Proposal to modify the interpretation text for para. 8.1.7.1.(a) to replace “ensures” with “focuses on” in the statement describing the element for periodic independent internal audits and external audits.
Proposal to delete and amend the draft guidance on para. 8.1.7.1. to replace “The intention of this requirement is to ensure that organizations have robust mechanisms to verify, monitor, and continuously improve safety performance. The regulatory text emphasizes” with “The Regulation implies,” delete “evidence-based” from the description of safety assurance as a continuous process, replace “aimed at ensuring that” with “to monitor the effectiveness of,” delete “remain effective” after “safety measures,” replace “whether” with “insofar that” and delete “risk control measures remain effective and whether” in the definition of safety assurance, delete “systematic” before “processes,” replace “that” with “on” after “confidence,” delete “and” before “products,” replace “established” with deletion, replace “employee reporting” with “internal feedback,” add “to maintain the demonstrated performance” after “safety improvements,” add “of KPI for the organization” in the evaluation clause, and replace “improvement of” with deletion and restructure the final clause to read “of the products.”
70. The World Forum considered the draft amendments under items 4.9.1 and 4.9.2, and recommended their submission to AC.1 for voting.