Laboratory Accreditation & Standards Flashcards
6 cards from real FCC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Laboratory Accreditation & Standards flashcards as text
What is the difference between 'accreditation' and 'certification' in the FCC laboratory context?
Answer: Accreditation is formal recognition of a laboratory's technical competence by an accreditation body; certification is the granting of equipment authorization by the FCC or a TCB
Accreditation (by A2LA, NVLAP, etc.) demonstrates a laboratory's technical competence to perform specific tests, while equipment certification (by FCC/TCB) is the regulatory approval granted to a device based on test results from an accredited laboratory.
How often must an ISO/IEC 17025 accredited laboratory typically undergo re-assessment by its accreditation body?
Answer: Surveillance assessments annually and a full reassessment every four years (cycle varies by accreditation body)
Most accreditation bodies (A2LA, NVLAP) require annual or biennial surveillance visits and a full reassessment every 4–5 years to confirm ongoing conformance with ISO/IEC 17025 requirements.
What must an FCC-accredited laboratory do before using a new or modified test method?
Answer: Validate the method to confirm it achieves required performance characteristics before reporting results under that method
ISO/IEC 17025 requires laboratories to validate new or modified test methods—demonstrating that the method achieves the required performance characteristics (precision, range, uncertainty)—before using them to produce results for clients.
What is the purpose of a laboratory's 'quality manual' under ISO/IEC 17025?
Answer: To document the management system, quality policy, and how the laboratory meets ISO/IEC 17025 requirements
The quality manual (or equivalent documentation) describes the laboratory's management system, its quality policy, and the structure that ensures conformance with ISO/IEC 17025, serving as the top-level document of the quality system.
What does the FCC's 'Recognized Laboratory' list represent?
Answer: A public listing of laboratories that the FCC has recognized as meeting its requirements for performing tests to support equipment authorization
The FCC's Recognized Laboratory list identifies accredited testing laboratories that meet the agency's requirements and are accepted for providing test data in support of equipment authorization applications submitted through TCBs or directly to the FCC.
What is a 'corrective action' in the ISO/IEC 17025 quality system and how does it differ from a 'preventive action'?
Answer: Corrective action addresses root causes of identified nonconformities; preventive action addresses potential nonconformities before they occur
Corrective action is a reactive process that eliminates the root cause of an existing nonconformity to prevent recurrence, while preventive action (or risk-based thinking in ISO/IEC 17025:2017) is proactive, addressing potential problems before they cause nonconformities.