@oimlsmart/primmel-packages 0.3.0 → 0.4.0
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# ISO/IEC 17000:2020 — CONFORMITY-ASSESSMENT ACTIVITY ARCHETYPES (TODO.roadmap/39)
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# -----------------------------------------------------------------------------
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# The functional-approach activity taxonomy of ISO/IEC 17000:2020 as a register
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# of CLASSIFIABLE ACTIVITY KINDS. Abstract processes (the oiml-cs package's
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# evaluation/abstract-processes.yaml today; the 17065/17025 packages of tasks
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# 39b/c — evaluation/functional-approach.prl in those packages) classify
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# themselves against this register via the optional `activity_kind` facet — an
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# id list (multi-kind because ISO/IEC 17065 §7.4 "evaluation" is the
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# combination of the selection and determination functions, 17065 3.3).
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# Classification, not inheritance.
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#
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# Facets: label / clause / definition / parent?.
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# clause the ISO/IEC 17000:2020 clause the kind's definition comes from —
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# the normative term numbers (6.x/7.x/8.x), or the Annex-A section
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# for the two FUNCTIONS (selection A.2, determination A.3), which
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# are functional-approach concepts, not numbered terms
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# definition verbatim definition text from the source clause (the
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# terminology register — terminology.prl — carries the same text;
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# the SINGLE normative source is the standard itself)
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# parent hierarchy — recorded ONLY where the standard states a type-of
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# relationship:
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# · A.3.2: testing/inspection/audit/validation/verification/
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# peer assessment are "defined as types of determination
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# activities only" → parent determination
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# · A.4.3: declaration/certification/accreditation are "defined
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# as types of attestation only" → parent attestation
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# · A.2: representative sampling is a selection-function
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# activity → parent selection
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# Clause 8's title ("Terms relating to surveillance") is a
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# grouping, not a type-of relation — suspension/withdrawal/expiry/
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# restoration/appeal/complaint stay top-level.
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#
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# SOURCE CORRECTION (vs the task-39 brief): 17000:2020 clause 6.1 is
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# SAMPLING, not "selection" — "selection" and "determination" are the
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# functional-approach functions of informative Annex A (A.2/A.3), not
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# numbered vocabulary terms. Verified against the Metanorma source (see
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# layer.yaml editions.source).
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#
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# The register's own `parent` references and every classifying process's
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# activity_kind ids are checked package-side by the kernel's C58
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# activity-kind-resolves (per-register gated); the consumer's linker R23
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# still guards the regenerated YAML.
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#
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# This file is the single source of truth; the consumer's
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# data/iso-iec-17000/evaluation/activity-archetypes.yaml is its GENERATED
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# YAML twin (cd browser && npm run gen:data; schema
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# data/schemas/activity-archetypes.yaml).
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activity_archetype selection {
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label "selection"
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clause "A.2"
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definition "Planning and preparation activities in order to collect or produce all the information and input needed for the subsequent determination function."
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}
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activity_archetype determination {
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label "determination"
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clause "A.3"
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definition "Activities undertaken to develop complete information regarding fulfilment of the specified requirements by the object of conformity assessment or its sample."
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}
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activity_archetype sampling {
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label "sampling"
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clause "6.1"
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definition "Selection and/or collection of material or data regarding an object of conformity assessment (4.2)."
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parent selection
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}
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activity_archetype testing {
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label "testing"
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clause "6.2"
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definition "Determination of one or more characteristics of an object of conformity assessment (4.2), according to a procedure (5.2)."
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parent determination
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}
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activity_archetype inspection {
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label "inspection"
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clause "6.3"
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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."
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parent determination
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}
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activity_archetype audit {
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label "audit"
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clause "6.4"
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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."
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parent determination
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}
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activity_archetype validation {
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label "validation"
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clause "6.5"
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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."
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parent determination
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}
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activity_archetype verification {
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label "verification"
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clause "6.6"
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definition "Confirmation of truthfulness through the provision of objective evidence that specified requirements (5.1) have been fulfilled."
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parent determination
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}
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activity_archetype peer_assessment {
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label "peer assessment"
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clause "6.7"
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definition "Assessment of a body against specified requirements (5.1) by representatives of other bodies in, or candidates for, an agreement group (9.10)."
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parent determination
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}
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activity_archetype review {
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label "review"
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clause "7.1"
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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)."
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}
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activity_archetype decision {
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label "decision"
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clause "7.2"
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definition "Conclusion, based on the results of review (7.1), that fulfilment of specified requirements (5.1) has or has not been demonstrated."
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}
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activity_archetype attestation {
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label "attestation"
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clause "7.3"
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definition "Issue of a statement, based on a decision (7.2), that fulfilment of specified requirements (5.1) has been demonstrated."
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}
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activity_archetype declaration {
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label "declaration"
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clause "7.5"
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definition "First-party attestation (7.3)."
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parent attestation
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}
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activity_archetype certification {
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label "certification"
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clause "7.6"
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definition "Third-party attestation (7.3) related to an object of conformity assessment (4.2), with the exception of accreditation (7.7)."
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parent attestation
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}
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activity_archetype accreditation {
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label "accreditation"
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clause "7.7"
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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."
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parent attestation
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}
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activity_archetype surveillance {
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label "surveillance"
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clause "8.1"
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definition "Systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity."
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}
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activity_archetype suspension {
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label "suspension"
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clause "8.2"
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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)."
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}
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activity_archetype withdrawal {
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label "withdrawal"
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clause "8.3"
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definition "Revocation of the statement of conformity by the body that issued the statement."
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}
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activity_archetype expiry {
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label "expiry"
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clause "8.4"
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definition "Ending of the validity of the statement of conformity after a specified period."
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}
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activity_archetype restoration {
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label "restoration"
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clause "8.5"
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definition "Reinstatement of the full or partial statement of conformity."
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}
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activity_archetype appeal {
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label "appeal"
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clause "8.6"
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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."
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}
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activity_archetype complaint {
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label "complaint"
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clause "8.7"
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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."
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}
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# ISO/IEC 17025 REFERENCE PACKAGE — THE TEST LIFECYCLE AS ABSTRACT
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# PROCESSES (ISO/IEC 17025:2017, clause 7; TODO.roadmap/39, sub-task 39c)
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# -----------------------------------------------------------------------------
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# The ISO/IEC 17025:2017 laboratory test lifecycle (clause 7, mirroring the
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# operational-process schematic of informative Annex B, Figure B.1) as
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# ABSTRACT processes (the abstract form per TODO.roadmap/02 — signature +
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# invariants, no steps), the TL-competence reference model the OIML-CS
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# delegates to (B 18:2025 §5.3): request_review (7.1) → method_selection
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# (7.2.1) → method_validation (7.2.2) → sampling (7.3) → item_handling
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# (7.4) → test_execution (the determination proper — Figure B.1's
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# "Calibration / test execution", recorded per 7.5.1) →
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# measurement_uncertainty (7.6) → validity_monitoring (7.7) → reporting
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# (7.8), with the off-sequence technical_records (7.5), complaint_handling
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# (7.9) and nonconforming_work (7.10).
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#
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# Fields follow the iso-iec-17065 functional-approach exemplar
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# (the iso-iec-17065 package's evaluation/functional-approach.prl):
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# roles the ISO/IEC 17025 functional actors — `customer` and
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# `laboratory` (3.6) — NOT the OIML-CS scheme roles.
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# signature CONCEPTUAL record stores of the lifecycle (test_requests,
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# method_records, …) — this package declares no entity classes;
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# the stores name the information flow, nothing resolves
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# against them (bare untyped store references — the kernel's
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# abstract-form signature grammar).
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# realized_by / approved_by — empty: the platform's concrete Core
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# processes realize the OIML-CS's OWN abstract model; the
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# OIML-CS↔17025 mapping lands in tasks 40–43. The documentary
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# halves here are the provisions bindings (every
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# /req/iso-17025/process/* provision binds to exactly one
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# abstract process — the R2 targeting exemption).
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#
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# activity_kind — the ISO/IEC 17000 activity-archetype register ids
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# (the iso-iec-17000 package's evaluation/activity-archetypes.prl; C58
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# resolves every id when the register is in scope — this package uses
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# iso-iec-17000). Per-process tagging decisions (folded up from the YAML
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# draft's body comments):
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# request_review / method_selection / item_handling → [selection] —
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# A.2 selection: collecting/producing the information, methods and
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# conditioned items the determination function needs.
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# method_validation → [validation] (6.5, a determination type per
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# 17000 A.3.2).
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# sampling → [sampling] (6.1, a selection-function activity per A.2).
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# NOTE: in OIML type evaluation the laboratory normally receives the
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# samples the Issuing Authority selects (OIML D 30, G.7.3.1-1/-2) —
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# this process is conditional on the laboratory itself sampling.
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# test_execution → [testing] (6.2) — the laboratory's core
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# determination activity.
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# measurement_uncertainty → [determination] (the A.3 parent function:
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# MU evaluation is integral to every determination — testing (7.6.3)
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# and calibration (7.6.2) alike — so the parent kind classifies it,
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# not the testing subtype).
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# validity_monitoring → [verification] — the 17000:2020 6.6 kind
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# ("confirmation of truthfulness through the provision of objective
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# evidence"), NOT the 17025 3.8 / VIM 2.44 metrology term of this
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# package's own vocabulary (the two standards' definitions genuinely
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# differ — the collision is documented in terminology.prl).
