ISO 13485:2016 Internal Auditor Refresher Course
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.
The Course provides you with the Knowledge of the Standard and the practical application of that knowledge with Audit Scenarios to enable you to undertake Internal Audits and Supplier Audits.
What will I learn from this ISO 13485 Internal Auditor Refresher Course?
The ISO 13485 Refresher Training is divided into two modules:
- 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
- Terms & Definitions – ISO 13485:2016
- Some Key aspects of QMS Auditing
- Fundamentals of Quality 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 modules)
- Part 8: Measurement, Analysis & Improvement (2 modules)
- Annexes ZA & ZB (Amendment 11)
- 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
- FAQs about the Auditing Experience
- Online Final Examination
What materials are included in this ISO 13485 Internal Auditor Refresher Course?
This ISO 13485 Internal Auditor refresher Course includes:
- Diagram: Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Nonconformity Report
- Sample Working Document & Checklist
- ‘ISO 13485:2016 & You’ – a guide to new and changed requirements
- The Design & Development Process in ISO 13485
- Documented information in ISO 13485:2016 (130+ instances)
- A typical Process Map – practical application of the process approach
- Terms & Definitions in ISO 13485:2016
Who should enroll in this ISO 13485 Internal Auditor Refresher Course?
You should take this ISO 13485 Internal Auditor Refresher Course if your knowledge of the Standard is below par and …
- You would like to update your ISO 13485 Internal Auditor Certification,
- You are required to perform quality system internal audits within your organization,
- You will be called on to perform supplier audits on current or new vendors, or
- You wish to improve your career prospects
Key Features
- Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
- An ISO 14001 Consultant and Lead Auditor certification is awarded upon passing the certification exam
- Certificate is immediately available online after the successful passing of the exam
- Certificate comes with a shareable QR code for instant verification of credentials
- Lessons range from 15 minutes to 1 hour, typically 20–30 minutes, ensuring that each topic is covered in suitable detail
- Course includes practice with scenarios that include dialogues
- Course includes 24/7 Live-chat Learner Support
- Course includes a learner manual, a copy of the standard, and samples of relevant forms and other documents
- Course comes with full-audio narration and Closed Captions for accessibility
- Courses are hosted on your browser so that no software has to be downloaded avoiding security risks.
- Course comes with quizzes, practice with scenarios, and open-book certification exam
- Course is hosted on your browser so that no software has to be downloaded avoiding security risks.
- Features cross-device compatibility (courses can be taken on any desktop, tablet, or mobile)
- Offers full-resume feature (end a session mid-lesson and continue exactly where you left off, even from a different device)
- Features real-time interactive content in a secure web-based environment
- Offers a clear learning path (once you’ve completed the internal auditor course, you have the option to progress to the lead auditor, up to the consultant and lead auditor course)
- Examination and certificate fee are already included in the course fee
- Payable via PayPal or Stripe using any credit or debit cards
- Option to pay in 4 monthly installments available
Enrollment and Registration Process
To enroll in a deGRANDSON’s ISO auditor course, you would need to go through the following steps:
- Select desired course
- Complete check out proces
- Wait for Payment Confirmation email
- Check your email for the enrollment instructions
- Complete the sign up process
Flexible Payment Options
Pay by Credit Card, Debit Card, SEPA, PayPal Account and more.
Installment Option
Spread the cost of your purchase. Option to pay in 4 monthly installments available for most courses.
Group Discount
Get 10, 15, and 25% discount when you enroll 3, 10, 20 or more people.
About the Course Author
Dr John FitzGerald graduated with a 1st class honours degree in chemistry and a PhD in synthetic organic chemistry. He worked for 15 years in the manufacturing industry, then as a trainer and consultant in the UK and Ireland before founding deGRANDSON Global in 2009.
He serves as the company Director and course developer while occasionally working as a Lead Auditor on ISO 9001, ISO 13485, ISO 14001, ISO 27001, ISO 45001, and ISO 55001 audits for an accredited certification body (CAB).
How is this ISO 13485 Internal Auditor Refresher Course delivered?
The program is delivered online from our Learning Management System (LMS) provided by Inquisiq.
All Modules (or Lessons) 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 11 and,
- Complete the Module at home on your Notebook PC running on Windows 10.
Are there any prequalifications to enroll in this ISO 13485 Internal Auditor Refresher Course?
If you have previously completed an Internal Auditor Program with deGRANDSON Global, you are pre-qualified. Just log-in, enroll and start your program immediately.
