Home
Courses
Medical Industry
ISO 13485 2016 Course: Quality Management System for Medical Devices
ISO 13485 2016 Course: Quality Management System for Medical Devices
Curriculum
7 Sections
13 Lessons
3 Hours
Expand all sections
Collapse all sections
Module 1: Introduction to ISO 13485:2016
2
1.1
Module 1 – Introduction to ISO 13485:2016
1.2
Quiz on Module 1 of ISO 13485:2016
10 Questions
Module 2: Quality Management System (Clause 4)
2
2.1
Quality Management System (ISO 13485:2016)
2.2
Quiz on Module 2 of ISO 13485:2016
10 Questions
Module 3: Management Responsibility (Clause 5)
2
3.1
ISO 13485:2016 Module 3 – Management Responsibility
3.2
Quiz on Module 3 of ISO 13485:2016
10 Questions
Module 4: Resource Management (Clause 6)
2
4.1
ISO 13485:2016 Module 4 – Resource Management
4.2
Quiz on Module 4 of ISO 13485:2016
10 Questions
Module 5: Product Realization (Clause 7) – Overview
10
5.1
ISO 13485:2016 Module 5.1 – Planning and Customer-Related Processes
5.2
Quiz on Module 5.1 of ISO 13485:2016
10 Questions
5.3
ISO 13485:2016 Module 5.2 – Design and Development
5.4
Quiz on Module 5.2 of ISO 13485:2016
10 Questions
5.5
ISO 13485:2016 Purchasing and Supplier Controls
5.6
Quiz on Module 5.3 of ISO 13485:2016
10 Questions
5.7
ISO 13485:2016 Module 5.4 – Production and Service Provision
5.8
Quiz on Module 5.4 of ISO 13485:2016
10 Questions
5.9
ISO 13485:2016 Monitoring and Measuring Equipment: Ensuring Compliance and Reliability
5.10
Quiz on Module 5.5 of ISO 13485:2016
10 Questions
Module 6: Measurement, Analysis, and Improvement (Clause 8)
6
6.1
ISO 13485:2016 Module 6.1 – Monitoring and Measurement
6.2
Quiz on Module 6.1 of ISO 13485:2016
10 Questions
6.3
Control of Nonconforming Product in ISO 13485:2016
6.4
Quiz on Module 6.2 of ISO 13485:2016
10 Questions
6.5
ISO 13485:2016 Module 6.3 – Data Analysis and Improvement
6.6
Quiz on Module 6.3 of ISO 13485:2016
10 Questions
Module 7: Course Wrap-Up and Certification
2
7.1
ISO 13485:2016 Certification Readiness & Course Wrap-Up
7.2
Quiz on Module 7 of ISO 13485:2016
10 Questions
This content is protected, please
login
and
enroll
in the course to view this content!
ISO 13485:2016 Module 6.3 – Data Analysis and Improvement
ISO 13485:2016 Certification Readiness & Course Wrap-Up
Live Consultation
Documents
ISO 9001 2015 Package
ISO 17025 2017 Package
ISO 14001 2015 Package
ISO 22716 2007 Package
ISO 22000 2018 Package
Additional Standards
Services
ISO 9001 Done For You
ISO 17025 Done For You
ISO 22716 Done For You
Courses
Blog
Support
Careers
Log In
Modal title
Main Content