@oimlsmart/primmel-packages 0.2.1 → 0.4.0

package/iso-iec-17000/evaluation/activity-archetypes.prl

@@ -0,0 +1,189 @@
+# ISO/IEC 17000:2020 — CONFORMITY-ASSESSMENT ACTIVITY ARCHETYPES (TODO.roadmap/39)
+# -----------------------------------------------------------------------------
+# The functional-approach activity taxonomy of ISO/IEC 17000:2020 as a register
+# of CLASSIFIABLE ACTIVITY KINDS. Abstract processes (the oiml-cs package's
+# evaluation/abstract-processes.yaml today; the 17065/17025 packages of tasks
+# 39b/c — evaluation/functional-approach.prl in those packages) classify
+# themselves against this register via the optional `activity_kind` facet — an
+# id list (multi-kind because ISO/IEC 17065 §7.4 "evaluation" is the
+# combination of the selection and determination functions, 17065 3.3).
+# Classification, not inheritance.
+#
+# Facets: label / clause / definition / parent?.
+#   clause   the ISO/IEC 17000:2020 clause the kind's definition comes from —
+#            the normative term numbers (6.x/7.x/8.x), or the Annex-A section
+#            for the two FUNCTIONS (selection A.2, determination A.3), which
+#            are functional-approach concepts, not numbered terms
+#   definition verbatim definition text from the source clause (the
+#            terminology register — terminology.prl — carries the same text;
+#            the SINGLE normative source is the standard itself)
+#   parent   hierarchy — recorded ONLY where the standard states a type-of
+#            relationship:
+#              · A.3.2: testing/inspection/audit/validation/verification/
+#                peer assessment are "defined as types of determination
+#                activities only" → parent determination
+#              · A.4.3: declaration/certification/accreditation are "defined
+#                as types of attestation only" → parent attestation
+#              · A.2: representative sampling is a selection-function
+#                activity → parent selection
+#            Clause 8's title ("Terms relating to surveillance") is a
+#            grouping, not a type-of relation — suspension/withdrawal/expiry/
+#            restoration/appeal/complaint stay top-level.
+#
+# SOURCE CORRECTION (vs the task-39 brief): 17000:2020 clause 6.1 is
+# SAMPLING, not "selection" — "selection" and "determination" are the
+# functional-approach functions of informative Annex A (A.2/A.3), not
+# numbered vocabulary terms. Verified against the Metanorma source (see
+# layer.yaml editions.source).
+#
+# The register's own `parent` references and every classifying process's
+# activity_kind ids are checked package-side by the kernel's C58
+# activity-kind-resolves (per-register gated); the consumer's linker R23
+# still guards the regenerated YAML.
+#
+# This file is the single source of truth; the consumer's
+# data/iso-iec-17000/evaluation/activity-archetypes.yaml is its GENERATED
+# YAML twin (cd browser && npm run gen:data; schema
+# data/schemas/activity-archetypes.yaml).
+activity_archetype selection {
+  label "selection"
+  clause "A.2"
+  definition "Planning and preparation activities in order to collect or produce all the information and input needed for the subsequent determination function."
+}
+
+activity_archetype determination {
+  label "determination"
+  clause "A.3"
+  definition "Activities undertaken to develop complete information regarding fulfilment of the specified requirements by the object of conformity assessment or its sample."
+}
+
+activity_archetype sampling {
+  label "sampling"
+  clause "6.1"
+  definition "Selection and/or collection of material or data regarding an object of conformity assessment (4.2)."
+  parent selection
+}
+
+activity_archetype testing {
+  label "testing"
+  clause "6.2"
+  definition "Determination of one or more characteristics of an object of conformity assessment (4.2), according to a procedure (5.2)."
+  parent determination
+}
+
+activity_archetype inspection {
+  label "inspection"
+  clause "6.3"
+  definition "Examination of an object of conformity assessment (4.2) and determination of its conformity with detailed requirements or, on the basis of professional judgement, with general requirements."
