: New "asterisk" (*) questions (P 3.4 and P 4.4) have been added to emphasize planning, monitoring procurement, and supplier capability before SOP. Removed Elements
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(Implementation) regarding procurement monitoring and supplier management. Remote Audits : New "asterisk" (*) questions (P 3
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Minor non-conformity; no impact on product safety or function.
– Assesses the design of manufacturing lines and product specifications.
