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.