ISO 13485 Lead Auditor Refresher Content
If your knowledge of the Standard is not what it should be, this ISO 13485:2016 Lead Auditor Refresher training 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.
What will I learn from the course?
This comprehensive ISO 13485 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 – Overview of the ISO 13485 standard, its purpose, and significance in medical device quality management, covering regulatory compliance with MDR, IVDR, and FDA QSR/QMSR; industry applications across manufacturing, distribution, and supply chains.[deleted text].
- EU, UK, USA Regulations & MDSAP – EU, UK, USA Regulations & MDSAP – Discussion of regulatory frameworks for medical devices in the European Union, United Kingdom, and United States, including:
- EU Medical Device Regulation (MDR) 2017/745,
- In Vitro Diagnostic Regulation (IVDR) 2017/746,
- Harmonized Standards & ISO 13485, UK Medical Device Regulations 2002 (as amended),
- MHRA Oversight,
- Transitional Arrangements,
- Food and Drug Administration (FDA) Regulations including 21 CFR Part 820 – Quality System Regulation (QSR),
- 510(k) Premarket Notification,
- Premarket Approval (PMA),
- Unique Device Identification (UDI) System, and
- Medical Device Single Audit Program (MDSAP) covering regulatory requirements in: USA (FDA), Canada (Health Canada), EU (Notified Bodies, voluntary participation), Australia (Therapeutic Goods Administration – TGA), Brazil (ANVISA), Japan (PMDA & MHL).
- Developing & Implementing a QMS – Steps for establishing a Quality Management System (QMS) aligned with ISO 13485, including documentation of procedures, work instructions, and records; processes for design, manufacturing, and post-market activities; best practices for compliance, efficiency, and risk reduction; managing risks in product development and lifecycle; regulatory requirements for medical device approval and market access.
- Terms & Definitions – ISO 13485:2016 – Explanation of key terminology and definitions used in ISO 13485:2016, ensuring clarity in Quality Management System (QMS) implementation. Covers Quality Management System (QMS), Medical Device, Risk Management, Regulatory Requirements, Post-Market Surveillance (PMS), Corrective and Preventive Actions (CAPA), Nonconformity, Validation & Verification (V&V), and Unique Device Identification (UDI).
- Some Key aspects of QMS Auditing – Introduction to auditing principles, audit types, and key considerations for assessing compliance with ISO 13485, including first-party (internal), second-party (supplier), and third-party (certification) audits; audit planning, execution, and reporting; identifying nonconformities and corrective actions; evaluating process effectiveness and regulatory compliance; risk-based auditing approaches; auditor competencies and ethical considerations.
- Fundamentals of Medical Device Management Systems – Core concepts of managing medical devices within a QMS covering risk management in design, manufacturing, and post-market phases; product lifecycle from development to decommissioning; regulatory requirements for safety, performance, and market approval; document control for device specifications and compliance records; change management for design modifications; supplier management for component quality; and post-market surveillance for adverse event reporting and continuous improvement.
- Structure & content of ISO 13485:2016 – Breakdown of the standard’s clauses, detailing the requirements and expectations for compliance, including scope and applicability; normative references; terms and definitions; general QMS requirements; management responsibility and leadership; resource management; product realization processes; design and development controls; production and service provision; risk management integration; measurement, analysis, and improvement; and documentation and record-keeping obligations.
- Parts 1, 2 & 3 – Explanation of the first three sections of ISO 13485, covering general requirements for a QMS; documentation requirements, including quality manual, procedures, and records; risk-based approaches for decision-making, process controls, and regulatory compliance; and the standard’s alignment with global medical device regulations.
- Part 4: Quality Management System Requirements – Detailed discussion of the essential QMS requirements, including documentation of policies, procedures, and records; risk management integration into design, manufacturing, and post-market activities; operational controls for product realization and regulatory compliance; management of roles, responsibilities, and authorities; validation and verification of processes; and continual improvement through corrective and preventive actions.
- Part 5: Management Responsibility – Focuses on leadership commitment, policy development, planning, and review processes in a compliant Quality Management System (QMS), including establishing a quality policy and objectives; defining organizational roles, responsibilities, and authorities; conducting management reviews for performance evaluation and regulatory compliance; resource allocation for QMS effectiveness; risk-based decision-making in strategic planning; and ensuring regulatory and customer requirements are met.
- Part 6: Resources – Covers resource management, including personnel qualifications, training, and competency assessment; infrastructure requirements for facilities, equipment, and utilities; work environment controls to ensure product quality and safety; maintenance and calibration of equipment; supplier and external provider management; and allocation of resources for effective QMS implementation and continuous improvement.
- Part 7: Product Realization (3 lessons) – Examines the stages of product development, including design and development planning, inputs, outputs, verification, validation, and design changes; production and process controls to ensure product conformity; traceability requirements for identification and tracking; supplier management for procurement and quality assurance; control of monitoring and measuring equipment; and regulatory requirements for manufacturing and distribution.
- Part 8: Measurement, Analysis & Improvement (2 lessons) – Discusses performance evaluation, corrective actions, and continuous improvement methodologies, including monitoring and measuring QMS effectiveness; data analysis for identifying trends and risks; internal audits for compliance verification; corrective and preventive actions (CAPA) for addressing nonconformities; customer feedback and complaint handling; process validation and control; and ongoing improvements to enhance product quality and regulatory compliance.
- Annexes ZA & ZB (Amendment 11) – Analysis of key amendments related to the standard’s alignment with EU medical device regulations, including harmonization with the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746; conformity assessment requirements; integration of risk management and post-market surveillance obligations; notified body expectations for certification; and regulatory transition provisions for compliance with updated EU directives.
- Advanced aspects of QMS Auditing (3 lessons) – In-depth exploration of audit techniques, risk-based auditing, and handling nonconformities, including advanced audit planning and execution strategies; risk-based auditing approaches for prioritizing high-impact areas; root cause analysis for identifying systemic issues; effective communication and interviewing techniques during audits; handling major and minor nonconformities; corrective action verification and follow-up audits; and best practices for ensuring continuous improvement and regulatory compliance.
- 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 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
Who should take this Course?
This ISO 13485 Lead Auditor Refresher 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 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 the ISO 13485 Lead Auditor Refresher Course delivered?
The ISO 13485 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 for this ISO 13485 Lead Auditor Refresher Course?
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.
Examination and Certification Process
- Finish the ISO 13485 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 Lead Auditor Certification
After successfully passing the certification exam, you will receive your ISO Lead 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.
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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
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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