ISO 17025 Laboratory Quality Management System

ISO/IEC 17025 Accreditation gives your clients and supply chain absolute assurance of your commitment to quality. ISO 17025 applies to all laboratory environments, regardless of the number of employees or the extent of the testing. Demonstrate that you understand and adhere to international standards and improve efficiency and the integrity of your laboratory environment.

Committed to quality Achieving an ISO standard demonstrates that your company is serious about delivering quality systems through tested processes. Internally ISO standards provide focus and discipline and externally you will achieve credibility, authority and recognition.

ISO 9001 is the general standard which specifies the requirements for a quality management system. Laboratories which meet the requirements of ISO 17025 also operate in accordance with the requirements of ISO 9001 that are relevant to calibration and testing activities.

What this means in practice is that an organization which holds ISO 9001 certification may use a laboratory accredited against ISO 17025 as a supplier of test data without the need to carry out its own audit of the laboratory’s quality system.

The question often arises of whether laboratories should be accredited/certified to ISO 9001 or to ISO 17025. In general it is agreed that the appropriate accreditation for commercial testing and calibration laboratories is to ISO 17025. As a result of agreements with laboratory accreditation bodies many ISO 9001 certification bodies will not allow their certification to be cited by commercial testing or calibration laboratories in support of their services.

What this means in reality is that if you are an ISO 9001 certified organization with an in-house laboratory which forms part of your quality control system, the laboratory will be included in the ISO 9001 external audit. However, if you then want to sell the services of that laboratory to outsiders as a testing service you cannot advertise it as an ISO 9001 accredited/certified laboratory. You would need to obtain accreditation to ISO 17025.

It is not uncommon, however, for organizations with laboratories used purely for internal quality control purposes to seek to accredit the laboratory to ISO 17025. This is generally done to enhance the laboratory’s, and hence the overall quality control system’s, credibility or as part of the application of an ISO 9001-compliant system.

Benefits of ISO 17025 Accreditation

  • ISO 17025 will enhance your laboratory reputation
  • Demonstrate your commitment to operational efficiency and quality management practices
  • Outlines robust quality controls for choosing and authenticating methods, analyzing statistics and controlling data
  • Verify the quality, capability and expertise of your laboratory
  • Evaluation of staff, methods, equipment, calibration and reporting to guarantee test result validity
  • Increasing staff accountability and clearly delineates individual responsibilities
  • May minimize the need for independent supplier audits, saving time and money
  • Open up business opportunities on a global scale
  • Meet with regulatory and safety requirements in the operation of laboratories