What will I learn from this ISO 13485 Lead Implementer Course?
This comprehensive ISO 13485 Certification Course covers all aspects of Internal Auditing and is divided into four Courses:
- Module 1: 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
- 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 Lead Implementer Course?
The ISO 13485 Lead Implementer Certification 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 Lead Implementer Course?
This ISO 13485 certification 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 Lead Implementer 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 Lead Implementer Course delivered?
The Program 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 Lead Implementer 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 Lead Implementer 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 Lead Implementer 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.
Course Finder Tool
Having a hard time figuring out which course will be best for you? Our CourseFinder tool can help you decide.
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 including the following:
- Initiating the Medical Device Management Systems Project
- Obtain management support
- Example of a high-level Quality Policy Statement
- Assemble Medical Device Management Systems Project Team
- Complete Gap Analysis
- Prepare Medical Device Management Systems Project Plan
- The Context of the Organisation
- Determine the context of the organisation
- Identify the applicable legal and regulatory requirements
- Example of addition of applicable Legislation to Scope of Medical Device Management Systems Statement
- Regulation of Medical Devices – the Global Scene
- Determine other interested parties’ needs
- Define and establish a Medical Device Management System
- Define the System’s Processes and their inter-relationships
- Define the Scope of the Medical Device Management Systems
- Example of Scope of Medical Device Management Systems Statement
- Prepare detailed Quality Policies
- Define Key Roles and Responsibilities
- The Planning
- What is Risk-based Thinking?
- Where does Risk-based Thinking arise in the revised Standard?
- Determine actions to address Risks and Opportunities
- Risk-based thinking, PDCA and the process approach
- Establish Medical Device Management Systems Objectives and plan to achieve them
- Establish Design & Development Processes
- Operational Planning and Controls
- Determine the operational planning and control needs
- Identify Monitoring and Measurement Needs [incl. Calibration]
- Establish Operational Controls and Monitoring
- Develop the Documentation required
- Establish Customer Satisfaction Methods
- Develop a process for managing Medical Device Management Systems Changes
- Develop operational and other necessary documentation
- The 29 specific requirements for documented information
- Determine and secure the required Resources
- Determining the Resources Required
- Identify and secure the Human Resources
- Identify and secure the Infrastructure (hardware, software, support services & utilities)
- Establish suitable working environments
- Establish Procurement Provision
- Establish Procurement Policy and Criteria
- Supplier Evaluation
- Product and Service Specification, Sourcing and Verification
- Establish Process for the control of Out-sourced Products and Services
- Pre-launch Activities
- Establish Internal and External Communications
- Deliver Employee Awareness Training
- Finalise & issue Medical Device Management Systems Documentation
- Complete Job-specific Training
- Example of Employee Training Record incl. competency check
- Go Live! Implement policies, procedures and quality objectives plan
- Deploy Policies
- Implement Procedures
- Control of nonconforming outputs
- Establish Customer-related Requirements
- Establish Customer Communication
- Determine Customer requirements
- Review Customer Requirements, including changes
- Establish Production and Service Provision Processes
- Establish control of Production & Service Provision
- Establish Identification, traceability and quality status requirements
- Establish control of customer property, Preservation, Post-delivery Activities & Control of changes
- Release of Products and Services
- Monitor the effectiveness of the Medical Device Management Systems implementation
- Conduct periodic Internal Audits
- Conduct periodic analysis and evaluation [incl. Customer Satisfaction]
- Conduct periodic Management Reviews
- Implement Continual Improvement
- Example: Medical Device Management Systems Improvement Plan outline
- Prepare for a Certification Audit
- Ask for help
- Appendices
- The Path to ISO 13485:2016 Certification – the 33 Steps
- The question of Retained Documentation in ISO 13485:2016
- Typical Medical Device Management Systems Documentation
- Policies & Procedures
- Records
- Sample Procedures & Records
- Customer Contract Processing
- Purchasing
- Control of Maintained Documentation
- Control of Retained Documentation
- Medical Device Management Systems Internal Audits
- Medical Device Management Systems Management Reviews
- Control of Monitoring and Measuring Devices
- Design and Development of Products & Services
- Non-conformances, Corrective Action & Preventive Action
- Example of Management Review Record
- Seventeen ISO Guidance Documents for ISO 13485:2016
- Overview of the International Regulatory Scene for Medical Devices
- The 2020s will be a period of continuous Regulatory change
- It’s complicated!
- Regulation of Medical Devices – the global scene
- Definitions
- Classification
- Standardization & regulatory concerns
- The Medical Device Regulations of the European Union (EMA)
- The Medical Device Regulations of the United Kingdom (MHRA)
- The Medical Device Regulations of the United States (FDA)
- The Medical Device Regulations of the MDSAP Countries
- The Medical Device Regulations of the Rest of the World (WHO)
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.
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 Lead Auditor Skills Checker
See how your current Lead 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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