The Medical Devices Introductory Course 2020

What you will need for EN ISO 13485.5

You will need a process/SOP for: Management review

You will also need:

Commitment from top management A quality policy Quality objectives A management representative Job specifications An organization chart

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

13

EN ISO 13485.6: Resource Management

• Resources include human resources, infrastructure and work environment • Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience • Infrastructure includes buildings, equipment, etc • Work environment includes clean rooms, where requirements for employee health, cleanliness, clothing, etc must be specified and controlled

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

14