To regulators and customers, because a quality manual is like the road map for getting an overview of your QMS and how it works. There are three sides to who is the Quality Manual important: However, its quality manual is here to outline the critical quality control guidelines and QMS requirements needed to keep safe users and manufacturers. ISO 13485 standard describes requirements for a QMS where you, as a MedDev company need to show the ability to provide a safe medical device and related services that consistently meet customer and relevant regulatory requirements.
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