+  parent determination
+}
+
+activity_archetype audit {
+  label "audit"
+  clause "6.4"
+  definition "Process for obtaining relevant information about an object of conformity assessment (4.2) and evaluating it objectively to determine the extent to which specified requirements (5.1) are fulfilled."
+  parent determination
+}
+
+activity_archetype validation {
+  label "validation"
+  clause "6.5"
+  definition "Confirmation of plausibility for a specific intended use or application through the provision of objective evidence that specified requirements (5.1) have been fulfilled."
+  parent determination
+}
+
+activity_archetype verification {
+  label "verification"
+  clause "6.6"
+  definition "Confirmation of truthfulness through the provision of objective evidence that specified requirements (5.1) have been fulfilled."
+  parent determination
+}
+
+activity_archetype peer_assessment {
+  label "peer assessment"
+  clause "6.7"
+  definition "Assessment of a body against specified requirements (5.1) by representatives of other bodies in, or candidates for, an agreement group (9.10)."
+  parent determination
+}
+
+activity_archetype review {
+  label "review"
+  clause "7.1"
+  definition "Consideration of the suitability, adequacy and effectiveness of selection and determination activities, and the results of these activities, with regard to fulfilment of specified requirements (5.1) by an object of conformity assessment (4.2)."
+}
+
+activity_archetype decision {
+  label "decision"
+  clause "7.2"
+  definition "Conclusion, based on the results of review (7.1), that fulfilment of specified requirements (5.1) has or has not been demonstrated."
+}
+
+activity_archetype attestation {
+  label "attestation"
+  clause "7.3"
+  definition "Issue of a statement, based on a decision (7.2), that fulfilment of specified requirements (5.1) has been demonstrated."
+}
+
+activity_archetype declaration {
+  label "declaration"
+  clause "7.5"
+  definition "First-party attestation (7.3)."
+  parent attestation
+}
+
+activity_archetype certification {
+  label "certification"
+  clause "7.6"
+  definition "Third-party attestation (7.3) related to an object of conformity assessment (4.2), with the exception of accreditation (7.7)."
+  parent attestation
+}
+
+activity_archetype accreditation {
+  label "accreditation"
+  clause "7.7"
+  definition "Third-party attestation (7.3) related to a conformity assessment body (4.6), conveying formal demonstration of its competence, impartiality (5.3) and consistent operation in performing specific conformity assessment activities."
+  parent attestation
+}
+
+activity_archetype surveillance {
+  label "surveillance"
+  clause "8.1"
+  definition "Systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity."
+}
+
+activity_archetype suspension {
+  label "suspension"
+  clause "8.2"
+  definition "Temporary restriction of the statement of conformity by the body that issued the statement, for all or part of the specified scope of attestation (7.4)."
+}
+
+activity_archetype withdrawal {
+  label "withdrawal"
+  clause "8.3"
+  definition "Revocation of the statement of conformity by the body that issued the statement."
+}
+
+activity_archetype expiry {
+  label "expiry"
+  clause "8.4"
+  definition "Ending of the validity of the statement of conformity after a specified period."
+}
+
+activity_archetype restoration {
+  label "restoration"
+  clause "8.5"
+  definition "Reinstatement of the full or partial statement of conformity."
+}
+
+activity_archetype appeal {
+  label "appeal"
+  clause "8.6"
+  definition "Request by the person or organization that provides, or that is, the object of conformity assessment (4.2) to a conformity assessment body (4.6) or an accreditation body (4.7) for reconsideration by that body of a decision (7.2) it has made relating to that object."
+}
+
+activity_archetype complaint {
+  label "complaint"
+  clause "8.7"
+  definition "Expression of dissatisfaction, other than appeal (8.6), by any person or organization to a conformity assessment body (4.6) or an accreditation body (4.7), relating to the activities of that body, where a response is expected."
