Solution Briefs

ISO/IEC 17025: give your laboratory a more traceable quality record

ISO/IEC 17025 accreditation depends on more than a laboratory’s test results. Laboratories need to show how controlled methods, competent personnel, equipment records, technical data, and quality actions connect to support reliable testing and calibration.

A laboratory may hold its data across LIMS, instrument software, calibration-management tools, and quality systems. The challenge is not duplicating every record in one place. It is preserving a controlled path from the applicable method and trained user through the work performed, the evidence produced, and any review or corrective action that follows.

Uncountable’s eQMS supports the controlled records and quality workflows that make laboratory evidence easier to maintain, retrieve, and explain. It can help teams manage document control, training, nonconforming work, CAPA, change control, audits, and related evidence while keeping specialized laboratory and instrument systems in their appropriate role.

This one-pager is for laboratory quality leaders, technical managers, and operations teams preparing for or maintaining ISO/IEC 17025 accreditation. It explains how a connected eQMS can strengthen evidence management without claiming to confer accreditation or guarantee an assessment outcome.

‍

Inside this one-pager:

  • The evidence chain behind reliable testing and calibration
  • How controlled methods, training, equipment, and records fit together
  • Ways to manage nonconforming work, deviations, CAPA, and change control
  • How to support internal audits, findings, actions, and follow-up
  • Why audit readiness depends on evidence that is traceable and understandable in context
  • Where a connected eQMS complements LIMS, instrument, and calibration systems

‍

Make laboratory quality evidence easier to control, trace, and retrieve. For more depth, read the white paper ISO/IEC 17025: the evidence chain behind every lab result.

FAQs

What is ISO/IEC 17025?

ISO/IEC 17025 is an international standard for testing and calibration laboratories. It addresses laboratory competence, impartiality, and consistent operation, helping build confidence in the accuracy and reliability of test and calibration results.

Is a laboratory certified or accredited to ISO/IEC 17025?

Laboratories are typically accredited to ISO/IEC 17025 rather than certified. Accreditation is assessed within an agreed scope and depends on the laboratory’s people, methods, equipment, operating practices, and supporting evidence.

Can eQMS software make a laboratory ISO/IEC 17025 accredited?

No. An eQMS cannot confer accreditation or guarantee an assessment outcome. It can support the controlled records, workflows, and evidence management that laboratories need when preparing for or maintaining accreditation.

What evidence supports ISO/IEC 17025 accreditation?

Laboratories need to be able to demonstrate controlled methods and procedures, relevant training and competence, equipment and calibration records, technical records, nonconforming-work handling, corrective actions, controlled changes, internal audits, and retrievable evidence related to the work performed.

How does an eQMS work alongside a LIMS for ISO/IEC 17025?

A LIMS usually handles the testing itself: samples, test execution and results. An eQMS handles the quality system around that work, including controlled methods and procedures, training and competence, nonconforming work, CAPA, change control and internal audits. Assessors often follow a thread across both systems. For example, they may trace a reported result back to the method version used, the analyst’s training record and any deviation raised along the way. Linking the two systems lets the lab show that thread quickly, without copying records from one system into the other.

See the Platform Behind the Guide

Uncountable connects R&D, quality, and product lifecycle data in one platform. Book a personalized demo and we'll show you how it applies to your lab.