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# reporting → [review, declaration] — 7.8.1.1's results review and
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# authorization before release is the 17000 7.1 review kind; a report
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# carrying a 7.8.6 statement of conformity is a FIRST-PARTY
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# attestation (the laboratory states conformity of items it tested),
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# i.e. the 17000 7.5 declaration kind — explicitly NOT certification:
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# 7.8.7's Note distinguishes lab statements from product
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# certification per ISO/IEC 17065.
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# complaint_handling → [complaint] (8.7 — 17025 3.2 adopts the
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# 17000:2004 definition with the laboratory as addressee).
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# nonconforming_work → [review, decision] — the significance evaluation
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# reviews the laboratory's own determination results (incl. the
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# impact analysis); the acceptability decision concludes.
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# One deliberate non-tag: technical_records (7.5) — the record-keeping
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# discipline has no functional-approach activity kind (it produces no
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# selection/determination/review/decision/attestation/surveillance
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# outcome; same doctrine as the 17065 model's records process).
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#
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# ID-NAMESPACE NOTE: in a rec's composed effective tree this file
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# deep-merges with the iso-iec-17065 package's same-named twin (see
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# layer.yaml) — the two process lists union by id. Every id here is
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# deliberately disjoint from the 17065 set (application … complaints):
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# the 7.9 complaint process is complaint_handling, never complaints. The
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# process_model id likewise differs (test_lifecycle vs
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# functional_approach) — one composed model map, no overwrite.
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#
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# The clause-7 flow: request review → method selection → method
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# validation (conditional: non-standard/developed/out-of-scope/modified
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# methods only) → sampling (conditional: when the laboratory itself
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# samples — in OIML type evaluation the Issuing Authority selects, OIML
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# D 30 G.7.3.1) → item handling → test execution → MU evaluation →
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# validity monitoring → reporting. technical_records, complaint_handling
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# and nonconforming_work are off-sequence: the records discipline spans
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# every stage; complaints and nonconforming work may be initiated any
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# time after reporting.
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#
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# Provenance: ISO/IEC 17025:2017 (see layer.yaml editions.source); every
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# clause anchor verified against the source's [[sec_x.y]] anchors. Each
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# process's `source` block carries its clause-7 anchor as free-text doc
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# + empty clause (the consumer's YAML twin restores it as the
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+
# `reference:` citation verbatim).
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+
#
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+
# This file is the single source of truth; the consumer's
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+
# data/iso-iec-17025/evaluation/functional-approach.yaml is its GENERATED
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+
# YAML twin (cd browser && npm run gen:data; schema
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+
# data/schemas/abstract-processes.yaml).
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+
process request_review {
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103
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+
name "Review of requests, tenders and contracts"
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104
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+
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)."
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105
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+
validate_provision {
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106
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+
/req/iso-17025/process/request-review
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107
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+
/req/iso-17025/process/decision-rule
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+
}
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109
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+
signature {
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110
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+
out { test_requests }
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+
}
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112
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+
invariants {
|
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113
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+
"[test_request].requirements_defined = true"
|
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114
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+
"[test_request].conformity_statement_requested = true implies [test_request].decision_rule is not null"
|
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115
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+
}
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116
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+
activity_kind { selection }
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117
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+
roles { customer laboratory }
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118
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+
evidence {
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119
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+
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 }
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+
}
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121
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+
executor actor
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122
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+
source { doc "ISO/IEC 17025:2017, 7.1" clause "" }
|
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123
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+
}
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124
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+
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125
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+
process method_selection {
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126
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+
name "Selection and verification of methods"
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127
|
+
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)."
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+
validate_provision {
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129
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+
/req/iso-17025/process/method-selection
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130
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+
/req/iso-17025/process/method-verification
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+
}
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+
signature {
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133
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+
in { test_requests }
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134
|
+
out { method_records }
|
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135
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+
}
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136
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+
invariants {
|
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137
|
+
"[method_record].verified_before_introduction = true"
|
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138
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+
"[method_record].deviations->forAll(d | d.authorized = true and d.customer_accepted = true)"
|
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|
+
}
|
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140
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+
activity_kind { selection }
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141
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+
roles { laboratory }
|
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142
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+
evidence {
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143
|
+
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 }
|
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144
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+
}
|
|
145
|
+
executor actor
|
|
146
|
+
source { doc "ISO/IEC 17025:2017, 7.2.1" clause "" }
|
|
147
|
+
}
|
|
148
|
+
|
|
149
|
+
process method_validation {
|
|
150
|
+
name "Validation of methods"
|
|
151
|
+
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."
|
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152
|
+
validate_provision {
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153
|
+
/req/iso-17025/process/method-validation
|
|
154
|
+
}
|
|
155
|
+
signature {
|
|
156
|
+
in { method_records }
|
|
157
|
+
out { validation_records }
|
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158
|
+
}
|
|
159
|
+
invariants {
|
|
160
|
+
"[validation_record].validity_statement is not null"
|
|
161
|
+
}
|
|
162
|
+
activity_kind { validation }
|
|
163
|
+
roles { laboratory }
|
|
164
|
+
evidence {
|
|
165
|
+
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 }
|
|
166
|
+
}
|
|
167
|
+
executor actor
|
|
168
|
+
source { doc "ISO/IEC 17025:2017, 7.2.2" clause "" }
|
|
169
|
+
}
|
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170
|
+
|
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171
|
+
process sampling {
|
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172
|
+
name "Sampling"
|
|
173
|
+
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."
|
|
174
|
+
validate_provision {
|
|
175
|
+
/req/iso-17025/process/sampling-plan
|
|
176
|
+
/req/iso-17025/process/sampling-records
|
|
177
|
+
}
|
|
178
|
+
signature {
|
|
179
|
+
in { test_requests }
|
|
180
|
+
out { sample_records }
|
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+
}
|
|
182
|
+
invariants {
|
|
183
|
+
"[sample_record].sampling_method_ref is not null"
|
|
184
|
+
}
|
|
185
|
+
activity_kind { sampling }
|
|
186
|
+
roles { laboratory }
|
|
187
|
+
evidence {
|
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188
|
+
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." }
|
|
189
|
+
}
|
|
190
|
+
executor actor
|
|
191
|
+
source { doc "ISO/IEC 17025:2017, 7.3" clause "" }
|
|
192
|
+
}
|
|
193
|
+
|
|
194
|
+
process item_handling {
|
|
195
|
+
name "Handling of test or calibration items"
|
|
196
|
+
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)."
|
|
197
|
+
validate_provision {
|
|
198
|
+
/req/iso-17025/process/item-handling
|
|
199
|
+
/req/iso-17025/process/item-receipt-storage
|
|
200
|
+
}
|
|
201
|
+
signature {
|
|
202
|
+
in { sample_records }
|
|
203
|
+
out { item_records }
|
|
204
|
+
}
|
|
205
|
+
invariants {
|
|
206
|
+
"[item_record].identification is not null"
|
|
207
|
+
"[item_record].receipt_deviations_recorded = true"
|
|
208
|
+
}
|
|
209
|
+
activity_kind { selection }
|
|
210
|
+
roles { laboratory }
|
|
211
|
+
evidence {
|
|
212
|
+
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 }
|
|
213
|
+
}
|
|
214
|
+
executor actor
|
|
215
|
+
source { doc "ISO/IEC 17025:2017, 7.4" clause "" }
|
|
216
|
+
}
|
|
217
|
+
|
|
218
|
+
process test_execution {
|
|
219
|
+
name "Test / calibration execution"
|
|
220
|
+
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)."
|
|
221
|
+
validate_provision {
|
|
222
|
+
/req/iso-17025/process/activity-records
|
|
223
|
+
}
|
|
224
|
+
signature {
|
|
225
|
+
in { item_records method_records }
|
|
226
|
+
out { technical_records }
|
|
227
|
+
}
|
|
228
|
+
invariants {
|
|
229
|
+
"[technical_record].original_observations_recorded_when_made = true"
|
|
230
|
+
"[technical_record].responsible_personnel is not null"
|
|
231
|
+
}
|
|
232
|
+
activity_kind { testing }
|
|
233
|
+
roles { laboratory }
|
|
234
|
+
evidence {
|
|
235
|
+
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 }
|
|
236
|
+
}
|
|
237
|
+
executor actor
|
|
238
|
+
source { doc "ISO/IEC 17025:2017, 7.5.1 (Figure B.1 — calibration / test execution)" clause "" }
|
|
239
|
+
}
|
|
240
|
+
|
|
241
|
+
process measurement_uncertainty {
|
|
242
|
+
name "Evaluation of measurement uncertainty"
|
|
243
|
+
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)."
|
|
244
|
+
validate_provision {
|
|
245
|
+
/req/iso-17025/process/measurement-uncertainty
|
|
246
|
+
}
|
|
247
|
+
signature {
|
|
248
|
+
in { technical_records }
|
|
249
|
+
out { mu_evaluations }
|
|
250
|
+
}
|
|
251
|
+
invariants {
|
|
252
|
+
"[mu_evaluation].contributions.count >= 1"
|
|
253
|
+
}
|
|
254
|
+
activity_kind { determination }
|
|
255
|
+
roles { laboratory }
|
|
256
|
+
evidence {
|
|
257
|
+
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 }
|
|
258
|
+
}
|
|
259
|
+
executor actor
|
|
260
|
+
source { doc "ISO/IEC 17025:2017, 7.6" clause "" }
|
|
261
|
+
}
|
|
262
|
+
|
|
263
|
+
process validity_monitoring {
|
|
264
|
+
name "Ensuring the validity of results"
|
|
265
|
+
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)."
