Igor Stameski How can ISO 17025 help improve laboratory measurements? Present industry research and development depends heavily on precise measuring. To be able to meet that requirement, modern laboratories must use high-quality measuring equipment. Also, to obtain the correct measurement result, the laboratory must employ an organized approach in the measurement process.
The process approach to this topic clearly highlights the large number of activities that could influence a measurement result. For any test you wish to be accredited for, the starting point is to map the processes and activities related to the measurement test. Then, look at the risks and determine which controls should be put in place.
- Management of personnel competency
- Document control of procedures
- Effective technical records
- Suitable facilities and conditions
- Suitable calibrated equipment
- Certified reference materials
- Suitable reagents
- Suitable test method
- Validated methods
- Correct handling of samples
As the requirements of the ISO 17025:2017 standard state that laboratories must demonstrate their competence, practical work requires the proper use of laboratory equipment and commits to following controlled procedures.
Laboratory equipment – Procedures and usage
The main tools for work in a laboratory are known as laboratory equipment. Laboratory equipment may include the main measurement instruments, measurement software, auxiliary measurement modules and equipment, reagents, consumables, and certified reference materials needed for the correct performance of the measurement procedure.
Not all measurement equipment ensures success in the laboratory. To show its competence under the associated clauses (6.2, 6.4.6, and 6.4.13), the laboratory must provide proof that it uses uniquely identified and calibrated equipment, that this equipment is in the correct state and that it is regularly tested and maintained and, of course, that it provides skilled personnel to operate that equipment.
Valid use of laboratory equipment is influenced by the place where the measurement is performed. Measurement can be done on the laboratory premises, where environmental conditions are controlled and it is easier to maintain repeatability for any consecutive measurement. But, in some cases, measurements must be performed onsite, where environmental conditions vary and may influence the validity of the measurement.
In any case, for the laboratory’s reputation to be preserved, it is necessary to use auxiliary measurement equipment to monitor, control, and record environmental conditions.
The quality of the measurement equipment must be maintained through following procedures for use of the laboratory equipment. Those procedures must define and continuously provide information about the “health” / suitability of the measurement equipment (as required in clause 6 of the standard), including:
- proper methods of handling
- proper methods of transport in the case of on-site measurement, service repairs, proficiency testing (inter-comparisons), or recalibration
- proper methods for handling of equipment during measurement, maintenance, or storage by the laboratory personnel
- regular and repeatable testing of equipment for basic verification checks that equipment can achieve the measurement accuracy and/or measurement uncertainty required to provide a valid result
- tracking of laboratory equipment age and possible physical damage, firmware version updates, or software failure
- provision of records detailing equipment usage, repair, proficiency testing, recalibration, etc.
Defining measurement procedures (methods)
The laboratory must select appropriate methods and work procedures that specify the performance criteria and proper handling of measurement equipment. There are two options for such procedures:
Internal procedure for measurement. If a laboratory has developed its own procedure for measurement, it must first provide proof through validation that this measuring method is appropriate, and secondly, that it is relevant and, most of all, that it provides precision and quality in the measuring results. All of the subsequent actions during the measurement must be well-defined, risks known and controlled, and confirmed as repeatable. This procedure must provide a validated performance that meets the needs of customers, and the laboratory must show its ability to explain and prove measurement accuracy during this process.
A procedure that follows the requirements of a specifically related measurement standard. If the laboratory chooses to show its competence for measuring under a relevant standard test method, it is necessary to show that this process is evaluated, tested, and used for any new customer, i.e., verified as adequate for use. These confirmations (performance criteria) must be listed in the guidelines, and the actions included in the procedure. It must be defined what exactly will be done, and which actions will follow which part of the standard. Those actions will present the handling of equipment and guidelines for the employees who provide measurement, and they must ensure that this process is repeatable for any new customer.
A procedure must point out which part of the measuring standard is covered and followed with the procedure of measurement. To comply with its accreditation, the measurement laboratory must ensure that it properly uses all parts of its equipment, that it takes into consideration environmental conditions during the measurement before providing the measurement result, and that it takes uncertainty into consideration in the final report. Also, this procedure must define if there are mathematical calculations and/or additional assessments on the measured result. All of those procedural steps are needed for future laboratory quality enhancement, reevaluation, or addressing customer complaints.
Importance of the measurement procedures
Evidence of the control of measurement procedures must be available in laboratory technical records, which show laboratory activity through results, reports, and related information during the measurement process. That information will provide traceability for laboratory actions, activities, and responsibilities for the specific tasks during the measurement. This provides objective evidence of compliance and also assists with troubleshooting incidents.
The purpose of following a controlled, validated measurement procedure of known performance capabilities (e.g., accuracy) is to ensure the quality of the measuring process. This reassures customers and regulatory and accreditation bodies that the laboratory is working within its scope of accreditation and is producing consistent, reliably valid results to meet the technical capability required (e.g., limit of detection). If deviations occur, the nonconforming events must be investigated and the laboratory must provide actions for evaluation and correction of the cause, whether due to damaged measuring equipment, employee actions, or misleading instructions in the procedure.
ISO 17025 compliance
Monitoring the overall process and control of the actions brings conformity in the measurement procedures and accuracy in the measurement results. Laboratories must build a system for control and employ skilled personnel. Operation according to procedural documents and proper use of the measuring equipment ensures the expected performance of the method to produce a valid measurement result.
Finally, the published final report must comply with the detailed requirements of ISO 17025:2017 clause 7.8.
Learn more about quality management measurement techniques by attending this free online training: ISO 9001 Foundation Course.
