ISO 13485 Lead Auditor Course Content
Be an internationally-certified Lead Auditor
This ISO 13485 Lead Auditor Training course provides you with the Auditing Skills, the Knowledge of the Standard and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Team Leader, to undertake and manage Certification Audits.
This ISO 13485 Lead Auditor Training course is intended for:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
- Medical affairs
- Legal Professionals
This comprehensive ISO 13485 Lead Auditor Training course covers all aspects of Internal Auditing and is divided into five Courses:
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- Module 0: Introduction and background to the Standard and auditing. Includes EU, UK, USA Regulations & MDSAP
- Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018
- Auditing Skills
- Terms and definitions
- Principles of auditing
- Auditor skills
- Managing an audit programme
- Audit Team Leadership
- Overview of Audit activities
- Audit activities – Step 1
- Audit activities – Step 2
- Audit activities – Step 3 (2 modules)
- Audit activities – Step 4
- Audit activities – Step 5
- Audit Activities – Step 6
- FAQs about Auditing
- Online Course Examination
- Module 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Introduction to ISO 13485:2016
- Developing & Implementing a QMS
- Terms & Definitions – ISO 13485:2016
- Some Key aspects of QMS Auditing
- Fundamentals of Medical Device Management Systems
- Structure & content of ISO 13485:2016
- Parts 1, 2 & 3
- Part 4: Quality Management System Requirements
- Part 5: Management Responsibility
- Part 6: Resources
- Part 7: Product Realisation (3 lessons)
- Part 8: Measurement, Analysis & Improvement (2 lessons)
- Annexes ZA & ZB (from Amendment 11)
- Advanced aspects of QMS Auditing (3 lessons)
- FAQs about the Standard
- Online Course Examination
Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.
- Audit Scenarios – Internal Auditor
- More Audit Scenarios – Lead Implementers
- FAQs about the Auditing Experience
- Online Final Examination
The ISO 13485 Lead Auditor Certification course comes with:
- Diagram: ISO Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Code of Ethics
- Management of an Audit Programme
- Sample Audit Plan
- Sample Audit Work Order
- Sample Nonconformity Report
- Sample Working Document & Checklist
- Risk Assessment Tools and Methodologies
- Documented Information Requirements of ISO 13485:2016
- Determining the Context of the Organization
- ISO 13485:2016 and Risk Management
- Risk Assessment Tools and Methodologies (with examples)
- Terms & Definitions
- Typical Process Map
The ISO 13485 Lead Auditor Training course is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).
All Modules have a full resume and scaling capabilities. This means, for example, you can…
- Start a Module at work on your Work Station running on Windows 10,
- Continue the Module on the train home on your iPad running on iOS 9 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1
For this ISO lead auditor training online the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience, with at least 2 at managerial/supervisory level, is recommended.
You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
Not sure this is the best ISO 13485 Course for you?
See our full list of ISO 13485 courses or see our answers to frequently asked questions about ISO 13485 for more information.
Related Courses
ISO 13485 Internal Auditor Course – to conduct effective internal audits
ISO 13485 Lead Auditor Extension Course – to add to your existing certification
ISO 13485 Lead Auditor Refresher Course – to refresh your knowledge and skills
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