ISO Accreditation Document Auditor

What it does

It takes a lab/organization document (procedure, quality manual, record set, measurement data) and maps it clause-by-clause to ISO/IEC 17025:2017 and/or ISO 9001:2015, surfacing the nonconformities an accreditation assessor would write. It opens the standard's CASCO structure (Cl.4 General / impartiality-confidentiality, Cl.5 Structural, Cl.6 Resource, Cl.7 Process, Cl.8 Management System) as a checklist, searches the document for evidence per clause, and applies a decision tree: requirement not addressed and affecting result reliability → Major NC (critical); isolated deviation / missing record → Minor NC (warn); improvement opportunity → OFI (info). If evidence is not visible but may exist, it does not write an NC — it logs a gap instead (no false certainty).

It applies dedicated rules to the surfaces that most often generate major NCs: metrological traceability (Cl.6.5) — if the calibration chain is not unbroken to SI/CRM it defaults to major; the most common field trap is not a "missing certificate" but a broken traceability link (one broken link generates an NC across every method that instrument touches). Measurement uncertainty (Cl.7.6) — major if there is no GUM (JCGM 100) budget or it is inconsistent with control charts / PT claims. CAPA (8.7) — it separates correction from corrective action; a valid CAPA requires four elements: root cause (5-Whys/Ishikawa) + correction + systemic action + effectiveness verification.

It outputs a 0-100 Compliance/Maturity Score (100 − Σ weighted findings), a verdict threshold and a confidence level. Hard rule: if ≥1 major NC exists, the verdict caps at "Conditional" however high the score — a single major blocks the accreditation decision.

When to use it

• "Audit this procedure against ISO 17025 / are we ready for the accreditation assessment / which clause are we failing?"
• Pre-internal-audit self-assessment; external accreditation assessment dry-run; 17025:2005 → 2017 transition check (risk-based thinking 8.5, impartiality 4.1, decision rule 7.8.6, Option A/B); CAPA adequacy check against a finding.

Method / frameworks

• ISO/IEC 17025:2017 CASCO clause architecture — Cl.4-8 one-to-one mapping.
• ILAC/IAF nonconformity classification — Major / Minor / Observation(OFI) → critical/warn/info.
• Metrological traceability & GUM — Cl.6.5 + 7.6, ILAC-P10/G24, JCGM 100 uncertainty budget.
• Root cause & CAPA — 8.7 + ISO 9001 Cl.10.2; 5-Whys / Ishikawa.
• PDCA + risk-based thinking — Annex SL HLS; internal audit → finding → CAPA → management review closed loop.
• Document & record control — ISO 9001 Cl.7.5 documented information.
• Validity of results (7.7) — IQC (control charts) + EQA/PT expected together.