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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