+}
+

package/iso-iec-17025/evaluation/functional-approach.prl

@@ -0,0 +1,382 @@
+# ISO/IEC 17025 REFERENCE PACKAGE — THE TEST LIFECYCLE AS ABSTRACT
+# PROCESSES (ISO/IEC 17025:2017, clause 7; TODO.roadmap/39, sub-task 39c)
+# -----------------------------------------------------------------------------
+# The ISO/IEC 17025:2017 laboratory test lifecycle (clause 7, mirroring the
+# operational-process schematic of informative Annex B, Figure B.1) as
+# ABSTRACT processes (the abstract form per TODO.roadmap/02 — signature +
+# invariants, no steps), the TL-competence reference model the OIML-CS
+# delegates to (B 18:2025 §5.3): request_review (7.1) → method_selection
+# (7.2.1) → method_validation (7.2.2) → sampling (7.3) → item_handling
+# (7.4) → test_execution (the determination proper — Figure B.1's
+# "Calibration / test execution", recorded per 7.5.1) →
+# measurement_uncertainty (7.6) → validity_monitoring (7.7) → reporting
+# (7.8), with the off-sequence technical_records (7.5), complaint_handling
+# (7.9) and nonconforming_work (7.10).
+#
+# Fields follow the iso-iec-17065 functional-approach exemplar
+# (the iso-iec-17065 package's evaluation/functional-approach.prl):
+#   roles      the ISO/IEC 17025 functional actors — `customer` and
+#              `laboratory` (3.6) — NOT the OIML-CS scheme roles.
+#   signature  CONCEPTUAL record stores of the lifecycle (test_requests,
+#              method_records, …) — this package declares no entity classes;
+#              the stores name the information flow, nothing resolves
+#              against them (bare untyped store references — the kernel's
+#              abstract-form signature grammar).
+#   realized_by / approved_by — empty: the platform's concrete Core
+#              processes realize the OIML-CS's OWN abstract model; the
+#              OIML-CS↔17025 mapping lands in tasks 40–43. The documentary
+#              halves here are the provisions bindings (every
+#              /req/iso-17025/process/* provision binds to exactly one
+#              abstract process — the R2 targeting exemption).
+#
+# activity_kind — the ISO/IEC 17000 activity-archetype register ids
+# (the iso-iec-17000 package's evaluation/activity-archetypes.prl; C58
+# resolves every id when the register is in scope — this package uses
+# iso-iec-17000). Per-process tagging decisions (folded up from the YAML
+# draft's body comments):
+#   request_review / method_selection / item_handling → [selection] —
+#     A.2 selection: collecting/producing the information, methods and
+#     conditioned items the determination function needs.
+#   method_validation → [validation] (6.5, a determination type per
+#     17000 A.3.2).
+#   sampling → [sampling] (6.1, a selection-function activity per A.2).
+#     NOTE: in OIML type evaluation the laboratory normally receives the
+#     samples the Issuing Authority selects (OIML D 30, G.7.3.1-1/-2) —
+#     this process is conditional on the laboratory itself sampling.
+#   test_execution → [testing] (6.2) — the laboratory's core
+#     determination activity.
+#   measurement_uncertainty → [determination] (the A.3 parent function:
+#     MU evaluation is integral to every determination — testing (7.6.3)
+#     and calibration (7.6.2) alike — so the parent kind classifies it,
+#     not the testing subtype).
+#   validity_monitoring → [verification] — the 17000:2020 6.6 kind
+#     ("confirmation of truthfulness through the provision of objective
+#     evidence"), NOT the 17025 3.8 / VIM 2.44 metrology term of this
+#     package's own vocabulary (the two standards' definitions genuinely
+#     differ — the collision is documented in terminology.prl).
+#   reporting → [review, declaration] — 7.8.1.1's results review and
+#     authorization before release is the 17000 7.1 review kind; a report
+#     carrying a 7.8.6 statement of conformity is a FIRST-PARTY
+#     attestation (the laboratory states conformity of items it tested),
+#     i.e. the 17000 7.5 declaration kind — explicitly NOT certification:
+#     7.8.7's Note distinguishes lab statements from product
+#     certification per ISO/IEC 17065.
