Supplier & External Provider Auditing Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Supplier & External Provider Auditing flashcards as text
What does ISO 9001:2015 require an organization to do when significant changes occur at a supplier, such as new manufacturing processes or relocated facilities?
Answer: Re-evaluate or re-audit the supplier to confirm continued conformance to requirements
Significant supplier changes can affect capability and conformance, so ISO 9001:2015 requires re-evaluation to verify the supplier's continued suitability.
Which elements are TYPICALLY included in an initial supplier qualification process?
Answer: Assessment of QMS capability, process capability, and quality performance history
Supplier qualification focuses on QMS capability, process capability, and quality history — the technical and quality factors that determine whether the supplier can consistently meet requirements.
What is the PRIMARY purpose of a Supplier Corrective Action Request (SCAR)?
Answer: To require the supplier to identify root cause and implement corrective actions to prevent recurrence
A SCAR is a formal mechanism requiring the supplier to investigate root cause and implement effective corrective actions, driving accountability and preventing recurrence.
When auditing a supplier, which ISO 9001:2015 clause focuses on the supplier's ability to identify and control nonconforming outputs?
Answer: Clause 8.7 — Control of Nonconforming Outputs
Clause 8.7 requires that outputs not conforming to requirements be identified and controlled to prevent unintended use or delivery, and this applies when auditing supplier operations.
Which approach BEST demonstrates that an organization has verified externally provided products meet requirements before use?
Answer: Maintaining incoming inspection records that document acceptance criteria and verification results
Documented incoming inspection records with acceptance criteria and results provide the objective evidence that ISO 9001:2015 requires to demonstrate verification of externally provided products.
What documented information should be captured when an organization decides to qualify a new supplier?
Answer: The evaluation criteria used, results of the assessment, and the approval decision
ISO 9001:2015 requires documented information of evaluation results; capturing criteria, assessment results, and the approval decision ensures traceability and demonstrates a systematic qualification process.
Under ISO 9001:2015, which statement BEST describes the organization's accountability for externally provided processes?
Answer: The organization retains responsibility for ensuring externally provided processes conform to customer and applicable statutory requirements
ISO 9001:2015 clause 8.4 makes clear that even when processes are performed externally, the organization remains accountable for ensuring those processes conform to all requirements.