Quiz · ISO 13485:2016 1/10

QMS Processes and the Quality Manager Role

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (9:55).

1Which description best defines a QMS process?Choose one

A folder containing the latest templates A list of every employee’s job title Connected activities with inputs, responsibilities, controls and outputs A certification audit checklist

2A supplier receives revision B while receiving inspection uses revision C. What is the main concern?Choose one

The handoff between purchasing and receiving is inconsistent The procedure titles use different fonts Receiving needs no control if it catches mistakes later The supplier must decide which revision the company intended

3What should primarily drive the extent of QMS process controls?Choose one

The number of pages in a competitor’s manual Risks to device safety, performance and regulatory compliance The preference to use one identical checklist everywhere The purchase price of the document-control software

4A simple process is reliably controlled by a short instruction. What is appropriate?Choose one

Expand it to match the longest procedure in the company Replace it with an oral agreement because the team is small Omit review of its effectiveness because it is simple Keep it concise while ensuring the necessary requirements and evidence are covered

5A Quality Manager organizes a design review. What else is needed for technical approval?Choose one

Only the Quality Manager’s course-completion certificate Only a meeting invitation accepted by the team An appropriately competent and authorized technical decision-maker Automatic approval if all required documents are attached

6Which is the strongest evidence that a receiving process is working?Choose one

The fact that a receiving procedure exists Recorded acceptance results and monitoring of recurring receiving issues The number of pages in the receiving procedure The fact that one employee remembers the last delivery

7Before changing an inspection workflow, what should be evaluated?Choose one

Effects on connected processes, records, training and product Only whether the new form fits on one page Only whether the new process takes less time Only whether the supplier agrees to the change

8A contract laboratory performs a test for the manufacturer. Who retains responsibility for conformity?Choose one

The laboratory takes over all product-release responsibility The laboratory’s certification body takes over responsibility No organization retains responsibility once the contract is signed The manufacturer retains responsibility and must control the outsourced work

9What should a written quality agreement help establish?Choose one

An exemption from reviewing supplier evidence Responsibilities and controls for the outsourced activity A replacement for all purchasing requirements A guarantee that no future changes need review

10A spreadsheet calculates a product acceptance result. What is the relevant software question?Choose one

Whether the spreadsheet brand is widely used Whether the file opens without an error message Whether the author has used spreadsheets before Whether this intended use is validated in proportion to its risk