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United StatesISO 13485 Lead Auditor Training is for anyone that wants to gain the knowledge and skills required to conduct full system first, second and third-party audits based on ISO 13485 2016, in accordance with ISO 19011 and ISO IEC 17021.
Our industry-leading blended methodology requires Learners to first complete interactive eLearning modules on the underlying theory that better prepares them before attending Live Classes with an Instructor that focus on practical application in a real life context.
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Our Methodology
How Blended Learning Works
Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.
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Gain an Accredited ISO 13485 Lead Auditor Qualification
Advance your knowledge and enjoy more flexibility & higher learning effectiveness with blended learning.
Course Overview
ISO 13485 Lead Auditor Training
Explain the purpose of a medical device quality management system (MD-QMS), interaction
with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021
Plan, conduct, report, and follow-up an audit of a medical device quality management system
to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011 and ISO/IEC 17021
Overview of ISO 13485
- Introduction to ISO 13485
- Terms and Definitions
- Plan Do Check Act
- Documentation Requirements
- Process Based QMS
- Risk Based Thinking
- Management Commitment
- Related Standards
Introduction to Auditing
- Management System Audits
- Audit Terminology
- Principles of Auditing
- Audit Program Management
- Certification Audit Program
- Audit Lifecycle
Planning the Audit
- Audit Objectives, Scope and Criteria
- Selection of Audit Location
- Selection of Audit Team
- Auditee, Observer & Guides
Audit Initiation and Preparation
- Establishing Contact with Auditee
- Determining Audit Feasibility
- Document Review
- Audit Preparation Activities
- 1st and 2nd party Audit Plan
- Initial Certification Audit Plan
- Assigning Work to Audit Team
- Audit Working Documents
- Audit Checklist
- Process Analysis
- Sampling Sheets
Conducting the Audit
- Opening Meeting
- Communication during the Audit
- Auditee Reactions
- Audit Sampling
Generating Audit Findings and Closing Meeting
- Audit Findings
- Non Conformity Grading
- Non Conformity Reporting
- Final Audit Team Meeting
- Audit Conclusion
- Closing Meeting
Audit Reporting, Completion and Follow Up
- Audit Reporting
- Completing the Audit
- Audit Follow Up Activities
- Addressing Non Conformities
- Initial Certification Decision
- Re-Certification
CQI & IRCA certify this course (No. 2244). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Before completing this course, each Learner should have the following prior knowledge:
- It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485)
- The Plan, Do Check, Act (PDCA) Cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
Fluency in written and spoken English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
Copy of ISO 13485 (International Standard)
- It is recommended that each Learner should have a printed copy of ISO 13485 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment & final examination.
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
- Fully attend the Live Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
- Complete a 2hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination which is completed securely online (under strict examination conditions).
*Note: the final examination is closed book and will assess each Learner on the full course program – including knowledge of the ISO 13485 Requirements.
For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Why Choose Comply Guru
About Our ISO 13485 Lead Auditor Training
Learn about how our IRCA Accredited ISO 13485 Lead Auditor Training is leading the industry for innovation & learning effectiveness
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.7
Average Rating
543 global ratings
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great teacher. always avilable to take more time after training session to answer any question. i would recommend this training to anyone who looking for experience and good support
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Fantastic course! Michelle was great tutor, would highly recommend this course.
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The training was very efficient and well delivered. I would use Comply Guru again in the future.
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This was my first training with Comply Guru but definitely I would recommend it as it was good presented and very beneficent for my knowledge.
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The layout of the course was excellent. The online self paced course was good to get a background and build / refresh knowledge. The class lead course was excellent I thought the way it was presented was very effective as we were straight into practice and interacting. I found this course really enjoyable and have recommended to my colleagues
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