The answer is an emphatic no. No two ISO labs are equivalent any more than are two accredited universities, physicians, or service organizations. The differences, in fact, can be vast. While some testing labs exceed the stated requirements, others remain static. By asking a few key questions, you can learn if a laboratory is operating at a peak level of quality and technical commitment. Here are a few standard practices of the world’s top-tier ISO 17025 testing laboratories:
- Effective Quality Control measures. Top labs use multiple quality control precautions, including structured and systematic protocols, controls, operational checks, and redundancies to ensure against analytical and testing error. A few of the most important ones:
- Regular use of control samples to safeguard against false positives and false negatives. In a DNA-based speciation test, for example, an appropriate negative control is a sample verified to be free of the target species DNA. This critical control acts to confirm that there is no risk of a false positive result.
- Duplicate analyses. Here, samples are assayed in duplicate. Obtaining comparable results with both samples provides an extra measure of confidence in the accuracy of the results.
- Systems for self-correction. The most effective labs structure into their analytical program controls and assessment procedures that can detect and immediately correct instrument malfunctions or operator errors that sometimes occur in analysis. If such a problem is detected, the affected sample is flagged for re-analysis.
- Full traceability of all reagents, instruments, and personnel involved in analysis. Method, operator, and sample accuracy are all bolstered by an unbroken chain of documentation and calibration.
- Flexible scope of accreditation. Labs granted flexible scope of accreditation have demonstrated a high level of technical competence in one or more areas; as a result, assay development and validation require less frequent external monitoring. This means the lab can rapidly offer new tests to the market. In contrast, labs limited by fixed scope of accreditation must undergo a formal, often lengthy accreditation process for each additional test. The more optimal flexible scope confirms competence and responsiveness.
- Established proof of competency. A sure indication of a high-quality testing lab—one that goes above and beyond ISO—is participation in relevant proficiency programs such as GeMMA, AOCS, ISTA, and FAPAS. In ring trials, a lab provides measurable data to gauge the accuracy of its results against an established standard as well as against other labs’ results. Participation in several ring trials highlights a strong commitment to excellence.
- Development of proprietary technologies. Another demonstration of technical expertise is a lab’s ability to create innovative new products in its field. Very few labs create their own products; the ones that do so are often the technical leaders.
Are there important measures of a testing laboratory’s capabilities beyond its ISO 17025 accreditation? Absolutely. When investigating a laboratory you entrust key aspects of your business process, be sure to look beyond ISO into the lab’s inner workings, where quality and commitment become evident.