Quiz · ISO 13485:2016 6/10

Supplier and Purchasing Controls

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:26).

1What should supplier selection criteria consider?Choose one

Only quoted price and delivery speed Only the presence of a certification logo Only whether the supplier has worked with a large company Capability, performance, device impact and associated risk

2What does an ISO certificate establish by itself for a particular purchase?Choose one

Automatic acceptance of every item supplied Potential supporting evidence that still needs evaluation against the purchase requirements Transfer of the manufacturer’s responsibility Permission to omit supplier monitoring

3When should purchasing requirements be checked for adequacy?Choose one

Only after the product arrives Only after a complaint Before they are communicated to the supplier Only during the supplier’s annual audit

4Which order is least ambiguous for a controlled component?Choose one

A specific part or specification with the applicable revision and acceptance requirements Any equivalent part selected at the supplier’s discretion The component used last time, without an identified reference A photograph without performance requirements

5What should determine the extent of purchased-product verification?Choose one

An identical test plan for every supplier regardless of risk Whether the item was supplied free of charge Whether the supplier prefers no inspection Supplier evaluation results and the risk of the purchased product

6Does the handbook require the organization to physically test every incoming item?Choose one

Yes; 100% physical testing is required for every purchase No; a supplier certificate always eliminates further control No; appropriate defined controls can provide the needed confidence Yes; services must be tested exactly like components

7A certificate references an obsolete specification. What is the appropriate response?Choose one

Accept the item because a certificate exists Resolve the conformity and revision mismatch before acceptance Change the order record to match the certificate without review File the certificate without connecting it to the delivery

8A previously approved supplier starts producing repeated failures. What should happen?Choose one

Use the performance information in risk-based action and reevaluation Wait until the approval certificate expires Leave the approval untouched because selection occurred once Ignore the issue if receiving catches every failure

9A supplier changes a critical material and calls it equivalent. What is needed?Choose one

Acceptance based only on the supplier’s equivalence statement Only a price update in the purchasing system An assessment of effects on the device and processes before relying on it A new supplier name for the same unreviewed change

10An external laboratory performs an outsourced test. Which statement is correct?Choose one

The manufacturer retains responsibility and controls the work through defined arrangements The laboratory assumes all manufacturer obligations The quality agreement eliminates the need for oversight The manufacturer needs only the laboratory invoice