@oimlsmart/primmel-packages 0.1.0

package/iso-iec-17065/specification/requirements/body.prl

@@ -0,0 +1,446 @@
+requirement_class /req/iso-17065/body {
+  title "ISO/IEC 17065 organizational requirements"
+  name "ISO/IEC 17065 certification-body organizational requirements"
+  description "Organizational requirements of ISO/IEC 17065:2012 (clauses 4–6) on a body certifying products, processes and services: legal and contractual matters, management of impartiality, the impartiality safeguarding mechanism, personnel competence and records, and the resources for evaluation. The OIML-CS relies on these for Issuing Authority competence (B 18:2025 §5.2); they are verified by assessment of the body (accreditation or peer assessment), not by the type-evaluation workflow."
+  subject "Product certification body — legal status, impartiality, structure and resources"
+}
+
+requirement /req/iso-17065/body/legal-entity {
+  name "Legal entity"
+  statement "The certification body shall be a legal entity, or a defined part of a legal entity, such that the legal entity can be held legally responsible for all its certification activities. (A governmental certification body is deemed to be a legal entity on the basis of its governmental status.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Legal-entity status (or defined part of one) documented for the body"
+      - description: "Legal responsibility for all certification activities traceable to that entity"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment), outside the per-application certification process." }
+  source { doc "ISO/IEC 17065:2012, 4.1.1" clause "" }
+}
+
+requirement /req/iso-17065/body/certification-agreement {
+  name "Certification agreement"
+  statement "The certification body shall have a legally enforceable agreement for the provision of certification activities to its clients, taking into account the responsibilities of the certification body and its clients. The agreement shall require that the client comply at least with: always fulfilling the certification requirements (including implementing communicated changes); continued fulfilment of the product requirements where certification applies to ongoing production; making all necessary arrangements for the conduct of the evaluation and surveillance, for the investigation of complaints and for the participation of observers; claims consistent with the scope of certification; no use of certification that brings the body into disrepute or is misleading; discontinuing advertising references upon suspension, withdrawal or termination; reproducing certification documents only in their entirety or as specified by the scheme; compliance with body/scheme requirements when referring to its certification; compliance with scheme requirements on the use of marks of conformity; keeping records of complaints known to it and making them available on request; and informing the body without delay of changes affecting its ability to conform (4.1.2 a–k)."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Legally enforceable certification agreement in place with every client"
+      - description: "Agreement covers the client obligations of 4.1.2 a–k"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 4.1.2" clause "" }
+}
+
+requirement /req/iso-17065/body/impartiality-responsibility {
+  name "Impartiality responsibility"
+  statement "Certification activities shall be undertaken impartially. The certification body shall be responsible for the impartiality of its certification activities and shall not allow commercial, financial or other pressures to compromise impartiality. The certification body shall have top management commitment to impartiality."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Responsibility for impartiality assigned and top-management commitment demonstrable"
+      - description: "No commercial, financial or other pressure compromising impartiality identified"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 4.2.1, 4.2.2, 4.2.5" clause "" }
+}
+
+requirement /req/iso-17065/body/impartiality-risk-management {
+  name "Impartiality risk management"
+  statement "The certification body shall identify risks to its impartiality on an ongoing basis, including those risks that arise from its activities, from its relationships, or from the relationships of its personnel (see 4.2.12); such relationships may not necessarily present a certification body with a risk to impartiality. If a risk to impartiality is identified, the certification body shall be able to demonstrate how it eliminates or minimizes such risk, and this information shall be made available to the mechanism specified in 5.2."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Ongoing impartiality risk identification covering activities and (personnel) relationships"
+      - description: "Elimination/minimization of identified risks demonstrable to the 5.2 mechanism"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 4.2.3, 4.2.4" clause "" }
+}
+
+requirement /req/iso-17065/body/no-conflicting-activities {
+  name "No conflicting activities"
