ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers 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 general 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.
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 harmonised QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence it gives patients and other stakeholders through its implicit promise of quality, consistency, and continuous improvement.
Whether you are looking to get certified against a globally recognised 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:
Many of our technical experts are hand-selected to provide input into the work of ISO technical committees, and can give you first-hand insight into the requirements of ISO 13485 and its logic. We also have a distinguished team of microbiologists who assess compliance within the sterile products area as part of a routine QMS assessment.