As ISO’s catalog of standards grows to proportions that some would argue are a bit preposterous, it’s sometimes hard to find useful offerings amidst the dross. The ISO 17xxx series of standards have quite a few ingots floating around in it, however. One such standard is ISO 17034: “General Requirements for the Competence of Reference Material Producers.

We are surrounded every day by “reference materials,” and likely don’t even know it. Tests for the pH of chemicals or in healthcare examinations require that pH meters be calibrated with certified “buffer solutions.” Oil refineries require comparing their products against certified oil standards. Blood sugar meters used by millions of diabetics every day require calibration against “reference strips.”

If any of those reference materials are faulty, unreliable or just plain defective, bad things happen.

ISO 17034 tries to fix this problem, by laying out detailed requirements for the producers of those materials, to ensure they can manufacture them reliably and consistently. The standard is a similar-looking cousin to ISO 17025, the standard for calibration and test laboratories, but adds requirements related to reliable and traceable manufacturing, something 17025 obviously does not discuss.

Like any of the ISO 17xxx series, implementation is not as straightforward as the more famous quality system standards ISO 9001. The stakes are a bit higher, since users are pursuing “accreditation” and not mere “certification.” The end result is the organization obtains the authorization to certify the reference materials one produces, which itself is a bit unusual; normally, self-certification is not allowed, but is essentially required for reference material producers. As a result, the rules are strict, and complex.

Whereas we at Oxebridge have been clear to advise organizations to attempt self-implementation for standards such as ISO 9001 and AS9100, and have provided a host of free tools to aid companies in doing just that, with ISO 17034 the use of a consultant is nearly obligatory. Expertise related to uncertainty, homogeneity, stability and other aspects is critical.

The end result, however, is that one’s reference materials are then qualified as being produced under a fully accredited system, with worldwide recognition and authority. For the RM industry, this is critical. No one will trust, much less buy, standards or reference materials which do not come with the necessary authority.

For a quote on ISO 17034 implementation at your company, click here. The standard is well suited for fully-remote implementation, so overall costs are lower than for standards requiring on-site work, and the related travel expenses. And Oxebridge is one of the only consultancies on the planet that provides these implementation services.

 

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