If your knowledge of the Standard is not what it should be, this ISO 13485:2016 Lead Auditor Refresher Course will quickly get your Certification up-to-date.
It will provide you with 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 against the requirements of the ISO 13485 Standard.
Who should take this Course?
This 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
What will I learn?
This comprehensive ISO 13485:2016 Lead Auditor Refresher Course is divided into three modules:
- Module 0: Introduction and background to the Standard and to auditing.
- Module 1: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Introduction to ISO 13485:2016
- EU, UK, USA Regulations & MDSAP
- 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 (Amendment 11)
- Advanced aspects of QMS Auditing (3 lessons)
- FAQs about the Standard
- Online Course Examination
- Module 2: 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
- Yet more Audit Scenarios – Lead Auditors
- FAQs about the Auditing Experience
- Online Final Examination
What Course Materials are included?
The ISO 13485:2016 Lead Auditor Refresher 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
How is the Course delivered?
The ISO 13485:2016 Lead Auditor Refresher 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 11,
- Continue the Module on the train home on your iPad running on iOS 13 and,
- Complete the Module at home on your Notebook PC running on Windows 10.
What Qualifications do I need?
If you have previously completed a Lead Auditor Course with deGRANDSON Global, you are pre-qualified. Just log-in, enrol and start your program immediately.
If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you are advised to complete a free Pre-Test first in order to demonstrate adequate auditing skills.
The Pre-Test will take 30 minutes approx. and is FREE. Click this link to begin: Check your Lead Auditor Skills.
Regarding prerequisite qualifications generally for Lead Auditor Programs, 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 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 this program.
Not sure this is the best ISO 13485 Program for you?
See our suite of ISO 13485 Training courses for comparison or check out our answers to frequently asked questions about ISO 13485 certification.
ISO 13485 Lead Auditor Course – to programme and conduct audits
ISO 13485 Lead Auditor Extension Course – to add to your existing certification
ISO 13485 Internal Auditor Refresher Course – to refresh your knowledge and skills
Have you tried this course?
Let us know what you think by rating it and leaving a comment below!
Frequently Asked Questions
Is the program certified?
Yes, deGRANDSON is an ISO 21001 certified educational organization certified by BQAI, an internationally accredited certification body.
ISO 21001 is a university grade standard used globally by schools, colleges, and universities. We are also certified to ISO 29993: 2017 (Learning services outside formal education and Service requirements) and ISO 29994:2021 (Education and learning services; Requirements for distance learning).
Are there corporate discounts?
Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page.
How can I pay?
You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Click on this link to view the Payment Process.
Is there an Examination?
Yes. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. The decision to award a Certificate is based on the combined scores achieved. The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken online. There are no extra costs involved.
What do I get when I’ve completed the Program?
Once you have completed the Examination, your Certificate is immediately available to you. Your Certificate will be forwarded to you as an email attachment that you may print as often as you like. There is no time limit on the validity of your Certificate.
What else will I need to become a competent auditor?
Provided you have the required personal attributes, all you need to add is auditing experience.
Who can I contact for more information?
Just send an e-mail to [email protected] or, for other options, see Contact Us.[/fullwidth_section]