Following an intensive 3 day registration audit in November last year, Norcott have now been officially granted ISO13485:2016 approval.
Norcott Technologies have worked extremely hard over the past twelve months to gain this demanding approval.
This was partly due to encouragement from existing customers, but also as part of our development plan to acquire more high technology, high reliability business from the medical sector.
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. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.
Our team of Dave Forster (Quality Compliance Manager), Scott Hilton (Quality Engineer), Ted Reilly (Business Development Manager) and Martin Baker (Technical Manager) have all worked extremely hard over the past 12 months to fast-track the additional demands arising from the Medical standard. This has been a tough task but we have been able learn from the introduction of our AS9100 Aerospace approval programme, enabling a fairly smooth development of a lot of our already robust systems to meet the specified requirements.