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
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