ISO 13485 Certification | Bureau Veritas
Higher quality and transparency for the medical technology industry
Complying with regulatory and customer requirements for manufacturing and distributing medical devices in a global marketplace can be confusing. With so many regulations that vary from country to country, an organization must address a variety of quality, risk and process management issues to be internationally competitive.
Certification of your management system to ISO 13485 confirms that you take your customers' requirements into account and work in accordance with applicable regulations. It also underlines your ability to identify market opportunities for medical devices and to apply new technologies.
WHAT IS ISO 13485:2016?
ISO 13485:2016 is an international quality management standard that enables the implementation of regulatory requirements for medical devices, in vitro diagnostics and related services (Regulation (EU) 2017/745, Regulation (EU) 2017/746, Directive 93/42/EEC, Directive 98/79/EC, Directive 2007/47/EC and Directive 90/385/EEC). It is addressed to all organisations whose activities are related to medical devices: manufacturers and suppliers, subcontractors and distributors. Repair or maintenance companies are also affected.
This standard takes into account specific requirements for medical devices, in particular on the following points:
- Compliance with regulatory requirements
- Risk management and control
- Mastery of the design process (integration of risk analysis and clinical studies)
- Mastery of special processes (e.g. sterilisation)
- Dissemination and implementation of warning cards and reports to the competent authorities
The annexes to ISO 13485:2016 enable manufacturers of medical devices to comply with the essential requirements of the European Directives and Regulation 2017/745 with which their medical devices must comply.
WHY BUREAU VERITAS?
Our auditors have extensive industry knowledge, local regulations, markets and languages. This enables a wide range of tailor-made certification and audit services.
Bureau Veritas is a leading certification provider with more than 100,000 certified clients in 140 countries.
We are represented in over 140 countries. This global presence enables us to offer our customers international expertise combined with in-depth local knowledge.
The specialization of our auditors enables a better assessment of your business processes and contributes to their optimization with a professional certification service.
FREQUENTLY ASKED QUESTIONS ABOUT ISO 13485 CERTIFICATION (FAQ)
IMPLEMENTING A MANAGEMENT SYSTEM ACCORDING TO ISO 13485 - WHY?
In an increasingly competitive environment, it is necessary for the sustainability of a company to strengthen the trust of customers and to take their requirements into account. The ISO 13485:2016 standard, which contains specific requirements for medical devices, ensures that your partners (customers, suppliers, etc.) and the relevant authorities have an operational and management framework that can meet these requirements.
Taking into account specific approaches such as risk management and control, identification, traceability, cleanliness, contamination control, etc. shows that you are committed to providing a high quality service that complies with regulatory requirements and meets stakeholder expectations.
CAN MY ORGANISATION IMPLEMENT A COMMON ISO 9001:2015 AND ISO 13485:2016 QUALITY APPROACH?
If the activities of the organization are closely related to medical devices, the quality approach may refer to ISO 13485:2016. If your company develops in different areas, it is possible to integrate the requirements of both standards. Depending on the corporate strategy, the processes can then be the same or different.
In both cases, the Bureau Veritas team can carry out the audits according to the specific situation of the company.