@pikaa-ai/pikaa 0.3.0 → 0.3.4

package/skills/iso-standards-readiness/references/iso-14971.md

@@ -1,172 +0,0 @@
-# ISO 14971 Process Framework (No Standard Text)
-
-Research basis: **2026-07-26**, building on the 2026-07-23 device-lane baseline. This
-reference summarizes a preparation process and evidence architecture for medical device
-risk management. It does not reproduce requirements and is not a substitute for the
-standard.
-
-## Copyright and authorized access
-
-ISO publications are copyrighted. Obtain ISO 14971 and ISO/TR 24971 from
-[ISO](https://www.iso.org/standard/72704.html), an ISO national member, or another
-authorized source; see [ISO copyright](https://www.iso.org/copyright.html). Do not ask
-an agent to retrieve, transcribe, summarize clause-by-clause, or store proprietary
-text.
-
-## Current edition, the guidance companion, and the European amendment
-
-- [ISO 14971:2019](https://www.iso.org/standard/72704.html) is Edition 3, published
-  December 2019, reviewed and confirmed in 2025.
-- [ISO/TR 24971:2020](https://www.iso.org/standard/74437.html) is Edition 2 and is the
-  guidance companion, following the same clause structure. It is a **Technical
-  Report**: informative, not normative. Conformity is claimed to ISO 14971, never to
-  ISO/TR 24971, and a TR cannot relax or reinterpret a normative requirement. Record
-  which guidance the organization adopted and why.
-- **EN ISO 14971:2019/A11:2021** is a European amendment to the EN adoption, cited for
-  MDR and, through the corresponding decision, IVDR support. It does not change the
-  international normative part. Track it only where the European source basis applies.
-
-## No certification lane exists for this standard
-
-There is no ISO 14971 certificate. A body cannot certify a risk-management system to
-ISO 14971 the way it certifies a QMS to ISO 13485. Risk management is instead assessed
-*inside* other lanes:
-
-- an ISO 13485 certification audit examines the risk-management process as part of the
-  QMS;
-- an FDA inspection examines risk-based decisions against applicable FDA requirements;
-- an MDSAP audit treats risk management as a foundation across its process areas; and
-- EU conformity assessment examines the risk-management file as part of technical
-  documentation against the applicable general safety and performance requirements.
-
-Any claim of "ISO 14971 certification" is a category error. Report risk-management
-readiness as evidence supporting a named lane, never as its own assurance result.
-
-## Hard boundary
-
-This skill and its files cannot:
-
-- certify, approve, or validate a risk-management file or process;
-- determine device classification, intended use, reportability, conformity route,
-  market access, or product authorization;
-- decide whether a risk is acceptable, whether benefit outweighs residual risk, or
-  whether a risk-control measure is adequate or safe;
-- set or approve risk-acceptability criteria, severity or probability scales, or a
-  risk matrix;
-- replace top management, the risk-management owner, qualified clinical and engineering
-  reviewers, RA/QA, a notified body, or a regulator; or
-- infer that a hazard set is complete, or that residual risk is acceptable, from a
-  template, a matrix, a document count, or a script result.
-
-Use outputs as a list of evidence questions for accountable human review. **Completeness
-of hazard identification cannot be established by any check in this skill** — a
-zero-finding structural result says the declared links are present, not that the
-analysis found everything.
-
-## Process and evidence domains
-
-The `iso-14971` profile carries these domain labels for manifests and gap reports.
-They are workflow topics, not clause references:
-
-`risk-management-plan`, `risk-management-file`, `competence-and-authority`,
-`intended-use-and-characteristics`, `hazard-identification`,
-`risk-estimation-and-evaluation`, `risk-control-option-analysis`,
-`risk-control-implementation-and-verification`, `risk-control-side-effects-review`,
-`residual-risk-evaluation`, `benefit-risk-analysis`,
-`overall-residual-risk-evaluation`, `risk-management-review-and-report`,
-`production-and-postproduction-information`, `change-control`.
-
-Each domain needs an owner, status, evidence IDs, source/version reference, recorded
-approval, and links to open gaps.
