ISO 13485:2016 Consultant & Lead Auditor Diploma Course Content
This ISO 13485 Consultant and Lead Auditor Course is ideal for:
- An ISO 13485 Adviser: Where you wish to have a professional qualification to offer prospective clients.
- Experienced Medical Device Management Professionals: to upgrade your qualifications to a recognized international standard.
- Newcomers to MDMS: You don’t need to be an expert. You’ll be taken on a practical journey from getting started to Certification.
The 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 to develop, implement and maintain an MDMS and to audit ISO 13485 to Lead Auditor standard.
What will I learn from this ISO 13485 Consultant & Lead Auditor Diploma course?
This comprehensive ISO 13485 Consultant and Lead Auditor course covers all aspects of Internal Auditing and is divided into four Courses:
- Module 0: Introduction and background to the Standard and auditing.
- 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
- 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
- MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 lessons)
- Initiation
- Planning
- Implementation
- Securing Certification
- 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 Annexes)
- 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
What materials are included in this ISO 13485 Consultant & Lead Auditor Diploma course?
This ISO 13485 Consultant and Lead Auditor course includes course materials invaluable when implementing ISO 13485:2016 like:
- ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
- Diagram: The 33-step Path to ISO 13485:2016 Certification
- Documented Information Requirements of ISO 13485:2016
- Determining the Context of the Organisation
- ISO 13485:2016 and Risk Management
- Risk Assessment Tools and Methodologies (with examples)
- Terms & Definitions
- Typical Process Map
- Sample MDMS Policy Manual
- Sample MDMS Maintained Documentation (procedures), including…
- Sample Procedures
- Sample Records
- Sample Audit Plan
- Sample Audit Work Order
- Sample Nonconformity Report
- Sample Working Document & Checklist
- Sample Management Review Record
- Diagram: Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Code of Ethics
- Management of an Audit Programme
Who should enroll in this ISO 13485 Consultant & Lead Auditor Diploma course?
This ISO 13485 Consultant and Lead Auditor 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
Key Features:
- Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
- An ISO 13485 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
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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 Consultant & Lead Auditor Diploma course delivered?
This ISO 13485 Consultant and Lead Auditor course is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com. All Lessons have a full resume and scaling capabilities. This means, for example, you can…
- Start a Lesson at work on your Work Station running on Windows 10,
- Continue the Lesson on the train home on your iPad running on iOS 11 and,
- Complete the Lesson at home on your Notebook PC running on Windows 8.1
Are there any prequalifications to enroll in this ISO 13485 Consultant & Lead Auditor Diploma course?
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 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.
Examination and Certification Process
- Finish the ISO 13485 Consultant and Lead Auditor 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 Consultant and Lead Auditor Certification
After successfully passing the certification exam, you will receive your ISO Lead Implementer 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.
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Free ISO 13485 Implementation Handbook
This instruction manual is free with our ISO 13485 Lead Implementer Course. It is not for sale.
It goes over everything you’ll need to develop, implement, and maintain a management system that can achieve ISO 13485 Certification. This includes learning how to:
- Obtain Top Management Support (ISO 13485 Clause 0.1)
- Assemble MDMS Project Team
- Undertake a Gap Analysis of current QMS against ISO 13485 requirements and prepare Project Plan
- Identify the strategic purpose of the MDMS to the Organization (ISO 13485 Clause 0.1)
- Identify Regulatory and (for EU Market) the Annex requirements. ISO 13485 Clauses 4.1 and 5.2)
- Identify Regulator, Certification Body, Notified Body needs
- Establish MDMS and define Operational Processes (ISO 13485 Clause 4.1)
- Define Documentation including the Medical Device File (ISO 13485 Clauses 4.2.1 and 4.2.3)
- Prepare a Quality Policy (ISO 13485 Clauses 4.2.2 and 5.3)
- Define key Roles and Responsibilities (ISO 13485 Clause 5.5)
- Determine actions to address Risks (ISO 13485 Clauses 4.1.2, 4.1.5, 4.1.6, 6.2, 7.1, 7.3.3, 7.4.1,7.5.6, 7.6, and 8.2.1)
- Establish MDMS objectives and plans to achieve them (ISO 13485 Clause 5.4.1)
- Establish Design & Development Processes (ISO 13485 Clause 7.3)
- Determine Operational Planning and Controls (ISO 13485 Clause 7.1)
- Decide monitoring measurement and calibration needs (ISO 13485 Clause 7.6)
- Establish Operational Controls and Monitoring (ISO 13485 Clauses 8.1 and 8.2.5)
- Establish Feedback and Complaints Procedures (ISO 13485 Clause 9.1.2)
- Develop Mandatory and other Procedures (ISO 13485 Clause 4.2.4)
- Develop Mandatory and other Records (ISO 13485 Clause 4.2.5)
- Determine and secure required Resources (ISO 13485 Clauses 6.1, 6.3, and 6.4)
- Establish Procedure in provision (purchasing) (ISO 13485 Clause 7.4)
- Establish Internal and External Communications (ISO 13485 Clause 7.2.3)
- Develop general Staff Awareness (ISO 13485 Clause 5.5.2)
- Implement Operational Plans and issue documents (ISO 13485 Clauses 7.1 and 7.5)
- Complete Job-Specific Training (ISO 13485 Clause 6.2)
- Go Live! Implement Procedures (ISO 13485 Clause 7.5)
- Determine and review Customers’ requirements (ISO 13485 Clause 7.2)
- Manage Production and Service Provision including Non-conforming Product (ISO 13485 Clauses 7.5 and 8.3 )
- Establish Product & Service Release (ISO 13485 Clause 8.2.6)
- Conduct Internal Audits (ISO 13485 Clause 8.2.4)
- Conduct MDMS Performance Analysis & Evaluation (ISO 13485 Clause 8.4)
- Conduct Management Reviews (ISO 13485 Clause 5.6)
- Implement Improvement including CAPA (ISO 13485 Clause 8.5)
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
This free infographic walks you through the Path to ISO 13485:2016 certification in a simple 33-step journey. It’s split into three phases—Initiating (setting the groundwork and getting management buy-in), Planning (building your system and documentation), and Implementation (putting everything into practice through to certification).
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.
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- Option 1: The 5-minute Sample Lesson
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Free Lead Auditor Skills Checker
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Free CPD Logbook
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