If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you will need to complete a free Pre-Test first on order to demonstrate adequate auditing skills.
To begin please register and log-in, then enroll in the free Pre-Test, Course 004x. When that is completed, just log-in, enroll and start your program. The Pre-Test will take 30 minutes approx.
Regarding internal auditor programs generally, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 2 years’ work experience 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 course.
Examination and Certification Process
- Finish the ISO 13485 Internal Auditor Refresher course
- Take the certification exam (the exam is free of charge)
- Pass the certification exam (you have two attempts to pass it)
- Retake the certification exam if necessary
- Receive your certificate in your email within 5 minutes after you’ve successfully completed the certification exam
About your ISO 13485 Internal Auditor Certification
After successfully passing the certification exam, you will receive your ISO Auditor certificate providing formal recognition of your achievement.
It comes with features designed to enhance its credibility and make it easier to verify and share your qualification with employers, clients, and your professional network.
These include:
- Your full name
- The type of certificate that was awarded to you
- The issuer of the certificate (deGRANDSON Global)
- Your credential ID number
- The credential signatory (Dr John FitzGerald, Founder and CEO, deGRANDSON Global)
- The date the credential was issued
- A QR code that links to a page where you can share your credential on your social media profiles
Sample Learner Certificate
About deGRANDSON’s Certification
deGRANDSON’s ISO auditor, implementer, and consultant courses are certified to internationally recognized standards, including ISO 21001:2018 for educational organization management, ISO 29993:2017 for learning services outside formal education, and ISO 29994:2021 for distance learning requirements.
These certifications ensure that the courses are designed, delivered, and assessed according to globally accepted practices for both traditional and online learning environments.
The ISO 21001 certification is issued by Business Quality Assurance International (BQAI), which is accredited by the Irish National Accreditation Board (INAB), a member of international accreditation agreements that support global recognition.
Because of this learners benefit from enhanced credibility with employers and certification bodies, consistent and high-quality course delivery, and greater confidence in the effectiveness and reliability of online learning.
Course Finder Tool
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Free ISO 13485 Training and Certification FAQ Handbook for Auditors, Implementers, and Consultants
Free handbook answering Frequently Asked Questions on ISO 13485 Auditor, Implementer, and Consultant training. Covers Medical Device Management Systems and ISO 13485 certification benefits, differences between standard versions, course options, course benefits, and the enrollment, examination, and certification process among other things.
Free ISO 13485 Required Documentation Guide
Designed as a practical reference to help reduce complexity and support a more structured, manageable approach to compliance, this free ISO 13485 Required Documentation guidance helps you make sense of the expanded documentation requirements in ISO 13485:2016 by breaking down the procedures, supporting documents, and records that organizations are expected to maintain.
Free Path to ISO 13485 Certification Infographic
Make the most of your ISO Auditor training by tracking your ongoing professional development with a CPD Logbook.
Download your free copy below to record your learning, monitor your progress, and build clear evidence of your continued competence as an auditor.
Free ISO 13485 Gap Analysis Tool
Identify systems or process gaps in your management system that can be improved with our ISO 13485 Gap Analysis tool.
Free Risk Assessment Tools and Methodology Guide
Relying on just one approach for every situation can limit the effectiveness of your risk management process. Using ISO 31010 as a key reference for guidance, this material is designed to help you identify which Risk Assessment tool or methodology is the best fit for the task at hand.
Free Correction, Corrective Action & Preventive Action (CCAPA) Process Chart
This process flowchart shows a quick overview of how issues are identified, investigated, resolved, and verified.
It outlines the roles of the Reporter, Investigator, Approver, Implementer, and Verifier from input through CAPA activities to final output, with the follow-up stage determining whether the CAPA can be closed or if a New CAPA is needed for continued improvement.
Free Sample Lesson
Experience the deGRANDSON e-Training Method for yourself – user-friendly and intuitive – with one of these Free Sample Lesson.
Choose between:
- Option 1: The 5-minute Sample Lesson
- Option 2: The 30-minute Free Sample Lesson
Free Internal Auditor Skills Checker
See how your current internal auditing skills stack up against current standards before committing to a full course.
Free CPD Logbook
Make the most of your ISO Auditor training by tracking your ongoing professional development with a CPD Logbook.
Download your free copy below to record your learning, monitor your progress, and build clear evidence of your continued competence as an auditor.
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