What is ISO 17025 ?
ISO 17025 was developed so that testing & calibration laboratories were recognized for their capabilities & areas of competence. All measurements and decisions should be based on accurate, repeatable, verifiable, cost effective, timely, and believable measurements, opinions, and recommendations. ISO 17025 helps assures this happens first time, every time, and on-time. Without these assurances, the data, opinion, and recommendations are immediately suspect, questionable, risky, and of greatly reduced value and usability. Customers should ensure that all data and opinions upon which they rely can be traced back through an unbroken chain of data based on ISO 17025.
The International Organization for Standardization (ISO) issued standard number ISO-17025 (2005) that establishes extremely rigorous requirements for a calibration laboratory quality program. This standard is the international template for quality programs for calibration laboratories to promote consistency and quality of calibration and is widely used as the basis for many commercial calibration laboratories’ quality programs. Implementation and maintenance of an ISO 17025 quality program requires a considerable commitment of both technical talent and financial resources from the laboratories. Many calibration laboratories typically claim compliance with ISO 17025, however, the degree to which they actually adhere to the requirements of their quality program varies widely. There is no mandatory industry policing of calibration laboratories to ensure that actual implementation of their ISO-17025 quality program.
Formerly known as Guide 25, ISO 17025 is a standard for General Requirements for the Competence of Testing and Calibration Laboratories. Guide 25 was published in 1990 as internationally agreed set of quality system requirements applicable to laboratories who perform calibration and/or testing services. It was superseded in early 2000 by ISO/IEC 17025 which will form the basis for laboratory accreditation in the future.
ISO 17025 is becoming the main standard used by testing and calibration laboratories. There are many commonalities with the ISO 9001-2000 standard, but ISO 17025 adds in the concept of competence to the equation. 17025 directly affect companies that produce testing and calibration results. There are two main sections in ISO 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of the staff, methodology and test/calibration equipment itself. Laboratories use ISO 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
ISO 17025 – General Requirements for the Competence of Calibration and Testing Laboratories was published by ISO in December 1999 and revised in May 2005. It is the result of a joint partnership between the International Organization for Standardization and the International Electrotechnical Commission. The standard replaces ISO Guide 25 and EN 45001 and takes into consideration the operating experience gained since the previous standards were published. ISO 17025 was developed specifically to give guidance to laboratories on both quality management and the technical requirements for proper operation. This standard can be considered the technical compliment to ISO 9000. Consequently, any organization that satisfies the requirements of ISO 17025 also meets the intent of ISO 9000 requirements; however, the reverse is not true. While the ISO 9000 requirements are generic and are intended to be applicable to any type of organization, the ISO 17025 requirements are specific to testing and c
