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

    1. How to use this course

    1. ISO 13485-Lesson-02

    2. ISO 13485-Lesson-01 and 02-QUIZ

    1. ISO 13485-Lesson-03

    2. ISO 13485-Lesson-03-QUIZ

    1. ISO 13485-Lesson-04a

    2. ISO 13485-Lesson-04a-QUIZ

    3. ISO 13485-Lesson-04b

    4. ISO 13485-Lesson-04b_QUIZ

    1. Video-Summary-Leadership requirements

    2. ISO 13485-Lesson-05

    3. ISO 13485-Lesson-05-QUIZ

    1. Video-Summary-Support requirements

    2. ISO 13485-Lesson-06

    3. ISO 13485-Lesson-06-QUIZ

  • $495.00

Learning Objectives

After completing this training, students will:

  • Understand quality management definitions, concepts, and guidelines for ISO 13485:2016

  • Know the requirements of the ISO 13485:2016 standard

  • Understand the process approach

  • Know the records required for internal and external audits

  • Understand audit team leader responsibilities and how to communicate effectively during the audit

  • Possess the skills to evaluate the competence and skills of auditors and select the audit team members

  • Realize the roles and responsibilities of the auditor

  • Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances

  • Understand the requirements for planning the audit and conducting the opening and closing meetings

  • Know methods to prepare audit conclusions and the audit report

Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

Globally recognized and trusted online training provider for leading medical device customers

International Accreditation

Our courses are designed to International Standards for Educational and Training Organizations.

● ISO 21001:2018 Management Systems for Educational Organizations ● ISO/IEC 17024:2012 Personnel Certification Body, Conformity Assessment, General Requirements for Bodies Operating Certification of Persons. ● ANSI/ASTM E2659-9, Standard Practice for Certificate Programs. ● ISO 9001:2015 Quality Management System Requirements.