ISO 17025: 2017 Clause 6.4 Equipment (6.4.1 & 6.4.2)

Equipment plays an important role in the validity and accuracy of results. Proper use and maintenance of laboratory equipment are essential for laboratory safety and the validity of results.

6.4.1

In any laboratory, having the right tools is crucial for getting accurate results. These tools can include things like measuring devices, software, and standards for measurements. They're basically the equipment needed to carry out experiments and tests correctly. But it's not just about having any equipment; it's about having the right kind. The equipment a laboratory uses can actually impact the results they get. So, having access to the proper equipment is essential for the lab to perform its tasks accurately.

It's like making sure your kitchen has all the right ingredients and utensils before you start cooking. You wouldn't want to substitute salt for sugar or use a tablespoon instead of a teaspoon – the results could be terrible. The same principle applies in a lab having the right equipment is crucial for getting reliable and accurate outcomes.

In the laboratories, terms like reference materials and certified reference materials are very common. Reference materials come under various name, such as reference standards, standard reference materials, and quality control materials.

In this case, ISO 17034 has a crucial role. This set of standards (ISO 17034) provides additional understandings into Reference Material Producers (RMPs). RMPs meeting the ISO 17034 requirements are considered competent and reliable in producing materials.

The reference materials from these ISO 17034 compliant RMPs, they come with a handy product information sheet or certificate. This document is like the user manual for your high-tech gadget, but for science! It specifies important details like homogeneity (how consistent the material is) and stability for specific properties. For certified reference materials, it goes the extra mile, providing certified values, measurement uncertainty, and metrological traceability – ensuring the utmost accuracy in your experiments.

In the a testing laboratory, "reference material" and "certified reference material" refer to distinct types of materials used for calibration and quality control purposes.

Key Differences in "reference material" and "certified reference material"

 Certification Level:  The primary distinction lies in the certification level. While all certified reference materials are reference materials, not all reference materials are certified. Certified reference materials have undergone a more rigorous validation process to achieve a higher level of accuracy and reliability.

Accuracy and Precision:  Certified reference materials are expected to have a higher degree of accuracy and precision compared to general reference materials, making them suitable for applications where the utmost reliability is crucial like validation of method.

 6.4.2

One of the requirements is that when a laboratory uses equipment outside of its permanent control, it must ensure that the equipment meets the same requirements as equipment used within its own facilities. This helps to ensure the continued validity and reliability of the laboratory's test and calibration results. Following are the Some examples when a laboratory uses equipment outside its permanent control:

 Situation 1: Calibration at a client's site:

 A calibration laboratory needs to calibrate a client's pressure gauge on-site. The lab cannot perform its usual calibration procedures in its own facility.

 Action:

• The lab needs to ensure the client's site meets the environmental requirements for the calibration (e.g., temperature, humidity, cleanliness).
• The lab also needs to verify the calibration standards and reference materials used by the client meet the necessary accuracy and traceability requirements. This could involve verifying traceable standards.
• Records of these checks and verifications should be maintained by the lab to demonstrate compliance with ISO 17025.

 

Situation 2: Field testing with portable equipment:

An environmental testing laboratory conducts water quality testing at a remote location. They use portable instruments for measuring parameters like pH, dissolved oxygen, and turbidity.

 Action:

• The lab needs to ensure the portable instruments are properly calibrated and their calibration certificates are valid.
• They should also perform functional checks of the instruments before and after use to verify they are operating correctly.
• Additionally, the lab needs to consider environmental factors that might affect the performance of the instruments at the field site (e.g., temperature extremes, electromagnetic interference).
• Procedures for handling, transporting, and storing the instruments should be in place to prevent damage or contamination.
• Records of these should be maintained by the lab to demonstrate compliance with ISO 17025.

The key principle is that the laboratory must always take steps to ensure that equipment used outside its permanent control meets the same requirements as equipment used within its own facilities. This helps to ensure the continued validity and reliability of the laboratory's test  results.