For medical device manufacturers, ISO 13485 is the most reliable, internationally recognized standard of quality management. The ISO 13485 standard mentions all the requirements that an effective quality management system in the medical device industry should meet.

Some of the most common questions about ISO 13485 are discussed below:

1. What’s Difference About ISO 13485:2016?

Several changes were made in the latest revision to the standard, including a greater emphasis on risk, specifying the responsibilities of management, specifying training activities, and bringing design and development in sync with other regulations.

The revision also prioritized supplier control, added requirements to ensure better traceability, and emphasized complaint handling procedures.

2. Are ISO 9001 and ISO 13485 the Same?

ISO 13485 is a separate standard and not linked to ISO 9001.

ISO 9001 is designed to be applicable for every organization in every industry, whereas ISO 13485 features specific requirements for medical device manufacturers. Among other things, these requirements focus on work environment, sterile devices, cleanliness of medical products, and contamination control.

3. Is it Compulsory to Obtain an ISO 13485 Certification?

While it isn’t mandatory, by implementing the ISO 13485:2016 standard you can be confident of having an internationally recognized system in place.

While you’re free to develop your own quality management system, an ISO 13485 certification empowers you to better satisfy your customers, meet all legal and regulatory requirements, and continuously improve your quality processes.

4. How Can My Company Be ISO-Certified?

For your company to receive an ISO 13485 certification, it needs to have a quality management system that fulfills the requirements of the standard. Then, a recognized certification body should be enlisted to audit it and approve it as meeting all the requirements.

After approval, your quality management system should be allowed to work for some time, during which you’ll obtain records and collect evidence for the next part of the process.

You’ll need to conduct an internal audit to assess your quality management systems, followed by a management review in which your management systems should be evaluated. After the audit and review, you’ll have to resolve any problems that have been identified, and document the resolution.

Lastly, the certification body you selected will have its auditors review your documentation for alignment with ISO 13485, and audit your activities to make sure they’re in compliance with ISO 13485 and your prepared documentation.

5. The Certification Process Sounds Complicated. What Do I Do?

To make sure you get things right the first time, you can hire an ISO consultant. An ISO certification is a commitment to invest time and resources towards improvement, and you can benefit from the expertise of ISO 13485 consultants. Whether it’s a first-time certification or a renewal, ISO consultancy services simplify the whole process and guide you through it.

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As one of the leading ISO 13485 consultant companies in America, our ISO consulting services bring guaranteed results. To make sure your company meets the global standards of quality, get in touch with us today!