Many of us would need to read through the pages of the ISO 13485:2016 standard two or three or more times before becoming aware of what a Quality Management System is about.
ISO 13485:2016, clause 6.2.2 requires that personnel be aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. To help with your awareness of ISO 13485:2016, we have assembled a training package.
- Includes Technical Support
- The ISO 13485 Overview 47 slide PowerPoint includes detailed speaker’s notes covering:
- Fundamentals
- Who is ISO?
- What is a Management System?
- P-D-C-A Continual Improvement Cycle
- Process approach
- Risk-Based Thinking
- Basics of QMS and ISO 13485
- What is a QMS?
- What is ISO 13485?
- Benefits of certification
- Elements of ISO 13485:2016
- Establishing your QMS
- Key Elements
- Documenting your QMS
- Implementing the QMS in your Organization
- Training People
- Auditing the QMS
- Certification
- Managing the ISO 13485 QMS
- Key Elements of an ISO 13485 QMS
- ISO 13485 registration
- Fundamentals
- 51 Page Trainer’s Guide(PDF)
- Outline of speaker notes
- Answer key for the quizzes
- 20 page Student Guide
- Copy of the slides and space for notes
- Quizzes
- Quizzes (answer key) to ensure comprehension
- 21 questions in total
- Customizable Certificate in Microsoft Word
- Space for Student and Instructor’s names
- Sign in Sheet (Group Training Record)
