One area where the use of standards is long-standing is in metrology, the science of measurement. And one standard practice is the use of reference materials as part of various test procedures. You may think of this as quality control samples or check samples. Now there’s a new ISO Guide 80, “Guidance for the in-house preparation of quality control materials (QCMs).” It will help you understand the characteristics of various reference materials used for quality control. And it describes the processes your staff will use to prepare such material, as well as key considerations for setting up your system.
QCM’s are used to provide laboratories with a way of regularly checking routine test procedures for precision. They’re valuable in the preparation of QC charts, verifying the stability of a process or test. They can be used when developing a process, to establish consistency. Or they might be used to compare results using two types of similar tests. Of course, they can be used to measure variations in the environment and for instrument performance checks. And they are valuable for reproducibility studies.
Your ISO Guide 80 has 12 document-specific clauses, covering the following areas:
- Quality control materials themselves
- Applications of QCMs
- Steps for the in-house preparation of QCMs
- Material specification
- QCM preparation itself
- Homogeneity
- Characterization and value assignment
- Stability
- Transportation
- Documentation
- Storage
- Usage
There are six Annexes that cover specific case studies to provide examples of the use of this guide. A bibliography with 33 references finishes up the document.
You’ll see applications for this guide for processes as diverse as testing drinking water to the evaluation of raw materials for pharmaceuticals to verifying the grade of a commodity. You’ll find it to be a companion for the ISO Guide 34 and ISO Guide 35, both of which provide information on reference materials.
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