ISO 13485:2016

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

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.

CEU Credits: 0.1

Course Code: ELM-808

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Module 1: Introduction

Overview

Course Introduction

Course Objectives

CFR, ICH and The FDA

Challenges Facing the Medical Device Industry

Single User License

Module 8: Measurement Analysis & Improvement – Part B

Control of Nonconforming Product

General – Product Specification

General – SOP Nonconforming Materials

Actions in Response to Nonconforming Product Detected Before Delivery

Actions in Response to Nonconforming Product Detected Before Delivery – 100% Inspection

Actions in Response to Nonconforming Product Detected After Delivery

Actions in Response to Nonconforming Product Detected After Delivery – Minor Misprint

Actions in Response to Nonconforming Product Detected After Delivery – Major Misprint

Rework

Analysis of Data

Ultimate Goal – QMS is Effective

Pareto Analysis

Improvement

General – Corrective Action / Preventative Action

Corrective Action

Corrective Action – Two Factors

Corrective Action – Severity

Corrective Action – Initiation

Corrective Action – Team & Description

Corrective Action – Plan

Corrective Action – Investigation Phase

Corrective Action – Plan

Corrective Action – Evidence

Corrective Action – Effectiveness Check

Preventative Action

Annexes

Conclusion

Final Assessment

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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