ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Benefits of Implementing ISO 13485: 2016

  • Ensure compliance with standard and other requirements.
  • Cutting processes increases efficiency so as to result in significant time and cost savings.
  • Gain competitive advantage with third-party certification that is independent and globally recognized.
  • A source for all your testing and certification needs.
  • Providing experience, expertise and international competition in the medical equipment market.
  • Facilitating planning, controlling, monitoring, preventing and improving, auditing and reviewing activities to ensure that the policy is adhered to and that the management system remains appropriate.
  • Able to adapt to changing circumstances.

During the audit you will be assessed on:

  • Documentation control
  • Records being kept
  • Staff and management conformance to the system
  • How the system is working in each area of the organisation
  • Staff training necessary to meet the requirements

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Who is ISO 13485 for?

ISO 13485 is designed for use by organizations involved in the design, production, installation and service of medical devices and related services. This can also be used by internal and external parties, such as certification bodies, to help them with the audit process. ISO 13485: 2016 requirements apply to organizations regardless of size and type unless explicitly stated. Wherever the requirements are determined to be applied to medical devices, the requirements apply to related services as provided by the organization.