2023-10-17T05:26:07
7.5.1.1 General requirements
The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:—
(a) the availability of information that describes the characteristics of the product;
(b) the availability of documented procedures, documented
requirements, work instructions; and reference materials and
reference measurement procedures as necessary;
(c) the use of suitable equipment;
(d) the availability and use of monitoring and measuring devices;
(e) the implementation of monitoring and measurement;
(f) the implementation of release, delivery and post-delivery
activities; and
(g) the implementation of defined operations for labeling and
packaging.
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