-
-## The chain that has to hold together
-
-Risk-management evidence is judged as a connected chain, not as a set of documents. For
-each analysed item, the following must be traceable in both directions:
-
-intended use and reasonably foreseeable misuse → characteristics related to safety →
-hazard → foreseeable sequence of events → hazardous situation → harm with severity →
-probability basis → risk evaluation against declared criteria → risk-control option
-analysis and decision → implemented control → verification that the control was
-implemented → verification of its effectiveness → review for new or increased risks
-introduced by the control → residual risk evaluation → benefit-risk analysis where
-residual risk is not acceptable → contribution to overall residual risk → disclosure of
-residual risk → production and post-production information feeding back.
-
-Break any one link and the file stops being evidence. The two links most often missing
-are **verification of control effectiveness** (distinct from verifying the control
-exists) and **review of risks introduced by the control itself**.
-
-Build the traceability register with:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_traceability.py \
-  /path/to/traceability-matrix.json
-```
-
-That check links intended use, hazard or signal, risk evaluation, risk control, design
-input and output, verification, validation, production control, and post-market source.
-It verifies declared linkage, not analytical adequacy.
-
-## Where risk management meets the QMS
-
-ISO 14971 work is not separable from the device QMS. Keep these joins explicit and
-evidenced:
-
-- **Design and development** — risk controls that are design outputs must appear as
-  design inputs with verification, not only as risk-file rows.
-- **Production** — controls realized as process parameters, in-process checks, or
-  acceptance criteria need production evidence, and process validation where the
-  control cannot be fully verified on the finished device.
-- **Purchasing** — controls that depend on a supplier's process or component need
-  supplier controls and change notification. See
-  `scripts/check_supplier_controls.py`.
-- **Post-market** — complaints, service records, vigilance signals, and production
-  nonconformities must actually re-enter risk estimation, with evidence that the file
-  was reassessed and that changed estimates were acted on.
-- **CAPA** — where a risk estimate changes, the resulting action needs effectiveness
-  evidence before closure. See `scripts/check_capa.py`.
-- **Change control** — any change to intended use, design, process, supplier, or
-  materials triggers a documented risk reassessment.
-
-The production and post-production feedback loop is the single most common structural
-gap: files that were complete at design transfer and never updated by field
-experience.
-
-## Risk-acceptability criteria and the matrix problem
-
-Acceptability criteria belong in the risk-management plan, are set by authorized humans
-with a documented rationale, and must be applied consistently. Recurring failure modes
-to look for, none of which this skill can adjudicate:
-
-- criteria written after the analysis so that every risk lands acceptable;
-- probability values asserted with no stated basis and no data;
-- a matrix whose cells were adjusted per project to move results across the boundary;
-- risk reduction claimed from labelling or an instruction alone, where a design or
-  protective measure was available;
-- residual risk described as acceptable with no benefit-risk analysis where the
-  declared criteria were not met;
-- overall residual risk never evaluated as a whole — only item by item; and
-- no disclosure of residual risk to users where the analysis assumed it.
-
-Flag these as blockers for authorized review. Do not resolve them.
-
-## Shared checks that apply here
-
-- `scripts/validate_scope_intake.py --standard iso-14971` — declared scope, product
-  families, intended use references, and applicability owners.
-- `scripts/check_traceability.py` — the risk/design/production/post-market chain.
-- `scripts/check_capa.py` — corrective action with effectiveness evidence.
-- `scripts/check_supplier_controls.py` — controls that depend on external providers.
-- `scripts/validate_evidence_manifest.py` and `scripts/gap_analyzer.py` with
-  `--standard iso-14971`.
-
-## Sources
-
-- [ISO 14971:2019](https://www.iso.org/standard/72704.html) — catalogue entry
-- [ISO/TR 24971:2020](https://www.iso.org/standard/74437.html) — guidance companion
-- [Decision (EU) 2022/757](https://eur-lex.europa.eu/eli/dec_impl/2022/757/oj/eng) —
-  EN ISO 14971:2019/A11:2021 citation basis
-- `references/iso-13485.md` — the QMS lane this evidence usually supports
-- `references/source-ledger.md` — dated baseline and provenance limitations
-- `references/assurance-lanes.md` — why this standard has no certification lane

package/skills/iso-standards-readiness/references/iso-15189.md

@@ -1,219 +0,0 @@
-# ISO 15189 Process Framework (No Standard Text)
-
-Research basis: **2026-07-26**. This reference summarizes a preparation process and
-evidence architecture for medical laboratory quality and competence work. It does not
-reproduce requirements and is not a substitute for the standard.
