IQC Global Australia

ISO 13485 Certification

ISO 13485 Medical Device Certification

ISO 13485 Medical Device Certification is a quality management system specifically designed for Medical Devices Industry. It covers the entire life cycle of the medical device from Procurement, Design, Manufacture, Installation and Commissioning , Servicing .

ISO 13485 Standard lays emphasis on Quality, Safety with Compliance on regulatory requirements. Lays emphasis on Risk Management and Risk Based Decision making. Suppliers in the supply chain should also meet regulatory requirements ,

Capturing  Latest regulatory requirements and updates and meeting these requirements is part of the ISO 13485 Standard requirements.

Having Jas Anz ISO accredited certification helps the business to grow both nationally as well as internationally as the Jas Anz certification is recognized worldwide and helps the business in selling the products nationally and internationally after meeting requirements of the regulatory bodies like TGA, FDA.

ISO 13485 certification enables medical device manufacturers to:

  • Access worldwide markets otherwise unattainable
  • Outline how to review and improve processes across your organisation
  • Cut down costs, increase efficiency and monitor supply chain performance
  • Easily demonstrate that your medical devices are safer and more effective
  • Easily meet regulatory requirements and enhance customer satisfaction
  • IQC is a registered issuer of certificates of compliance when the satisfactory compliance standards and documented procedures are met.

Click here to enquire about the ISO 13485.

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