ISO 13485:2016 Lead Implementer Course Content
If you want to be an MDMS Consultant or if you wish to develop and implement a medical device management system (MDMS), this ISO 13485 Implementer & Auditor Course is ideal. It will be especially beneficial to:
- Newcomers to MDMS: You don’t need to be an expert. You’ll be taken on a practical journey from getting started to Certification.
- ISO 13485 Consultants: Gives you the methodology on how to implement MDMS Projects faster and easier than ever before.
- Experienced Medical Device Management Professionals: Understand the impact of the revised Standard, the 130+ instances where documentation may be required, and best practice in maintaining an MDMS.
The course 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 Programme Manager, to undertake and manage Internal Audits for your organization.
The Program is intended for those who:
- need to develop and implement a medical device management system for their organization,
- wish to offer MDMS Consulting Services in the development and implementation of medical device management systems,
- are required to perform internal audits within your organization,
- are required to perform supplier audits,
- wish to improve your career prospects, and
- wish to understand the processes of conducting an internal audit or external audits.
- It is also recommended for the management involved in the audit process.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
And, yes, Auditor Skills are included.
This is a comprehensive online course covering all aspects of Internal Auditing is divided into four Courses:
- Module 0: Introduction and background to the Standard and auditing.
- Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018
- 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
- Online 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
- MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 modules)
- Securing Certification
- 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
- FAQs about the Standard
- Online Course Examination
Module 3: A Study of the Risk Management process
- 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 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
- Online Final Examination
These materials, invaluable when implementing ISO 13485:2016, include:
- ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
- Diagram: The 33-step Path to ISO 13485:2016 Certification
- Documented Information Requirements of ISO 13485:2016
- Determining the Context of the Organisation
- ISO 13485:2016 and Risk Management
- Risk Assessment Tools and Methodologies (with examples)
- Terms & Definitions
- Typical Process Map
- Sample MDMS Policy Manual
- Sample MDMS Maintained Documentation (procedures), including…
- Sample Procedures
- Sample Records
- Sample Audit Plan
- Sample Audit Work Order
- Sample Nonconformity Report
- Sample Working Document & Checklist
- Sample Management Review Record
- Diagram: Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Code of Ethics
- Management of an Audit Programme
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
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 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 the Program.
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