CCIL ISO 17025 Quality Management 4

Question 1

A laboratory changes to a new lot of reagent for a standard test method. Under ISO 17025, this change should be treated as:

Accepted Answer

A change requiring assessment of its impact and appropriate verification before use

Answer

Changes to reagent lots should be assessed for potential impact, and verification testing may be required before the new lot is used in routine testing.

Question 2

Under ISO 17025, which statement about 'impartiality' is correct?

Accepted Answer

Management must identify risks to impartiality, including financial pressures or relationships that could bias results

Answer

Management must proactively identify and mitigate risks to impartiality, including financial, organizational, or relational pressures that could bias outputs.

Question 3

What is the purpose of an 'inter-laboratory comparison' (ILC) in the context of ISO 17025?

Accepted Answer

To provide an external check on measurement capability and identify any systematic errors

Answer

ILCs, including proficiency testing, provide external verification of a laboratory's measurement capability and can reveal systematic biases.

Question 4

ISO 17025 requires laboratories to have a policy for handling and storing samples. Which of the following is a key element of this requirement?

Accepted Answer

Procedures must protect sample integrity and prevent deterioration, contamination, or loss

Answer

Sample handling procedures must be designed to protect sample integrity from deterioration, contamination, loss, or damage throughout the laboratory's custody.

Question 5

A laboratory operates a quality management system where the quality manager also performs testing. Under ISO 17025, this arrangement:

Accepted Answer

Is acceptable provided the individual demonstrates competence in both roles and impartiality is maintained

Answer

ISO 17025 does not prohibit dual roles; it requires that personnel are competent in their roles and that impartiality is not compromised.

CCIL - Canadian Council of Independent Laboratories Practice Test

CCIL - Canadian Council of Independent Laboratories Practice Test

CCIL ISO 17025 Quality Management 4