+#   complaint_handling → [complaint] (8.7 — 17025 3.2 adopts the
+#     17000:2004 definition with the laboratory as addressee).
+#   nonconforming_work → [review, decision] — the significance evaluation
+#     reviews the laboratory's own determination results (incl. the
+#     impact analysis); the acceptability decision concludes.
+# One deliberate non-tag: technical_records (7.5) — the record-keeping
+# discipline has no functional-approach activity kind (it produces no
+# selection/determination/review/decision/attestation/surveillance
+# outcome; same doctrine as the 17065 model's records process).
+#
+# ID-NAMESPACE NOTE: in a rec's composed effective tree this file
+# deep-merges with the iso-iec-17065 package's same-named twin (see
+# layer.yaml) — the two process lists union by id. Every id here is
+# deliberately disjoint from the 17065 set (application … complaints):
+# the 7.9 complaint process is complaint_handling, never complaints. The
+# process_model id likewise differs (test_lifecycle vs
+# functional_approach) — one composed model map, no overwrite.
+#
+# The clause-7 flow: request review → method selection → method
+# validation (conditional: non-standard/developed/out-of-scope/modified
+# methods only) → sampling (conditional: when the laboratory itself
+# samples — in OIML type evaluation the Issuing Authority selects, OIML
+# D 30 G.7.3.1) → item handling → test execution → MU evaluation →
+# validity monitoring → reporting. technical_records, complaint_handling
+# and nonconforming_work are off-sequence: the records discipline spans
+# every stage; complaints and nonconforming work may be initiated any
+# time after reporting.
+#
+# Provenance: ISO/IEC 17025:2017 (see layer.yaml editions.source); every
+# clause anchor verified against the source's [[sec_x.y]] anchors. Each
+# process's `source` block carries its clause-7 anchor as free-text doc
+# + empty clause (the consumer's YAML twin restores it as the
+# `reference:` citation verbatim).
+#
+# This file is the single source of truth; the consumer's
+# data/iso-iec-17025/evaluation/functional-approach.yaml is its GENERATED
+# YAML twin (cd browser && npm run gen:data; schema
+# data/schemas/abstract-processes.yaml).
+process request_review {
+  name "Review of requests, tenders and contracts"
+  summary "The laboratory reviews requests, tenders and contracts before accepting work: requirements adequately defined, documented and understood; capability and resources confirmed; external-provider activities advised and approved by the customer; appropriate methods selected (7.1.1) — and, when the customer requests a statement of conformity, the specification or standard and the decision rule clearly defined and, unless inherent, communicated to and agreed with the customer (7.1.3)."
+  validate_provision {
+    /req/iso-17025/process/request-review
+    /req/iso-17025/process/decision-rule
+  }
+  signature {
+    out { test_requests }
+  }
+  invariants {
+    "[test_request].requirements_defined = true"
+    "[test_request].conformity_statement_requested = true implies [test_request].decision_rule is not null"
+  }
+  activity_kind { selection }
+  roles { customer laboratory }
+  evidence {
+    request_review_record { description "The review record: defined requirements, capability/resource confirmation, external-provider advice and approval (7.1.1 c), the selected methods, and — for requested statements of conformity — the defined specification/standard and decision rule with the customer agreement (7.1.3). Records of reviews and pertinent discussions are retained per 7.1.8." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.1" clause "" }
+}
+
+process method_selection {
+  name "Selection and verification of methods"
+  summary "The laboratory uses appropriate methods and procedures for all laboratory activities in the latest valid version (7.2.1.1/7.2.1.3), selects an appropriate method and informs the customer when the customer did not specify one (7.2.1.4), verifies it can properly perform methods before introducing them — repeating verification on method revision and retaining the records (7.2.1.5) — and permits deviations only when documented, technically justified, authorized and accepted by the customer (7.2.1.7)."
