LR is the first UKAS accredited ISO 13485:2016 assurance provider globally to have successfully achieved accreditation for ‘Parts & Services’. ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The extension to scope covers the newly defined category of ‘Parts & Services’ and the specific activities now defined and introduced within MD9:2017. “This is a significant achievement for LR,” said John Howlett, LR’s technical lead for Medical Devices certification under ISO 13485. “Safety and quality are central and non-negotiable when it comes to medical device manufacturing. The introduction of ‘Parts & Services’ now clarifies those activities that fall within the scope of ISO 13485 and allows organisations to seek certification in support of their medical device customers. Certification with LR to ISO 13485 allows an organisation to demonstrate compliant processes and best practice across the board.”
To support medical device manufacturers and related suppliers with their transition to ISO 13485:2016, LR is providing a range of assessment and training services to organisations worldwide. There are some clear timelines in place in terms of transitioning; from March 2019, all accredited certifications to ISO 13485:2012 will cease to be valid.
“In addition, the International Accreditation Forum has also stated that 2 years from publication, all new certifications and re-certifications issued must be to ISO 13485: 2016, so this latest global accreditation is both timely and significant,” summarised Howlett.
More information about LR’s wide range of ISO 13485 assessment and training services can be found here.