ISO 13485:2016 Lead Auditor Extension Course Content
With this Course, you can add ISO 13485:2016 lead auditor certification to your current Lead Auditor Certification,
and participate in Certification Body and Registration Body auditing.
Already a Lead Auditor for ISO 9001 or other Management System? Add ISO 13485:2016 Lead Auditor Certification with this online program. It provides you with the Auditing Skills, the Knowledge of the Standard, Knowledge of Risk Management and associated Tools, and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Team Leader, to undertake and manage Certification Audits.
Who should take the ISO 13485 Lead Auditor Extension course?
This program is intended for those who:
- want to offer consultancy support in Medical Device Management Systems (MDMS),
- wish to understand the processes of conducting ISO 13485 Certification Audits,
- want to audit for Certification Bodies or for Accreditation Boards,
- need to develop and implement an MDMS for their own organization,
- are a Management Representative for their organization and/or are the Audit Programme Manager for internal audits,
- wish to improve their career prospects.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
What does this Certified ISO 13485 Lead Auditor Extension Course cover?
This comprehensive program is divided into four courses:
- 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
- Developing & Implementing a QMS
- Terms & Definitions – ISO 13485:2016
- Some Key aspects of QMS Auditing
- Fundamentals of Medical Device 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 & ZC
- Advanced aspects of QMS Auditing (3 modules)
- FAQs about the Standard
- Online Course Examination
- Module 2: A Study of the Risk Management process based on ISO 14971
- Risk Assessments (risk identification, risk analysis, and risk evaluation)
- Risk Controls (risk reduction, risk acceptance, and residual risk)
- Risk Reports and Risk Reviews
- The practical methods and tools used, including….
- PHA – Preliminary Hazard Analysis
- FTA – Fault Tree Analysis
- FMEA– Failure Mode and Effects Analysis
- HAZOP – Hazard and Operability Analysis
- HACCP – Hazard Analysis & Critical Control Points
- For each risk assessment tool completed examples are provided throughout.
- 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
- Yet more Audit Scenarios – Lead Auditors
- FAQs about the Auditing Experience
- Online Final Examination
How is this ISO 13485 Lead Auditor Extension Course delivered?
The Program is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).
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.
What course materials does it include?
This course includes:
- 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
Are there any prerequisite requirements?
If you have previously completed a Lead Auditor Program with deGRANDSON Global, you are pre-qualified for this ISO 13485 lead auditor extension program. Just log-in, enroll 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 on 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 GCSE, 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.