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.
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
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 –Â 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 –Â 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 –Â 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 –Â 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 –Â 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) –Â 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) –Â 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
 How is the 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?
If you have previously completed a Lead Auditor Course with deGRANDSON Global, you are pre-qualified. Â 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 ISO 13485 Lead Auditor Refresher Course is your best choice?
Check out our full suite of ISO 13485 courses or see our answers to frequently asked questions about ISO 13485 training and certification.
Related Courses
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
Related Articles
ISO Transition, Migration, Conversion & Extension Explained
ISO 13485 and Supplying to the Medical Device Sector: 9 FAQs
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]
