ASQ Illiana Section 1213 February 2024 Meeting: How to Make and Interpret a Statement of Conformity

When a calibration report is provided by a calibration supplier, a typical concern for the customer is to know if the item calibrated is within the tolerance specified so it can used with confidence. While this traditional approach is still thought to be fine over the years, measurement science has evolved where it is not a simple binary issue of a “pass” or “fail” status within manufacturer’s specification.

Laboratory accreditation to ISO/IEC 17025 has advanced the good practices related to calibration to include more information to the process of calibrating an item and calling it within conformance (“pass” or “fail”).

This presentation describes what is involved in making a statement of conformity. What was traditionally the job of a calibration laboratory (“the experts”) to make a call (“pass” or “fail”) now requires interaction up front from the customer before they can make that call on a calibration certificate. The contract review phase becomes more important in specifying the calibration requirements by the customer.

This presentation educates both the consumer and supplier of calibration services on what is required of them to ensure that an “appropriate” pass or fail call is made to meet the requirements of the customer when a calibration activity takes place.

The learning objectives of this presentation are:

• Understanding the decision rules for a statement of conformity
• Specifying the conformity requirements by the customer.
• How measurement uncertainty impacts a decision rule.
• How a statement of conformity should be reported.
• Understanding the conformity decision and minimizing the risk for a safer use of the calibrated item with confidence.

Expected outcome after attending the presentation:

• Specifying exact calibration requirements including decision rules by the customer.
• Better understanding of customer requirements.
• Better Reporting of the calibration results by the supplier after implementing the decision rule(s).
• Less misinterpretation of customer requirements.
• Better understanding of risk mitigation.