ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)
Description:
As one of the measurements of the effectiveness of the quality management system the organization must have documented processes to gather and monitor information to show that the customer requirements have been met.
Curriculum for this course:
Module 1: Introduction
Overview | 45 secs |
Course Introduction | 1 min 31 secs |
Course Objectives | 1 min 21 secs |
CFR, ICH and The FDA | 1 min 10 secs |
Challenges Facing the Medical Device Industry | 58 secs |
Single User License | 1 min 09 secs |
Module 8: Measurement Analysis & Improvement – Part A
General Introduction | 1 min 02 secs |
ISO Systems | 1 min 10 secs |
Monitoring and Measurement | 48 secs |
Feedback – Identify, Define, Document & Implement | 1 min 10 secs |
Feedback – Methods | 45 secs |
Complaint Handling | 58 secs |
Complaint Handling – Incident | 59 secs |
Complaint Handling – Process | 1 min 10 sec |
Complaint Handling – Difficult to Manage | 1 min 05 sec |
Complaint Handling – A Common Mistake | 1 min 30 sec |
Reporting to Regulatory Authorities | 55 secs |
Reporting to Regulatory Authorities – Adverse Events | 1 min 21 secs |
Reporting to Regulatory Authorities – USA Reporting Timelines | 1 min 10 secs |
Reporting to Regulatory Authorities – EU Reporting Timelines | 1 min 22 secs |
Reporting to Regulatory Authorities – Canada Reporting Timelines | 57 secs |
Reporting to Regulatory Authorities – Reporting Formats – Part 1 | 1 min 37 secs |
Reporting to Regulatory Authorities – Reporting Formats – Part 2 | 50 secs |
Reporting to Regulatory Authorities – Conclusion | 56 secs |
Internal Audit – Effectiveness of Quality System | 1 min 30 secs |
Internal Audit – Two Different Approaches | 45 secs |
Internal Audit – Auditors and Lead Auditors | 1 min 44 sec |
Internal Audit – Table of Regulations | 55 secs |
Internal Audit – Findings | 1 min 09 secs |
Monitoring and Measuring for Processes – Introduction | 55 secs |
Monitoring and Measuring for Processes – KPI’s | 1 min 15 secs |
Monitoring and Measuring for Processes – Corrective and Preventative Actions | 1 min 46 secs |
Monitoring and Measuring for Processes – Other Factors | 1 min 10 secs |
Monitoring and Measuring of Product – Introduction | 50 secs |
Monitoring and Measuring of Product – Product Conformity | 1 min 50 secs |
Monitoring and Measuring of Product – Tracking & Trending | 1 min 10 secs |
Monitoring and Measuring of Product – Out of Control | 52 secs |
Conclusion
Final Assessment
Certification
Talk to us
Find out how we can help you bring your life science training to the next level.