ISO 17025 4

Courtesy: ISO 17025

Scope

The scope of the standard is described over six points. It states what type of testing and calibration is covered; who it’s applicable to; the purpose for the standard; what’s not covered; and how it relates to ISO 9001.

Normative references

This section states both ISO/IEC 17000 and the International Vocabulary of Metrology (VIM) are vital to applying the standard.

Terms and definitions

This section simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM. The 2017 version added nine new terms to be defined, including “impartiality,” “complaint,” and “validation.”

General requirements

This section discusses the risks associated with creating biased results (impartiality) and risks associate with handling protected information (confidentiality) to the standard. The requirements are broken down into two subsections

Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.

National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories can use either a domestic organization or some other internationally recognized body in cases where the domestic organization “has either no international recognition or where it lacks recognition in parts of the world relevant to the laboratory’s operations.” Laboratories typically select a range of common and frequently used methodologies that could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.