CCIL ISO 17025 Quality Management 3 — Questions and Answers
Question 1: ISO 17025 distinguishes between 'verification' and 'validation' of methods. Which statement correctly differentiates them?
- Verification applies to new methods; validation applies to standard methods
- Verification confirms a standard method can be correctly applied in the lab; validation confirms a non-standard method is fit for purpose (Correct answer)
- Verification is performed by customers; validation is performed internally
- Both terms are interchangeable under ISO 17025
Correct answer: Verification confirms a standard method can be correctly applied in the lab; validation confirms a non-standard method is fit for purpose
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?
- Immediately issuing a corrected report at no charge
- Notifying the accreditation body within 24 hours
- Investigating the complaint and communicating the outcome to the complainant (Correct answer)
- Suspending testing in the affected area until resolved
Correct answer: Investigating the complaint and communicating the outcome to the complainant
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:
- The external provider must be ISO 17025 accredited
- The laboratory informs the customer and uses technically competent external providers (Correct answer)
- The outsourced calibration is re-verified internally before acceptance
- The accreditation body pre-approves each outsourced activity
Correct answer: The laboratory informs the customer and uses technically competent external providers
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?
- Title, laboratory identification, unique identifier, date of issue, and results with measurement uncertainty where relevant (Correct answer)
- Only the final numerical results and pass/fail status
- Customer name, sample description, and the test method reference number only
- A full description of the measurement procedure used
Correct answer: Title, laboratory identification, unique identifier, date of issue, and results with measurement uncertainty where relevant
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?
- The corrective actions should be closed as-is and rescheduled for next year
- The root cause of the delay should be analyzed and new timelines or additional actions assigned (Correct answer)
- The accreditation body must be informed immediately
- Staff responsible should receive disciplinary action
Correct answer: The root cause of the delay should be analyzed and new timelines or additional actions assigned
Incomplete corrective actions require root cause analysis of why they failed and reassignment with realistic timelines or additional measures.
Question 6: Which ISO 17025 clause specifically addresses the laboratory's obligation to keep customer information confidential?
- Impartiality
- Confidentiality within the management system structure clauses (Correct answer)
- Complaints handling
- Control of management system documents
Correct answer: Confidentiality within the management system structure clauses
ISO 17025 requires laboratories to manage information obtained in laboratory activities as confidential through legally enforceable commitments.
Question 7: In ISO 17025, 'uncertainty of measurement' must be reported when:
- Only when requested by the customer in writing
- Whenever it is relevant to the validity or application of the test results, or when required by the customer (Correct answer)
- Only for calibration certificates, never for test reports
- Only when uncertainty exceeds 5% of the measured value
Correct answer: Whenever it is relevant to the validity or application of the test results, or when required by the customer
Measurement uncertainty must be reported when it is relevant to the result's validity or application, or when the customer or specification requires it.
CCIL ISO 17025 Quality Management 3
ISO 17025 distinguishes between 'verification' and 'validation' of methods.
Which statement correctly differentiates them?