ISO 13485:2016 Lead Implementer Course Content
If you want to be an ISO 13485 Consultant or if you wish to develop and implement a medical device management system (MDMS), this ISO 13485 certification for lead implementers 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.
This ISO 13485 certification 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
And, yes, Auditor Skills are included.
This comprehensive ISO 13485 Certification Course covers all aspects of Internal Auditing and 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
- EU, UK, USA Regulations & MDSAP
- 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 lessons)
- Initiation
- Planning
- Implementation
- 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 lessons)
- Part 8: Measurement, Analysis & Improvement (2 lessons)
- Annexes ZA & ZB (Amendment 11 Annexes)
- Advanced aspects of QMS Auditing
- FAQs about the Standard
- Online Course Examination
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
- FAQs about the Auditing Experience
- Online Final Examination
The ISO 13485 Lead Implementer Certification Course includes course materials invaluable when implementing ISO 13485:2016 like:
- 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
The Program is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com.
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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ISO 13485 Implementation Handbook Contents List
Not sure this is the best ISO 13485 Course for you?
See our full suite of ISO 13485 Training courses for comparison or check out our answers to frequently asked questions about ISO 13485 certification.
Related Courses
ISO 13485 Internal Auditor Course – to conduct effective internal audits
ISO 13485 Transition Course – to migrate your MDMS to the 2016 Standard
Related Articles
Lead Implementer Courses: Overview
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