|
|
266
|
+
validate_provision {
|
|
267
|
+
/req/iso-17025/process/validity-of-results
|
|
268
|
+
}
|
|
269
|
+
signature {
|
|
270
|
+
in { technical_records mu_evaluations }
|
|
271
|
+
out { validity_records }
|
|
272
|
+
}
|
|
273
|
+
invariants {
|
|
274
|
+
"[validity_record].out_of_criteria = true implies [validity_record].action_taken is not null"
|
|
275
|
+
}
|
|
276
|
+
activity_kind { verification }
|
|
277
|
+
roles { laboratory }
|
|
278
|
+
evidence {
|
|
279
|
+
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 }
|
|
280
|
+
}
|
|
281
|
+
executor actor
|
|
282
|
+
source { doc "ISO/IEC 17025:2017, 7.7" clause "" }
|
|
283
|
+
}
|
|
284
|
+
|
|
285
|
+
process reporting {
|
|
286
|
+
name "Reporting of results"
|
|
287
|
+
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)."
|
|
288
|
+
validate_provision {
|
|
289
|
+
/req/iso-17025/process/results-review-release
|
|
290
|
+
/req/iso-17025/process/report-common-content
|
|
291
|
+
/req/iso-17025/process/test-report-content
|
|
292
|
+
/req/iso-17025/process/conformity-statements
|
|
293
|
+
/req/iso-17025/process/opinions-interpretations
|
|
294
|
+
/req/iso-17025/process/report-amendments
|
|
295
|
+
}
|
|
296
|
+
signature {
|
|
297
|
+
in { technical_records mu_evaluations }
|
|
298
|
+
out { test_reports }
|
|
299
|
+
}
|
|
300
|
+
invariants {
|
|
301
|
+
"[test_report].reviewed_and_authorized = true"
|
|
302
|
+
"[test_report].carries_conformity_statement = true implies [test_report].decision_rule is not null"
|
|
303
|
+
"[test_report].opinions.count > 0 implies [test_report].opinion_authorizer.authorized_for_opinions = true"
|
|
304
|
+
}
|
|
305
|
+
activity_kind { review declaration }
|
|
306
|
+
roles { laboratory }
|
|
307
|
+
evidence {
|
|
308
|
+
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 }
|
|
309
|
+
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)." }
|
|
310
|
+
}
|
|
311
|
+
executor actor
|
|
312
|
+
source { doc "ISO/IEC 17025:2017, 7.8" clause "" }
|
|
313
|
+
}
|
|
314
|
+
|
|
315
|
+
process technical_records {
|
|
316
|
+
name "Technical records"
|
|
317
|
+
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)."
|
|
318
|
+
validate_provision {
|
|
319
|
+
/req/iso-17025/process/record-amendments
|
|
320
|
+
}
|
|
321
|
+
signature {
|
|
322
|
+
in { technical_records test_reports }
|
|
323
|
+
out { records_register }
|
|
324
|
+
}
|
|
325
|
+
invariants {
|
|
326
|
+
"[amendment].previous_version_ref is not null"
|
|
327
|
+
}
|
|
328
|
+
roles { laboratory }
|
|
329
|
+
evidence {
|
|
330
|
+
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 }
|
|
331
|
+
}
|
|
332
|
+
executor actor
|
|
333
|
+
source { doc "ISO/IEC 17025:2017, 7.5" clause "" }
|
|
334
|
+
}
|
|
335
|
+
|
|
336
|
+
process complaint_handling {
|
|
337
|
+
name "Complaints"
|
|
338
|
+
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)."
|
|
339
|
+
validate_provision {
|
|
340
|
+
/req/iso-17025/process/complaints
|
|
341
|
+
}
|
|
342
|
+
signature {
|
|
343
|
+
in { test_reports }
|
|
344
|
+
out { complaint_records }
|
|
345
|
+
}
|
|
346
|
+
invariants {
|
|
347
|
+
"[complaint_record].outcome_reviewer_involved_in_original_activity = false"
|
|
348
|
+
}
|
|
349
|
+
activity_kind { complaint }
|
|
350
|
+
roles { laboratory }
|
|
351
|
+
evidence {
|
|
352
|
+
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 }
|
|
353
|
+
}
|
|
354
|
+
executor actor
|
|
355
|
+
source { doc "ISO/IEC 17025:2017, 7.9" clause "" }
|
|
356
|
+
}
|
|
357
|
+
|
|
358
|
+
process nonconforming_work {
|
|
359
|
+
name "Nonconforming work"
|
|
360
|
+
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)."
|
|
361
|
+
validate_provision {
|
|
362
|
+
/req/iso-17025/process/nonconforming-work
|
|
363
|
+
}
|
|
364
|
+
signature {
|
|
365
|
+
in { technical_records test_reports }
|
|
366
|
+
out { nonconformity_records }
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}
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invariants {
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"[nonconformity_record].acceptability_decision is not null"
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}
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activity_kind { review decision }
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roles { laboratory }
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evidence {
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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 }
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}
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executor actor
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source { doc "ISO/IEC 17025:2017, 7.10" clause "" }
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}
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process_model test_lifecycle {
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sequence { request_review method_selection method_validation sampling item_handling test_execution measurement_uncertainty validity_monitoring reporting }
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}
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# ISO/IEC 17065 REFERENCE PACKAGE — THE FUNCTIONAL APPROACH AS ABSTRACT
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# PROCESSES (ISO/IEC 17065:2012, clause 7; TODO.roadmap/39, sub-task 39b)
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# -----------------------------------------------------------------------------
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# The ISO/IEC 17065:2012 certification process (clause 7) as ABSTRACT
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# processes (the abstract form per TODO.roadmap/02 — signature +
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# invariants, no steps), the IA-competence reference model the OIML-CS
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# delegates to (B 18:2025 §5.2): application (7.2) → application_review
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# (7.3) → evaluation (7.4) → review (7.5) → decision (7.6) → attestation
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# (7.7 + the 7.8 directory) → surveillance (7.9), with the off-sequence
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# lifecycle processes changes (7.10), termination (7.11), records (7.12)
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# and complaints (7.13).
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#
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# Fields follow the oiml-cs abstract process model
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# (data/oiml-cs/evaluation/abstract-processes.yaml) with three deliberate
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# differences:
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# roles the ISO/IEC 17065 functional actors — `client` (3.1) and
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# `certification_body` (3.12) — NOT the OIML-CS scheme roles;
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# the functional PERSONNEL sets the segregation constraints
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# quantify over (evaluation/review/decision/complaint-
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# resolution personnel, 6.1.2 d)) are identified by the
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# processes themselves (see segregation below).
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# signature CONCEPTUAL record stores of the functional approach
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# (certification_applications, evaluation_results, …) — this
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# package declares no entity classes; the stores name the
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# information flow, nothing resolves against them (bare
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# untyped store references — the kernel's abstract-form
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# signature grammar).
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# realized_by / approved_by — empty: the platform's concrete Core
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# processes realize the OIML-CS's OWN abstract model; the
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# OIML-CS↔17065 mapping lands in tasks 40–43. The
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# documentary halves here are the provisions bindings
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# (every /req/iso-17065/process/* provision binds to exactly
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# one abstract process — the R2 targeting exemption; C5
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# counts a validate_provision'd requirement as covered).
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#
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# activity_kind — the ISO/IEC 17000 activity-archetype register ids
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# (the iso-iec-17000 package's evaluation/activity-archetypes.prl; C58
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# resolves every id when the register is in scope — this package uses
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# iso-iec-17000). Multi-kind per the standard's own definitions:
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# evaluation = selection + determination (17065 3.3). Per-process tagging
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# rationales (folded up from the YAML draft's body comments):
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# application / application_review → [selection] — A.2 selection: the
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# client (resp. the body) collects/produces all information and input
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# needed for the subsequent determination function; the review is NOT
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# 17000 7.1 review — no determination results exist yet to consider.
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# evaluation → [selection, determination] — the canonical multi-kind
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# case (17065 3.3).
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# review → [review]; decision → [decision] (NOTE the deliberate
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# NON-constraint below); attestation → [certification] (7.6 — the
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# formal certification documentation is third-party attestation
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# related to the product); surveillance → [surveillance] (8.1).
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# changes → [decision, certification] — a change re-decides and may
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# re-issue documentation; the evaluation/review legs are the
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# delegated 7.4/7.5 processes (7.10.3).
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# termination → [suspension, withdrawal] (8.2/8.3) — termination by
|
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# client request and scope reduction have no dedicated archetype.
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# complaints → [complaint, appeal] (8.7/8.6).
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# One deliberate non-tag: records (7.12) — the record-keeping obligation
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# has no functional-approach activity kind (it produces no
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# selection/determination/review/decision/attestation/surveillance
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# outcome).
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#
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# ═══ ROLE SEGREGATION (the `segregation` facet — TODO.roadmap/39b) ═══
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# The clause-7 non-involvement constraints are FIRST-CLASS structured
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# declarations, machine-checked package-side by the kernel's C59
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# segregation-members-resolve (the consumer's linker R24 mirrors it).
