ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)

Description:

On occasion there will be product that is nonconforming to the required product specification. This may occur at any stage of product realization, from an incoming material to an in-process check, or finished product testing or inspection prior to entering the market, or in some cases, even after a product has entered into the market. The organization must have a process to ensure that product which does not conform to the product requirements is identified and controlled to prevent its unintended use or delivery.

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 B
Control of Nonconforming Product 1 min 21 secs
General – Product Specification 1 min 21 secs
General – SOP Nonconforming Materials 50 secs
Actions in Response to Nonconforming Product Detected Before Delivery 1 min 30 secs
Actions in Response to Nonconforming Product Detected Before Delivery – 100% Inspection 1 min 09 secs
Actions in Response to Nonconforming Product Detected After Delivery 1 min 10 secs
Actions in Response to Nonconforming Product Detected After Delivery – Minor Misprint 1 min 50 secs
Actions in Response to Nonconforming Product Detected After Delivery – Major Misprint 55 secs
Rework 1 min 09 secs
Analysis of Data 1 min 10 secs
Ultimate Goal – QMS is Effective 59 secs
Pareto Analysis 1 min 30 secs
Improvement 1 min 15 secs
General – Corrective Action / Preventative Action 51 secs
Corrective Action 1 min 14 secs
Corrective Action – Two Factors 58 secs
Corrective Action – Severity 1 min 41 secs
Corrective Action – Initiation 56 secs
Corrective Action – Team & Description 1 min 09 secs
Corrective Action – Plan 56 secs
Corrective Action – Investigation Phase 1 min 30 secs
Corrective Action – Plan 1 min 28 secs
Corrective Action – Evidence 49 secs
Corrective Action – Effectiveness Check 1 min 20 secs
Preventative Action 56 secs
Annexes 1 min 29 secs
Conclusion
Final Assessment
Certification
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