Selecting a Certification Body for Your ISO 13485 Audit

There are several terms used to describe the third-party entities that perform audits of medical device ISO 13485 quality management systems and associated technical documentation. They are Notified Bodies (Europe), Registrars (Canada), Conformity Assessment Bodies (Australia) and Registered Certification Bodies (Japan). You can read more about each one here. For purposes of simplicity, we will refer to these entities as Certification Bodies (CB) since all perform the same function: to certify that you are in conformance with the ISO 13485 standard and applicable regulations.

When you are evaluating an ISO 13485 Certification Body, consider the following:

Future market expansion plans – If you are looking to acquire European CE Marking, consider your future plans. Might you expand to Canada or Japan? Not all Certification Bodies can audit to the Canadian and Japanese regulations so you would need to hire yet another auditing firm to conduct audits for these regulations. If there is a reasonable chance you may expand to other markets in the future, be sure to select one that will be able to offer you certification in those markets.

Size of the certification body – This depends on your goals. Having a large brand name as your Certification Body can have a direct impact on your ability to secure new contracts with overseas firms simply because the name recognition of your auditor lends credibility to your company. If your company is trying to break into the Japanese market, for example, using a widely known Certification Body such as TUV, BSI or UL could be beneficial. On the other hand, many small to mid-sized Certification Bodies are reputable and can sometimes offer faster service at lower prices than the big players.

Customer service – Make sure the company you select will provide the level of service you expect. Evaluate whether the firm follows up with a proposal quickly. Ask how long it will be before the company can conduct a registration audit, issue a CE certificate or review technical files. Ask how many of their auditors are in-house versus contracted. You should be aware that many use contract auditors, and their ability to control an auditor’s schedule is limited. While most firms use contract auditors, allowing them to have a bigger pool to talent at their disposal, you need to be aware of the downside. Ask for non-competitor references and call them.

Extra fees – Before making your selection, ask the Certification Body if it charges any special administrative, renewal or address change fees. If you are also seeking CE Marking, find out how much it would cost to get extra copies of your CE certificate. Ask where the auditor will be traveling from to conduct your audits. Some firms include travel costs in their quote while others do not. Once you sign a contract, you will not have any choice but to pay those fees so it is better to know about them now.

Select a firm experienced with your medical device – It is always good to ask the Certification Body whether it has experience with your specific devices, especially if you manufacture a higher risk (Class IIb, III or IV) device. Experience also is critically important if you manufacture a product for which classification may be open to interpretation (example: teeth whitening products). In this case, you want a Certification Body that will support your classification if challenged by a Ministry of Health or a competitor.

There are several firms authorized to conduct audits for European, Canadian, Australian, Japanese and other international regulations and standards. Working with one of these ISO 13485 certification bodies can be very beneficial if you intend to sell your devices in several international markets.

Please contact us for more information or a free proposal on our ISO 13485 services.