$1,499.00 AUD

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ISO 13485:2016 Lead Auditor

⭐ 100% Online and Self-Paced
⭐ Exemplar Global Recognized Training Provider
⭐ Ready-to-use templates and materials

⭐ Internationally Recognized Certificate
⭐ No Prior Experience in Auditing and Management Systems Required

This course is designed for those who seek to develop, implement, improve, manage, or audit against multiple disciplines and are interested in becoming an external auditor, continuing their career as auditors across various industries and organizations.

This course provides a comprehensive and practical understanding on how to conduct a successful audit, either as part of an audit team or as the team lead. This course will give participants a thorough knowledge of the audit process, integrated management systems, team management, standards fundamentals, and risk-based approach methodologies.

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”

By enrolling in this course you will access to the course materials and ready-to-use templates such as:

  • Explanation of ISO 13485 and workshops
  • ISO 13485 audit checklist
  • ISO 13485 documentation requirements
  • ISO 14971:2019 Overview of structure and contents
  • Clean room technologies and validation
  • Biological evaluation of medical devices
  • Process approach guide
  • Risk management guide
  • Risk-based thinking guide
  • Sample audit plan
  • Sample audit report
  • Auditor meeting guide

Exemplar Global recognized certificate (formerly RABQSA).


International in This Course
  • ISO 19011:2018
  • ISO 13485:2016
Qualification
  • Exemplar Global – TL Management Systems Lead Auditors
  • Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
  • Exemplar Global-MD- Medical Devices ISO 13485:2016

What People Are Saying:

First, I am thankful for this training as it increased my knowledge and expertise in my field of work. It gave me the opportunity to be more efficient as Auditor, thus provided more methods to be applied in my specialization. There are times that I have no access to the internet, but because of the study materials provided, I can still review offline . Moreover, the educators were utmost in support and approachable, making me feel secure in gaining knowledge. Lastly, I am hoping to have another opportunity for education from your training courses. Appreciate everything from you. Thank you very Much LMS TRG.“- Edmer

Highly recommend courses from LMS TRG. Excellent course material with easy to understand templates and worksheets. The course contains very practical real world knowledge of audits without the added fluff. It is a goto training organisation for anyone who wants certification with maximum ease and professionalism. No time wastage on useless course material or unnecessary work. As a working professional it was easy for me to complete the course along side with work and gave me the insights needed to improve my work and helped me in upskilling. Great admin support with very quick response time. Will definitely come back for another course. Preet

An excellent, self paced course with value for money. The presentations and courseware provided valuable tools for understanding and successfully completing the course. Neil