Know the ISO/IEC 17025 and Its Relevance Across Laboratories

The ISO/IEC 17025 standard is a standard that is popular around the worldwide testing and calibration laboratories to demonstrate their ability to create a reliable output.

This standard, which is sometimes abbreviated as ISO 17025, mandates that laboratories emphasise superior quality procedures and establish a trustworthy quality management system to prove their proficiency.

Any organization that conducts sampling, testing, or calibration must keep ISO 17025 requirements in mind if it wishes to show that the results are reliable. We'll describe the standard, demonstrate how to comply with it, and go over how a LIMS can assist compliance in this guide.

Explain in Depth ISO/IEC 17025 Standard

The ISO 17025 is a globally recognized standard that specifies the requirements of competence, impartiality and consistent operations of laboratories. Officially recognised as ISO/IEC 17025:2017, the most recent standard underwent revisions in 2017. The redesign emphasised senior management's responsibilities more and included changes in IT (information technology) and quality management system procedures.

About every five years, the standard is evaluated. In 2023, the 2017 version was examined and verified once more.

To increase confidence in laboratories' work both domestically and internationally, this standard acts as a global baseline for those who want to show that they can generate dependable results.

The ISO/IEC 17025 standard can be in the 5 basic requirements:

• General Requirements
• Structural Requirements
• Resource Requirements
• Process Requirements
• Management Requirements

Which Laboratory Should Consider in ISO/IEC 17025 Standard?

ISO 17025 applies to all laboratories, regardless of size, industry they serve, or complexity of analysis performed, that are involved in testing, calibration, and sampling activities.

To put it briefly, ISO/IEC 17025 is applicable if your lab takes measurements and wants to show that the data are reliable.

The following are some instances of laboratories that must adhere to ISO 17025:

Testing Laboratories: Chemical, biological, microbiological, environmental, food, pharmaceutical, and materials testing labs are examples of testing labs. They conduct a range of tests on various products and materials to guarantee quality, safety, and compliance.

Calibration Laboratories: These facilities must adhere to regulations if they offer calibration services for measurement devices in domains including temperature, pressure, electrical, dimensional, and optical. By doing this, the measurement tools they calibrate are guaranteed to be accurate and traceable.

Government and Regulatory laboratories: These are facilities run by government bodies or as part of their mandate, performing assessments and calibrations for public health, safety, and environmental monitoring as well as regulatory compliance in the public interest.

Research and Development Labs: If a lab performs testing and calibration services that call for acknowledgement of their technical proficiency and dependability of outcomes, the lab may also pursue compliance.

Quality Control Laboratories: These labs conduct vital testing on goods and materials to make sure they adhere to strict standards and laws in sectors including building, manufacturing, and medicines.

Are ISO 17025 Required for Laboratories?

For laboratories, ISO 17025 compliance is not required. However, it is frequently a prerequisite for individuals who want to show clients, authorities in charge of regulations, and accreditation organisations their technical proficiency and dependability. Businesses that are not ISO 17025 accredited will not collaborate with labs that are not.

Consider whether it would be financially feasible for you to not receive accreditation instead of focusing on whether the accuracy—or inaccuracy—of your data could have major repercussions.

What Should be Included in the ISO 17025 Accreditation Documents?

The following are the key ISO 17025 document packages for testing and calibration labs that should be included in maintaining an effective laboratory management system:

• ISO/IEC 17025 Manual
• ISO/IEC 17025 Procedures
• ISO 17025 Audit Checklist
• Blank Formats
• Exhibits
• SOPs
• Sample Risk Formats

Michel Adrien has published so many articles regarding ISO Certification Documentation. As ISO Consultant profession since last many years Michel has rich experience in preparing such certification documents within ISO guideline to his global clients