+  validate_provision {
+    /req/iso-17025/process/method-selection
+    /req/iso-17025/process/method-verification
+  }
+  signature {
+    in { test_requests }
+    out { method_records }
+  }
+  invariants {
+    "[method_record].verified_before_introduction = true"
+    "[method_record].deviations->forAll(d | d.authorized = true and d.customer_accepted = true)"
+  }
+  activity_kind { selection }
+  roles { laboratory }
+  evidence {
+    method_verification_record { description "The method verification record: the required performance achieved before introduction (7.2.1.5), the method version in use (7.2.1.3), any supplemented application details, and every deviation with its documentation, technical justification, authorization and customer acceptance (7.2.1.7)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.2.1" clause "" }
+}
+
+process method_validation {
+  name "Validation of methods"
+  summary "The laboratory validates non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified — as extensively as the application needs (7.2.2.1), re-validating when changes affect the original validation (7.2.2.2) — and retains the validation records 7.2.2.4 a–e, including the statement on the validity of the method for its intended use."
+  validate_provision {
+    /req/iso-17025/process/method-validation
+  }
+  signature {
+    in { method_records }
+    out { validation_records }
+  }
+  invariants {
+    "[validation_record].validity_statement is not null"
+  }
+  activity_kind { validation }
+  roles { laboratory }
+  evidence {
+    validation_record { description "The validation record per 7.2.2.4: the procedure used, the specification of the requirements, the determined performance characteristics, the results obtained, and the statement on the validity of the method detailing its fitness for the intended use." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.2.2" clause "" }
+}
+
+process sampling {
+  name "Sampling"
+  summary "When the laboratory carries out sampling of substances, materials or products for subsequent testing or calibration, it works to a sampling plan and method — addressing the factors to be controlled for the validity of the results, available at the sampling site, statistically based whenever reasonable (7.3.1/7.3.2) — and retains the sampling records of 7.3.3 a–h."
+  validate_provision {
+    /req/iso-17025/process/sampling-plan
+    /req/iso-17025/process/sampling-records
+  }
+  signature {
+    in { test_requests }
+    out { sample_records }
+  }
+  invariants {
+    "[sample_record].sampling_method_ref is not null"
+  }
+  activity_kind { sampling }
+  roles { laboratory }
+  evidence {
+    sampling_record { description "The sampling record per 7.3.3: method reference, date/time, sample identification and description, personnel, equipment, environmental/transport conditions, sampling-location diagrams where appropriate, and any deviations/additions/exclusions." }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.3" clause "" }
+}
+
+process item_handling {
+  name "Handling of test or calibration items"
+  summary "The laboratory transports, receives, handles, protects, stores, retains and disposes of or returns test or calibration items under a documented procedure with integrity precautions (7.4.1), identifies every item unambiguously for the whole period of its responsibility (7.4.2), records receipt deviations and consults the customer before proceeding on doubtful items — disclaiming affected results where the customer requires testing acknowledging a deviation (7.4.3) — and maintains, monitors and records specified storage/conditioning conditions (7.4.4)."
+  validate_provision {
+    /req/iso-17025/process/item-handling
+    /req/iso-17025/process/item-receipt-storage
+  }
+  signature {
+    in { sample_records }
+    out { item_records }
+  }
+  invariants {
+    "[item_record].identification is not null"
+    "[item_record].receipt_deviations_recorded = true"
+  }
+  activity_kind { selection }
+  roles { laboratory }
+  evidence {
+    item_record { description "The item record: the unambiguous identification (7.4.2), receipt deviations and customer consultations (7.4.3), and the monitored storage/conditioning conditions (7.4.4)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.4" clause "" }
+}
+
+process test_execution {
+  name "Test / calibration execution"
+  summary "The laboratory performs the laboratory activity — the determination proper (Annex B, Figure B.1's \"Calibration / test execution\" stage) — under the verified method, recording original observations, data and calculations at the time they are made as technical records that identify the factors affecting the result and its measurement uncertainty, enable repetition under near-original conditions, and name the responsible personnel and data/result checkers (7.5.1)."
