医疗相关 ISO 标准准备与证据整理

references/iso-17025.md

Research basis: 2026-10-01. This reference summarizes a preparation process and evidence architecture for testing and calibration laboratory competence work. It does not reproduce requirements and is not a substitute for the standard.

Copyright and authorized access

ISO and IEC publications are copyrighted. Obtain ISO/IEC 17025 from ISO, IEC, an ISO national member, or another authorized source; see ISO copyright. Do not ask an agent to retrieve, transcribe, summarize clause-by-clause, or store proprietary text. Accreditation-body checklists that quote the standard are equally copyrighted and are usually licensed only to the accredited laboratory.

Current edition

• ISO/IEC 17025:2017 is Edition 3. No successor edition was identified at the research basis date. The catalogue confirms the 2017 edition after its 2023 review. Its listed 2018 corrections concern French and Spanish versions, not the English text.
• The 2017 edition restructured the 2005 edition around laboratory activities and risk-based thinking. Using a 2005 clause checklist as current criteria is obsolete. A manual may retain an older internal organization if its controlled cross-reference and implementation address the current standard; headings alone do not determine conformity.
• Record publisher, title, edition, amendments/corrigenda, authorized location, access date, source owner, currency-review date, impact decision, and approval in the controlled source ledger.

The vocabulary trap: laboratories are accredited, not certified

A laboratory is accredited to ISO/IEC 17025 by an accreditation body. It is not "ISO 17025 certified." A document labelled a certificate does not substitute for accreditation or establish accredited technical scope. Writing "certified" in a report, tender response, or quality manual is a substantive error that assessors and customers both notice.

• Accreditation bodies operate under ISO/IEC 17011 and are peer-evaluated through the recognition arrangement. Certification bodies operate under ISO/IEC 17021-1. These are different schemes with different scope statements.
• Since 2026-01-01, Global Accreditation Cooperation Incorporated has replaced the former ILAC and IAF and operates its own Multilateral Recognition Arrangement. Results and certificates issued under the former ILAC MRA / IAF MLA remain recognized during the transition. Verify current logo, claim, and endorsement wording with the accreditation body before reproducing any of it.
• ISO/IEC 17025 accreditation is not ISO 9001 certification, not a product approval, not a regulatory authorization, and not a statement that any particular result is correct.

Hard boundary

This skill and its files cannot:

• accredit a laboratory, issue or validate an accreditation certificate or schedule, or predict an assessment outcome;
• decide which accreditation scheme, jurisdiction requirement, or customer specification applies;
• replace the laboratory's technical management, quality manager, authorized signatory, accreditation body, assessor, or proficiency-testing provider;
• validate a method, compute or approve a measurement uncertainty budget, establish metrological traceability, or judge whether a decision rule is fit for purpose; or
• infer competence from a document title, keyword, template, checklist, or script result.

Use outputs as a list of evidence questions for accountable human review.

Scope of accreditation is per activity, not per organization

The accredited scope is defined item by item: field or discipline, method or procedure and its issue, the measurand or property determined, and the range with the reported uncertainty basis. For calibration laboratories this is normally expressed through calibration and measurement capability statements.

Consequences for evidence preparation:

• Work outside the accredited scope must not carry an accreditation claim or endorsement, even at an accredited site under an accredited quality system.
• A method change, a range extension, a new location, or a new authorized signatory is a scope question, not only an internal change-control question.
• Subcontracted work has its own rules for customer notification and for the subcontractor's own accreditation status. Record both.

Capture scope items with:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_scope_intake.py \
  /path/to/laboratory-scope-intake.json --standard iso-17025

Copy assets/templates/laboratory-scope-intake-template.json outside the skill first. The distributed template fails closed by design.

Process and evidence domains

The iso-17025 profile carries these domain labels for manifests and gap reports. They are workflow topics, not clause references:

scope-and-impartiality, organizational-structure-and-management, personnel-competence, facilities-and-environmental-conditions, equipment-and-calibration, metrological-traceability, externally-provided-products-and-services, review-of-requests-and-contracts, method-selection-verification-and-validation, sampling, handling-of-items, technical-records, measurement-uncertainty, validity-of-results-and-proficiency-testing, reporting-and-decision-rules, complaints, nonconforming-work, data-and-information-management, internal-audit, management-review, corrective-action-and-improvement.

Each domain needs an owner, status, evidence IDs, source/version reference, recorded approval, and links to open gaps. Sample records, not only procedures: a procedure describing uncertainty evaluation is not evidence that a budget exists for a reported measurand.

