ISO 17025 Accreditation
Pipettes.com is an accredited laboratory, certified by the ANSI National Accreditation Board (ANAB). Pipettes.com calibration competency is verified by our accreditation to all the industry standards, including:
- ISO/IEC 17025:2017 – a Quality Framework for
Device-Independent Calibration - ISO/IEC 8655 – a Quality Framework for Pipette Calibration
- ANSI/NCSL Z540.3 2006
- USP41
ISO/IEC 17025 Accreditation Explained
ISO/IEC 17025 is the international standard for both calibration and testing laboratories. It was initially known as ISO/IEC guide 25; ISO/IEC 17025 was originally issued by the international organization for standardization in 2000.
The two sections in ISO/IEC 17025 – Technical Requirements and Management Requirements.
Technical Requirements determine the competence of staff, mythology, and test/calibration equipment. Management Requirements are related to the effectiveness and operation of the quality management system within the laboratory.
A prerequisite for a laboratory to obtain accreditation is to have a documented quality management system addressing the elements of the standard. The contents of the quality manual detail the outline of the ISO/IEC 17025 standard.
ISO/IEC 17025:2017
The ISO/IEC 17025:2017 is the most up-to-date version of ISO/IEC 17025, the previous iteration was ISO/IEC 17025:2005. This standard specifies the general requirements for competence, impartiality, and consistent operation of laboratories. This standard applies to all organizations performing laboratory activities, regardless of the number of personnel.
What does ISO/IEC 17025 measure?
- Individual competence of staff to perform.
- Use of proper equipment and its maintenance and calibration.
- Having in place sufficient quality assurance and quality control processes.
- Sampling in place to the appropriate degree.
- Procedures in place for their inspection/testing/calibration.
- Validated methods for obtaining data.
- The ability to report and record accurate data.
- Traceability to national standards whenever appropriate.
- Proper environmental conditions to perform testing/calibration/inspection
What evidence does an accredited laboratory have to prove its accreditation status?
Accredited laboratories have both a Certificate of Accreditation (stating ISO/IEC 17025 accreditation has been granted) and they have a “Scope of Accreditation”, this scope is determined by the laboratory, and assessment activities will be focused on those processes that affect this scope.
ISO/IEC 17025 vs. ISO 9001
ISO 9001 is applicable to many businesses and industries, while ISO 17025 is specifically valuable for testing and calibration.
Even though labs can be certified and audited (or registered) to internal management systems such as ISO 9001 (the standard typically used in manufacturing and service type organizations for managing the quality of their product or services) – ISO 9001 DOES NOT evaluate technical competence – this means that evaluation of ISO 9001 won’t ensure that the testing/calibration/inspection data provided is accurate, competent, or reliable. ISO/IEC 17025 Accreditations fill the “gap” of technical competence not addressed by ISO 9001.
Where ISO 9001 covers the facility, ISO/IEC 17025 specifically covers methods or functions detailed in each laboratory’s “Scope of Accreditation”.