ISO 17025 – a Quality Framework for Device-Independent Calibration

Accredited compliance with ISO 17025 ensures that a vendor has developed a framework and processes for high quality, device-independent calibration. Specifically, it addresses the structures and processes necessary in the areas of quality, administrative, procedure and documentation of technical services for a wide range of devices requiring calibration, including not just pipettes, but also medical devices, communication equipment, electronic devices, weight scales, pressure meters, calipers, and many more.

For TTE customers, accredited compliance with ISO 17025 is also the foundation upon which we build our compliance to the more stringent and pipette calibration-specific standards of ISO 8655.

3 Reasons Why ISO 17025 Is Important

  1. ISO 17025 is a regular and extensive review of a vendor’s quality management system.
  2. ISO 17025 is not required. To increase trust, calibration labs volunteer to be reviewed by a third-party accreditation body based on their adherence to ISO 17025 standards.
  3. ISO 17025 certifies that a lab has demonstrated an ability to produce accurate tests and/or calibration data and has displayed excellence in technical and management competence.  (It is silent, however, on the methods and procedures that must be used to calibrate since it is device agnostic: see Why 8655 Should Matter to You)

5 Elements of ISO 17025 certification:

  1. Scope: The area of the lab being evaluated that will represent the lab as a whole (i.e. mechanical equipment, environmental conditions)
  2. Normative References: Documents that give the most recent information about every area of the process and equipment standards.
  3. Terms and Definitions: The labeling of all equipment, instruments, work stations, employees, and defining instructions, protocol, procedure, and safety measures.
  4. Management Requirements: document control, service to clients, contract reviews, preventative actions, internal audits, management reviews, etc.
  5. Technical Requirements: Safe working conditions, functional equipment, proper calibration of devices, handling of tests and substances, result reporting etc.

5 Steps Toward ISO 17025 Compliance

  1. Provide specific, documented procedures to explain your calibration lab’s process or methodology.
  2. Designate an internal enforcer of quality management who reviews and maintains the management system daily.
  3. Create names, terms, titles, instructions, records, and definitions for every aspect of the lab space (e.g., label equipment, give employees job titles (i.e. lab assistant, chemist), indicate what each work station is for, and use signs to make safety information visible to the entire lab staff and visitors).
  4. Keep thorough documentation of all clients, tests, employees, incidents/accidents, inventory, complaints, shipments, training, protocol, orders, etc. Organized records are essential for a quality ISO compliant management system.
  5. Maintain safe, working, clean, and new equipment. Make sure the lab space is an environment that promotes accuracy, employee health, and reliable equipment.

    ISO 17025 and The FDA

    Regular FDA audits are required for clients of calibration labs, those organizations involved in the development or manufacturing of pharmaceuticals. ISO 17025 audit evaluations are also required at regular intervals, as they ensure the compliance of calibration and test labs to the quality standard. These accreditation audits are conducted by internationally recognized independent accreditation bodies. Both the FDA and ISO provide many of the standards that guide the development quality, integrity, and standard traceability required for drug approval.

    Labs that do well in FDA pipette calibration audits generally have strong personnel, with well-managed quality systems that comply with both ISO 17025 and ISO 8655, such as TTE Labs. To be sure, an FDA audit will include the evaluation of analytical methods and how comprehensive a test process is described.

    The Relationship Between ISO and IEC

    ISO: International Organization for Standardization

    • Global standards for worldwide proprietary, commercial, and industry

    IEC: International Electrotechnical Commission

    • Global standards for electrical and electronic technologies

    These two international standards often work side by side because their areas of standardization tend to overlap. The use of electro-technical equipment is prevalent in many ISO areas of worldwide proprietary, commercial, and industrial work places. This often results in an interdependent relationship between the two organizations of standards.