ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam - ISO 13485 LA Practice Questions

Question 1

Which ISO standard provides the requirements for a Medical Devices Quality Management System (MDQMS) that ISO 13485 Lead Auditors must audit against?

ISO 9001:2015 Quality Management Systems ISO 13485:2016 Medical Devices — Quality Management Systems ISO 14971:2019 Medical Devices — Risk Management ISO/IEC 17021-1:2015 Conformity Assessment

Correct Answer:

ISO 13485:2016 Medical Devices — Quality Management Systems

Question 2

ISO 13485:2016 Clause 4.1 requires the organization to document the MDQMS scope. Which statement best describes how exclusions from ISO 13485 requirements are handled?

Exclusions are not permitted under any circumstances in ISO 13485 Any clause may be excluded provided justification is documented in the quality manual Exclusions are permitted only for clauses in Section 7 where requirements do not apply due to the nature of the organization's activities, and such exclusions must be stated in the quality manual Exclusions require prior written approval from the certification body before audit

Correct Answer:

Exclusions are permitted only for clauses in Section 7 where requirements do not apply due to the nature of the organization's activities, and such exclusions must be stated in the quality manual

Question 3

During an ISO 13485 audit, you find that the organization's management review records show reviews conducted once every 18 months. What is the most appropriate audit finding?

Observation — management review frequency is not specified in ISO 13485 Minor nonconformity — ISO 13485 requires reviews at planned intervals but the organization has not defined its own schedule Major nonconformity — ISO 13485 Clause 5.6.1 requires management reviews at planned intervals; 18 months without an interval defined constitutes a systemic failure No finding — the standard does not prescribe a minimum frequency

Correct Answer:

Major nonconformity — ISO 13485 Clause 5.6.1 requires management reviews at planned intervals; 18 months without an interval defined constitutes a systemic failure

Question 4

A PECB ISO 13485 Lead Auditor is planning a Stage 1 audit for an organization manufacturing Class II medical devices. What is the PRIMARY purpose of the Stage 1 audit?

To verify all product conformity records and release decisions To review the organization's documented MDQMS and assess readiness for the Stage 2 audit To issue the ISO 13485 certificate if documentation is satisfactory To conduct full process sampling and raise all nonconformities

Correct Answer:

To review the organization's documented MDQMS and assess readiness for the Stage 2 audit

Question 5

ISO 13485:2016 Clause 7.5.9 requires traceability records for implantable medical devices. What is the minimum retention period for these records per the standard?

2 years from the date of manufacture 5 years from the date of manufacture The lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements — whichever is longer 10 years from the date of product release

Correct Answer:

The lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements — whichever is longer

Question 1

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Prepare with the ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam practice quiz. This question bank includes 100 questions covering audit, auditor, lead, clause, and organization. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam

This practice set contains 100 questions from the matching question bank and focuses on audit, auditor, lead, clause, and organization. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam

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