ISO 13485:2016

ISO 13485:2016 certification is a medical industry international standard that sets specific quality requirements for manufacturers of medical devices. This standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices and was meant to incorporate various standards previously in use throughout the world.  After completing first and second stage assessments, APS Materials is currently in compliance with this rigorous industry standard.

Because ISO 13485:2016 is harmonized with ISO 9001:2015, APS Materials has had a mature base of processes and procedures since 1996 to carry out the extension of our quality system certification to ISO 13485:2016 standards.

Certification to ISO 13485:2016 ensures our customers:

  • that we promote and maintain awareness of regulatory requirements as a management responsibility,
  • provide controls in the work environment to ensure product safety,
  • focus on risk management activities and design transfer,
  • provide inspection and traceability for implantable devices,
  • document and validate our processes,
  • and provide CAPA activites in support of our service to this industry