About ISO 13485:2016 - MEDICAL DEVICE

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488.

Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Advantages of ISO 13485 certification:

As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485:2003 certification:

  • Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets
  • Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements.
  • ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.
  • Certification can lead to increased efficiency, better product quality, and improved customer service within your company
  • Demonstrate your consumers and partners a commitment to quality.