ISO 13485 - Medical Devices.

What is ISO 13485 ?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations 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 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.

Requirements of ISO 13485 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organisation.

The processes required by ISO 13485 that are applicable to the organisation, but are not performed by the organisation, are the responsibility of the organisation and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity to ISO 13485 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organisation or the nature of the medical device for which the quality management system is applied, the organisation does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organisation records the justification as described in 4.2.2.

The good news is that the documentation required for ISO 13485 implementation has a consistent format and layout, focused on the requirements of and echoing the terminology of the standard. Our templates do exactly that. Written by qualified auditors they are tried and tested. All you have to do is adapt a few areas of the text to reflect your own organisation.

       Benefits of ISO 13485 Certification

  • Achieve better scores in pre-qualification questionnaires (PQQ’s)
  • Improved Internal Processes and control of services
  • Improved management of suppliers / outsourced services
  • Improved relations with suppliers / other interested parties
  • Checks that staff training / competency / licences managed correctly
  • Checks that equipment, maintenance, facilities and calibration managed correctly
  • Effective systems for dealing with issues and problems
  • Ongoing checks and reviews of operational activities
  • Systems for improvements and continual improvement of management systems
  • ISO 9001 Registered Logo for use in marketing
  • Enhanced systems for getting feedback from customers / end users
  • Controls over design and variations
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