-
-## Copyright and authorized access
-
-ISO publications are copyrighted. Obtain ISO 15189 from
-[ISO](https://www.iso.org/standard/76677.html), an ISO national member, or another
-authorized source; see [ISO copyright](https://www.iso.org/copyright.html). Do not ask
-an agent to retrieve, transcribe, summarize clause-by-clause, or store proprietary
-text. Accreditation-body and CAP checklists that quote requirements are separately
-licensed material — do not paste them into shared repositories or prompts.
-
-## Current edition and the closed transition
-
-- [ISO 15189:2022](https://www.iso.org/standard/76677.html) is Edition 4, published
-  December 2022, cancelling and replacing ISO 15189:2012. Confirm on the ISO catalogue
-  page, which refused automated access during this research.
-- The 2022 edition aligns structurally with ISO/IEC 17025:2017 and **incorporates
-  point-of-care testing requirements previously held in ISO 22870**. Do not cite
-  ISO 22870 as a separate current POCT basis without confirming its status.
-- The ILAC-agreed transition for accredited medical laboratories ran to **December
-  2025**. A 2012-based quality system is out of date, not "in transition" — do not
-  build a gap baseline that assumes a future deadline.
-- Record publisher, title, edition, amendments, authorized location, access date,
-  source owner, currency-review date, impact decision, and approval in the controlled
-  source ledger.
-
-## Keep four lanes separate
-
-### 1. ISO 15189 accreditation
-
-An accreditation body grants accreditation for a defined scope of examinations, per
-laboratory and per location, under ISO/IEC 17011. A medical laboratory is
-**accredited**, not "ISO 15189 certified." Since 2026-01-01 the recognition arrangement
-sits with Global Accreditation Cooperation Incorporated; verify current claim and logo
-wording with the accreditation body.
-
-### 2. United States CLIA certification
-
-CLIA certification by CMS is **mandatory** before a US laboratory may accept human
-specimens for testing. It is federal law, not a voluntary quality scheme.
-
-**ISO 15189 accreditation does not satisfy CLIA and cannot replace a CLIA-based
-accreditation.** Deemed status flows only from a CMS-approved accreditation
-organization's program. CMS approves a limited set of accreditation organizations whose
-standards must meet or exceed CLIA requirements, with reapproval every six years or
-more often; read the
-[current AO list](https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf)
-rather than relying on a remembered count. The CAP 15189 program is layered on top of
-CAP Laboratory Accreditation Program accreditation rather than offered as a standalone
-substitute — confirm current prerequisites with CAP.
-
-Never let an ISO 15189 readiness output be read as CLIA compliance, deemed status,
-licensure, or an inspection result.
-
-### 3. Other national licensure and inspection regimes
-
-State licensure, national health-authority requirements, and payer conditions of
-participation are separate again, with their own inspection processes and their own
-records. Non-US jurisdictions may make ISO 15189 accreditation mandatory, voluntary, or
-irrelevant. This is an applicability decision for authorized humans.
-
-### 4. IVD device regulation
-
-The performance of an in vitro diagnostic device, and any laboratory-developed test
-regime that applies to it, is regulated separately from laboratory accreditation. EU
-IVDR conformity assessment, notified-body involvement, and performance-study
-requirements are not laboratory accreditation questions. See `references/iso-13485.md`
-and the EU entries in `references/source-ledger.md`.
