Brief description

ISO 13485:2016 specifies requirements for the quality management system that needs to be applied by organizations operating in the medical device industry.

Detailed description

This standard specifies the Quality Management System requirements for companies active in the design, production, sale, installation and servicing of medical devices. This standard:

• Puts special emphasis on risk management and decision making based on the risks involved in the processes that do not concern implementation of the product. Focuses on the risks related to the safety and performance of medical devices and their compliance with regulatory requirements.
• Requires organizations to carry out stricter controls in case of outsourcing of processes, implementing written agreements for assessment of their suppliers based on risk. Responds to the increased regulatory requirements for organizations throughout the medical-device supply chain.

It should be noted that this standard does not follow Annex SL structure employed in the new versions of ISO 9001:2015 and ISO 14001:2015. In the current release of EN ISO 13485:2016/A11:2021, Annexes are added in which the requirements of the standard paragraphs are correlated with the requirements found in the two regulations, EU 2017/745 concerning Medical Devices and EU 2017/746 pertaining to In Vitro Diagnostic Medical Devices.

What is the certification procedure?

Who is it for?

This certification is designed for all businesses operating in the medical device industry.

What are the benefits of certification?

The advantages of application and certification of an ELOT EN ISO 13485 Quality Management System are summarized as follows:

• demonstrating the ability of the Management System to ensure that the company complies with the legislative, regulatory, and contractual requirements related to medical devices.

• ensures the business’s compliance with the requirements of the applicable national and European Legislation on medical device products
• Strengthens user/consumer confidence and assurance that the medical device complies with the requirements of the international, European and national standards, as well as with the existing European and national legislative and regulatory provisions
• timely notification of consumers, users, the National Organization for Medicines (EOF) and the competent European authorities regarding any incident involving the medical device, and confirmation of the effectiveness of corrective actions taken
• recognition of the certification by all interested parties (users, consumers, manufacturers, authorized dealers, importers, distributors, the EOF and the competent European authorities) in the international, European and national markets.

Who do I contact for certification?

Customer Service Department Contact Person: Ms. Anna Topaltziki, Tel: +30 210 5220920, Ext: 2064