Terms Used in Industry Briefly Explained: Part 3
Throughout the industry, some associated terms have a history of being misunderstood or confusing. In our last attempt to concisely define the most frequently used expressions, we break down the meaning of terms that relate to requirements for quality and testing.
ISO 9001 is a worldwide recognized quality system and sets out the requirements for a quality management system. A quality management system like ISO 9001 defines all the processes involved to produce an end-product; from design and purchase to warehouse management and production, as well as anything in between. The product can be anything, including hardware, software, a service, etc. The ISO 9001 quality management system establishes the processes to repeatedly produce a product with a quality level of ‘A’ – whatever that may be in relation to that particular product. If something has to change in one of the processes that results in a product with a quality level of ‘B’ – again whatever that means for that particular product – the rules can be changed as long as it is appropriately documented.
Third-party certification bodies, such as the Bureau Veritas and Lloyd’s Register, audit the organizations and provide the confirmation that they meet the requirements. This is what is meant when a company is ISO 9001 certified. However, it is a widespread misunderstanding that the ISO 9001 quality system provides a statement about the quality of a product. It certainly does not! The question “Does this product have an ISO 9001 certificate?” is senseless.
ISO/IEC 17025 sets out general requirements for the competence of testing and calibration laboratories. ISO/IEC 17025 is the standard in most major countries for which most labs must hold accreditation to be deemed technically competent. In many cases, regulatory authorities and suppliers will not accept calibration or test results from a lab that is not accredited. The standard permits laboratories to conduct procedures in their own ways, but an assessor (also known as an auditor) may require the laboratory to justify using a particular process.
There is a common misunderstanding with this term as well. Normally, manufacturers of instrumentation do not have an accredited calibration laboratory. They utilize calibration equipment for their own products, but they don’t provide calibration as a commercial service. Therefore, there is no requirement to be ISO/IEC 17025 certified. Normally, they do not maintain a full-fledged calibration laboratory; instead, they might have a few calibration standards for measuring applications such as flow, pressure or temperature, etc., checked and calibrated on a regularly scheduled basis by an ISO/IEC 17025 accredited calibration laboratory.
These laboratories are accredited by assessors such as the American Association for Laboratory Standards or the Lab Accreditation Bureau. The manufacturer’s calibration certificate provides details on the calibration standard used and its traceability.
All of the measurement instruments we supply, such as dew point transmitters, meet testing and quality requirements of the industry. For more details on the devices we distribute, visit our website.