CCIL ISO 17025 Quality Management 4 — Questions and Answers
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:
- A major modification requiring full revalidation
- A routine change requiring no documentation
- A change requiring assessment of its impact and appropriate verification before use (Correct answer)
- An immediate nonconformity to be reported to the accreditation body
Correct answer: A change requiring assessment of its impact and appropriate verification before use
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?
- Impartiality only applies to commercial laboratories, not those within larger organizations
- Management must identify risks to impartiality, including financial pressures or relationships that could bias results (Correct answer)
- Impartiality is ensured solely by having two analysts check each result
- Accreditation bodies are responsible for ensuring laboratory impartiality
Correct answer: Management must identify risks to impartiality, including financial pressures or relationships that could bias results
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?
- To rank laboratories by performance for marketing purposes
- To provide an external check on measurement capability and identify any systematic errors (Correct answer)
- To fulfill the internal audit requirement of ISO 17025
- To allow laboratories to share workloads on large sample volumes
Correct answer: To provide an external check on measurement capability and identify any systematic errors
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?
- All samples must be stored at 4°C regardless of type
- Procedures must protect sample integrity and prevent deterioration, contamination, or loss (Correct answer)
- Samples must be destroyed within 30 days of reporting
- Only samples from regulated industries require documented handling procedures
Correct answer: Procedures must protect sample integrity and prevent deterioration, contamination, or loss
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:
- Is prohibited because it creates a conflict of interest
- Is acceptable provided the individual demonstrates competence in both roles and impartiality is maintained (Correct answer)
- Requires special written approval from the accreditation body
- Is only allowed in laboratories with fewer than 5 employees
Correct answer: Is acceptable provided the individual demonstrates competence in both roles and impartiality is maintained
ISO 17025 does not prohibit dual roles; it requires that personnel are competent in their roles and that impartiality is not compromised.
Question 6: Under ISO 17025, what must a laboratory do when equipment is found to be out of calibration after having been used for testing?
- Immediately destroy all test records from that equipment
- Assess the validity of previous results, take corrective action, and notify affected customers if required (Correct answer)
- Only recalibrate the equipment and continue without further action
- Suspend all laboratory activities until a full audit is completed
Correct answer: Assess the validity of previous results, take corrective action, and notify affected customers if required
Out-of-calibration equipment triggers a requirement to assess the impact on past results and notify customers if their results may have been affected.
Question 7: Which of the following best describes the role of 'risk-based thinking' as incorporated into ISO 17025?
- It replaces the need for preventive action procedures
- It requires laboratories to identify risks and opportunities that could affect their ability to achieve intended outcomes and act on them (Correct answer)
- It applies only to safety risks in the laboratory environment
- It mandates a formal risk register be submitted to the accreditation body annually
Correct answer: It requires laboratories to identify risks and opportunities that could affect their ability to achieve intended outcomes and act on them
Risk-based thinking requires laboratories to proactively identify risks and opportunities affecting their ability to deliver valid results and act to address them.
CCIL ISO 17025 Quality Management 4
A laboratory changes to a new lot of reagent for a standard test method.
Under ISO 17025, this change should be treated as: