The transition period between ISO 13485:2003 and ISO 13485:2016
The new ISO 13485:2016 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements.
ISO 13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose.
The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.
Medical device and in vitro diagnostics manufacturers are now ready to take the big jump and set to start a 3 year transition journey. The transition time was initially introduce as an attempt to allow manufacturers absorb the changes while evaluating the gap between the previous version of the standard published in 2003 and their Quality Management Systems and procedures.
It is expected however that by the end of the three year, manufacturers will have successfully completed the transition to ISO 13485: 2016, as ISO 13485:2003 version of certificate will be discontinued and replaced by ISO 13485:2016 versions (Feb 28, 2019).
Learn more about it: NEW ISO 13485:2016 MEDICAL DEVICE QMS TRANSITION TRAINING – RECORDED WEBINAR