@oimlsmart/primmel-packages 0.1.0

package/iso-iec-17000/terminology.prl

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+term conformity-assessment {
+  label "conformity assessment"
+  definition "demonstration that specified requirements (5.1) are fulfilled"
+  section "4.1"
+  note "Conformity assessment includes activities defined elsewhere in the document, such as but not limited to testing (6.2), inspection (6.3), validation (6.5), verification (6.6), certification (7.6), and accreditation (7.7); it is explained in Annex A as a series of functions."
+  source "ISO/IEC 17000:2020, 4.1"
+}
+
+term object-of-conformity-assessment {
+  label "object of conformity assessment"
+  definition "entity to which specified requirements (5.1) apply"
+  section "4.2"
+  note "Examples: product, process, service, system, installation, project, data, design, material, claim, person, body or organization, or any combination thereof."
+  source "ISO/IEC 17000:2020, 4.2"
+  aliases { object }
+}
+
+term first-party-conformity-assessment-activity {
+  label "first-party conformity assessment activity"
+  definition "conformity assessment activity that is performed by the person or organization that provides or that is the object of conformity assessment (4.2)"
+  section "4.3"
+  source "ISO/IEC 17000:2020, 4.3"
+}
+
+term second-party-conformity-assessment-activity {
+  label "second-party conformity assessment activity"
+  definition "conformity assessment activity that is performed by a person or organization that has a user interest in the object of conformity assessment (4.2)"
+  section "4.4"
+  source "ISO/IEC 17000:2020, 4.4"
+}
+
+term third-party-conformity-assessment-activity {
+  label "third-party conformity assessment activity"
+  definition "conformity assessment activity that is performed by a person or organization that is independent of the provider of the object of conformity assessment (4.2) and has no user interest in the object"
+  section "4.5"
+  source "ISO/IEC 17000:2020, 4.5"
+}
+
+term conformity-assessment-body {
+  label "conformity assessment body"
+  definition "body that performs conformity assessment activities, excluding accreditation (7.7)"
+  section "4.6"
+  source "ISO/IEC 17000:2020, 4.6"
+}
+
+term accreditation-body {
+  label "accreditation body"
+  definition "authoritative body that performs accreditation (7.7)"
+  section "4.7"
+  source "ISO/IEC 17000:2020, 4.7"
+}
+
+term conformity-assessment-system {
+  label "conformity assessment system"
+  definition "set of rules and procedures (5.2) for the management of similar or related conformity assessment schemes (4.9)"
+  section "4.8"
+  source "ISO/IEC 17000:2020, 4.8"
+}
+
+term conformity-assessment-scheme {
+  label "conformity assessment scheme"
+  definition "set of rules and procedures (5.2) that describes the objects of conformity assessment (4.2), identifies the specified requirements (5.1) and provides the methodology for performing conformity assessment (4.1)"
+  section "4.9"
+  note "A scheme can cover all or part of the conformity assessment functions explained in Annex A. A \"certification scheme\" is not a normative 17000 term — it is derived in informative A.4.3 as a conformity assessment scheme that includes selection, determination, review, decision and finally certification as the attestation activity."
+  source "ISO/IEC 17000:2020, 4.9"
+  aliases { "conformity assessment programme" }
+}
+
+term specified-requirement {
+  label "specified requirement"
+  definition "need or expectation that is stated"
+  section "5.1"
+  source "ISO/IEC 17000:2020, 5.1"
+}
+
+term procedure {
+  label "procedure"
+  definition "specified way to carry out an activity or a process"
+  section "5.2"
+  source "ISO/IEC 17000:2020, 5.2"
+}
+
+term impartiality {
+  label "impartiality"
+  definition "objectivity with regard to the outcome of a conformity assessment activity"
+  section "5.3"
+  source "ISO/IEC 17000:2020, 5.3"
+}
+
+term independence {
+  label "independence"
+  definition "freedom of a person or organization from the control or authority of another person or organization"
+  section "5.4"
+  source "ISO/IEC 17000:2020, 5.4"
+}
+
+term selection {
+  label "selection"
+  definition "planning and preparation activities in order to collect or produce all the information and input needed for the subsequent determination function"
+  section "A.2"
+  note "Function of the functional approach (A.1), not a numbered term. Representative sampling (6.1) is a selection activity (A.2)."
+  source "ISO/IEC 17000:2020, A.2"
+}
+
+term determination {
+  label "determination"
+  definition "activities undertaken to develop complete information regarding fulfilment of the specified requirements by the object of conformity assessment or its sample"
+  section "A.3"
+  note "Function of the functional approach (A.1), not a numbered term. Testing (6.2), inspection (6.3), audit (6.4), validation (6.5), verification (6.6) and peer assessment (6.7) are defined as types of determination activities only (A.3.2)."
+  source "ISO/IEC 17000:2020, A.3"
+}
+
+term sampling {
+  label "sampling"
+  definition "selection and/or collection of material or data regarding an object of conformity assessment (4.2)"
+  section "6.1"
+  note "Selection can be on the basis of a procedure, an automated system, professional judgement etc."
+  source "ISO/IEC 17000:2020, 6.1"
+}
+
+term testing {
+  label "testing"
+  definition "determination of one or more characteristics of an object of conformity assessment (4.2), according to a procedure (5.2)"
+  section "6.2"
+  note "The output of testing can include comments (e.g. opinions and interpretations) about the test results and fulfilment of specified requirements."
+  source "ISO/IEC 17000:2020, 6.2"
