What is ISO 13485:2016

ISO 13485:2016 is a quality management standard developed for the medical device and related service industries. The standard provides guidelines to ensure that an organization can consistently meet customer and applicable regulatory requirements.

Unlike many of the other ISO standards, ISO 13485:2016 does not following the structure of the ISO 9001:2015 revision of the standard, instead it is based on the previous ISO 9001:2008 revision of the standard. This can be an ‘inconvenience’ for those companies that hold multiple ISO certifications.

For those companies that supply the European Market, and, who are required to show a CE mark on their products, ISO 13485:2016 is the preferred Quality Management System (QMS) by the notified bodies carrying out certification audits.

Who Should Use ISO 13485

ISO 13485:2016 may be applicable to organizations involved in one or more of the following life-cycle stages: design and development, production, storage and distribution, installation or servicing of a medical device, design and development or provision of associated activities (such as technical support). additionally, suppliers or external parties that provide products or service to the medical industry may want to consider complying with the requirements of the standard.

What Are the Benefits of ISO 13485

Some of the main benefits of ISO 13485 certification include:

  • Expanded market access
  • Higher customer satisfaction
  • More effective risk management
  • Greater regulatory compliance
  • Globally recognized standard
  • Compatible with other ISO standards

How Do I Get Started with ISO 13485

When determining how to get started it is important to look at your internal resources. Do you have anyone on your team that knows the standard and can implement its criteria properly? If not, you may want to consider reaching out to an experienced consultant who can assess your organization and systems to determine what is needed for an effective implementation. Contact us.

If you are working towards the standard a copy of  ISO 13485:2016 can be purchased here.

For our Massachusetts clients, State funding is available to help with ISO 13485 training.

Get in touch

Email or call - we can give you an idea of what is involved in ISO 13485 Certification, how long it will take, give an estimate of the costs or help with any other questions you might have.

For our Massachusetts clients, there is State funding available to offset the cost of training. Details here.