ISO 13485 with its current version of 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).

Requirements of ISO 13485:2016 are applicable to organizations 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 organization.

What it does:

  • Establishes and streamlines processes through complete documentation
  • Improves and establishes training processes
  • Defines roles and responsibilities
  • Greatly increases operational efficiency
  • Increases ability to troubleshoot
  • Develops and builds relationships that help to retain existing customers
  • Provides advantages over competitors that aren’t certified ISO 9001:2015
  • Builds opportunities for global commerce with international recognition
  • Improves customer relations
  • Improves relationships with suppliers due to clear, concise production standards·
    Provides basis for consistent and fact-based decision making
  • Carefully planned improvements, based on documentation and analysis
  • Provides for regular audits/reviews of performance