Proposal to modify para. 8.1.7.1.(h) to replace “aims to ensure that” with “focuses on”, replace “Assessment of how organizations coordinate” with “Assessment that organizations coordinate”, delete “and product reviews” from the list of change management triggers, and delete “the approach and output from various” before “monitoring procedures” and delete “including operational data, safety reports and performance indicator” from the examples of monitoring procedures.
Proposal to improve the interpretation of para. 8.1.5.1. concerning the scope and contents of the manufacturer’s SMS safety policy.