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# They are NOT stated as `invariants` because that mechanism cannot check
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# them: the linker never parses invariant strings (they are opaque
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# documentation over one process's own signature records), while
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# segregation is a CROSS-process relation over PERSONNEL SETS, per case.
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# Members are abstract-process ids — a member names that process's
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# personnel set for the case at hand — with ONE reserved token:
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# case_personnel — the personnel involved in the certification
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# activities of the case the complaint relates to (7.13.5's
|
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# case-relative set; no static process pair can name it).
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# Roles are NOT used as members: the consuming scheme binds ONE role
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# (issuing_authority) to evaluation, review AND decision, so role-level
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# disjointness is both unsatisfiable and unfaithful — the norms quantify
|
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# over process INVOLVEMENT (7.5.1 "not been involved in the evaluation
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# process"; 7.6.2 "not been involved in the process for evaluation";
|
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# 7.13.5 "not involved in the certification activities related to the
|
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# complaint or appeal"). The verbatim norms behind the constraints:
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# 7.5.1: "The review shall be carried out by person(s) who have not
|
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# been involved in the evaluation process."
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# 7.6.2: "The certification decision shall be carried out by a person
|
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# or group of persons … that has not been involved in the process
|
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# for evaluation (see 7.4)."
|
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# 7.13.5: "The decision resolving the complaint or appeal shall be
|
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# made by, or reviewed and approved by, person(s) not involved in
|
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# the certification activities related to the complaint or appeal."
|
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# 7.13.6: "personnel (including those acting in a managerial capacity)
|
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+
# who have provided consultancy for a client, or been employed by a
|
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# client, shall not be used … to review or approve the resolution of
|
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# a complaint or appeal for that client within two years following
|
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# the end of the consultancy or employment." (the fixed P2Y period)
|
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# 4.2.10: the general consultancy bar on review/decision personnel —
|
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# the period is body-specified here (the standard's NOTE records
|
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# that two years is often used), so those constraints carry none.
|
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+
# Kinds (the C59 kind-conditional shapes):
|
|
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+
# case_personnel_disjoint — within one certification case, the two
|
|
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# processes' personnel sets are disjoint (pair of exactly two
|
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# distinct members; the constrained process owns its constraints —
|
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# one pair member is the declaring process).
|
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# consultancy_bar — personnel barred from a process for a period after
|
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# a consultancy/employment relation with the client (barred list
|
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# required; period ISO-8601 only when the standard fixes it).
|
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# NOTE the deliberate NON-constraint: review and decision personnel need
|
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# NOT be disjoint from each other — 7.5.2 and 7.6.2 (Note) allow the
|
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+
# review and the certification decision to be completed concurrently by
|
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+
# the same person or group. No segregation entry separates review from
|
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+
# decision.
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+
# Runtime (per-assignment) enforcement is platform task 44 — this file is
|
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+
# the declarative model + static checks.
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+
#
|
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# The sequence: application → application review → evaluation → review →
|
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+
# decision → attestation, with surveillance where the scheme (or
|
|
117
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+
# continued mark use) requires it. The lifecycle processes (changes,
|
|
118
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+
# termination, records, complaints) are off-sequence — they may be
|
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+
# initiated any time after attestation (mirroring the oiml-cs model's
|
|
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+
# revision convention).
|
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+
#
|
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122
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+
# Provenance: ISO/IEC 17065:2012 (see layer.yaml editions.source);
|
|
123
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+
# subclause numbering per the corpus audit (analysis/
|
|
124
|
+
# oiml-cs-corpus-audit-2026-07.md, Corpus D §1.2) verified against the
|
|
125
|
+
# in-source cross-references. Each process's `source` block carries its
|
|
126
|
+
# clause-7 anchor as free-text doc + empty clause (the consumer's YAML
|
|
127
|
+
# twin restores it as the `reference:` citation verbatim).
|
|
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|
+
#
|
|
129
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+
# This file is the single source of truth; the consumer's
|
|
130
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+
# data/iso-iec-17065/evaluation/functional-approach.yaml is its GENERATED
|
|
131
|
+
# YAML twin (cd browser && npm run gen:data; schema
|
|
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|
+
# data/schemas/abstract-processes.yaml).
|
|
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+
process application {
|
|
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+
name "Application"
|
|
135
|
+
summary "The certification body obtains all the information needed to complete the certification process in accordance with the relevant certification scheme: the product(s) to be certified, the normative documents sought, the client's features, outsourced processes affecting conformity, and the information needed for initial evaluation and surveillance."
|
|
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+
validate_provision {
|
|
137
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+
/req/iso-17065/process/application-information
|
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+
}
|
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139
|
+
signature {
|
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+
out { certification_applications }
|
|
141
|
+
}
|
|
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|
+
invariants {
|
|
143
|
+
"[certification_application].product_identification is not null"
|
|
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|
+
"[certification_application].normative_documents.count >= 1"
|
|
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|
+
}
|
|
146
|
+
activity_kind { selection }
|
|
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|
+
roles { client }
|
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|
+
evidence {
|
|
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|
+
application_record { description "The application record: product(s) to be certified, standards and/or other normative documents sought (7.1.2), client features (name, locations, significant process/operation aspects where the scheme requires, legal obligations), outsourced processes affecting conformity, and the information needed for initial evaluation and surveillance (7.2 Note 1)." required true }
|
|
150
|
+
}
|
|
151
|
+
executor actor
|
|
152
|
+
source { doc "ISO/IEC 17065:2012, 7.2" clause "" }
|
|
153
|
+
}
|
|
154
|
+
|
|
155
|
+
process application_review {
|
|
156
|
+
name "Application review"
|
|
157
|
+
summary "The certification body reviews the application information for sufficiency, resolves differences in understanding, defines the scope of certification sought, and confirms the means, competence and capability to perform the certification activity — declining the certification when any competence or capability is lacking (7.3.4), and recording the justification for undertaking no-prior-experience certifications (7.3.3)."
|
|
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|
+
validate_provision {
|
|
159
|
+
/req/iso-17065/process/application-review
|
|
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|
+
/req/iso-17065/process/decline-without-competence
|
|
161
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+
}
|
|
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|
+
signature {
|
|
163
|
+
in { certification_applications }
|
|
164
|
+
out { certification_applications }
|
|
165
|
+
}
|
|
166
|
+
invariants {
|
|
167
|
+
"[certification_application].scope_of_certification is not null"
|
|
168
|
+
"[certification_application].declined = true implies [certification_application].decline_reason is not null"
|
|
169
|
+
}
|
|
170
|
+
activity_kind { selection }
|
|
171
|
+
roles { certification_body }
|
|
172
|
+
evidence {
|
|
173
|
+
application_review_record { description "The review record: sufficiency of information (7.3.1 a), resolved differences (b), the defined scope of certification (c), means/competence/capability confirmation (d/e), and — for no-prior-experience requests — the justification record (7.3.3) or the decline decision (7.3.4)." required true }
|
|
174
|
+
}
|
|
175
|
+
executor actor
|
|
176
|
+
source { doc "ISO/IEC 17065:2012, 7.3" clause "" }
|
|
177
|
+
}
|
|
178
|
+
|
|
179
|
+
process evaluation {
|
|
180
|
+
name "Evaluation"
|
|
181
|
+
summary "The certification body plans the evaluation activities, assigns personnel to each evaluation task it undertakes with internal resources (outsourced tasks per 6.2.2), provides the necessary information and documentation, and carries out the evaluation against the requirements covered by the scope of certification — informing the client of all nonconformities and documenting all results prior to review (7.4.9)."
|
|
182
|
+
validate_provision {
|
|
183
|
+
/req/iso-17065/process/evaluation-plan
|
|
184
|
+
/req/iso-17065/process/evaluation-results
|
|
185
|
+
}
|
|
186
|
+
signature {
|
|
187
|
+
in { certification_applications }
|
|
188
|
+
out { evaluation_plans evaluation_results }
|
|
189
|
+
}
|
|
190
|
+
invariants {
|
|
191
|
+
"[evaluation_results].documented_prior_to_review = true"
|
|
192
|
+
"[evaluation_task].assigned_personnel.count >= 1"
|
|
193
|
+
}
|
|
194
|
+
activity_kind { selection determination }
|
|
195
|
+
roles { certification_body }
|
|
196
|
+
evidence {
|
|
197
|
+
evaluation_plan { description "The plan for the evaluation activities (7.4.1) with the per-task personnel assignments (7.4.2)." required true }
|
|
198
|
+
evaluation_results_record { description "The documented results of all evaluation activities (7.4.9), produced prior to review, with the record of nonconformities communicated to the client (7.4.6) and any additional-task cycle (7.4.7/7.4.8)." required true }
|
|
199
|
+
}
|
|
200
|
+
executor actor
|
|
201
|
+
source { doc "ISO/IEC 17065:2012, 7.4" clause "" }
|
|
202
|
+
}
|
|
203
|
+
|
|
204
|
+
process review {
|
|
205
|
+
name "Review"
|
|
206
|
+
summary "The certification body assigns at least one person to review all information and results related to the evaluation — carried out by person(s) who have NOT been involved in the evaluation process (7.5.1) — and documents the recommendations for the certification decision (unless review and decision are completed concurrently by the same person, 7.5.2)."