+  validate_provision {
+    /req/iso-17025/process/activity-records
+  }
+  signature {
+    in { item_records method_records }
+    out { technical_records }
+  }
+  invariants {
+    "[technical_record].original_observations_recorded_when_made = true"
+    "[technical_record].responsible_personnel is not null"
+  }
+  activity_kind { testing }
+  roles { laboratory }
+  evidence {
+    technical_record { description "The technical record of the activity per 7.5.1: results and report, the factors affecting the measurement result and its uncertainty, date and identity of the responsible personnel and of the data/result checkers, and the original observations, data and calculations recorded at the time they were made." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.5.1 (Figure B.1 — calibration / test execution)" clause "" }
+}
+
+process measurement_uncertainty {
+  name "Evaluation of measurement uncertainty"
+  summary "The laboratory identifies all significant contributions to measurement uncertainty — including those arising from sampling — using appropriate methods of analysis (7.6.1); evaluates MU for all calibrations, including of its own equipment (7.6.2); and evaluates MU for testing, estimating it from theoretical principles or practical experience where the test method precludes rigorous evaluation (7.6.3 — following a well-recognized method that limits the major MU sources and prescribes the presentation of results satisfies it)."
+  validate_provision {
+    /req/iso-17025/process/measurement-uncertainty
+  }
+  signature {
+    in { technical_records }
+    out { mu_evaluations }
+  }
+  invariants {
+    "[mu_evaluation].contributions.count >= 1"
+  }
+  activity_kind { determination }
+  roles { laboratory }
+  evidence {
+    mu_evaluation { description "The MU evaluation: the identified significant contributions (7.6.1) and the evaluated or estimated uncertainty per activity kind (7.6.2/7.6.3)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.6" clause "" }
+}
+
+process validity_monitoring {
+  name "Ensuring the validity of results"
+  summary "The laboratory monitors the validity of its results under a planned and reviewed procedure — trend-detectable recording, statistical review, and the 7.7.1 monitoring menu (reference materials, check standards, intermediate checks, replicates, retesting, blind samples …) — monitors its performance against other laboratories via proficiency testing and/or interlaboratory comparisons (7.7.2), and acts on out-of-criteria analysis to prevent incorrect results from being reported (7.7.3)."
+  validate_provision {
+    /req/iso-17025/process/validity-of-results
+  }
+  signature {
+    in { technical_records mu_evaluations }
+    out { validity_records }
+  }
+  invariants {
+    "[validity_record].out_of_criteria = true implies [validity_record].action_taken is not null"
+  }
+  activity_kind { verification }
+  roles { laboratory }
+  evidence {
+    validity_record { description "The validity-monitoring record: the planned monitoring data with their statistical review (7.7.1), the proficiency-testing / interlaboratory-comparison participation (7.7.2), and the actions taken on out-of-criteria analysis (7.7.3)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.7" clause "" }
+}
+
+process reporting {
+  name "Reporting of results"
+  summary "The laboratory reviews and authorizes results before release (7.8.1.1) and issues them accurately, clearly, unambiguously and objectively in a report carrying the 7.8.2.1 a–p common content — with the test-report additions of 7.8.3.1 (test conditions, statement of conformity, MU where relevant or conformity-affecting, opinions and interpretations) — statements of conformity under a documented, risk-informed decision rule identifying the results covered and the specifications met or not met (7.8.6), opinions and interpretations released only by personnel authorized for them with their basis documented (7.8.7), and post-issue amendments only as identified amendment documents or uniquely identified replacements (7.8.8)."
