ISO 13485:2016 Certification

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ISO 13485: 2016 is an international standard that represents the necessities for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory necessities, an organization does not essential to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2016 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal necessities.

ISO 13485:2016 has now been issued which will supersede the present version ISO 13485:2003. Though, it is the European version that has been updated and other countries outside of Europe therefore still use ISO 13485:2003.

ISO 13485 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article that is intended by the manufacturer to be used alone or in combination. Receiving ISO 13485 certification needs a valuation of all aspects of a company’s business processes and procedures to confirm conformity with the necessities outlined in the standard. Registration signifies that a manufacturer has applied an integrative management system that complies with the applicable regulatory necessities for quality management.

Benefits of ISO 13485

  • Provides assurance that appropriate regulatory necessities are applied within your organizational procedures
  • Provides confidence that best practice validation and GMP have been implemented and evaluated
  • Provides confidence of quality risk management and good manufacturing practices within the medical device supply chain throughout the medical device product life cycle
  • Allows your organization to prepare for product-to-market regulatory necessities for the medical device markets of Europe, Australia, Asia and all major developed as well as emerging markets