ISO 13485:2016 Medical Devices Quality Management Systems (QMS MD) Lead/External 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
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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:

  • 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).

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

  1. Exemplar Global – TL Management Systems Lead Auditors
  2. Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
  3. 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
Standards in this Course

ISO 19011:2018, ISO 9001:2015

Duration

Complete the course module by module at your own pace. The course is equivalent to 48 hours (six days full-time study)

Qualifications
  1. Exemplar Global – TL Management Systems Lead Auditors
  2. Exemplar Global – AU Auditing Management Systems – ISO 19011:2018
  3. Exemplar Global – QM Quality Management Systems – ISO 9001:2015
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.

Frequently Asked Questions

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.

ISO 9001 Quality Management Systems (QMS) Lead Auditor ISO Certificate

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

"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

"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

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Who We Are

LMS TRG is an Exemplar Global Recognised Training Provider for courses in Management Systems Auditing. We come together from various specialist backgrounds to produce unique online learning experiences. Our team is composed of auditors, management systems consultants and providers, with over fifteen years of experience in delivering high-level quality training.

We were founded with the policy of being pioneers in fully online and smart training solutions.