Why an ISO 13485 2016 Quality Management System is Critical to Medical Devices

In the heavily regulated and safety conscious world of healthcare, in particular, medical devices, a practical and thorough foundation built around a strong Quality Management System is not only recommended but a necessity for survival for manufacturers in this space. ISO 13485:2016 is one of the medical device industry’s most widely used and accepted international standards, designed to address regulations, medical device directives, safety, and quality within an organization’s given processes.

Smithers offers ISO 13485:2016 certification services to medical device manufacturers who are looking to realize or establish consistent supplier quality, clear best practices for design, and efficient manufacturing and distribution programs.

What is ISO 13485 Certification?

Established in 2003, ISO 13485 was built as an international standard focusing on the design, manufacturing, and distribution of medical devices.

The ISO 13485 Certification Process

To become Quality Management System ISO 13485 certified, it is required for an organization to show its ability to produce medical devices, and their related services, in such a way that they consistently meet all regulatory requirements, as well as consumers' needs. Manufacturers or service groups that seek this certification may also be involved with a single stage, or multiple stages of a medical device’s lifecycle. For instance, device design or development, production, distribution, installation, or repairs.

Although it’s compatible with an ISO 9001 quality management system, an ISO 13485:2016 audit does not require a company to demonstrate continuous improvement, but it does require proof of implementation and maintenance.

The Benefits of ISO13485 2016 and Why Choosing Smithers for Certifications Services Leads to Growth

Organizations that achieve the ISO 13485 2016 standard can benefit from:
  • Enhanced safety controls within the work/production environment
  • Documentation for preventative and corrective actions
  • Alignment with the FDA and other regulatory bodies
  • Product and service improvements

As a certification body, Smithers is staffed with fully trained and highly skilled ISO 13485:2016 auditors that strive to become an integral part of your team by providing you with valuable tools, like checklists and workbooks that assist in facilitating successful certifications and their future maintenance. Additionally, many of our ISO third-party auditors in this field have a wealth of rich experience in the medical device industry as a whole, and convenient access to their knowledge can be a huge asset to you and your company as you go through the certification process or help you transfer your ISO certification to a new registrar.

Contact us to get started and learn more about our services today!

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