CCIL ISO 17025 Quality Management 3

Question 1

ISO 17025 distinguishes between 'verification' and 'validation' of methods. Which statement correctly differentiates them?

Accepted Answer

Verification confirms a standard method can be correctly applied in the lab; validation confirms a non-standard method is fit for purpose

Answer

Verification checks that a standard method can be properly implemented by the lab, while validation establishes fitness-for-purpose of non-standard methods.

Question 2

A laboratory receives a complaint from a customer about a test result. Under ISO 17025, what is a required element of the complaint-handling process?

Accepted Answer

Investigating the complaint and communicating the outcome to the complainant

Answer

ISO 17025 requires that complaints be investigated and that the outcome and conclusion be communicated to the complainant.

Question 3

When a laboratory outsources a calibration to an external provider, ISO 17025 requires that:

Accepted Answer

The laboratory informs the customer and uses technically competent external providers

Answer

The laboratory must inform the customer and ensure any outsourced work goes to technically competent providers, though ISO 17025 accreditation is preferred but not always strictly mandated.

Question 4

Under ISO 17025, what is the minimum required content of a test or calibration report?

Accepted Answer

Title, laboratory identification, unique identifier, date of issue, and results with measurement uncertainty where relevant

Answer

Reports must include at minimum: title, laboratory identification, a unique identifier, date of issue, and results including uncertainty where applicable.

Question 5

A laboratory's management review finds that corrective actions from a previous cycle were not completed on time. According to ISO 17025, what should happen next?

Accepted Answer

The root cause of the delay should be analyzed and new timelines or additional actions assigned

Answer

Incomplete corrective actions require root cause analysis of why they failed and reassignment with realistic timelines or additional measures.

CCIL - Canadian Council of Independent Laboratories Practice Test

CCIL - Canadian Council of Independent Laboratories Practice Test

CCIL ISO 17025 Quality Management 3