|
|
207
|
+
validate_provision {
|
|
208
|
+
/req/iso-17065/process/review-independence
|
|
209
|
+
}
|
|
210
|
+
signature {
|
|
211
|
+
in { evaluation_results }
|
|
212
|
+
out { review_records }
|
|
213
|
+
}
|
|
214
|
+
invariants {
|
|
215
|
+
"[review_record].reviewer_ids.count >= 1"
|
|
216
|
+
"[review_record].recommendation is not null"
|
|
217
|
+
}
|
|
218
|
+
activity_kind { review }
|
|
219
|
+
roles { certification_body }
|
|
220
|
+
evidence {
|
|
221
|
+
review_record { description "The review record over all evaluation information and results, with the assigned reviewer(s) and the documented recommendation for the certification decision (7.5.2)." required true }
|
|
222
|
+
}
|
|
223
|
+
segregation {
|
|
224
|
+
constraint review_not_evaluation {
|
|
225
|
+
kind case_personnel_disjoint
|
|
226
|
+
clause "7.5.1"
|
|
227
|
+
pair { review evaluation }
|
|
228
|
+
statement "Within one certification case, the personnel assigned to the review shall not have been involved in the evaluation process for that case (ISO/IEC 17065:2012, 7.5.1)."
|
|
229
|
+
}
|
|
230
|
+
constraint review_consultancy_bar {
|
|
231
|
+
kind consultancy_bar
|
|
232
|
+
clause "4.2.10"
|
|
233
|
+
barred { consultancy }
|
|
234
|
+
statement "Within a period specified by the certification body, personnel shall not be used to review a product for which they have provided consultancy (ISO/IEC 17065:2012, 4.2.10; a specified period of two years is often used)."
|
|
235
|
+
}
|
|
236
|
+
}
|
|
237
|
+
executor actor
|
|
238
|
+
source { doc "ISO/IEC 17065:2012, 7.5" clause "" }
|
|
239
|
+
}
|
|
240
|
+
|
|
241
|
+
process decision {
|
|
242
|
+
name "Certification decision"
|
|
243
|
+
summary "The certification body — retaining responsibility and authority for its certification decisions (7.6.1) — assigns at least one person to make the certification decision based on all information related to the evaluation, its review, and any other relevant information, by person(s) who have NOT been involved in the evaluation (7.6.2), and notifies the client of a decision not to grant certification with the reasons (7.6.6)."
|
|
244
|
+
validate_provision {
|
|
245
|
+
/req/iso-17065/process/decision-independence
|
|
246
|
+
/req/iso-17065/process/decision-employment
|
|
247
|
+
}
|
|
248
|
+
signature {
|
|
249
|
+
in { evaluation_results review_records }
|
|
250
|
+
out { decision_records }
|
|
251
|
+
}
|
|
252
|
+
invariants {
|
|
253
|
+
"[decision_record].decider_ids.count >= 1"
|
|
254
|
+
"[decision_record].granted = false implies [decision_record].reasons is not null"
|
|
255
|
+
}
|
|
256
|
+
activity_kind { decision }
|
|
257
|
+
roles { certification_body }
|
|
258
|
+
evidence {
|
|
259
|
+
decision_record { description "The certification-decision record: the assigned decision person(s) or committee (5.1.4), the decision, and — on a decision not to grant — the reasons identified to the client (7.6.6)." required true }
|
|
260
|
+
}
|
|
261
|
+
segregation {
|
|
262
|
+
constraint decision_not_evaluation {
|
|
263
|
+
kind case_personnel_disjoint
|
|
264
|
+
clause "7.6.2"
|
|
265
|
+
pair { decision evaluation }
|
|
266
|
+
statement "Within one certification case, the personnel making the certification decision shall not have been involved in the process for evaluation for that case (ISO/IEC 17065:2012, 7.6.2)."
|
|
267
|
+
}
|
|
268
|
+
constraint decision_consultancy_bar {
|
|
269
|
+
kind consultancy_bar
|
|
270
|
+
clause "4.2.10"
|
|
271
|
+
barred { consultancy }
|
|
272
|
+
statement "Within a period specified by the certification body, personnel shall not be used to make a certification decision for a product for which they have provided consultancy (ISO/IEC 17065:2012, 4.2.10; a specified period of two years is often used)."
|
|
273
|
+
}
|
|
274
|
+
}
|
|
275
|
+
executor actor
|
|
276
|
+
source { doc "ISO/IEC 17065:2012, 7.6" clause "" }
|
|
277
|
+
}
|
|
278
|
+
|
|
279
|
+
process attestation {
|
|
280
|
+
name "Attestation (certification documentation + directory)"
|
|
281
|
+
summary "The certification body issues the formal certification documentation — only after, or concurrent with, the certification decision, fulfilled certification requirements, and the completed/signed certification agreement (7.7.3) — conveying the body, grant date (never preceding the decision date), client, scope of certification, term/expiry and scheme-required information (7.7.1), signed or otherwise authorized (7.7.2); and maintains the directory information on certified products (7.8)."
|
|
282
|
+
validate_provision {
|
|
283
|
+
/req/iso-17065/process/certification-documentation
|
|
284
|
+
/req/iso-17065/process/attestation-preconditions
|
|
285
|
+
/req/iso-17065/process/directory
|
|
286
|
+
}
|
|
287
|
+
signature {
|
|
288
|
+
in { decision_records }
|
|
289
|
+
out { certification_documents certified_product_directory }
|
|
290
|
+
}
|
|
291
|
+
invariants {
|
|
292
|
+
"[certification_document].date_granted >= [decision_record].decision_date"
|
|
293
|
+
"[certification_document].scope_of_certification is not null"
|
|
294
|
+
}
|
|
295
|
+
activity_kind { certification }
|
|
296
|
+
roles { certification_body }
|
|
297
|
+
evidence {
|
|
298
|
+
certification_document { description "The formal certification documentation with the 7.7.1 a–f content and the signature or defined authorization of the assigned person(s) (7.7.2)." required true }
|
|
299
|
+
issuance_preconditions_record { description "Evidence the 7.7.3 preconditions held at issuance: the grant/extension decision made, certification requirements fulfilled, the certification agreement completed/signed." required true }
|
|
300
|
+
directory_record { description "The maintained certified-product information (product, normative documents, client — 7.8.1) with validity information provided on request (7.8.2)." }
|
|
301
|
+
}
|
|
302
|
+
executor actor
|
|
303
|
+
source { doc "ISO/IEC 17065:2012, 7.7, 7.8" clause "" }
|
|
304
|
+
}
|
|
305
|
+
|
|
306
|
+
process surveillance {
|
|
307
|
+
name "Surveillance"
|
|
308
|
+
summary "Where the certification scheme requires surveillance (or 7.9.3 / 7.9.4 requires it), the certification body initiates surveillance of the certified product(s) in accordance with the scheme — mandatory periodic surveillance wherever a certification mark continues in use — fulfilling 7.4/7.5/7.6 whenever surveillance utilizes evaluation, review or a certification decision (7.9.2)."
|
|
309
|
+
validate_provision {
|
|
310
|
+
/req/iso-17065/process/surveillance
|
|
311
|
+
/req/iso-17065/process/surveillance-marked-products
|
|
312
|
+
}
|
|
313
|
+
signature {
|
|
314
|
+
in { certification_documents }
|
|
315
|
+
out { surveillance_records }
|
|
316
|
+
}
|
|
317
|
+
invariants {
|
|
318
|
+
"[certification_document].mark_in_continued_use = true implies [surveillance_record].periodic = true"
|
|
319
|
+
}
|
|
320
|
+
activity_kind { surveillance }
|
|
321
|
+
roles { certification_body }
|
|
322
|
+
evidence {
|
|
323
|
+
surveillance_record { description "The surveillance record per the scheme-defined criteria and process (7.9.1 Note 2), including the periodic surveillance of marked products where mark use continues (7.9.3/7.9.4)." required true }
|
|
324
|
+
}
|
|
325
|
+
executor actor
|
|
326
|
+
source { doc "ISO/IEC 17065:2012, 7.9" clause "" }
|
|
327
|
+
}
|
|
328
|
+
|
|
329
|
+
process changes {
|
|
330
|
+
name "Changes affecting certification"
|
|
331
|
+
summary "The certification body communicates new or revised scheme requirements to all clients and verifies their implementation (7.10.1), considers other changes affecting certification (including client-initiated ones, 7.10.2) and decides upon the appropriate action — re-entering evaluation, review, decision and re-issuance as required, with the rationale for exclusions recorded (7.10.3)."
