Free PECB ISO 13485 Foundation Exam Practice Questions

Sample Practice Questions

Try these 10 sample questions from the PECB ISO 13485 Foundation Exam practice bank. Each includes the answer and explanation. Continue with the interactive practice above to review the full question set.

1. 1What is the principal subject of ISO 13485?

   1. A.Quality management systems for medical devicesCorrect answer: A
   2. B.Environmental management systems for medical devices
   3. C.Occupational health systems for medical personnel
   4. D.Information security systems for medical records

   Explanation: ISO says the standard "sets out the requirements for a quality management system specific to the medical devices industry." This describes its subject.

   Reference: ISO 13485 — Medical devices — Introduction

2. 2When documenting the quality manual, how should the organization address relationships among its QMS processes?

   1. A.Document interfaces only when processes have the same owner
   2. B.List processes without describing their interfaces
   3. C.Describe their interactionsCorrect answer: C
   4. D.Describe interactions only after processes are retired

   Explanation: The MDSAP audit approach states: "describe the interaction of processes" This directly addresses the requirement or control in the question.

   Reference: MDSAP Audit Approach — Chapter 1, Task 1, Quality system procedures and instructions, pp. 18–19

3. 3Which organization can use ISO 13485 in connection with medical devices?

   1. A.A business that installs and services the devicesCorrect answer: A
   2. B.Only the government body that licenses the devices
   3. C.Only the original designer of the devices
   4. D.Only organizations that manufacture finished devices

   Explanation: ISO states: "ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services." This directly supports the selected answer.

   Reference: ISO 13485 — Medical devices — Who is ISO 13485 for?

4. 4Why should QMS planning be used when changes to the QMS are contemplated?

   1. A.To maintain continuing conformity of the QMSCorrect answer: A
   2. B.To preserve the existing QMS without assessing the change
   3. C.To determine conformity only after a later external audit
   4. D.To replace the evaluation of changes with document retention

   Explanation: The MDSAP audit approach states: "Quality management system planning should also be used when changes to the quality management system are contemplated or required in order to ensure the continuing conformity of the QMS." This directly addresses the requirement or control in the question.

   Reference: MDSAP Audit Approach — Chapter 1, Task 1, p. 19

5. 5How does ISO describe third-party certification to ISO 13485?

   1. A.It is not a requirement of the standardCorrect answer: A
   2. B.It replaces the quality management system
   3. C.It is carried out by ISO for every user
   4. D.It is required before the standard can be used

   Explanation: ISO states: "certification to ISO 13485 is not a requirement of the standard" This directly supports the selected answer.

   Reference: ISO 13485 — Medical devices — Certification to ISO 13485

6. 6Which documents should be covered by document-control procedures in the QMS?

   1. A.Only documents created by the manufacturer
   2. B.Required documents of both internal and external originCorrect answer: B
   3. C.Only external documents issued by regulators
   4. D.Only documents whose revisions have never changed

   Explanation: The MDSAP audit approach states: "control of documents and records of both internal and external origin required by the quality management system." This directly addresses the requirement or control in the question.

   Reference: MDSAP Audit Approach — Chapter 1, Task 8, p. 26

7. 7In ISO 13485:2016, how does the risk-based approach apply to QMS processes?

   1. A.It extends beyond product realization processesCorrect answer: A
   2. B.It applies exclusively to product realization processes
   3. C.It applies only to processes outsourced to suppliers
   4. D.It applies only after devices have been released

   Explanation: ISO explains: "The new version of ISO 13485 places greater emphasis on risk management and risk-based decision making for processes outside the realm of product realization." The emphasis therefore extends to other QMS processes.

   Reference: ISO 13485: Quality management for medical devices — What are the key improvements?, p. 6

8. 8A worker follows an obsolete controlled procedure. What potential document-control weakness does this observation indicate?

   1. A.Controls may not identify the approved supplier list
   2. B.Controls may not retain calibration records
   3. C.Controls may not prevent use of obsolete documentsCorrect answer: C
   4. D.Controls may not record the results of acceptance testing

   Explanation: The MDSAP audit approach states: "evidence that the document controls process is ineffective might be the observation of obsolete procedures being used" This directly addresses the requirement or control in the question.

   Reference: MDSAP Audit Approach — Chapter 1, Task 8, Implementation of document and record control procedures, p. 27

9. 9What is the role of a quality management system in an organization?

   1. A.Specify the technical dimensions of each product
   2. B.Direct and control activities to achieve intended resultsCorrect answer: B
   3. C.Assess an individual device for market authorization
   4. D.Set legal regulatory requirements for each jurisdiction

   Explanation: ISO's practical guide states: "A QMS is the way your organization directs and controls those activities that are related, either directly or indirectly, to achieving its intended results." This supports the indicated distinction or purpose.

   Reference: ISO 13485:2016 Medical devices — A practical guide — Foreword, p. 6

10. 10What responsibility does the management representative have concerning regulatory requirements?

    1. A.Treat product specifications as a substitute for regulatory awareness
    2. B.Promote awareness only among staff who file regulatory submissions
    3. C.Limit awareness of regulatory requirements to top management
    4. D.Promote awareness of regulatory requirements throughout the organizationCorrect answer: D

    Explanation: The MDSAP audit approach states: "ensuring the promotion of awareness of regulatory requirements throughout the medical device organisation." This directly addresses the requirement or control in the question.

    Reference: MDSAP Audit Approach — Chapter 1, Task 2, p. 20