CCIL ISO 17025 Quality Management 2

Question 1

Under ISO 17025, what is the primary purpose of an internal audit program?

Accepted Answer

To verify that the laboratory's management system conforms to requirements and is effectively implemented

Answer

Internal audits verify conformance to the management system requirements and effective implementation, not to replace external assessments.

Question 2

When a laboratory identifies a nonconforming piece of work, which action should be taken FIRST?

Accepted Answer

Stop work and evaluate the significance of the nonconformity

Answer

The first step is to stop work and evaluate the significance before deciding corrective actions or notifications.

Question 3

ISO 17025 requires that laboratories retain records of original observations. What is the key reason for this requirement?

Accepted Answer

To enable reconstruction of the test or calibration if needed

Answer

Retaining original observations allows the laboratory or auditors to reconstruct the test or calibration activity if questions arise.

Question 4

In ISO 17025, what does 'metrological traceability' specifically require?

Accepted Answer

Reference to an international measurement standard through an unbroken chain of calibrations

Answer

Metrological traceability requires an unbroken chain of calibrations linking measurements to recognized national or international standards.

Question 5

Which of the following scenarios best describes a 'method validation' activity under ISO 17025?

Accepted Answer

Confirming that a non-standard method is fit for its intended purpose through experimental testing

Answer

Method validation involves experimentally confirming that a non-standard or in-house method is fit for its intended purpose.

CCIL - Canadian Council of Independent Laboratories Practice Test