Evaluating Metrological Traceability on Certificates (ISO/IEC 17025)

Metrological traceability is a fundamental requirement of ISO/IEC 17025 and a cornerstone of laboratory competence. Determining whether traceability has been adequately demonstrated can be challenging, given the variety of certificates a laboratory receives, including calibration certificates, certificates of analysis, and reference material certificates. These certificates carry varying levels of traceability information, and the laboratory must evaluate that information to determine whether it is suitable for its operations.

This webinar provides a practical approach to evaluating metrological traceability on certificates and determining whether the stated traceability supports the laboratory’s needs under ISO/IEC 17025. Watching this video will help you learn how to assess traceability claims, identify key supporting information, recognize potential gaps, and document traceability evaluations in a way that supports the laboratory’s management system and accreditation requirements. Real-world examples illustrate effective calibration certificate review practices and support compliance with ISO/IEC 17025 accreditation requirements.

Whether you review certificates daily or only occasionally, this webinar will help you evaluate traceability claims with greater consistency and confidence. Watch to strengthen your understanding of traceability and gain confidence in your certificate review process.

Key Takeaways

• Understand the elements of metrological traceability
• Evaluate traceability information on certificates
• Recognize common deficiencies and red flags
• Document traceability evaluations
• Support compliance with management system and accreditation requirements

Who Should Watch?

• Laboratory managers, quality managers, and technicians
• Purchasing personnel responsible for calibration and reference material procurement
• Personnel responsible for supplier evaluation and approval
• Staff who review calibration certificates, certificates of analysis, and reference material certificates

Presenter: Patrick Selig, ANAB

Audience Questions

At the end of the webinar, questions were asked by the webinar’s attendees. These included:

• Is it obligatory that the provider be certified by ISO 17034 for reference materials?
• What are other requirements for a calibration lab to be considered competent, besides being accredited to ISO/IEC 17025?
• Are you required to maintain traceability through every available aspect of a procedure, for example, if a procedure uses a balance, a pipette, and a volumetric flask, do all three need to maintain traceability?
• Is our reference material mixtures whose traceability is established through a calibrated balance considered valid?
• Is it appropriate to request a copy of the calibration procedure cited on a calibration certificate?
• How much documentation is needed when reviewing calibration certificates?
• Is it obligatory that the provider of calibrations be accredited to 17025 thinking in instances where a manufacturer can calibrate their equipment, but they are not calibrated?
• What do you do when you are using a reference material for a specific measurement, but your provider doesn’t provide that measurement on the certificate? Can you still use it for method verification?
• Can you define direct realization?
• Do GCMS instruments fall under metrological traceability? Do they need to be calibrated annually by an external vendor?
• We recently had a vendor calibrate pipettes but realized after that we did not specifically request to have a 17025 calibration. Is this type of calibration per ANAB?
• If we have equipment that cannot be calibrated by a 17025 provider, but the provider states that it is calibrated with missed traceable equipment, but the equipment does perform measuring, how do we assess the contributions of that equipment to measurement uncertainty?