Differences

This shows you the differences between two versions of the page.

--- articles:nist_traceability [2023/02/02 01:32] – [What are "International Standards"?] rrandall
+++ articles:nist_traceability [2025/11/18 20:33] (current) – [An "unbroken chain of calibrations" to what?] rrandall
@@ Line 53: / Line 53: @@
 Sec. 820.72 Inspection, measuring, and test equipment. \\
 (b) (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be __traceable to national or international standards__. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.</WRAP>
+<WRAP info center round box 80%>On February 2, 2024, the U.S. FDA issued an [[https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments|official ruling incorporating, by reference, the 2016 edition of ISO 13485]] (effective February 2, 2026). However, this incorporation does not change the requirements contained in Sec. 820.72(b)(1). Even if it did, ISO 13485:2016, sec. 7.6a also requires measuring equipment to be "calibrated or verified, or both, at specified intervals or prior to use, against measurement standards //traceable to international or national measurement standards...//".</WRAP>
 Similar antiquated language appears in [[http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL-STD-1309D_87/|MIL-STD-1309D]], (12 February 1992), which doesn't even recognize international standards or offer alternatives where no national measurement standards exist:
@@ Line 83: / Line 85: @@
 I describe the above pyramid as "//typical//" because, contrary to the antiquated language of ISO 9001:2015 & AS9100:2016, it is possible to “bypass” the National Metrology Institutes (NMIs) to obtain traceability directly to SI units. Using the example of DC volts, [[https://www.fluke.com|Fluke]], a world leader in the field of metrology, owns a [[https://nvlpubs.nist.gov/nistpubs/jres/095/jresv95n3p219_A1b.pdf|Josephson voltage system]], which they can use to realize the SI Units directly.
-Also, while not strictly speaking a National Metrology Institute (NMI), the [[https://www.bipm.org|"Bureau International des Poids et Mesures" (BIPM)]] offers [[https://www.bipm.org/en/bipm-services/|calibration & Measurement services]] (with traceability to SI Units) to its [[https://www.bipm.org/en/about-us/member-states/|Member States]]. In that instance, the BIPM would serve as equivalent to a NMI.
+Also, while not strictly speaking a National Metrology Institute (NMI), the [[https://www.bipm.org|"Bureau International des Poids et Measures" (BIPM)]] offers [[https://www.bipm.org/en/bipm-services/|calibration & Measurement services]] (with traceability to SI Units) to its [[https://www.bipm.org/en/about-us/member-states/|Member States]]. In that instance, the BIPM would serve as equivalent to a NMI.
 Transcat has an excellent White Paper on this topic at: [[https://www.transcat.com/calibration-resources/white-papers/what-is-measurement-traceability]].