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Monday, December 9, 2019

What are the requirements of ISO 17025:2017 for laboratory measurement equipment and related procedures?

Implementation of the ISO/IEC 17025 standard, Laboratory accreditation is obtained through the process that determines the competence of laboratories to provide accurate results. At the global level, with the economic crisis, manufacturers and suppliers must reduce their operating costs. To be able to meet that ISO 17025:2017 requirement, modern laboratories must use the ISO 17025 for high-quality measuring equipment.

To obtain the correct measurement result for equipment, the laboratory must employ an organized approach in the measurement process. As per the ISO 17025:2017 standard’s requirements state that laboratories must demonstrate their competence, practical work requires the proper use of laboratory equipment and commits to following controlled procedures.

Here, the topic highlights the large number of activities that could influence a measurement result. For any testing laboratories you wish to be ISO 17025 accredited for, the starting point is to map the processes and activities related to the measurement test. So, Following are the risks and determine controls that should be placed: 
  • 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
According to the standard, ISO/IEC 17025, 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.

There is not all measurement equipment ensures success in the laboratory. With the competence of associated clauses, 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.

Laboratory equipment is influenced by the place where the measurement is performed and its valid use. For the laboratory premises, Measurement can be done, where environmental conditions are controlled and it is easier to maintain repeatability for any consecutive measurement. But, in some of conditions, measurements must be performed onsite, where environmental conditions are different 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 ISO 17025 procedures must define and continuously provide information about the “health” / suitability of the measurement equipment which 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
  • For detailing equipment usage provision of records, repair, proficiency testing, recalibration, etc.
The audits done by certification firms ensure that the businesses square measure in compliance with the ISO standards or not. The professionals from the businesses assess and valuate the corporate policies, practices and ISO 17025:2017 documents procedures. The ISO 17025 certification involves many alternative processes all levels of labor in among the corporate.



2 comments:

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