Proposal to delete “This clarifies that corrective” and replace with “Corrective”, and delete “/systemic” in para. 8.1.7.1.(e). The revised text states: Corrective actions may address both technical aspects (ADS) and organizational aspects (SMS).
Proposal to delete “The intention is to ensure that”, delete “organizations have”, insert “This element focuses on”, insert “the”, and insert “organization’s” in para. 8.1.7.1.(d) to improve and streamline the text, changing “The intention is to ensure that organizations have processes to identify, implement, and track corrective actions to maintain safety at an acceptable level” to “This element focuses on the organization’s processes to identify, implement, and track corrective actions to maintain safety at an acceptable level.”
Proposal to delete "This provision ensures that " and insert “This element focuses on” before “changes”, delete “systematically”, and insert "that " after “changes” in para. 8.1.7.1.© to improve and streamline the text so that the description reads “This element focuses on changes that are assessed and managed, recognizing that modifications can introduce new risks.”
Proposal to delete “The requirement highlights that safety assurance is expected to extend beyond the organization to include” from para. 8.1.7.1.(b), insert “Safety assurance covers the organization and also” in its place, and delete “, reflecting a system-of-systems perspective” from the same para. Document ADS-21-42.
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Proposal to delete and amend the draft guidance on para. 8.1.7.1.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.”