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Why is “ISO 13485” Important to me when buying a portable oxygen concentrator?



ISO 13485:2003 is a quality management system that is specific to organisations needing to demonstrate that they are able to supply medical devices and services that meet, not only customer requirements, but also the various regulatory demands relating to medical equipment. All requirements of ISO13485:2003 are specific to organisations providing medical devices, regardless of the type or size of the organisation.

This means that all the quality management systems of Intermedical (UK) Ltd., our reporting systems, recall systems, servicing and repair procedures and our product traceability procedures are audited every year by SGS auditors. This ensures that each member of staff adheres to the necessary procedure to ensure that our clients receive product safe to use.

Our clients can also be sure that we adhere to all of the regulatory requirements relative to the equipment we supply and potential clients should seek this certification as the minimum when choosing a supplier of medical devices. It shows that the supplier is a serious, quality conscious supplier of medical devices. Companies having this level of quality certification will also be likely to have ISO 9001:2000, a quality management standard not specific to the medical device industry. Intermedical (UK) Ltd is proud to have been awarded both certificates and we are audited annually to ensure continuing compliance.

Look for the ISO 13485 and ISO 9001 Quality Marks on correspondence and advertising!

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