What is a Calibration Standard Reference as per ISO/IEC 17025?

In this article, you will learn what is a calibration standard according to the FDA requirements and ISO/IEC 17025 Testing and Calibration Laboratories.

Calibration standards are known as reference standard instruments typically with 3 or more times more accuracy than the instruments that will be calibrated with.  Calibration standards are also called calibration reference.

Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards (NIST Traceable calibrations.

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.

ISO/IEC 17025 Testing and Calibration Laboratories.

This document (ISO/IEC 17025) enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.

In addition, it also helps facilitate cooperation between laboratories using calibration standards and other bodies by generating wider acceptance of results between countries.

Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

For more information about what is a Calibration Standard, refer to:

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 — QUALITY SYSTEM REGULATION

Subpart G–Production and Process Controls

Sec. 820.72 Inspection, measuring, and test equipment.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.72

ISO/IEC 17025 TESTING AND CALIBRATION LABORATORIES

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.

ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

httpss://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html

TITLE 21–FOOD AND DRUGS

PART 111 — CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS – Calibration Management System

Subpart D–Equipment and Utensils

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.35

21 CFR § 58.63 – Maintenance and calibration of equipment.

• 58.63 Maintenance and calibration of equipment.

httpss://www.law.cornell.edu/cfr/text/21/58.63

40 CFR § 160.63 – Maintenance and calibration of equipment.

• 160.63 Maintenance and calibration of equipment.

httpss://www.law.cornell.edu/cfr/text/40/160.63

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