ISO IEC 17025 Laboratory Requirements: Calibration and Testing

Laboratory accreditation for testing and calibration falls under the ISO IEC 17025 standard. Any laboratory that wants to demonstrate their conformity to the highest levels of quality for their results would be well-advised to seek ISO IEC 17025 accreditation. The accreditation was designed alongside eighteen liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC).

Who Does the ISO IEC 17025 Apply To?

Accreditation should be a priority for labs that do testing, sampling, or equipment calibrations. Whether the lab is government-run or private doesn’t make a difference. While many labs believe they already run at peak efficiency, implementing ISO IEC 17025 usually reveals a lot of gaps in their processes and management methodologies. Among the perks of achieving ISO IEC 17025 accreditation are:

  • Quality control systems can anticipate problems and deal with preventative actions.
  • Methods of testing have specific accuracies, precision, and limits of detection.
  • The institution starts using globally published and accepted standards for their testing methodologies and calibration of instruments.
  • The accreditation similarly outlines an acceptable set of methods that the lab can use.

The Benefits that ISO IEC 17025 Brings to Institutions

Accreditation can take a lot of time, but the sheer benefits that it offers to an institution are second to none. An accredited lab is one that is afforded respect in their dealings with their business clientele. By starting on the path of ISO IEC 17025 accreditation, an institution removes any doubt that a client may have regarding their operation and methodologies. In the business of laboratory testing, trust is the most important thing for clients. The accreditation encourages trust in a laboratory because the accreditation shows that the company conforms to professional, accepted standards that are approved globally.

Clients will no longer have to worry about retesting leading to different results. The generated results from the labs’ test would be accurate and precise. This peace of mind is critical to a client’s decision to return for future business. Not only does ISO IEC 17025 affect the way a client sees the institution, but how other companies in the industry view them as well.

Institutions that are certified as ISO IEC 17025 compliant tend to be seen in a better light by other labs, both certified and uncertified. Cooperation and sharing of results will be a lot easier with other labs because of this accreditation. The partner labs will have peace of mind that their results will not end up in unauthorized hands. Since this accreditation is accepted globally, international boundaries don’t matter to this level of trust. A certified institution is accorded the same respect anywhere in the world they choose to do business.

How Long does ISO IEC 17025 Accreditation Take

Accreditation doesn’t have a specific timeline. There is no set number of days or weeks that can be applied to every organization. Accreditation depends on a handful of critical practices that may vary, depending on the institution. These are:

  • Number of locations where testing /calibration is done
  • How complex the testing methodologies and equipment calibrations are
  • How many employees the business employs
  • The number of tests or calibrations that are within the institution’s scope of operations

The 2017 Update to ISO IEC 17025

In 2017, the ISO IEC 17025 received a series of updates. Rapid progress in the technology and within the market’s demands made revamping the process of accreditation necessary to deal with these changes. The changes sought to incorporate developments within the realms of IT and technical methodologies while updating the accreditation’s vocabulary to meet the demands of the modern world. The new amendments integrated changes to the ISO 9001 standard, hoping to bring about further integration of both standards.

Significant Changes in the 2017 Amendment

With the ISO IEC 17025:2017 amendment, the industry saw the accreditation change some areas significantly, including:

  • Accreditation Scope: All of a laboratory’s sampling techniques, equipment calibration, and testing will now be covered under the new scope of the accreditation.
  • Alignment between ISO IEC 17000 and ISO IEC 17025: The accreditation was redesigned to bring about a closer alignment between the two standards.
  • Improved Approach to Processes: The accreditation system has been developed to synchronize more closely with existing accreditation systems, including ISO 15189 (Quality of Medical Laboratories), IEC 17000 (Standard of Conformity Assessment Activities), and ISO 9001 (Quality Management System).
  • Reduction in Paperwork: A broader focus on IT and software reduces the amount of paperwork a business needs to perform to conform to the accreditation’s standard.
  • Risk-Based Considerations: A section has been added to the accreditation that allows for closer integration with ISO 9001:2015.
  • Synchronization of Terms: Terminology and vocabulary have been updated to reflect standard conformity assessments.

Display of Accreditation

Once a lab has successfully achieved ISO IEC 17025, they can proudly display the certificate wherever they see fit. Additionally, they can include the accreditation in all their marketing materials, not limited to the company’s website and brochures. Accreditation puts the clients’ minds at ease since it allows them to trust the institution as an internationally recognized organization for their work.

Are you trying to get ISO IEC 17025 accreditation for your institution? Contact us today, and we can work through any questions you might have about the process or the application.