ED Decision 2022/021/R
QUALITY SYSTEM ELEMENT
The quality system element is an organisational structure, included in the production management system, with responsibilities, procedures, processes, and resources that implement a management function to determine and enforce quality principles.
The quality system should be documented in such a way that the documentation can be made easily available to personnel who need to use the material for performing their normal duties, in particular:
— procedures, instructions, data to cover the issues of point 21.A.139(d)(2) are available in a written form;
— distribution of relevant procedures to offices/persons is made in a controlled manner,
— procedures which identify persons responsible for the prescribed actions are established; and
— the updating process is clearly described.
The competent authority will verify on the basis of the exposition and by appropriate investigations that the production organisation (PO) has established and can maintain their documented quality system.
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