ISO 13485:2016 Medical Devices Quality Management Systems (QMS MD) Lead/External Auditor
✅ 100% Online and Self-Paced
✅ No booking is required; start upon enrollment
✅ Learn Whenever Wherever
✅ Exemplar Global Recognised Training Provider
✅ Ready-to-use templates and materials
✅ Internationally Recognised certificate
✅ No Prior Experience in Auditing and Management Systems is Required
Enrol Now $1,499.00 AUD (inc. GST)
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About this course
This course is designed to provide participants with the skills and knowledge required to perform first, second, and third-party management systems audit against the ISO 13485:2016 requirements, in accordance with the guidance given in ISO 19011. You will acquire the skills to plan, conduct, report, and follow up a QMS MD audit that establishes conformity and enhances overall organizational performance. After successful completion of this course, you will learn about how to act as a team leader and how to manage your team during the audit.
Some of the ready-to-use templates and materials of this course:
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Explanation of ISO 13485 and workshops
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ISO 13485 audit checklist
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ISO 13485 documentation requirements
- ISO 14971:2019 Overview of structure and contents
- Clean room technologies and validation
- Biological evaluation of medical devices
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Process approach guide
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Risk management guide
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Risk-based thinking guide
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Sample audit plan
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Sample audit report
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Auditor meeting guide
Exemplar Global recognized certificate (formerly RABQSA).
Standards in this Course
ISO 19011:2018, ISO 13485:2016
Duration
Complete the course module by module at your own pace. The course is equivalent to 48 hours (six days full-time study)
Qualifications
- Exemplar Global – TL Management Systems Lead Auditors
- Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
- Exemplar Global – QMS MD Quality Management Systems Medical Devices – ISO 13485:2016
Prerequisite
No prior experience in auditing and management systems is required.
Assessment
At the end of every module, you will take a short multiple-choice quiz which assesses your knowledge and understanding gained throughout the training. The quizzes are based on the topic that you have completed. Once you complete and submit the quiz, the scores are marked instantly by LMS TRG. The quizzes consist of questions with single answer and multiple answers. You can do the practice quiz as many times as you like until you pass.
Final Exam
Similar to the end-of-module quiz, the final quiz is shaped based on questions of single or multiple answers. To obtain your qualification, you will be required to pass the final exam. The final quiz questions are based on all the course modules. The score is marked instantly by LMS TRG. You can redo the final exam if you fail.
Course structure
100% Online and Self-Paced
Seventeen (17) topics and there will be a quiz at the end of each topic.
Topics:
- Course introduction
- Management systems
- HLS (High-Level Structure)
- Quality management systems in medical devices
- Audit fundamentals
- Audit cycle
- Audit sampling
- Auditor roles and responsibilities
- Planning an audit
- How to conduct an audit
- Auditor principles and behavior
- Team and stress management
- Read and comprehend
- Audit findings
- Audit reports
- Case study
- Final exam
Who should attend
- The QMS MD Lead Auditor course is ideal for those looking to conduct external or third-party audits, as well as providing comprehensive coverage of the internal audit process for those who conduct internal audits.
- Anyone responsible to develop, implement, maintain, improve, manage, or audit against ISO 13485
- Individuals who want to become a third party QMS MD auditor
- Managers who need to write and implement a QMS MD
- Anyone involved in the Quality Management Systems processes
- Professionals who wish to consolidate their existing knowledge into a formal qualification
Learning outcomes
Our practical course will leave you with an understanding of:
- The principles and concept of internal auditing
- Comprehensive understanding of ISO 13485:2016
- Auditor roles and responsibilities
- Interpersonal skills of an auditor
- How to conduct the audit
- How to manage an audit meeting
- Stress and team management
- Effective methods of communication
- How to read and comprehend the standard requirements
- How to prepare and distribute an audit report
- Work as an auditor in a Certification Body
Frequently Asked Questions
What is ISO 13485?
ISO 13485 is an international standard that outlines the requirements for a quality management system in the medical device industry.
Why is ISO 13485 important?
ISO 13485 is important because it provides a framework for ensuring the safety, reliability, and effectiveness of medical devices.
What are the requirements of ISO 13485?
The requirements of ISO 13485 include having a quality management system that covers areas such as management responsibility, resource management, product realization, and measurement, analysis, and improvement.
What is the benefit of taking an ISO 13485 online self-paced lead auditor course?
Any organization involved in the design, development, production, installation, or servicing of medical devices can benefit from compliance with ISO 13485.
What is the benefit of taking an ISO 13485 online self-paced lead auditor course?
The benefit of taking an ISO 13485 online self-paced lead auditor course is that it provides individuals with the knowledge and skills needed to conduct effective audits of medical device quality management systems. This can be useful for individuals who work in the medical device industry or who are interested in pursuing a career as an auditor.
What are the Quality Management Systems Lead Auditor course recognitions?
After successfully completing the course, you will receive an Exemplar Global recognized certificate for the following competency units:
- Exemplar Global – TL Management Systems Lead Auditors
- Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
- Exemplar Global –MD ISO 13485:2016
How long do I have access to the training material?
Once you sign up with LMS TRG, your access remains valid for the next 12 months. You can finish your training over a period of twelve months.
Can I access my LMS TRG training via my phone or tablet?
Do I need advanced IT skills to start the LMS TRG courses?
Testimonials
"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.“
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- 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."
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- Preet
"An excellent, self-paced course with value for money. The presentations and courseware provided valuable tools for understanding and successfully completing the course."
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- Neil
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Who We Are
At core, LMS TRG is a compliance consulting and training organisation that builds and delivers powerful and practical products for people and businesses. Born and bred in Melbourne, Australia with an amazing team of expert auditors, consultants, and entrepreneurs.
Our area of expertise lies in providing training and guidance on compliance with the National Disability Insurance Scheme (NDIS) and the International Organisation for Standardisation (ISO). We also assist organisations in implementing effective management systems that are tailored to their specific needs and requirements. Our comprehensive approach to compliance training and management systems ensures our clients have the knowledge and tools necessary to meet regulatory requirements and industry standards. We are committed to helping our clients achieve success and maintain a culture of excellence in their operations.
We Care for each other, our members, and our society.
We Dare to discover and experiment, trying to be different and be fearless, and innovative.
We share our knowledge and experience, work together and continue to support our members.