+  validate_provision {
+    /req/iso-17025/process/results-review-release
+    /req/iso-17025/process/report-common-content
+    /req/iso-17025/process/test-report-content
+    /req/iso-17025/process/conformity-statements
+    /req/iso-17025/process/opinions-interpretations
+    /req/iso-17025/process/report-amendments
+  }
+  signature {
+    in { technical_records mu_evaluations }
+    out { test_reports }
+  }
+  invariants {
+    "[test_report].reviewed_and_authorized = true"
+    "[test_report].carries_conformity_statement = true implies [test_report].decision_rule is not null"
+    "[test_report].opinions.count > 0 implies [test_report].opinion_authorizer.authorized_for_opinions = true"
+  }
+  activity_kind { review declaration }
+  roles { laboratory }
+  evidence {
+    test_report { description "The issued report: the 7.8.2.1 a–p content plus the 7.8.3.1 test-report additions, with the authorizing person(s) identified (7.8.2.1 o) and the pre-release review/authorization recorded (7.8.1.1)." required true }
+    decision_rule_record { description "The documented decision rule for every statement of conformity (7.8.6.1) — risk taken into account unless prescribed — with the statement's identification of the results covered, the specifications met/not met and the rule applied (7.8.6.2)." }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.8" clause "" }
+}
+
+process technical_records {
+  name "Technical records"
+  summary "The records discipline spanning all laboratory activities: technical records enable repetition under near-original conditions and identify the responsible personnel (7.5.1), and amendments to technical records stay trackable to previous versions or original observations, with original and amended data retained including the date, the altered aspects and the responsible personnel (7.5.2)."
+  validate_provision {
+    /req/iso-17025/process/record-amendments
+  }
+  signature {
+    in { technical_records test_reports }
+    out { records_register }
+  }
+  invariants {
+    "[amendment].previous_version_ref is not null"
+  }
+  roles { laboratory }
+  evidence {
+    amendment_record { description "The amendment trail per 7.5.2: the previous version or original observation the amendment tracks to, the date of alteration, the altered aspects, and the personnel responsible." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.5" clause "" }
+}
+
+process complaint_handling {
+  name "Complaints"
+  summary "The laboratory receives, validates, investigates and decides complaints under a documented process available to any interested party — confirming whether the complaint relates to its own activities, gathering and verifying the validating information, acknowledging receipt and providing progress reports and the outcome — with outcomes made by, or reviewed and approved by, individuals NOT involved in the original laboratory activities in question (7.9.6), and formal notice of the end of the handling (7.9.7)."
+  validate_provision {
+    /req/iso-17025/process/complaints
+  }
+  signature {
+    in { test_reports }
+    out { complaint_records }
+  }
+  invariants {
+    "[complaint_record].outcome_reviewer_involved_in_original_activity = false"
+  }
+  activity_kind { complaint }
+  roles { laboratory }
+  evidence {
+    complaint_record { description "The complaint record: receipt acknowledgement and responsibility confirmation (7.9.2/7.9.5), the gathered and verified information (7.9.4), the tracked actions (7.9.3 b/c), the outcome with its uninvolved maker/reviewer/approver (7.9.6), and the formal notice of closure (7.9.7)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.9" clause "" }
+}
+
+process nonconforming_work {
+  name "Nonconforming work"
+  summary "When any aspect of the laboratory's activities or results does not conform to its own procedures or the customer's agreed requirements, the laboratory manages the nonconforming work under a documented procedure: defined responsibilities, risk-based actions (halting, repeating, withholding reports), evaluation of the significance including an impact analysis on previous results, a decision on acceptability, customer notification and recall where necessary, defined resumption authority (7.10.1), retained records (7.10.2), and corrective action where the nonconformity could recur (7.10.3)."
+  validate_provision {
+    /req/iso-17025/process/nonconforming-work
+  }
+  signature {
+    in { technical_records test_reports }
+    out { nonconformity_records }
+  }
+  invariants {
+    "[nonconformity_record].acceptability_decision is not null"
+  }
+  activity_kind { review decision }
+  roles { laboratory }
+  evidence {
+    nonconformity_record { description "The nonconforming-work record per 7.10.1/7.10.2: the evaluated significance with the impact analysis on previous results, the risk-based action, the acceptability decision, the customer notification/recall where necessary, the resumption authorization, and any corrective action (7.10.3)." required true }
+  }
+  executor actor
+  source { doc "ISO/IEC 17025:2017, 7.10" clause "" }
+}
+
+process_model test_lifecycle {
+  sequence { request_review method_selection method_validation sampling item_handling test_execution measurement_uncertainty validity_monitoring reporting }
+}