ISO 13485 certification

ISO 13485:2016 is an international standard that defines the requirements of a Quality Management System (QMS ) for medical devices. Aimed at manufacturers, suppliers and distributors, it guarantees patient safety, product quality and regulatory compliance.

Recognized worldwide, it serves as a benchmark for demonstrating compliance with regulatory and industry requirements applicable to medical devices.

It ensures the implementation of a structured system to meet quality and safety standards in the medical field, making it a global benchmark of trust for all stakeholders.

ISO 13485 covers any product or service related to the medical devices sector, including :

• Manufacturing,
• The design,
• Distribution,
• Parts supply,
• Services,
• Subcontracting activities ,

• And other related functions.

All players in this sector are thus eligible for certification, proof of their commitment to meeting specific customer requirements.

The number of ISO 13485 certifications is increasing worldwide.

By December 31, 2020, over 25,000 ISO 13485 certificates had been issued worldwide, with around 1,000 in France.

ISO 13485 is based on a number of fundamental principles designed to ensure the quality, safety and regulatory compliance of medical devices.

These principles structure the Quality Management System (QMS ) and enable organizations to optimize their processes while meeting the specific requirements of the sector.

1. Process approach
   Each activity is considered as an integrated, interdependent process. This approach ensures the consistency, efficiency and continuous improvement of the QMS by structuring complex operations into manageable processes.
2. Proactive risk management
   Risk management is a central pillar of ISO 13485:2016. It involves the identification, assessment and control of risks at every stage of the medical device life cycle: design, manufacture, distribution and use.
   This approach aims to ensure the safety and efficacy of products while guaranteeing compliance with applicable regulatory requirements defined by the competent authorities.‍
3. Customer focus
   Understand and anticipate customer needs and requirements while complying with regulatory requirements.
   Customer satisfaction is a central element of the QMS and contributes to improving the quality of medical devices.‍
4. Continuous improvement
   Adopt a culture of continuous improvement at all levels of the organization.
   Applying the PDCA cycle (Plan, Do, Check, Act) optimizes the control and efficiency of processes and products.‍
5. Staff involvement
   Encourage theactive involvement of employees in the QMS.
   Ensure their competence through appropriate training, thereby reinforcing the quality and conformity of medical devices.‍
6. Documentation and regulatory compliance
   Maintain rigorous documentation to demonstrate compliance with standards and facilitate audits.
   Comply with local and international requirements to access global markets.

These principles enable organizations to guarantee the quality, safety and efficacy of their medical devices, while meeting customer expectations and regulatory requirements.

The certification cycle lasts three years.

It begins with an initial audit in two stages: first a document review to check that processes comply with the specific requirements of ISO 13485, followed by an on-site audit to assess their practical application.

Once certification is obtained, annual surveillance audits are conducted for the following two years to ensure continued compliance.

After three years, the process must be renewed to retain certification.

Experts in cyber security for over 15 years, our approach is to help you achieve a level of security in line with your objectives. Without imposing ready-made practices, we'll build an action plan in line with management guidelines, based on actual risks.

It is essential to be independent of the certifier from the outset of your certification. It's up to the company to decide on its approach and its security program. Many auditors come from large groups, and don't have the pragmatic approach needed by small and medium-sized businesses.

That's why it's important to have the right experts at your side to help you successfully implement your QMS.