ISO 13485:2003 Foundation Training Course Syllabus


(1 day)


(9:00 am - 5:00 pm)

Introduction

  • Course Programme
  • Course Leading Objectives
  • Delegate Responsibilities
  • Continuous Assessment Process

Management Systems

  • Quality Management System
  • Key Vocabulary
  • Quality Management Process Model

What is Continual Improvement

Root Cause Analysis

Risk Assessment

Quality Management Principles

Workshop - Case Study 1 ... Quality Management Principles

Roundtable Discussion

ISO 13485:2003 ... The Components

Workshop - Case Study 2 ... ISO 13485:2003

Roundtable Discussion

Questionnaire No. 1

Delegate Review and Wrap-up ... General Knowledge Review

close


Published course dates are subject to change or cancellation. Ashbrooke Quality Assurance Ltd. is not responsible for any expenses incurred prior to confirmation that the course is running. Student initiated date change or cancellation is permitted only with written notice received into Ashbrooke's offices not less than ten working days prior to course commencement.

Please note that course dates are subject to change without notice.


Our activities extend from Canada to Europe to Asia to Africa to Middle East.


Ashbrooke Quality Assurance Ltd. | 78038 - 3295 Coast Meridian Road | Port Coquitlam | British Columbia | Canada | V3B 7H5


ISO 13485:2003 Foundation Training Course Syllabus

 
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