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Medical Devices
There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices.
Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.
NQA has significant expertise in the medical device manufacturing sector and is ideally placed to assist clients to successfully implement ISO 13485 and supporting standards:
- Bespoke Solutions
NQA provides specialist expertise to help organisations improve performance and manage competitiveness by tailoring its assessment, certification and reporting services.
- BS / ISO / IEC 27001:2005
ISO 27001 is the international standard for Information Security Management Systems (ISMS) based largely upon the previously adopted BS 7799 used commonly since 1995 for managing information security.
- ISO 13485:2003
ISO 13485 is based on the ISO 9001:2008 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.
- The TickIT Guide
TickIT is a guidance document that interprets ISO 9001 for specific application to software development.
- ISO 9001:2008
ISO 9001 is the internationally recognised standard for Quality Management Systems (QMS).
- ISO 14001:2004
ISO 14001 is the international standard for environmental management systems now the most widely used EMS in the world, with over 6,000 organisations certified in the UK and an estimated 111,000 organisations certified in 138 countries world-wide.
- OHSAS 18001
OHSAS 18001:2007 is an internationally recognised occupational health and safety management system standard.
- OHSAS Online Quote form
Health and safety management systems questionnaire.
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