ISO 13485-2016 Lead Auditor | Certification
This ON DEMAND 32-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Quality Management standard and ISO 19011 Lead Auditing and includes a certified training Certificate of Competence. 3.2 CEUs.
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Course curriculum
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How to use this course
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ISO 13485-Lesson-02
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ISO 13485-Lesson-01 and 02-QUIZ
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ISO 13485-Lesson-03
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ISO 13485-Lesson-03-QUIZ
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ISO 13485-Lesson-04a
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ISO 13485-Lesson-04a-QUIZ
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ISO 13485-Lesson-04b
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ISO 13485-Lesson-04b_QUIZ
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Video-Summary-Leadership requirements
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ISO 13485-Lesson-05
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ISO 13485-Lesson-05-QUIZ
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Video-Summary-Support requirements
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ISO 13485-Lesson-06
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ISO 13485-Lesson-06-QUIZ
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- $495.00
Learning Objectives
After completing this training, students will:
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Understand quality management definitions, concepts, and guidelines for ISO 13485:2016
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Know the requirements of the ISO 13485:2016 standard
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Understand the process approach
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Know the records required for internal and external audits
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Understand audit team leader responsibilities and how to communicate effectively during the audit
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Possess the skills to evaluate the competence and skills of auditors and select the audit team members
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Realize the roles and responsibilities of the auditor
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Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances
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Understand the requirements for planning the audit and conducting the opening and closing meetings
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Know methods to prepare audit conclusions and the audit report
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