|
|
332
|
+
validate_provision {
|
|
333
|
+
/req/iso-17065/process/changes
|
|
334
|
+
}
|
|
335
|
+
signature {
|
|
336
|
+
in { certification_documents }
|
|
337
|
+
out { change_records certification_documents }
|
|
338
|
+
}
|
|
339
|
+
invariants {
|
|
340
|
+
"[change_record].decided_action is not null"
|
|
341
|
+
}
|
|
342
|
+
activity_kind { decision certification }
|
|
343
|
+
roles { certification_body }
|
|
344
|
+
evidence {
|
|
345
|
+
change_record { description "The change record: the scheme-change communication and implementation verification (7.10.1), the action decided (7.10.2), and the rationale for any excluded 7.4–7.8 activity (7.10.3)." required true }
|
|
346
|
+
}
|
|
347
|
+
executor actor
|
|
348
|
+
source { doc "ISO/IEC 17065:2012, 7.10" clause "" }
|
|
349
|
+
}
|
|
350
|
+
|
|
351
|
+
process termination {
|
|
352
|
+
name "Termination, reduction, suspension or withdrawal of certification"
|
|
353
|
+
summary "On a substantiated nonconformity with certification requirements, the certification body considers and decides the appropriate action — continuation under conditions, scope reduction, suspension or withdrawal (7.11.1) — applying 7.4/7.5/7.6 when the action re-enters them (7.11.2), and makes all necessary modifications to certification documents, public information and mark authorizations so nothing indicates continued certification (7.11.3), with suspension-restoration communication (7.11.4–7.11.6) and reinstatement modifications (7.11.7)."
|
|
354
|
+
validate_provision {
|
|
355
|
+
/req/iso-17065/process/termination
|
|
356
|
+
}
|
|
357
|
+
signature {
|
|
358
|
+
in { certification_documents surveillance_records }
|
|
359
|
+
out { termination_records certification_documents }
|
|
360
|
+
}
|
|
361
|
+
invariants {
|
|
362
|
+
"[termination_record].action is not null"
|
|
363
|
+
"[termination_record].action = 'SUSPENSION' implies [termination_record].restoration_actions is not null"
|
|
364
|
+
}
|
|
365
|
+
activity_kind { suspension withdrawal }
|
|
366
|
+
roles { certification_body }
|
|
367
|
+
evidence {
|
|
368
|
+
termination_record { description "The termination/reduction/suspension/withdrawal record: the substantiated nonconformity, the action decided, and the modifications to documents, public information and mark authorizations (7.11.3); for suspensions, the restoration actions communicated to the client (7.11.4)." required true }
|
|
369
|
+
}
|
|
370
|
+
executor actor
|
|
371
|
+
source { doc "ISO/IEC 17065:2012, 7.11" clause "" }
|
|
372
|
+
}
|
|
373
|
+
|
|
374
|
+
process records {
|
|
375
|
+
name "Records"
|
|
376
|
+
summary "The certification body retains records demonstrating that all certification process requirements (this International Standard and the scheme's) have been effectively fulfilled, keeps them confidential in transport, transmission and transfer, and retains them at least for the current and previous re-evaluation cycle where the scheme re-evaluates within a determined cycle."
|
|
377
|
+
validate_provision {
|
|
378
|
+
/req/iso-17065/process/records
|
|
379
|
+
}
|
|
380
|
+
signature {
|
|
381
|
+
in { certification_applications evaluation_results review_records decision_records certification_documents }
|
|
382
|
+
out { certification_records }
|
|
383
|
+
}
|
|
384
|
+
invariants {
|
|
385
|
+
"[certification_records].retention_period is not null"
|
|
386
|
+
}
|
|
387
|
+
roles { certification_body }
|
|
388
|
+
evidence {
|
|
389
|
+
records_register { description "The certification-process records with their retention period (at least current + previous cycle where 7.12.3 applies) and confidentiality handling (7.12.2)." required true }
|
|
390
|
+
}
|
|
391
|
+
executor actor
|
|
392
|
+
source { doc "ISO/IEC 17065:2012, 7.12" clause "" }
|
|
393
|
+
}
|
|
394
|
+
|
|
395
|
+
process complaints {
|
|
396
|
+
name "Complaints and appeals"
|
|
397
|
+
summary "The certification body receives, evaluates and decides complaints and appeals under a documented process — confirming relevance, acknowledging receipt, gathering and verifying the information — with the resolving decision made by, or reviewed and approved by, person(s) NOT involved in the related certification activities (7.13.5) and never by personnel within two years of consultancy for or employment by that client (7.13.6), and gives formal notice of the outcome (7.13.7/7.13.8)."
|
|
398
|
+
validate_provision {
|
|
399
|
+
/req/iso-17065/process/complaints-process
|
|
400
|
+
/req/iso-17065/process/complaint-resolution-independence
|
|
401
|
+
/req/iso-17065/process/complaint-consultancy-bar
|
|
402
|
+
}
|
|
403
|
+
signature {
|
|
404
|
+
in { certification_documents certification_records }
|
|
405
|
+
out { complaint_records }
|
|
406
|
+
}
|
|
407
|
+
invariants {
|
|
408
|
+
"[complaint_record].acknowledged = true"
|
|
409
|
+
"[complaint_record].resolution_decider_ids.count >= 1"
|
|
410
|
+
}
|
|
411
|
+
activity_kind { complaint appeal }
|
|
412
|
+
roles { certification_body }
|
|
413
|
+
evidence {
|
|
414
|
+
complaint_record { description "The complaint/appeal record: receipt acknowledgement (7.13.3), the gathered and verified information (7.13.4), the resolving decision with its maker/reviewer/approver (7.13.5), and the formal notice of outcome and process end (7.13.7/7.13.8)." required true }
|
|
415
|
+
}
|
|
416
|
+
segregation {
|
|
417
|
+
constraint complaint_resolution_not_case {
|
|
418
|
+
kind case_personnel_disjoint
|
|
419
|
+
clause "7.13.5"
|
|
420
|
+
pair { complaints case_personnel }
|
|
421
|
+
statement "Within one complaint or appeal case, the personnel making, reviewing or approving the resolving decision shall not have been involved in the certification activities related to that complaint or appeal (ISO/IEC 17065:2012, 7.13.5)."
|
|
422
|
+
}
|
|
423
|
+
constraint complaint_consultancy_two_year_bar {
|
|
424
|
+
kind consultancy_bar
|
|
425
|
+
clause "7.13.6"
|
|
426
|
+
period P2Y
|
|
427
|
+
barred { consultancy employment }
|
|
428
|
+
statement "Personnel (including those acting in a managerial capacity) who have provided consultancy for a client, or been employed by a client, shall not be used to review or approve the resolution of a complaint or appeal for that client within two years following the end of the consultancy or employment (ISO/IEC 17065:2012, 7.13.6)."
|
|
429
|
+
}
|
|
430
|
+
}
|
|
431
|
+
executor actor
|
|
432
|
+
source { doc "ISO/IEC 17065:2012, 7.13" clause "" }
|
|
433
|
+
}
|
|
434
|
+
|
|
435
|
+
process_model functional_approach {
|
|
436
|
+
sequence { application application_review evaluation review decision attestation surveillance }
