Chapter Intro

This chapter will teach you the best practices for writing effective QMS procedures. You will be provided with fundamental questions you must ask yourself before starting the development of your new QMS. You will also be introduced to the basic requirements of any QMS, such as Management Responsibilities, deviations, CAPA management, Internal Audit, etc. 

Additionally, the chapter emphasizes the importance of mapping processes, translating high-level steps into simple instructions, and reviewing procedures to comply with legal or regulatory obligations. Finally, you will learn about controlling and issuing SOPs and setting up key users for success.