The four technical areas that carry most findings

1. Metrological traceability

Traceability is a documented, unbroken chain to a stated reference with stated uncertainty at each step — not a drawer of calibration certificates. The governing policy is ILAC P10:07/2020 (implementation July 2021, revised for the 2017 edition), still carried in the current Global ACI library. Its proposed successor Global ACI-TECH-1-011 remains in process in the September 2026 cross-reference table; do not cite that identifier as a published policy.

Evidence to assemble per measurement: the stated reference, the calibration provider and its accreditation status and scope, certificate identity and date, the uncertainty contribution carried forward, interval justification, and intermediate-check records.

2. Measurement uncertainty

For calibration, use Global ACI-TECH-1-009 (M), version 1.0 (2026-06-26), successor to ILAC P14, for the policy basis. A scope CMC and a delivered calibration's uncertainty are distinct. Record which measurands have evaluated uncertainty, the evaluation basis, the contributions included, how uncertainty is reported, and how it interacts with the decision rule. An uncertainty budget that exists only in a spreadsheet with no controlled revision, owner, or approval is a gap, not evidence.

This skill does not compute uncertainty. For the repo's uncertainty tooling, see the uncertainty-and-units skill; its outputs still require authorized technical review before entering a controlled record.

3. Method selection, verification, and validation

For a standard method used as published, record verification that the laboratory can achieve the required performance before use; an unmodified method is not an exemption from verification. Distinguish modified, out-of-scope, non-standard, and laboratory-developed methods, and document the validation needed for their intended use. The evidence expected differs in each case. Record the performance characteristics evaluated, the acceptance criteria, the data, and the authorized approval to put the method into service.

4. Decision rules and statements of conformity

If reports state conformity to a specification, the decision rule must be documented, agreed with the customer where required, and applied consistently — including how measurement uncertainty is treated at the specification limit. The guidance basis is Global ACI-TECH-1-002 (G), version 1.0 (2026-06-26), the successor to ILAC G8:09/2019. JCGM 106:2012 / ISO/IEC Guide 98-4:2012 is the metrological companion. Confirm the scheme's adopted basis and current issues before controlled use.

Assemble, per scope item that reports conformity: the rule, the agreement record, the uncertainty treatment, the report wording, and the authorized signatory.

Validity of results and proficiency testing

Interlaboratory comparison and proficiency-testing participation is monitoring evidence, and a passing result is not a competence conclusion. Record the plan (which scope items, what frequency, what provider), each result, the evaluation against acceptance criteria, and — most importantly — the investigation and corrective action for any questionable or unsatisfactory outcome. An unsatisfactory result with no documented investigation is a blocker; treat it as one.

Where the laboratory cannot participate because no scheme exists for a measurand, record the alternative approach and its authorization rather than leaving a silence.

Shared checks that apply here

• scripts/audit_document_records.py — controlled documents, technical records, retention basis, and external-source currency. Standard-agnostic.
• scripts/check_capa.py — nonconforming work and corrective action, including effectiveness evidence before closure.
• scripts/check_supplier_controls.py — externally provided products and services, including calibration providers, reference-material suppliers, and subcontracted laboratories.
• scripts/validate_evidence_manifest.py and scripts/gap_analyzer.py with --standard iso-17025 — bounded evidence manifest and domain-level gap view.

scripts/check_traceability.py and scripts/check_qmsr_transition.py are device-lifecycle checks and do not apply to laboratory accreditation work. Note that check_traceability.py concerns design/risk traceability, not metrological traceability — the words collide and the check is the wrong tool here.

Common preparation failures

• Claiming "ISO 17025 certified" instead of accredited, or attaching an accreditation symbol to results outside the accredited scope.
• Treating calibration certificates as traceability evidence without the uncertainty chain, provider scope, or interval justification.
• Reporting conformity with no documented decision rule, or a rule that ignores uncertainty at the limit.
• Verifying a standard method once at introduction and never revisiting it after a method issue, instrument, or personnel change.
• Recording proficiency-testing scores while leaving unsatisfactory results uninvestigated.
• Presenting an impartiality statement with no identified risks, no controls, and no review.
• Filing a document register as the deliverable when no technical records were sampled.

Sources

• Global ACI document library — current policy/guidance designations
• BIPM JCGM publications — JCGM 106:2012
• ISO/IEC 17025:2017 — catalogue entry
• ISO/IEC 17025 landing page
• ILAC policy series — legacy policy archive; P10 is still carried by Global ACI
• GLOBAC launch
• Specifying use of GLOBAC accreditation
• references/source-ledger.md — dated baseline and provenance limitations
• references/assurance-lanes.md — how this lane differs from certification and regulatory inspection