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Showing posts with label ISO 17025 documents. Show all posts
Showing posts with label ISO 17025 documents. Show all posts

Tuesday, July 21, 2020

Requirement of ISO 17025: 2017 for Laboratory Measurement Equipment and Related Procedures

The Present research in industry relies heavily on direct measurements. To meet that requirement, modern laboratories have to use high-tech equipment. Also, to obtain the appropriate measurement result, the laboratory must use a systematic approach to the measurement process.


The approach to learn clearly emphasizes the large number of factors that can influence the outcome of a measurement. Whatever test you wish to be approved for, the first point in mapping the processes and activities related to the evaluation test. Then look at the risk and decide which controls should be included:
  • Human resource management
  • Document management of processes
  • Successful technical records
  • Appropriate facilities and conditions
  • Suitable equipment that can be repaired
  • Certified consumables
  • Appropriate reagents
  • Appropriate test method
  • Proven methods
  • Proper handling of samples
As per the ISO 17025:2017 Standard requirement is that laboratories must demonstrate their skills, the work done requires the proper use of laboratory equipment and is committed to regulatory processes.

The best tools for working in a laboratory environment are known as laboratory materials. Laboratory equipment can include key measuring instruments, measurement software, auxiliary measuring modules and equipment, reagents, equipment, and verification materials required for the proper operation of the measurement process.

Not all measuring machines guarantee success in the lab. the laboratory must provide proof that it is using special equipment identified and measured, that the equipment is in good condition and that it is regularly inspected and maintained, and, that it provides qualified personnel to perform the work.

The effective use of laboratory equipment is influenced by the area in which the measurement is performed. Measurements can be made on the premises of the laboratory, where environmental conditions are controlled and it is very easy to maintain repetition at any consecutive measurement. However, in some cases, estimates should be made onsite, where environmental conditions vary and may influence the accuracy of the estimate.

In any case, in order for the lab's reputation to be maintained, it is necessary to use measurement equipment to help monitor, control, and record environmental conditions.

The measuring equipment’s quality must be maintained by the following procedures for using laboratory equipment. Such procedures must define, including:
  • proper ways to catch
  • appropriate methods of measurement in the area of ​​measurement, service adjustment, quality assessment (comparison), or return
  • appropriate methods of handling equipment during the evaluation, repair, or retention of laboratory staff
  • routine and repetitive testing of basic test equipment to ensure that the equipment can achieve the measurement accuracy and/or uncertain measurement required to give a valid result
  • tracking age of laboratory equipment and potential physical damage, firmware version updates, or software failures
  • provision of records describing the use of equipment, repairs, skills testing, retrieval, etc.
Monitoring the whole process and control of actions brings consistency to measurement procedures and accuracy to measurement outcomes. Laboratories must create a control system and hire skilled workers. According to process ISO 17025 Documents of Performance and proper use of measurement equipment ensures the expected performance of the method to produce the appropriate measurement result. For implementing ISO 17025 in your company successfully, Visit Punyam.com, which provides ISO 17025 Consultancy for all types of laboratories, such as testing laboratory in the field of civil engineering material testing, metallurgical testing, environmental parameters testing, chemical testing, optical testing, thermal testing, fluid flow testing, etc., as well as calibration laboratories in India.

Wednesday, September 18, 2019

What is the Difference in ISO/IEC 17025:2017 from 2005 Version?


The ISO/IEC 17025 standard specifies the requirements for the competence of testing and calibration laboratories, which has been developed specifically for guiding laboratories to cover every aspect of laboratory management system. The requirements of the ISO/IEC 17025:2017 version of the standard are applicable to all organizations performing testing, calibration, and/or sampling. 

ISO/IEC 17025:2005 vs. ISO/IEC 17025:2017

With beginning of the ISO/IEC 17025:2005 version included the following:
  • Scope
  • Normative references
  • Terms and definitions
  • Management requirements
  • Technical requirements
Whereas, the ISO/IEC 17025:2017 version includes the following:
  • Scope
  • Normative references
  • Terms and definitions
  • General requirements
  • Structural requirements
  • Resource requirements
  • Process requirements
  • Management system requirements
When the thing is to compare the scope of ISO/IEC 17025:2005 version with the scope of ISO/IEC 17025:2017 version, it is noted that the 2017 version of the ISO/IEC 17025 standard considers the general requirements for the competence, impartiality, and consistent operation of laboratories.

In Addition, in the reference section of ISO/IEC 17025:2017, ISO/IEC Guide 99 is listed as a reference which gives the basic and general concepts, and associated terms. ISO/IEC 17000 is also listed as a reference, which considers the vocabulary and the general principles for conformity assessment. 

As well as the terminology has been updated, which means that the standard of ISO/IEC 17025 with 2017 version covers the newest ISO/IEC terminology and the modifications that have been included in the International Vocabulary of Metrology (VIM). In the section terms and definitions of the ISO/IEC 17025:2017 standard, the term "laboratory" has been added.

This term mentions to the bodies that perform one or more activities such as testing, calibration, and/or sampling, associated with subsequent testing or calibration. It is very important to specify that the newest standard focuses more on information technology, mainly in the use of systems, the provision of electronic test results, and the provision of electronic records.

Documents Requirements for ISO/IEC 17025:2017

When laboratories are going for accreditation, there is required to be fulfilled some specific ISO/IEC 17025:2017 documents as well as ISO 17025 documents are beneficial to design and develop testing and calibration laboratories. 

There are various categories are available to fulfil such requirements for better understanding and defining quality systems in laboratory as per the ISO/IEC 17025:2017 standard. The document categories are as following:
  • ISO 17025 Quality Manual
  • Quality Procedures
  • Exhibits
  • Word Instructions
  • Standard Operating System
  • Forms / Record Templates
  • ISO 17025 Audit Checklist