ISO/IEC 17025:2017 Laboratory Management Systems

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is the international benchmark for laboratory quality, and it supports confidence in test and calibration results both domestically and internationally.

The standard covers all laboratory activities, including testing, calibration, and the sampling associated with subsequent calibration and testing.

ISO/IEC 17025 promotes cooperation between laboratories and other bodies to assist in the exchange of information and experience and the harmonization of standards and procedural goals.

The standard sets out what testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.

Click here to see how Omnex can assist with Implementation Support and/or Assessments

What Changed in the ISO/IEC 17025:2017 Version?

ISO identifies six main changes in the 2017 revision.

• Process approach. The process approach now matches that of newer standards such as ISO 9001, putting the emphasis on the results of a process instead of the detailed description of its tasks and steps.
• New structure. The revision aligns the standard with the other existing ISO/IEC conformity assessment standards, such as the ISO/IEC 17000 series. The requirements are set out in Clauses 4 to 8.
• Risk-based thinking. The standard includes a chapter on risk-based thinking and describes the commonalities with ISO 9001:2015.
• Information technology. The standard recognizes and incorporates the use of computer systems, electronic records, and the production of electronic results and reports.
• Scope of laboratory activities. Coverage now extends to all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.
• Updated terminology. The language has been refreshed to be more in step with today's world and the fact that hard-copy manuals, records and reports are slowly being phased out.

Publication and Current Status

• ISO/IEC 17025:2017 is the third edition, published in November 2017.
• It was reviewed and confirmed in 2023 and remains the current edition. There is no successor edition published.
• ISO/IEC 17025:1999 replaced ISO/IEC Guide 25:1990 and EN 45001:1989 as the standard to be adhered to by testing and calibration laboratories.

Why Laboratories Implement ISO/IEC 17025

• ISO/IEC 17025 lab standards are widely accepted by everyone from the FDA, to governmental water testing, to electronic labs.
• The standard sets out what a laboratory must meet to demonstrate that it operates a management system, is technically competent, and is able to generate technically valid results.
• The global nature of the standard enables any laboratory to comply with it. Where the accreditation bodies of various countries negotiate mutual agreements, the acceptance of testing and calibration results among those nations is the mutually beneficial outcome.
• The standard supports confidence in test and calibration results both domestically and internationally, and facilitates wider acceptance of results across borders.

How Omnex Can Help with ISO/IEC 17025

ISO/IEC 17025 lab standards are being widely accepted by everyone from the FDA, to governmental water testing, to electronic labs. Omnex has supported and helped all of them implement ISO 17025 lab quality management standards.

Omnex provides management consulting that elevates the performance of client organizations. Omnex specializes in a number of key methodologies and can implement a QMS with integrated New Product Development, Disciplined Problem Solving, or Quality/Business Operating System management system.

Laboratories Omnex has helped

Henkel Corporation, Michigan plants and corporate, Wisconsin and Illinois . Lucent, Allentown and Bethlehem, PA . Magna Corporation, Toronto, Canada . Nascote, Nashville, IL . Freudenberg-NOK, Ligonier, IN . TAKAO, Bangkok, Thailand . Yazaki NA, Canton, MI . Inspec, Inc., Canton, Michigan . FDA, USA

Recommended alongside ISO/IEC 17025

Omnex recommends that labs implement both ISO 17025 and Measurement Systems Analysis as best practices.

ISO/IEC 17025 Lead Auditor Training — IRCA Certified

The Omnex ISO/IEC 17025 Lead Auditor course is IRCA certified under certificate 17082, and meets the training requirements for the Lead QMS Auditor grade. The course runs five days, eight hours per day.

The program covers the ISO/IEC 17025:2017 standard changes and requirements in Clauses 4 to 8, the audit process and audit program development, audit planning and document review, conducting audits, writing nonconformity statements, closing meetings and audit reporting, corrective action procedures, and audit team leadership. The final day is a mock audit and examination. Participants receive seminar manuals and workbooks with auditing case studies.

Prerequisites: an understanding of quality management principles including the PDCA cycle and process approach, familiarity with ISO 17025 requirements and laboratory quality management terminology, and prior completion of an IRCA-certified foundation training course or equivalent experience with ISO 17025.

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Which Training Programs Does Omnex Offer for ISO/IEC 17025?

Who these courses are for

Laboratory managers, responsible company and corporate management, lab personnel, persons responsible for documenting, implementing, maintaining or auditing laboratory systems, and second or third party auditors. The Executive Overview is designed for upper management supporting the implementation team's efforts.