Common Questions about ISO 13485

Emergo Group has been assisting medical device manufacturers with ISO 13485 consulting and GMP quality system implementation and auditing since 1997. Here are the most frequent questions posed by our clients over the years.

Does ISO 13485 apply to ALL medical device manufacturers?

No, most manufacturers of Class I medical devices that are not provided sterile or do not have a measuring function do not need to implement ISO 13485. See our page which shows exactly which medical device companies need ISO 13485. Also, Standards are voluntary and many international markets (Europe, Australia, Japan) offer other alternatives for meeting their national quality management system requirements. One exception is Canada which requires Class II, III and IV manufacturers to meet the ISO 13485 standard.

Who issues ISO 13485 certificates?

ISO 13485 certificates are issued by independent firms authorized by national Ministries of Health to conduct audits of manufacturers’ quality systems. ISO 13485 certificates are never issued by a Ministry of Heath itself.

Is a CE Marking certificate the same as an ISO 13485 certificate?

No. CE Marking certificates are intended to demonstrate compliance of a device with applicable European Directives. ISO 13485 certificates prove compliance of a company’s quality management system with the ISO 13485 standard. CE Marking certificates are sometimes accepted as proof of compliance with the national medical device regulations of some countries.

What is the difference between a Notified Body, Certification Body, Conformity Assessment Body and Registrar?

These terms are often used interchangeably to describe third-party organizations that conduct certification audits of medical device companies to ensure compliance with the ISO 13485 Standard and associated Directives. The difference between them is the scope of their auditing authority by geographic market. You can read more about the differences between them and how to select one.

How long does it take to implement ISO 13485?

You can read a more detailed discussion of how long it takes to implement ISO 13485. But the short answer is that most companies find it takes 4-7 months from the time they start the process until the time certification is achieved. This figure can vary dramatically depending on the company size, locations, complexity of manufacturing and dedication of resources.

What is the cost of achieving ISO 13485 certification?

See our discussion of ISO 13485 costs.

For how long is an ISO 13485 certificate valid?

Generally, certificates are valid for 3 or 4 years. However, nearly all manufacturers must submit to annual audits by their certification body. Manufacturers of high risk devices may also be subject to inspection by a national Ministry of Health.

Is the ISO 13485 standard free? Where can I get a copy?

The ISO 13485 standard is a copyrighted document published by the International Organization for Standardization (ISO). You may purchase a copy of the standard from the ISO website or from other websites authorized to sell standards documents.

We already have US FDA GMP or ISO 9001. How difficult will it be to upgrade to ISO 13485?

Companies that already have a well maintained and audited US FDA GMP or ISO 9001 quality system in place will find it relatively easy to make the changes necessary to achieve ISO 13485 certification. The US Food and Drug Administration does not recognize ISO 13485 but the US FDA did provide input when ISO 13485 was being crafted so FDA Good Manufacturing Practice is similar to ISO 13485. Likewise, ISO 9001 is the basis of ISO 13485 with additional requirements specifically for medical device manufacturers. Therefore, upgrading to ISO 13485 will be fairly straightforward and we can assist you in this process.

What is the difference between ISO 9001 and ISO 13485?

ISO 13485 is based on ISO 9001, although the two standards differ enough that a manufacturer with ISO 13485 cannot also claim compliance with ISO 9001. ISO 13485 was written to meet, and maintain compliance with, regulatory requirements so it does not have the same emphasis on customer satisfaction and continuous improvement found in ISO 9001. Companies that manufacture products with medical and non-medical applications are sometimes certified to both Standards.

We outsource manufacturing. Do we need to implement ISO 13485?

In general, yes. However, if your contract manufacturer already has ISO 13485 certification, your ability to prove to your certification body that you have “control” over the quality of goods being produced by your supplier becomes easier. Thus, selecting an OEM that already has ISO 13485 certification is beneficial, but not required.

Please contact us for more information on ISO 13485 consulting.