What's 'ISO 13485:2016; Medical Devices - Quality Management Systems - Requirement' for Regulatory Purposes?

ISO 13485:2016 is the international standard that defines Quality Management Systems' (QMS) requirements for organizations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturing of materials or component parts that are used in medical devices.

The latest version of the standard was published in March 2016.  It shares the same QMS principles and also follows the generally increased emphasis on risk management shown within the range of QMS standards.  It has not, however, adopted the Annex SL high level structure reflected within ISO 9001:2015.

ISO 13485 was originally derived from ISO 9001 and shared the same basic principles, but required greater documentation and placed additional emphasis on areas such as the work environment, risk management, design control and regulatory requirements.

Why is ISO 13485:2016 important for your organization?

These days, medical device manufacturers often insist that their suppliers and service providers are certified to ISO 13485 as a pre-requisite for doing business. ISO 13485 certification is therefore an increasingly important differentiator for organisations looking to improve their marketability.

Whilst the primary objective of ISO 13485 certification is to facilitate harmonized QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence that it gives patients and other stakeholders through its implicit promise of quality, consistency, and continuous improvement.

Certification to ISO 13485:2016

Whether you are looking to get certified against a globally recognized medical device QMS, or if it is towards compliance with the Medical Device Directive (MDD) 93/42/EEC or In Vitro Diagnostic Device Directive (IVDD) 98/79/EC, we provide a range of services including:

  • Gap analysis
  • Preliminary assessment
  • Assessment
  • Certification
  • Transitioning from ISO 13485:2003 to ISO 13485:2016