ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories

ISO 17025:2017 the new and updated version of ISO 17025 was released on November 29, 2017

This standard is applicable to all entities engaged in Calibration/Verification, Sampling or Testing Laboratories. Standard applies to all small, medium, large, government or privately owned Laboratories and other entities engaged in activities of Testing, and Calibration.

This standard is mostly used by Universities, Research Laboratories, Industries, Product Certifying Organizations and Inspection Bodies.

It is mandatory for entities seeking ISO certifications to get their Measuring Equipment Calibrated in an ISO 17025 certified laboratory.

The following are the basic requirements for ISO IEC 17025:

General requirements for the competence of testing and calibration laboratories

·         ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.

·         ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

·         Laboratory customers, regulatory authorities, organizations, and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories. (Source: ANSI)

 

Technical Requirements for seeking certification to ISO/IEC 17025:2017 are:

 

·         Structural Requirements. The laboratory should be a Legal entity and have defined Management structure, with defined roles, Responsibilities and range of Activities

·         Resource requirements include personnel, facilities, and environmental conditions, equipment, metrological traceability, externally provided products& services

·         Process requirements which include review of requests, tendering, controls verification validation of methods and sampling

·         Management system requirements which include management system documentation, control of management systems, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, and management review. (Source: ISO 17025;2017 standard)

The fundamental benefits of ISO IEC 17025 are all very direct. By implementing an ISO IEC 17025 management system, you can be sure to receive the following benefits:            

  • Implementing the ISO IEC 17025 quality management standards also provides a better customer satisfaction guarantee.
  • The reputation that the ISO IEC 17025 certification creates for your organization will be a very significant marketing tool that allows you to bid for a diverse range of contracts and will give you a reputable name in the global arena.
  • The ISO IEC 17025 also gives your organization a new and effective quality management approach that will help to identify strengths and weakness as well as opportunities and threats.
  • If certified or accredited with ISO/ IEC 17025, there is a great potential to expand your business to Automotive, Pharmaceutical, Food Processing Industries to name a few.

 

Our approach:

QSE adopts a “Ten Step Approach” to Registration. This approach, designed and perfected by QSE, addresses each element of the Standard in an easy to implement manner. Various elements merge with each other seamlessly and so effortlessly that the end-product is a top-notch quality system. This quality system meets or exceeds the requirements of any Registrar and promotes a culture of quality consciousness throughout the organization. Our approach is so complete that we have helped over 700 companies obtain certification, of which, a majority have obtained certification with zero deficiencies.