-
-## Hard boundary
-
-This skill and its files cannot:
-
-- accredit a laboratory, issue or validate an accreditation certificate or schedule,
-  or predict an assessment or inspection outcome;
-- establish CLIA certification, deemed status, licensure, or personnel qualification;
-- decide which scheme, jurisdiction requirement, or payer condition applies;
-- replace the laboratory director, quality manager, authorized signatory,
-  accreditation body, assessor, EQA provider, or competent authority;
-- verify or validate an examination procedure, set biological reference intervals,
-  establish traceability of assigned values, or judge clinical suitability; or
-- infer competence or patient safety 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 examination
-
-Each scope item is defined by discipline, the examination or measurand reported, the
-controlled procedure and its issue, and the primary sample type with its acceptance
-requirements. Point-of-care testing performed under the laboratory's responsibility
-belongs in the scope discussion explicitly, including devices operated by clinical
-staff outside the laboratory.
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_scope_intake.py \
-  /path/to/medical-laboratory-scope-intake.json --standard iso-15189
-```
-
-Copy `assets/templates/medical-laboratory-scope-intake-template.json` outside the skill
-first. The distributed template fails closed by design.
-
-## Process and evidence domains
-
-The `iso-15189` profile carries these domain labels for manifests and gap reports.
-They are workflow topics, not clause references:
-
-`scope-and-impartiality`, `organizational-structure-and-governance`,
-`personnel-competence`, `facilities-and-safety`, `equipment-and-calibration`,
-`metrological-traceability`, `reagents-and-consumables`,
-`externally-provided-products-and-services`, `pre-examination-processes`,
-`examination-methods-verification-and-validation`, `measurement-uncertainty`,
-`validity-of-results-and-external-quality-assessment`, `point-of-care-testing`,
-`post-examination-and-reporting`, `laboratory-information-management`, `complaints`,
-`nonconformity-and-corrective-action`, `risk-management-and-improvement`,
-`internal-audit`, `management-review`, `continuity-and-emergency-preparedness`.
-
-Each domain needs an owner, status, evidence IDs, source/version reference, recorded
-approval, and links to open gaps. Sample **records**, not only procedures.
-
-## Where medical laboratory evidence differs from ISO/IEC 17025
-
-### Pre-examination processes carry disproportionate risk
-
-Most avoidable patient harm originates before the analyser: request content and
-patient identification, collection and identification of the primary sample, transport
-and stability conditions, acceptance and rejection criteria, and handling of
-compromised samples. Sample: rejection records, identification-error events, transport
-excursions, and the resulting investigations — not only the collection manual.
-
-### Post-examination and reporting is clinical communication
-
-Assemble evidence for result review and authorization, reference intervals and
-clinical decision limits with their basis, interpretive comments and who is authorized
-to make them, report content and amendment or retraction handling, and — the item most
-often thin — **critical-result notification with documented read-back and
-timeliness**. Turnaround-time monitoring belongs here too.
-
-### Point-of-care testing is inside the scope
-
-POCT requirements now sit within ISO 15189. Record governance of devices outside the
-laboratory, operator training and authorization, connectivity and result capture into
-the patient record, quality-control regimes, and reconciliation with central
-laboratory methods.
-
-### Verification is the normal case, validation the exception
-
-Most medical laboratories verify commercial IVD examinations for their own setting
-rather than validating a new method. Record which performance characteristics were
-verified against the manufacturer's claims, the acceptance criteria, the data, and the
-authorized approval to report patient results. Laboratory-developed and modified
-procedures need the fuller validation evidence and the applicable regulatory analysis.
-
-### External quality assessment, not just proficiency testing
-
-Record EQA enrolment per scope item, results, evaluation against criteria, and
-investigation of unsatisfactory performance. Where no EQA scheme exists for an
-examination, record the alternative comparison approach and its authorization. An
-unacceptable EQA outcome with no documented investigation is a blocker.
-
-### Metrological traceability of assigned values
-
-For measurands where higher-order reference materials and reference measurement
-procedures exist, record the traceability of assigned values and the resulting
-commutability and comparability limitations. Where no reference system exists, record
-that fact and what the laboratory does about result comparability.
-
-### Risk and continuity are explicit
-
-The 2022 edition treats risk to patients as a running requirement rather than an annex.
