Quiz · QMSR 2/3

Navigating FDA QMSR

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (19:42).

1A team wants one FDA-prescribed procedure for every manufacturing task. What does the presentation describe instead?Choose one

A complete set of manufacturing instructions in part 820 A regulatory framework that the manufacturer implements for its devices and risks A framework that applies only to the quality department An optional framework once ISO certification is obtained

2Which section addresses requirements for the quality management system?Choose one

820.7 820.35 820.45 820.10

3An employee is locating FDA supplemental complaint and servicing record requirements. Which section is most relevant?Choose one

820.35 820.3 820.7 820.45

4Which section addresses FDA supplemental labeling and packaging controls?Choose one

820.10 820.35 820.45 820.7

5An ISO definition conflicts with the corresponding definition in the FD&C Act. Which has priority?Choose one

The definition in the newest ISO publication The definition in the FD&C Act The definition in the company quality manual Whichever definition the certification auditor prefers

6A company has incorporated ISO 13485 into its QMS. What still needs attention?Choose one

Other applicable FDA requirements, such as reporting and UDI Only the ISO clauses cited by its certification body Only requirements written in subpart B Only requirements that were present in the 1996 regulation

7What should happen before labeling is released or product is stored?Choose one

Review the labels only after the first shipment Rely solely on supplier approval of the artwork Check only that the label file has a revision number Examine labeling and packaging for accuracy and completeness

8What is the most useful starting point for adapting an existing QMS?Choose one

Replace every procedure regardless of its existing adequacy Wait for an inspection to identify all necessary changes Compare current practices with the applicable requirements to identify gaps Change the quality manual title and leave the processes untouched

9Procedures have been revised for QMSR. What should follow?Choose one

Train affected staff, implement the changes and monitor their operation Treat the saved revisions as proof that implementation is complete Delete previous training evidence because it relates to older procedures Wait until the next external audit before using the revisions

10A familiar requirement no longer appears as a separate old-QSR subpart. What should the reviewer do?Choose one

Conclude that the activity is no longer required Use only the former section number in the quality manual Check its location in the incorporated ISO requirements and supplemental FDA provisions Assume a certificate resolves the question without further review