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    BSI's “ISO 13485 2016 Lead Auditor” competency-based course teaches a general understanding of the concepts of the ISO 13485 2016 standard and the principles and practices of leading management systems and process audits in accordance with ISO 19011 2018, “Guidelines on

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  • ISOISO 13485 — Medical devices

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    Note All attendees must study the current published version of ISO 13485 before attending class.Evening study recommended. A 2-hour final exam is required. Quality Management System (QMS) BasicsDescribe the core components of an effective QMS. QMS RequirementsDescribe the ISO 9000 standard series as well as analyze requirements of and relationship between ISO 9001 2015 and ISO

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    This ISO 13485 auditor training online course comprises four sections, as given below Lectures. There is a total of 8 lecture sessions, which are given to the course participants as a presentation with explanatory audio to understand the subject. The topics discussed in the lecture sessions are listed below Session 1 Overview of ISO 13485 2016.

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