Course 036C: ISO 13485:2016 Lead Auditor Conversion Program Content
Already an ISO 13485 Lead Auditor?
If so, this ISO 13485:2016 Lead Auditor Conversion Program will quickly get your Certification up-to-date!
It will provide you with the Auditing Skills, 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 revised Standard.
Target Students
- If you wish to offer consultancy support in Medical Device Management Systems (MDMS),
- If you wish to understand the processes of conducting ISO 13485 Certification Audits,
- If you wish to audit for Certification Bodies or for Accreditation Boards,
- If you wish to develop and implement an MDMS for your organization,
- If you are Management Representative for your organization and/or are the Audit Programme Manager for internal audits,
- And if you wish to improve your career prospects.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
Course Content
This comprehensive program is divided into three 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: 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
Course Content
The Program 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 10,
- Continue the Module on the train home on your iPad running on iOS 9 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1.
Course Materials Included
The 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
Previous Qualifications Required
If you have previously completed a Lead Auditor Program with deGRANDSON Global, you are pre-qualified. 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 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 is the best ISO 13485 Program for you?
Click here to view all of the ISO 13485 Auditor Training options.
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