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Understanding Quality Standards for Analytical Laboratories: Comparing ISO 9001 vs ISO/IEC 17025

1/29/2025

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​What accreditation does your x-ray fluorescence service provider hold? It’s important to many clients of Eastern Applied Research that their XRF Analyzer service and support provider maintain compliance to a specific standard through an independent accreditation body. For those customers focused on ISO/IEC 17025, we are happy to announce that we have maintained our accreditation to this rigorous standard.
 
This is a timely extension of our accreditation because a new customer recently contacted us specifically because they wanted support that is covered by ISO/IEC 17025. Their current, now previous, provider certifies to ISO 9001.

Read a Comparison of ISO 9001 and ISO/IEC 17025
Quality management is critical in analytical laboratories, where precision, reliability, and consistency are paramount. These two internationally recognized standards, ISO 9001 and ISO/IEC 17025, play crucial roles in establishing and maintaining quality systems. However, they serve distinctly different purposes and have unique scopes of application.
 
The main difference between ISO 9001 and ISO/IEC 17025 is their focus and application.
 
ISO 9001 is a generic quality management system standard that can be applied to any organization across virtually every industry. It provides a comprehensive framework for establishing systematic processes that ensure consistent product or service quality, customer satisfaction, and continuous improvement.
 
ISO 9001 certification applies to an entire organization. It’s an effective tool for management but does not include the necessary technical content to show that test, inspection, and calibration data are reliable. When that is required, ISO/IEC 17025 is the highest quality management system and the primary standard for calibration laboratories.
​This standard (ISO/IEC 17025) is a specialized one that applies to testing and calibration laboratories. It is intended to be used as a requirement for the competence, impartiality, and consistent operation of testing and calibration laboratories of all sizes or numbers of employees, regardless of industry. 
 
The primary objective of the ISO/IEC 17025 is to demonstrate technical competence and ensure reliable test results through established measurement traceability and to validate testing methodologies. It’s primarily utilized to manage laboratory equipment and processes.
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Similarities of the two include:
  • continuous improvement through ongoing enhancement of quality systems
  • comprehensive documentation of procedures and activities
  • management responsibility in establishing and maintaining quality systems
  • risk management with each identifying and mitigating organizational risks
While they share these fundamental principles, they serve distinctly different purposes. Many laboratories will choose to implement both standards, using ISO 9001 as a foundational quality management system and ISO/IEC 17025 to address specific technical requirements.

While Eastern Applied Research is an authorized service provider for Hitachi High-Tech XRF analyzers, we can be considered as a third-party service provider for all models of x-ray fluorescence analyzers. Other third party, or ‘independent’, service providers exist, but very few of them offer accredited services because of the effort it takes to maintain such an accreditation.
​If you, or your associates, have questions on what accredited support of x-ray fluorescence reference materials and equipment is offered by Eastern Applied Research, then please contact us to discuss.

We are accredited by the ANSI National Accreditation Board (ANAB) and our accreditation documents can be reviewed here.
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