Medical Devices

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ISO 13485:2016 has been revised. It has not adopted the Annexe SL format common to other international standards. It follows the format of the former standard ISO 9001:2008. We have developed a one day course that focuses on the changes and the significant differences with ISO 9001:2015. We look at the implications for audit practice and use your own ISO 13485 process documents to illustrate the audit process. This course can be delivered on a stand alone basis or as a third day option with our two day CQI-IRCA approved ISO 9001:2015 internal auditor training course

Call us on 01543 404620 for an informal chat about the options

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