|
|
437
|
+
}
|
|
@@ -0,0 +1,292 @@
|
|
|
1
|
+
# ISO/IEC 17067:2013 — PRODUCT-CERTIFICATION SCHEME TYPES (TODO.roadmap/39d)
|
|
2
|
+
# -----------------------------------------------------------------------------
|
|
3
|
+
# The clause-5 scheme-type taxonomy of ISO/IEC 17067:2013 as a STRUCTURED,
|
|
4
|
+
# MACHINE-QUERYABLE REGISTER — the resolution register for the
|
|
5
|
+
# `scheme_type` facet a scheme layer declares in its manifest (today:
|
|
6
|
+
# data/oiml-cs declares `scheme_type: type_1a`, B 18:2025 §1.3). checkUses
|
|
7
|
+
# (the composition registry) resolves a declared type against the register
|
|
8
|
+
# of a layer composed earlier; task 43's oiml-cs→17067 coverage gate reads
|
|
9
|
+
# the facets to discharge type-conditioned provisions (a type-1a scheme
|
|
10
|
+
# carries NO surveillance — the
|
|
11
|
+
# /req/iso-17067/scheme-content/surveillance-procedures provision and the
|
|
12
|
+
# VI-activity content are N/A with the 5.3.1 justification).
|
|
13
|
+
#
|
|
14
|
+
# The register encodes clause 5 INCLUDING Table 1 ("Building a product
|
|
15
|
+
# certification scheme", 5.2):
|
|
16
|
+
# family common Table-1 rows I–IV — X for every scheme type
|
|
17
|
+
# (5.3.1: "All types of product certification schemes
|
|
18
|
+
# involve selection, determination, review, decision
|
|
19
|
+
# and attestation"); row I includes sampling, as
|
|
20
|
+
# applicable.
|
|
21
|
+
# family determination Table-1 row II a)–e) — "as applicable" for every
|
|
22
|
+
# type; the scheme selects per its purpose and scope
|
|
23
|
+
# (6.5.1 c).
|
|
24
|
+
# family attestation Table-1 row V a)–d) — attestation and licensing;
|
|
25
|
+
# the per-type `attestation` list carries the X-marks.
|
|
26
|
+
# family surveillance Table-1 row VI a)–d) — the surveillance menu; the
|
|
27
|
+
# per-type `surveillance.activities` list carries the
|
|
28
|
+
# X-marks.
|
|
29
|
+
# scheme_type the seven named types (5.3.2–5.3.8), each with
|
|
30
|
+
# its defining-subclause anchor, a verbatim-faithful
|
|
31
|
+
# description, the attestation object, the
|
|
32
|
+
# attestation/licensing X-marks, and the SURVEILLANCE
|
|
33
|
+
# facet — `required` is the 5.3.1 machine query ("For
|
|
34
|
+
# scheme types 1a and 1b, no surveillance is required
|
|
35
|
+
# since the attestation relates only to the product
|
|
36
|
+
# items which have been subjected to the
|
|
37
|
+
# determination activities").
|
|
38
|
+
#
|
|
39
|
+
# Table-1 notes carried by the register (5.2): NOTE c — a scheme includes
|
|
40
|
+
# at least the activities I, II, III, IV and V a) (hence issue_statement
|
|
41
|
+
# is on every type's attestation list); NOTE a — the activities can be
|
|
42
|
+
# coupled with initial audit and surveillance audit of the applicant's
|
|
43
|
+
# management system (an example is given in ISO/IEC Guide 53), the order
|
|
44
|
+
# defined within the scheme; NOTE b — ISO/IEC Guide 28 is the often-used,
|
|
45
|
+
# well-tried model corresponding to scheme type 5; NOTE d — the table's
|
|
46
|
+
# "N" column marks an undefined number of possible OTHER schemes based on
|
|
47
|
+
# different activities: a placeholder, deliberately NOT a register entry
|
|
48
|
+
# (a scheme_type value must name one of the seven defined types).
|
|
49
|
+
#
|
|
50
|
+
# X-MARK VERIFICATION: every per-type attestation/surveillance list was
|
|
51
|
+
# transcribed from the Metanorma AsciiDoc Table-1 rows (see layer.yaml
|
|
52
|
+
# editions.source) and cross-checked against the 5.3.x defining
|
|
53
|
+
# subclauses. One divergence from the corpus audit's summary table
|
|
54
|
+
# (analysis/oiml-cs-corpus-audit-2026-07.md, Corpus D §2.2): Table 1's
|
|
55
|
+
# raw V d) row marks X for type 6 (cells: 1a blank, X for 1b/2/3/4/5/6,
|
|
56
|
+
# N absent) — the audit's "type 6 has a)+b)" omits it. The raw table is
|
|
57
|
+
# authoritative; type 6 carries mark_licensing.
|
|
58
|
+
#
|
|
59
|
+
# X for row V d) is conditioned by the standard itself: "granting the
|
|
60
|
+
# right to use marks of conformity (licensing) is based on surveillance
|
|
61
|
+
# (VI) or certification of a batch" — type 1a (no surveillance, no batch)
|
|
62
|
+
# carries no mark licensing, matching the table.
|
|
63
|
+
#
|
|
64
|
+
# Cross-references (the per-type determination/attestation/surveillance
|
|
65
|
+
# ids against the activity-kind menus; a scheme manifest's scheme_type
|
|
66
|
+
# against this register when composed) are checked package-side by the
|
|
67
|
+
# kernel's C122 scheme-type-resolves (per-register gated).
|
|
68
|
+
#
|
|
69
|
+
# This file is the single source of truth; the consumer's
|
|
70
|
+
# data/iso-iec-17067/specification/scheme-types.yaml is its GENERATED YAML
|
|
71
|
+
# twin (cd browser && npm run gen:data; schema data/schemas/scheme-types.yaml).
|
|
72
|
+
scheme_activity_kind selection {
|
|
73
|
+
family common
|
|
74
|
+
row "I"
|
|
75
|
+
label "Selection, including planning and preparation activities, specification of requirements, e.g. normative documents, and sampling, as applicable"
|
|
76
|
+
}
|
|
77
|
+
|
|
78
|
+
scheme_activity_kind determination {
|
|
79
|
+
family common
|
|
80
|
+
row "II"
|
|
81
|
+
label "Determination of characteristics, as applicable, by: a) testing; b) inspection; c) design appraisal; d) assessment of services or processes; e) other determination activities, e.g. verification"
|
|
82
|
+
}
|
|
83
|
+
|
|
84
|
+
scheme_activity_kind review {
|
|
85
|
+
family common
|
|
86
|
+
row "III"
|
|
87
|
+
label "Review — Examining the evidence of conformity obtained during the determination stage to establish whether the specified requirements have been met"
|
|
88
|
+
}
|
|
89
|
+
|
|
90
|
+
scheme_activity_kind decision {
|
|
91
|
+
family common
|
|
92
|
+
row "IV"
|
|
93
|
+
label "Decision on certification — Granting, maintaining, extending, reducing, suspending, withdrawing certification"
|
|
94
|
+
}
|
|
95
|
+
|
|
96
|
+
scheme_activity_kind testing {
|
|
97
|
+
family determination
|
|
98
|
+
row "II a)"
|
|
99
|
+
label "testing"
|
|
100
|
+
}
|
|
101
|
+
|
|
102
|
+
scheme_activity_kind inspection {
|
|
103
|
+
family determination
|
|
104
|
+
row "II b)"
|
|
105
|
+
label "inspection"
|
|
106
|
+
}
|
|
107
|
+
|
|
108
|
+
scheme_activity_kind design_appraisal {
|
|
109
|
+
family determination
|
|
110
|
+
row "II c)"
|
|
111
|
+
label "design appraisal"
|
|
112
|
+
}
|
|
113
|
+
|
|
114
|
+
scheme_activity_kind service_process_assessment {
|
|
115
|
+
family determination
|
|
116
|
+
row "II d)"
|
|
117
|
+
label "assessment of services or processes"
|
|
118
|
+
}
|
|
119
|
+
|
|
120
|
+
scheme_activity_kind other_determination {
|
|
121
|
+
family determination
|
|
122
|
+
row "II e)"
|
|
123
|
+
label "other determination activities, e.g. verification"
|
|
124
|
+
}
|
|
125
|
+
|
|
126
|
+
scheme_activity_kind issue_statement {
|
|
127
|
+
family attestation
|
|
128
|
+
row "V a)"
|
|
129
|
+
label "issuing a certificate of conformity or other statement of conformity (attestation)"
|
|
130
|
+
}
|
|
131
|
+
|
|
132
|
+
scheme_activity_kind grant_use_of_statement {
|
|
133
|
+
family attestation
|
|
134
|
+
row "V b)"
|
|
135
|
+
label "granting the right to use certificates or other statements of conformity"
|
|
136
|
+
}
|
|
137
|
+
|
|
138
|
+
scheme_activity_kind batch_certificate {
|
|
139
|
+
family attestation
|
|
140
|
+
row "V c)"
|
|
141
|
+
label "issuing a certificate of conformity for a batch of products"
|
|
142
|
+
}
|
|
143
|
+
|
|
144
|
+
scheme_activity_kind mark_licensing {
|
|
145
|
+
family attestation
|
|
146
|
+
row "V d)"
|
|
147
|
+
label "granting the right to use marks of conformity (licensing) — based on surveillance (VI) or certification of a batch"
|
|
148
|
+
}
|
|
149
|
+
|
|
150
|
+
scheme_activity_kind market_sampling {
|
|
151
|
+
family surveillance
|
|
152
|
+
row "VI a)"
|
|
153
|
+
label "testing or inspection of samples from the open market"
|
|
154
|
+
}
|
|
155
|
+
|
|
156
|
+
scheme_activity_kind factory_sampling {
|
|
157
|
+
family surveillance
|
|
158
|
+
row "VI b)"
|
|
159
|
+
label "testing or inspection of samples from the factory"
|
|
160
|
+
}
|
|
161
|
+
|
|
162
|
+
scheme_activity_kind production_assessment {
|
|
163
|
+
family surveillance
|
|
164
|
+
row "VI c)"
|
|
165
|
+
label "assessment of the production, the delivery of the service or the operation of the process"
|
|
166
|
+
}
|
|
167
|
+
|
|
168
|
+
scheme_activity_kind management_system_audit {
|
|
169
|
+
family surveillance
|
|
170
|
+
row "VI d)"
|
|
171
|
+
label "management system audits combined with random tests or inspections"
|
|
172
|
+
}
|
|
173
|
+
|
|
174
|
+
scheme_type type_1a {
|
|
175
|
+
label "scheme type 1a"
|
|
176
|
+
clause "5.3.2"
|
|
177
|
+
description "In this scheme, one or more samples of the product are subjected to the determination activities. A certificate of conformity or other statement of conformity (e.g. a letter) is issued for the product type, the characteristics of which are detailed in the certificate or a document referred to in the certificate. Subsequent production items are not covered by the certification body's attestation of conformity. The samples are representative of subsequent production items which could be referred to by the manufacturer as being manufactured in accordance with the certified type. The certification body may grant to the manufacturer the right to use the type certificate or other statement of conformity (e.g. letter) as a basis for the manufacturer to declare that subsequent production items conform to the specified requirements."
|
|
178
|
+
sampling "One or more samples of the product are subjected to the determination activities; the samples are representative of subsequent production items which could be referred to by the manufacturer as being manufactured in accordance with the certified type (5.3.2)."
|
|
179
|
+
attestation_object product_type
|
|
180
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
181
|
+
attestation { issue_statement grant_use_of_statement }
|
|
182
|
+
surveillance {
|
|
183
|
+
required false
|
|
184
|
+
}
|
|
185
|
+
notes {
|
|
186
|
+
"No surveillance is required (5.3.1): the attestation relates only to the product items which have been subjected to the determination activities. Subsequent production items are NOT covered by the certification body's attestation of conformity."
|
|
187
|
+
"The OIML-CS case (B 18:2025 §1.3): the type certificate attests the TYPE — which is precisely why metrological verification exists as a separate pathway for production items, outside the product-certification frame."