-Record identified risks, controls, residual acceptance with authority, and improvement
-actions. Continuity and emergency preparedness — instrument failure, LIS outage,
-reagent supply interruption, facility loss — needs tested arrangements, not a plan
-nobody has exercised.
-
-## Shared checks that apply here
-
-- `scripts/audit_document_records.py` — controlled documents, records, retention basis,
-  and external-source currency. Standard-agnostic.
-- `scripts/check_capa.py` — nonconformity and corrective action with effectiveness
-  evidence before closure.
-- `scripts/check_supplier_controls.py` — reagents, consumables, calibration providers,
-  and referral laboratories, including the referral laboratory's own accreditation or
-  licensure status.
-- `scripts/validate_evidence_manifest.py` and `scripts/gap_analyzer.py` with
-  `--standard iso-15189`.
-
-`scripts/check_traceability.py` and `scripts/check_qmsr_transition.py` are
-device-lifecycle checks and do not apply here.
-
-## Common preparation failures
-
-- Presenting ISO 15189 readiness as CLIA compliance or deemed status.
-- Saying "certified" when the laboratory is accredited.
-- Citing ISO 22870 as the current separate POCT basis, or ISO 15189:2012 as current.
-- POCT devices operating outside the laboratory with no governance, training, or QC
-  evidence in the accreditation scope discussion.
-- Critical-result notification procedures with no notification records or timeliness
-  evidence.
-- Reference intervals adopted from a package insert with no documented basis for the
-  served population.
-- EQA scores filed without investigation of unsatisfactory results.
-- Continuity plans that have never been exercised.
-
-## Sources
-
-- [ISO 15189:2022](https://www.iso.org/standard/76677.html) — catalogue entry
-- [ILAC: ISO 15189:2022 published](https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/)
-- [CMS CLIA program](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
-- [CLIA accreditation and exemptions](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/accreditation-exemptions)
-- [CMS approved accreditation organizations](https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf)
-- [CAP 15189 program](https://www.cap.org/laboratory-improvement/accreditation/cap-15189-accreditation-program)
-- `references/source-ledger.md` — dated baseline and provenance limitations
-- `references/assurance-lanes.md` — how accreditation, certification, and regulatory
-  inspection differ

package/skills/iso-standards-readiness/references/iso-17025.md

@@ -1,208 +0,0 @@
-# ISO/IEC 17025 Process Framework (No Standard Text)
-
-Research basis: **2026-07-26**. 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](https://www.iso.org/standard/66912.html), IEC, an ISO national member, or another
-authorized source; see [ISO copyright](https://www.iso.org/copyright.html). 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](https://www.iso.org/standard/66912.html) is Edition 3. No
-  successor edition was identified at the research basis date — confirm on the ISO
-  catalogue page, which refused automated access during that research.
-- The 2017 edition restructured the 2005 edition around laboratory activities and
-  risk-based thinking. A quality system still organized around the 2005 clause
-  structure is out of date; do not treat a 2005-era manual as a current gap baseline.
-- 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," and no certification body issues an ISO/IEC 17025 certificate.
-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:
-
-```bash
-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); confirm its current designation, since the P/G series numbering may move
-under GLOBAC.
-
-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
-
-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
-
-Distinguish, per scope item: a standard method used as published, a standard method
-requiring verification of the laboratory's ability to perform it, a modified standard
-method, and a laboratory-developed method. 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
-**ILAC G8:09/2019**, with JCGM 106:2012 / ISO/IEC Guide 98-4 as the metrological
-companion. Confirm current issues before citing either in a controlled procedure.
-
-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
-
-- [ISO/IEC 17025:2017](https://www.iso.org/standard/66912.html) — catalogue entry
-- [ISO/IEC 17025 landing page](https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html)
-- [ILAC policy series](https://ilac.org/publications-and-resources/ilac-policy-series/) — P10 traceability policy
-- [GLOBAC launch](https://iaf.nu/en/news/global-accreditation-cooperation-incorporated-launch-unifies-international-accreditation-organisations-and-strengthens-worldwide-trust/)
-- [Specifying use of GLOBAC accreditation](https://ilac.org/latest_ilac_news/iaf-and-ilac-release-information-on-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