ISO 13485 is the internationally recognised standard for quality management within the medical device sector. It is based on the ISO 9001 process model and its main objective is to enable a harmonised approach in the medical device industry. There are further requirements for the design, manufacture, servicing and installation of medical devices.
ISO 13485 is applicable to any business working in the medical device sector, helping to demonstrate that the business understands relevant regulatory requirements.
The implementation of an ISO 13485 Management System will enable your company to realise a variety of benefits:
A UKAS (United Kingdom Accreditation Service) certified quality management system shows a commitment to quality, customers and a desire to improve efficiency.
It shows that the quality system is effective, satisfying the requirements of an external, and more importantly, independent audit.
It will give your company a competitive advantage by enhancing the company image from customers and employees and giving you a marketing edge.
Consulting Services Ltd
Implementation and maintenance of Management Systems that meet the requirements of: ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 and PAS 99.
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