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On how to access the online Student Handbook, which can be viewed, downloaded or printed. Soft Copy: You will receive an email prior to the course with instructions
#TRAINING ISO 13485 SERIES#
Understand the purpose of the ISO 9000 series.Understand quality management definitions, concepts, and guidelines.TL - Leading Management Systems Audit TeamsĪttendees successfully completing this course receive a Certificate of Competency for each of Exemplar Global Competency Units listed above.įor more information, please see our Understanding the TPECS Course Structure page.This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Students gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions. Qualified instructors will help you to boost your audit capabilities with the latest developments of the new 19011 standard. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through the entire audit process, from managing an audit program to reporting on audit results. 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 Auditing Management Systems”.