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articles:nist_traceability [2019/11/20 07:26] – [What are "intrinsic" standards?] rrandallarticles:nist_traceability [2019/11/20 07:28] – [An "unbroken chain of calibrations" to what?] rrandall
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 a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards __traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information__;//" a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards __traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information__;//"
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-Unfortunately, the language in ISO 9001:2015 & AS9100:2016 (Rev. D) is extremely antiquated in stating its requirements for "measurement traceability". In contrast, ISO 17025:2017 is much more modern and technically correct in stating:\\+Unfortunately, the language in ISO 9001:2015 & AS9100:2016 (Rev. D) is extremely antiquated in stating its requirements for "measurement traceability". And, unfortunately, similar antiquated language appears in U.S. Regulations. For example: 
 + 
 +<blockquote>TITLE 21--FOOD AND DRUGS \\ 
 +CHAPTER I--FOOD AND DRUG ADMINISTRATION \\ 
 +DEPARTMENT OF HEALTH AND HUMAN SERVICES \\ 
 +SUBCHAPTER H--MEDICAL DEVICES \\ 
 +PART 820 -- QUALITY SYSTEM REGULATION \\ 
 + 
 +Subpart G--Production and Process Controls \\ 
 + 
 +Sec. 820.72 Inspection, measuring, and test equipment. \\ 
 +(a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented. 
 + 
 +(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented. 
 + 
 +(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.</blockquote> 
 + 
 +In contrast, ISO 17025:2017 is much more modern and technically correct in stating:\\
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 **ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories”** \\ **ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories”** \\