$1,499.00 AUD

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ISO 13485:2016 Lead Auditor

⭐ 100% Online and Self-Paced
⭐ Exemplar Global recognised training provider
⭐ Ready-to-use templates and materials
⭐ Internationally recognised certificate
⭐ No prior experience in auditing and management systems required

This course is ideal for individuals looking to develop, implement, improve, manage, or audit multiple disciplines, whether aspiring to become external auditors or advancing their auditing careers across industries and organisations.

It offers comprehensive, practical training on conducting successful audits as a team member or lead. Participants will gain in-depth knowledge of the audit process, integrated management systems, team management, standards fundamentals, and risk-based methodologies.

The course focuses on the principles and practices of effective quality management system audits, aligned with ISO 13485:2016 and ISO 19011, Guidelines for Auditing Management Systems.

Enrolling grants you access to course materials and ready-to-use templates, including:

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 recognised 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