|
|
188
|
+
}
|
|
189
|
+
}
|
|
190
|
+
|
|
191
|
+
scheme_type type_1b {
|
|
192
|
+
label "scheme type 1b"
|
|
193
|
+
clause "5.3.3"
|
|
194
|
+
description "This scheme type involves the certification of a whole batch of products, following selection and determination as specified in the scheme. The proportion to be tested, which can include testing of all the units in the batch (100 % testing), would be based, for example, on the homogeneity of the items in the batch and the application of a sampling plan, where appropriate. If the outcome of the determination, review and decision is positive, all items in the batch may be described as certified and may have a mark of conformity affixed, if that is included in the scheme."
|
|
195
|
+
sampling "The proportion of the batch to be tested — which can include testing of all the units in the batch (100 % testing) — is based, for example, on the homogeneity of the items in the batch and the application of a sampling plan, where appropriate (5.3.3)."
|
|
196
|
+
attestation_object batch
|
|
197
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
198
|
+
attestation { issue_statement grant_use_of_statement batch_certificate mark_licensing }
|
|
199
|
+
surveillance {
|
|
200
|
+
required false
|
|
201
|
+
}
|
|
202
|
+
notes {
|
|
203
|
+
"No surveillance is required (5.3.1): the attestation relates only to the product items which have been subjected to the determination activities — here the whole batch."
|
|
204
|
+
}
|
|
205
|
+
}
|
|
206
|
+
|
|
207
|
+
scheme_type type_2 {
|
|
208
|
+
label "scheme type 2"
|
|
209
|
+
clause "5.3.4"
|
|
210
|
+
description "The surveillance part of this scheme involves periodically taking samples of the product from the market and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. While this scheme may identify the impact of the distribution channel on conformity, the resources it requires can be extensive. Also, when significant nonconformities are found, effective corrective measures may be limited since the product has already been distributed to the market."
|
|
211
|
+
sampling "Surveillance samples are taken periodically from the market (5.3.4; Table 1, VI a)."
|
|
212
|
+
attestation_object ongoing_production
|
|
213
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
214
|
+
attestation { issue_statement grant_use_of_statement mark_licensing }
|
|
215
|
+
surveillance {
|
|
216
|
+
required true
|
|
217
|
+
activities { market_sampling }
|
|
218
|
+
}
|
|
219
|
+
notes {
|
|
220
|
+
"May identify the impact of the distribution channel on conformity, but corrective measures can be limited once nonconforming product has already been distributed (5.3.4)."
|
|
221
|
+
}
|
|
222
|
+
}
|
|
223
|
+
|
|
224
|
+
scheme_type type_3 {
|
|
225
|
+
label "scheme type 3"
|
|
226
|
+
clause "5.3.5"
|
|
227
|
+
description "The surveillance part of this scheme involves periodically taking samples of the product from the point of production and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process. This scheme does not provide any indication of the impact the distribution channel plays on conformity. When serious nonconformities are found, the opportunity may exist to resolve them before widespread market distribution occurs."
|
|
228
|
+
sampling "Surveillance samples are taken periodically from the point of production (5.3.5; Table 1, VI b)."
|
|
229
|
+
attestation_object ongoing_production
|
|
230
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
231
|
+
attestation { issue_statement grant_use_of_statement mark_licensing }
|
|
232
|
+
surveillance {
|
|
233
|
+
required true
|
|
234
|
+
activities { factory_sampling production_assessment }
|
|
235
|
+
}
|
|
236
|
+
notes {
|
|
237
|
+
"Provides no indication of the distribution channel's impact on conformity, but serious nonconformities may be resolved before widespread market distribution occurs (5.3.5)."
|
|
238
|
+
}
|
|
239
|
+
}
|
|
240
|
+
|
|
241
|
+
scheme_type type_4 {
|
|
242
|
+
label "scheme type 4"
|
|
243
|
+
clause "5.3.6"
|
|
244
|
+
description "The surveillance part of this scheme allows for the choice between periodically taking samples of the product from the point of production, or from the market, or from both, and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process. This scheme can both indicate the impact the distribution channel plays on conformity and provide a premarket mechanism to identify and resolve serious nonconformities. Significant duplication of effort may take place for those products whose conformity is not affected during the distribution process."
|
|
245
|
+
sampling "Surveillance samples are taken periodically from the point of production, or from the market, or from both — the choice is defined within the scheme (5.3.6; Table 1, VI a + b)."
|
|
246
|
+
attestation_object ongoing_production
|
|
247
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
248
|
+
attestation { issue_statement grant_use_of_statement mark_licensing }
|
|
249
|
+
surveillance {
|
|
250
|
+
required true
|
|
251
|
+
activities { market_sampling factory_sampling production_assessment }
|
|
252
|
+
}
|
|
253
|
+
notes {
|
|
254
|
+
"Combines the type-2 and type-3 indications (distribution-channel impact AND a premarket mechanism), at the price of possible duplicated effort for products whose conformity is not affected during distribution (5.3.6)."
|
|
255
|
+
}
|
|
256
|
+
}
|
|
257
|
+
|
|
258
|
+
scheme_type type_5 {
|
|
259
|
+
label "scheme type 5"
|
|
260
|
+
clause "5.3.7"
|
|
261
|
+
description "The surveillance part of this scheme allows for the choice between periodically taking samples of the product either from the point of production, or from the market, or from both, and subjecting them to determination activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. The surveillance includes periodic assessment of the production process, or audit of the management system, or both. The extent to which the four surveillance activities are conducted may be varied for a given situation, as defined in the scheme. If the surveillance includes audit of the management system, an initial audit of the management system will be needed."
|
|
262
|
+
sampling "Surveillance samples are taken periodically from the point of production, or from the market, or from both — the extent of the four surveillance activities may be varied for a given situation, as defined in the scheme (5.3.7; Table 1, VI a–d)."
|
|
263
|
+
attestation_object ongoing_production
|
|
264
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
265
|
+
attestation { issue_statement grant_use_of_statement mark_licensing }
|
|
266
|
+
surveillance {
|
|
267
|
+
required true
|
|
268
|
+
activities { market_sampling factory_sampling production_assessment management_system_audit }
|
|
269
|
+
}
|
|
270
|
+
notes {
|
|
271
|
+
"If the surveillance includes audit of the management system, an initial audit of the management system will be needed (5.3.7)."
|
|
272
|
+
"ISO/IEC Guide 28 is the often-used and well-tried model for a product certification scheme corresponding to scheme type 5 (Table 1, Note b)."
|
|
273
|
+
}
|
|
274
|
+
}
|
|
275
|
+
|
|
276
|
+
scheme_type type_6 {
|
|
277
|
+
label "scheme type 6"
|
|
278
|
+
clause "5.3.8"
|
|
279
|
+
description "This scheme is mainly applicable to certification of services and processes. Although services are considered as being generally intangible, the determination activities are not limited to the evaluation of intangible elements (e.g. effectiveness of an organization's procedures, delays and responsiveness of the management). In some situations, the tangible elements of a service can support the evidence of conformity indicated by the assessment of processes, resources and controls involved. For both services and processes, the surveillance part of this scheme should include periodic audits of the management system and periodic assessment of the service or process."
|
|
280
|
+
sampling "Determination activities are not limited to the evaluation of intangible elements — the tangible elements of a service can support the evidence of conformity (e.g. inspection of the cleanliness of vehicles for the quality of public transportation); for processes, determination can include testing and inspection of samples of the resultant product (e.g. welds), if applicable (5.3.8)."
|
|
281
|
+
attestation_object service_or_process
|
|
282
|
+
determination { testing inspection design_appraisal service_process_assessment other_determination }
|
|
283
|
+
attestation { issue_statement grant_use_of_statement mark_licensing }
|
|
284
|
+
surveillance {
|
|
285
|
+
required true
|
|
286
|
+
activities { production_assessment management_system_audit }
|
|
287
|
+
}
|
|
288
|
+
notes {
|
|
289
|
+
"Mainly applicable to certification of services and processes (5.3.8). Table 1's V d) row marks X for type 6 (mark licensing based on the VI surveillance) — the corpus audit's summary table omits this mark; the raw table is authoritative."
|
|
290
|
+
}
|
|
291
|
+
}
|
|
292
|
+
|
package/package.json
CHANGED
|
@@ -1,6 +1,6 @@
|
|
|
1
1
|
{
|
|
2
2
|
"name": "@oimlsmart/primmel-packages",
|
|
3
|
-
"version": "0.
|
|
3
|
+
"version": "0.4.0",
|
|
4
4
|
"description": "The OIML SMART platform's authoritative model content: every Recommendation, the OIML-CS scheme, the CASCO foundations, the shared modules, and the product/program reference packages as Primmel (.prl) packages — the single source of truth the platform's data trees regenerate from. Consumed by the smart monorepo (oimlsmart/smart) at a pinned version (TODO.repos/02).",
|
|
5
5
|
"type": "module",
|
|
6
6
|
"repository": {
|
|
@@ -12,6 +12,6 @@
|
|
|
12
12
|
},
|
|
13
13
|
"license": "MIT",
|
|
14
14
|
"devDependencies": {
|
|
15
|
-
"@primmel/primmel": "^1.
|
|
15
|
+
"@primmel/primmel": "^1.12.0"
|
|
16
16
|
}
|
|
17
17
|
}
|