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Location Course By Location Online Classes Register Login
* Home
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* AATT AS9100
* AS9100
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* Manufacturing ISO 9001:2015
* Medical Device ISO 13485, FDA, EU, & MDSAP
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2-DAY HUMAN FACTORS – $1295
HUMAN FACTORS
AND HOW TO ADDRESS THEM
Days: 2
Time: 7:30 AM- 4:30 PM MST
Audience: Beginner to Advanced
OVERVIEW
Human Factors is a term that appears in the latest versions of several ISO
standards, including:
* ISO 9001:2015 General manufacturing QMS
* AS9100D:2016 Aerospace QMS
* ISO 14971:2007 Risk management for medical devices
* ISO 45001:2018 Occupational health and safety
This course helps you to understand human factors in the context of each
standard. You will learn how to apply the concept of human factors to your
management system and address the standard requirements. You will also receive
practical tools, proven methodologies, and helpful tips to make the job easier
for you.
As with all of Axeon’s courses, this is a practical, how-to course that is not
bogged down in academic discussions. We use case studies, practice exercises,
and learning activities to keep the training activities and build competence.
WHO SHOULD ATTEND?
· Quality managers Also: · Management representatives · Quality
consultants · Quality engineers · Those involved in performing
corrective actions · Safety managers · Those involved in medical device
risk management · Top management · Preparation Of Checklists From
Process Analysis · Regulatory affairs specialists
Prerequisites
None. Our students range from seasoned quality professionals to novices. Our
goal is to meet everyone at their current level of competence and increase it.
COURSE OBJECTIVES
* Understand the requirements of human factors in the context of each standard.
* Learn how to address human factors within your organization’s quality and/or
safety management system.
* Provide practical tools and methods for addressing human factors.
AGENDA
DAY 1
Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard
Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action
Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors
DAY 2
Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety
Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance
Final Test
Date/Registration
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Classroom - (June 28, 2023 - June 29, 2023)Online-Virtual Classroom - (September
27, 2023 - September 28, 2023)Online-Virtual Classroom - (December 14, 2023 -
December 15, 2023)
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BACK FINISHED
Whether you are interested in Audits, ISO 9001:2015, AS9100 Rev D, 13485:2016,
Risk Management, Lean, Project Management, Six Sigma, or any other business
improvement training, we can do it!
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