ISO 13485 Lead Implementer

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ISO 13485 Lead Implementer

Be able to evaluate the expectations and requirements of the customers
Be able to promote harmonisation of regulatory requirements for manufacturers
Be able to enhance the credibility and image of a company to represent compliance
Be able to engage management actively and undertake management system activities
Be able to design and development consultancy for a respiratory inhaler manufacturer

Overview

Off the shelf (OTS)

This ISO course has been designed to provide participants with the knowledge to effectively implement a quality management system in line with the requirements of ISO 13485.

Training will also indicate how to develop quality policies, the core characteristics of risk assessments, the significance of legislation, and how to create an efficacious management review process.