commitment to organisational criteria typically aligned with regulatory and market requirements in the medical device sector.

FOR MEDICAL DEVICE MANUFACTURERS
Subject to conformity assessment procedures involving a Notified Body, ISO 13485 certification ensures a direct and independent verification essential for any subsequent market surveillance activities conducted by the Ministry of Health.

FOR COMPANIES DISTRIBUTING OR MARKETING MEDICAL DEVICES
And for companies offering related services, ISO 13485 certification provides direct and independent verification of activities, increasing the likelihood of success in public tenders.

FOR USERS, CUSTOMERS AND PATIENTS
The certification of a Quality Management System for Medical Devices testifies to the organisation's commitment to provide products and/or services aligned with the latest legislative and regulatory standards, through the application of proven organisational models aimed at improvement.

FAQ – FREQUENTLY ASKED QUESTIONS ABOUT ISO 13485