Quiz · ISO 13485:2016 4/10

Competence and Training

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:34).

1What is the starting point for a training plan?Choose one

The longest available course The competence needed for the assigned work The employee’s preferred video length The number of certificates already filed

2An experienced inspector joins the company. What should be assessed?Choose one

Whether experience eliminates all need for local training Whether a familiar job title guarantees competence Whether the employee can skip all effectiveness checks Which requirements are already met and what company-specific gaps remain

3An operator understands the procedure but struggles with the measurement technique. What is a suitable next action?Choose one

Supervised practice with a defined performance check Send the same reading and assume the issue is resolved Record completion because the operator can describe the task Remove the measurement from the task record

4Which evidence most directly checks ability to perform a critical test?Choose one

A record that the test video was opened A course attendance list A witnessed demonstration against defined criteria A general statement that the employee is experienced

5How should the effectiveness check be selected?Choose one

By using the same quiz for every role In proportion to the risk and competence needed for the work By selecting the fastest method regardless of the task By omitting checks for long-serving employees

6A learner scores 8/10 on an external foundation quiz. What does this show by itself?Choose one

Evidence of the knowledge assessed, with practical competence still to be evaluated as needed Authorization to approve all quality records Proof that every assigned video was watched Qualification to perform every task covered by the QMS

7What is the source of this program’s proposed 80% quiz target?Choose one

A universal ISO 13485 pass mark A universal FDA training pass mark A threshold set by the Google Forms software A company-selected assessment criterion

8Which training record is most useful?Choose one

Only the name of the course Only a calendar invitation The person, material revision, date, evaluation method, result and evaluator Only the total time logged into the learning system

9A procedure changes the way a product acceptance decision is made. What should be considered?Choose one

Affected employees’ training and competence needs Only renaming the previous attendance record Only archiving the previous revision Waiting until the next annual review regardless of the change

10A trainee fails a practical demonstration after passing the quiz. What is the appropriate response?Choose one

Rely on the quiz score and authorize the task Remove the failed attempt from the evidence Address the skill gap and reevaluate before independent assignment Change the task criteria to match the observed performance