Designing of QMS (Quality Management System)

• Introduction
• The history of Quality Assurance
• The process approach
• System requirements of IS EN ISO 9001:2015 or ISO 13485:2016
• Other standards based on ISO 9001:2015
• Permissable exclusions
• Certification process & costs
• Quality Management System Documents
• Process Mapping & Metrics
• Introduction to Quality Management System Auditing
• Audit checklists

Programme overview

This Designing of QMS (Quality Management System) training course is a designed to introduce the trainee to the main elements of a quality system understanding the systemic interactions of the sub systems.

Who is the course for

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on developing a quality Management system.

Learning outcomes

Learners will have a complete understanding of:

• The system architecture of a quality system
• Systemic interactions of the sub systems
• Become aware of been customer focussed