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Quality Management Systems ISO 13485:2003


NSAI applies ISO 13485:2003 Quality Management Systems to assess a medical device manufacturer’s quality systems in support of the medical device directives. This internationally recognized quality standard outlines particular quality management system requirements tailored to the manufacture of medical devices. ISO 13485:2003 also references the international guidance document ISO 14969:2004 - Quality management systems -- Guidance on the application of ISO 13485: 2003, developed to assists device manufacturers on the application of ISO 13485:2003.

Once a manufacturer has met the requirements of the directive, then the device may carry the CE Marking, and where NSAI, as a Notified Body is involved, the Notified Body number (0050) is to appear with the CE Marking. Continuing compliance with the requirements of the directives is assessed through regular surveillance audits by NSAI .

If you would like a quotation please complete the attached form and return it to medical.devices@nsai.ie. Download the qoutation form here (Word doc).

For Application/Request for Quote to ISO 13485:2003 click here

For Application/Request for Quote to ISO 13485:2003/CMDCAS click here

For CE Marking Applications, Substantial Change, Non-Substantial Changes and links to Directives click here




Last Updated - [29 Oct 2008 @ 15:19:24]

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