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Free tool · ISO/IEC 17025:2017 · about two minutes

Ten questions between your lab and its ISO/IEC 17025 assessment.

Answer yes, partly or no. Each question is a clause an assessor will check. You get a score, the gaps in plain words, and the work that closes each one. Your answers stay in your browser.

ISO/IEC 17025:2017 · readiness self-check10 questions · about 2 minutes
  1. Clause 6.2 · PersonnelDoes every analyst have a training record and a signed authorization for each method they run?

    What an assessor asks to seeTraining records, competence checks, and a written authorization per analyst, per method.

  2. Clause 6.4 · EquipmentIs every instrument on a calibration and maintenance schedule, with current records and a visible status label?

    What an assessor asks to seeAn equipment list with calibration due dates, maintenance logs, intermediate checks and out-of-service tags.

  3. Clause 6.5 · Metrological traceabilityCan you trace every result to certified reference materials or accredited calibrations, with the certificates on file?

    What an assessor asks to seeCertificates for reference materials from ISO 17034 producers, and calibration certificates for balances, pipettes and thermometers.

  4. Clause 7.2.2 · Validation of methodsIs every method you report validated for each matrix you test, with a signed validation report?

    What an assessor asks to seeValidation reports per matrix: accuracy, precision, linearity, LOD and LOQ, selectivity and robustness.

  5. Clause 7.6 · Evaluation of measurement uncertaintyHave you estimated measurement uncertainty for each quantitative test, and can you show the calculation?

    What an assessor asks to seeAn uncertainty budget, or an estimate from validation and QC data, for each test, revisited when the method changes.

  6. Clause 7.7 · Ensuring the validity of resultsDo you run proficiency tests for each test you’ll accredit, and trend your QC data?

    What an assessor asks to seeA proficiency-testing plan and results, control charts for check standards, and what you did when a point fell outside its limits.

  7. Clause 7.11 · Control of data and information managementIs your LIMS validated, with access control and an audit trail that shows who changed a result, and when?

    What an assessor asks to seeLIMS validation records, user roles, audit trails, and checks on calculations and data transfers.

  8. Clause 8.3 · Control of management system documentsAre your SOPs and forms under document control: approved, versioned, and pulled from the bench when obsolete?

    What an assessor asks to seeA master list with revision status, approvals and review dates, and a way to retire obsolete copies.

  9. Clause 8.7 · Corrective actionWhen something goes wrong, do you record the root cause and check that the fix worked?

    What an assessor asks to seeCorrective action records: the nonconformity, its cause, the action taken and an effectiveness check.

  10. Clause 8.8 · 8.9 · Internal audits and management reviewsHave you completed a full internal audit and a management review, and closed what they found?

    What an assessor asks to seeAn audit program and report, closed findings, and management review minutes covering the inputs clause 8.9.2 lists.

Score it by hand. Count 2 points for each yes, 1 for each partly and 0 for each no. A score of 17 or more, with no “no” answers, is ready to schedule; 11 to 16 is close; 10 or less means significant gaps. Every partly or no is a gap to close before the assessment.

Your answers stay in this browser. Nothing is sent anywhere.

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