We provide ISO 13485 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.
It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.
The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) and the European Standard version, EN ISO 13485:2016, were published on 1 March 2016. According to the International Accreditation Forum (IAF), a three-year transition period will apply to all existing ISO 13485:2003 and EN ISO 13485:2012 certifications.
EN ISO 13485:2012 maintains its status as a harmonised standard and the presumption of conformity. It is expected that this will stand until the end of the transition period which will end on 1 March 2019.
How can ISO 13485 certification benefit my organisation?
Despite the similarities with the previous version of ISO 13485, there are numerous subtle and detailed changes within ISO 13485:2016.
To win in the highly regulated and high stakes world of medical devices manufacturing, it is crucial to beat the competition and minimise any potential losses from surprise product launch delays.
LRQA’s thorough yet streamlined approach ensures you get the right type of guidance at any stage of the product life cycle, towards a timely market launch.