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    ISO 13485 & MDR Knowledge base

    How to get ISO 13485 certified?

    If you are using ISO 13485:2016 to create a Quality Management System (QMS) for your medical device company, you will likely consider certification against this standard. Certification by an independent third-party registrar is a good way to demonstrate the compliance for your company, but you can also certify individuals in your organization along the way.

    So, what is ISO 13485 certification, you may ask?

    Difference between company certification and personal certification

    ISO 13485 certification is a general term that is used for two main things. First, you can certify a company, i.e., certify its medical device Quality Management System. Certification of the company QMS involves implementing all of the requirements in the ISO 13485:2016 standard, and then having auditors from an independent third-party certification body come and verify that your QMS processes meet all of the requirements of the ISO 13485 standard. Your QMS is then certified.

    Second, you can certify individuals because you will need people in your organization to gain knowledge about ISO 13485 in order to implement and maintain the necessary processes, including the critical process of internally auditing your QMS on an ongoing basis to verify conformance and find improvement. These individuals may find that certified training is helpful in gaining these skills.

    What are the steps for ISO 13485 certification?

    What does it mean to be ISO 13485 certified?

    For a company to be certified against ISO 13485, it needs to be in the medical device industry. Then, the ISO 13485 certification process starts with the decision to use the ISO 13485 requirements to create your QMS. The process of implementation is then to create and document all of the processes required by the ISO 13485 standard, as well as customer and regulatory needs. After the implementation, you will need to use your QMS processes and maintain the system for some time, conduct internal audits, perform at least one management review of the system, and take corrective action for any nonconformities found. Learn more about the implementation process here: Checklist of ISO 13485 implementation and certification steps.

    After the implementation is completed, you will need to hire a certification body to send auditors to assess your QMS against the ISO 13485 requirements. When this third-party audit is completed, and they determine that the system you have in place meets all of the ISO 13485 requirements, the certification body will issue a certificate stating that your company’s QMS meets ISO 13485. You can then consider your company to be ISO 13485 certified, and you will start the cycle of maintaining your QMS.

    The requirements of ISO 13485 mandate that the QMS be maintained and improved, meaning that your ISO certification is not simply a one-time activity. Typically, there is a three-year audit cycle for ISO 13485, which starts with the initial certification audit, which will look at all processes in the QMS. Over the next three years the certification body will perform ongoing surveillance audits of the system (sometimes called maintenance audits), where they only look at a portion of the system along with critical processes such as the internal audit, management review, and corrective action. The maintenance audits happen, at a minimum, once a year during the period in which the certificate is valid. The cycle will start again after the three-year certification period is over, if the company chooses to maintain the ISO 13485 certification and the benefits it provides. At this time, a recertification audit that reviews the entire system will be done to start the certification cycle again.

    For some help in choosing the certification body you want to use for your QMS, see this free List of questions to ask an ISO 13485 certification body.

    How do I get ISO 13485 certified?

    For individuals, there are training courses that individuals can take to get the ISO 13485 certificate. ISO 13485 courses are necessary to provide the information, knowledge, and skills needed to use the ISO 13485 standard for creating and maintaining a Quality Management System in a company. In addition to implementation, individuals who will be auditing the ISO 13485 QMS will need to learn how to do so, and taking an auditing course can be an important part of this knowledge acquisition. For people who want to develop or advance their career in quality management and auditing, these individual certifications are invaluable.

    There are many courses available: ISO 13485 foundations courses, which typically last one or two days, and ISO 13485 Internal Auditor courses that typically last two to three days. Probably the best known course is the ISO 13485 Lead Auditor training that is intended for auditors of the certification bodies. These are usually a five-day course that includes an exam, and they can only be delivered by a company that itself has been accredited for delivering the ISO 13485 Lead Auditor training. All certification auditors must have the lead auditor training; however, this can also be invaluable for practitioners and consultants, since it provides knowledge of what the certification auditors will look for during certification.

    For more information on ISO 13485 training and becoming an ISO 13485 lead auditor, see ISO 13485 training requirements & available courses.

    To help you get ready for your certification, see a graphical representation of the implementation process here: Diagram of ISO 13485:2016 Implementation Process.

    Advisera Kristina Zvonar Brkic
    Kristina Zvonar Brkic
    Kristina Zvonar Brkic has worked as a consultant and lead auditor for ISO 13485, ISO 9001, and ISO 22716 for more than 10 years. She has also worked as an auditor and assessor for medical devices under MDD for 7 years, and currently MDR. The portfolio of medical devices for which she has approval are plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, dental materials, different catheters, panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.