ISO 13485: 2016 - Medical devices Quality management systems


ISO 13485: 2016 - Medical devices Quality management systems

What is ISO 13485:2016?

ISO 13485: 2016 (Medical devices Quality management systems Requirements for regulatory purposes) is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2016 applies to design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal requirements.

ISO 13485:2016 Benefits:

  • Increased access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

Certification process

  • Complete a profiling form to customize a quote for your organization detailing the cost, planning and time required.
  • Conduct a pre-audit to determine if your organization already fulfills the requirements for ISO 13485:2016 and identify areas for improvement.
  • Stage 1 site visit by our auditors to verify the profile submitted during your application and determine your readiness for Stage 2.
  • Stage 2 on-site audit by MOODY auditors.
  • Propose and implement corrective actions, if any.
  • Receive your audit report and certificate from committee.

Why choose MOODY?

MOODY is a global leader in management systems solutions, having issued various management systems certifications to date. Our dedicated and experienced auditors across the globe can speak your language and help you explore the possibility of integrating your ISO 13485:2016 certification initiative with other management systems. We can also act as a one-stop provider for all your quality certification needs by offering bundled product testing and certification services. With the MOODY certification mark, you demonstrate your commitment to delivering quality products and services.