Supplier & External Provider Auditing Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
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Under ISO 9001:2015, which clause addresses the control of externally provided processes, products, and services?
Answer: Clause 8.4
Clause 8.4 of ISO 9001:2015 specifically covers the control of externally provided processes, products, and services.
Which criterion is MOST important when determining the type and extent of controls applied to an external provider?
Answer: The potential impact of the externally provided output on the organization's products and services
ISO 9001:2015 clause 8.4.1 requires that the type and extent of control reflect the potential impact on the organization's ability to consistently meet customer and applicable requirements.
What information must an organization communicate to external providers before work commences, per ISO 9001:2015 clause 8.4.3?
Answer: Requirements for processes, products, or services and criteria for release
Clause 8.4.3 requires communicating requirements including specifications, acceptance criteria, and competence requirements so the provider can deliver conforming outputs.
Which document type is most commonly used to formally establish quality requirements between an organization and an external provider?
Answer: Quality agreement or supplier quality manual
Quality agreements or supplier quality manuals formally document the quality requirements, responsibilities, and expectations agreed upon by both parties.
When conducting a supplier audit, which audit approach focuses on evaluating the supplier's processes rather than only inspecting end products?
Answer: Process audit
A process audit evaluates how well the supplier's processes are controlled and capable of consistently producing conforming outputs, going beyond final product inspection.
What is the PRIMARY purpose of maintaining an Approved Supplier List (ASL)?
Answer: To ensure only evaluated and qualified suppliers are used for critical procurement
The ASL ensures that only suppliers who have been evaluated and qualified are selected, supporting consistent conformance of purchased products and services.
According to ISO 9001:2015, what must occur before externally provided products or services are released or used?
Answer: Verification that externally provided products and services meet specified requirements
ISO 9001:2015 clause 8.4.1 requires organizations to verify that externally provided processes, products, and services meet requirements before acceptance.