The purpose of this training is to clarify the requirements of the ISO 13485 Standard and share information on how these requirements should be met.
What is the scope of the standard
What is a document? What is a record?
Requirements of the quality management system
Responsibilities described in the standard of the top management
What is a quality policy?
What are the quality goals?
How to plan the quality management system?
Scope and frequency of management review
Points to take into consideration during production of the products
How should customer related processes be carried out?
Design and development steps
General overview of risk analysis (management)
Purchasing process requirements
Measurement analysis and continuous improvement