Fundamentals of Quality, QMS & ISO-9001

A: Option A feels tempting because the numeric criterion is met, but ISO 9001 is about control of outputs, not box-checking. A negative trend is evidence the process may not be under control. Option C sounds proactive, yet overwriting records breaks traceability and data integrity. Option D imports a myth that ISO is paperwork-only; it explicitly requires action when conformity is in doubt. Option B fits the intent: contain, analyze cause, then decide disposition with evidence.

A: Option A reverses evidence and records; ISO expects records to reflect reality, not predict it. Option C is a common schedule-driven shortcut, but it removes objective evidence. Option D shifts responsibility downstream and weakens process control. Option B aligns field verification first, then records, preserving traceability and confidence that the output matches requirements.

A: Option A is exactly what risk-based thinking targets: preventing nonconforming outputs. Option B also fits, since corrective action effectiveness is central. Option D is covered because business risks tied to quality are in scope. Option C crosses into HAZOP and process safety; ISO 9001 doesn't replace safety risk controls even though engineers often blur the boundary.

A: Option A sounds right if you're used to older ISO language, but preventive action as a formal clause is gone. Option B ignores evidence of loss of control. Option D manipulates requirements instead of fixing the process. Option C matches the modern approach: act on causes when evidence shows the system isn't behaving as intended.