Course 036: ISO 13485 Lead Auditor Certification Program Content
Auditing Skills – Knowledge of Standard – Risk Management – Practice Scenarios
This ISO 13485 Lead Auditor Certification online program provides 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.
Who should take this Course?
This Course is intended for those who…
- wish to offer consultancy support in QMS.
- need to understand the processes of conducting Certification Audits.
- want to audit for Certification Bodies or for Accreditation Boards.
- need to develop and implement a quality management system (QMS) for their own organisation.
- you are Management Representative for their organisation and are the Audit Programme Manager for internal audits.
- are required to perform supplier audits.
- 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.
What does this ISO 13485 Lead Auditor Course cover?
This is a comprehensive Program covering all aspects of Internal Auditing is divided into five Courses…
- Module 0: Introduction and background to the Standard and to auditing.
- Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2011
- 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
- On-line 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
- 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
- On-line Course Examination
Module 3: 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 tool 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 4: 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
- On-line Final Examination
Extensive Program Materials
- 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 this ISO 13485:2016 Lead Auditor Course delivered?
All Modules have 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 i-Pad running on iOS 9 and,
- Complete the Module at home on your Notebook PC running on Windows 8.1
Are there any prerequisite requirements?
For this ISO lead auditor training online 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 at least 2 at managerial/supervisory level, is recommended.
You do not have to provide us with any evidence of you qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.