ISO 13485 Implementation | Things You Should Know About

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ISO 13485 is the international standard for setting up and maintaining a documented quality management system in the medical device industry. If a manufacturer has ISO 13485 implementation, it will have a foundation for certifying for regional medical device regulations like the EY Medical Device Regulation (MDR), EU Medical Device Directive (MDD), the US FDA 21 CFR 820, and other regulations that show a commitment to the quality and safety of medical devices.

COVID-19 Talks About The Rules For Cleanliness

Manufacturers of medical devices and products should think about how to keep the device from getting contaminated while it is being made. Sources of contamination include airborne particles, dirty machines, and raw materials, among other things. People who don’t know how to handle the devices right are also a source of contamination.

As part of their COVID-19 response, the International Organization for Standardization (ISO) released a new list of standards for PPE and medical devices on April 16. These product standards give manufacturers rules to follow to be proactive in the fight against the spread of the virus.

Requirements of ISO 13485 Certification

Here are the main goals the project should aim for to make sure medical products pass certification:

Define The Scope: 

What is the medical device, what is it used for, who is it for, and how is it categorised? What is the ISO product standard for collections, and what are the rules for this product in each region?

Conduct a Gap Analysis And ISO 13485 Audit:

This is a check to see how well the standards are being met.

Create a Project Plan:

After the audit and gap analysis, create a corrective plan that lists all non-conformities and how to fix them to meet ISO 13485 requirements and a related regional standard implementation.

Develop Documentation:

Put together the required paperwork, such as a Quality Manual, procedures, work instructions, and paperwork that shows proof of implementation.

Develop And Give Training:

This is one of the most important steps on this list. It is required that training be given to everyone who will be involved in any part of making the medical device. In the first training, the team learns about the ISO 13485 standards that apply to them, including those that deal with regional and product certifications. The next training is to set up a Quality Management System that provides a standard for following necessary sanitary procedures and work instructions and a way to record proof of ISO 13485 implementation on specific paperwork.


You have three to six months to set up the new Quality Management System and get the paperwork ready to show compliance.

Conduct an Internal Audit:

The supplier should audit the medical device internally to check for compliance and fix any problems. A third-party auditor, like Pro QC, can also do this internal audit.

Conduct a Management Review:

If the Quality Management System isn’t set up according to ISO 13485 and doesn’t meet the policy and goals that have been set, it needs to be changed to meet the requirements.

Apply for ISO certification:

The last step is an outside audit of ISO 13485 implementation. Certification bodies usually do this kind of outside audit. Depending on your organisation’s readiness, the certification body will either give you the ISO 13485 certificate or a non-conformance report that tells you what you need to do to fix things. In the case of non-compliance, Pro QC can advise and help the applicant put these corrective actions into place and ensure they work. Once all things that don’t meet standards have been fixed, the company can reapply for certification.

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