+}
+
+term inspection {
+  label "inspection"
+  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"
+  section "6.3"
+  note "Examination can include direct or indirect observations, which can include measurements or the output of instruments."
+  source "ISO/IEC 17000:2020, 6.3"
+}
+
+term audit {
+  label "audit"
+  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"
+  section "6.4"
+  note "For accreditation purposes, the audit process is called \"assessment\"."
+  source "ISO/IEC 17000:2020, 6.4"
+}
+
+term validation {
+  label "validation"
+  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"
+  section "6.5"
+  note "Validation can be applied to claims to confirm the information declared with the claim regarding an intended future use."
+  source "ISO/IEC 17000:2020, 6.5"
+}
+
+term verification {
+  label "verification"
+  definition "confirmation of truthfulness through the provision of objective evidence that specified requirements (5.1) have been fulfilled"
+  section "6.6"
+  note "Verification can be applied to claims to confirm the information declared with the claim regarding events that have already occurred or results that have already been obtained. Distinct from the metrology sense (ISO/IEC 17025 3.8 = VIM 2.44) — see the file header."
+  source "ISO/IEC 17000:2020, 6.6"
+}
+
+term peer-assessment {
+  label "peer assessment"
+  definition "assessment of a body against specified requirements (5.1) by representatives of other bodies in, or candidates for, an agreement group (9.10)"
+  section "6.7"
+  note "The term \"peer assessment\" is sometimes referred to as \"peer evaluation\"."
+  source "ISO/IEC 17000:2020, 6.7"
+}
+
+term review {
+  label "review"
+  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)"
+  section "7.1"
+  source "ISO/IEC 17000:2020, 7.1"
+}
+
+term decision {
+  label "decision"
+  definition "conclusion, based on the results of review (7.1), that fulfilment of specified requirements (5.1) has or has not been demonstrated"
+  section "7.2"
+  source "ISO/IEC 17000:2020, 7.2"
+}
+
+term attestation {
+  label "attestation"
+  definition "issue of a statement, based on a decision (7.2), that fulfilment of specified requirements (5.1) has been demonstrated"
+  section "7.3"
+  note "The resulting statement, referred to as a \"statement of conformity\", is intended to convey the assurance that the specified requirements have been fulfilled. First-party and third-party attestation are distinguished by the terms declaration (7.5), certification (7.6) and accreditation (7.7)."
+  source "ISO/IEC 17000:2020, 7.3"
+}
+
+term scope-of-attestation {
+  label "scope of attestation"
+  definition "range or characteristics of objects of conformity assessment (4.2) covered by attestation (7.3)"
+  section "7.4"
+  source "ISO/IEC 17000:2020, 7.4"
+}
+
+term declaration {
+  label "declaration"
+  definition "first-party attestation (7.3)"
+  section "7.5"
+  source "ISO/IEC 17000:2020, 7.5"
+}
+
+term certification {
+  label "certification"
+  definition "third-party attestation (7.3) related to an object of conformity assessment (4.2), with the exception of accreditation (7.7)"
+  section "7.6"
+  source "ISO/IEC 17000:2020, 7.6"
+}
+
+term accreditation {
+  label "accreditation"
+  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"
+  section "7.7"
+  source "ISO/IEC 17000:2020, 7.7"
+}
+
+term surveillance {
+  label "surveillance"
+  definition "systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity"
+  section "8.1"
+  source "ISO/IEC 17000:2020, 8.1"
+}
+
+term suspension {
+  label "suspension"
+  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)"
+  section "8.2"
+  source "ISO/IEC 17000:2020, 8.2"
+}
+
+term withdrawal {
+  label "withdrawal"
+  definition "revocation of the statement of conformity by the body that issued the statement"
+  section "8.3"
+  source "ISO/IEC 17000:2020, 8.3"
+  aliases { cancellation }
+}
+
+term expiry {
+  label "expiry"
+  definition "ending of the validity of the statement of conformity after a specified period"
+  section "8.4"
+  source "ISO/IEC 17000:2020, 8.4"
+}
+
+term restoration {
+  label "restoration"
+  definition "reinstatement of the full or partial statement of conformity"
+  section "8.5"
+  source "ISO/IEC 17000:2020, 8.5"
+}
+
+term appeal {
+  label "appeal"
+  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"
+  section "8.6"
+  source "ISO/IEC 17000:2020, 8.6"
+}
+
+term complaint {
+  label "complaint"
+  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"
+  section "8.7"
+  source "ISO/IEC 17000:2020, 8.7"
+}
+

package/iso-iec-17025/package.primmel

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+package {
+  id iso-iec-17025
+  kind core
+  title "OIML SMART iso-iec-17025 layer package"
+  description "ISO/IEC 17025:2017 reference package — the testing/calibration-laboratory competence model: the /req/iso-17025/* provisions (personnel competence, records and authorizations; equipment calibration, programme and the 6.4.13 a–h records; metrological traceability with the documented unbroken chain to the SI and the Annex-A conformity-only dissemination; the clause-7 test lifecycle — methods, sampling, item handling, technical records, measurement uncertainty, validity of results, and reporting incl. statements of conformity under a documented decision rule and opinions/interpretations by authorized personnel only), and the test lifecycle as abstract processes classified against the ISO/IEC 17000 activity taxonomy. Composed into each Recommendation via `uses: [iso-iec-17025]` after iso-iec-17065 and ahead of oiml-cs."
+  uses { iso-iec-17000 }
+  requires { iso-iec-17000 }
+  provides { iso-iec-17025 lab-requirements-17025 ca-terminology-17025 }
+  default_spelling eng-Latn
+}