+  statement "The certification body and any part of the same legal entity and entities under its organizational control (see 7.6.4) shall not: a) be the designer, manufacturer, installer, distributer or maintainer of the certified product; b) be the designer, implementer, operator or maintainer of the certified process; c) be the designer, implementer, provider or maintainer of the certified service; d) offer or provide consultancy to its clients; e) offer or provide management system consultancy or internal auditing to its clients where the certification scheme requires the evaluation of the client's management system."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "No design/manufacture/distribution/maintenance of the certified product by the body or controlled entities"
+      - description: "No consultancy (incl. management-system consultancy/internal auditing) offered to clients"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 4.2.6" clause "" }
+}
+
+requirement /req/iso-17065/body/consultancy-bar {
+  name "Consultancy bar on review and decision personnel"
+  statement "Within a period specified by the certification body, personnel shall not be used to review or make a certification decision for a product for which they have provided consultancy. (The period can be specified in the certification scheme or, if specified by the certification body, it reflects a period long enough to ensure that the review or decision does not compromise impartiality; a specified period of two years is often used.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Body-specified consultancy-bar period documented (scheme- or body-level)"
+      - description: "No review/decision assignment of personnel within the bar period for a consulted product"
+  }
+  verification { method deferred description "Declared constraint — the machine-checkable facet is the segregation entry of the review and decision abstract processes (evaluation/functional-approach.yaml); the assignment-level check is verified by assessment of the body." }
+  source { doc "ISO/IEC 17065:2012, 4.2.10" clause "" }
+}
+
+requirement /req/iso-17065/body/safeguarding-mechanism {
+  name "Mechanism for safeguarding impartiality"
+  statement "The certification body shall have a mechanism for safeguarding its impartiality, providing input on the policies and principles relating to the impartiality of its certification activities, on any tendency to allow commercial or other considerations to prevent the consistent impartial provision of certification activities, and on matters affecting impartiality and confidence in certification, including openness. The mechanism shall be formally documented to ensure a balanced representation of significantly interested parties, such that no single interest predominates (internal or external personnel of the certification body are considered to be a single interest, and shall not predominate), and access to all the information necessary to enable it to fulfil all its functions. If the top management of the certification body does not follow the input of this mechanism, the mechanism shall have the right to take independent action (e.g. informing authorities, accreditation bodies, stakeholders), respecting the confidentiality requirements of 4.5."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Documented safeguarding mechanism with balanced interested-party representation"
+      - description: "No single interest predominates; information access assured; independent-action right documented"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 5.2" clause "" }
+}
+
+requirement /req/iso-17065/body/personnel-competence {
+  name "Personnel competence management"
+  statement "The certification body shall employ, or have access to, a sufficient number of personnel to cover its operations related to the certification schemes and to the applicable standards and other normative documents; the personnel shall be competent for the functions they perform, including making required technical judgments, defining policies and implementing them. The certification body shall establish, implement and maintain a procedure for management of competencies of personnel involved in the certification process (see Clause 7), requiring the body to: a) determine the criteria for the competence of personnel for each function in the certification process, taking into account the requirements of the schemes; b) identify training needs and provide, as necessary, training programmes; c) demonstrate that the personnel have the required competencies for the duties and responsibilities they undertake; d) formally authorize personnel for functions in the certification process; e) monitor the performance of the personnel."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Competence criteria defined per certification-process function"
+      - description: "Personnel formally authorized per function (evaluation, review, decision per 6.1.2 d)"
+      - description: "Competence demonstrated and performance monitored"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 6.1.1, 6.1.2" clause "" }
+}
+
+requirement /req/iso-17065/body/personnel-records {
+  name "Personnel records"
+  statement "The certification body shall maintain the following records on the personnel involved in the certification process (see Clause 7): a) name and address; b) employer(s) and position held; c) educational qualification and professional status; d) experience and training; e) the assessment of competence; f) performance monitoring; g) authorizations held within the certification body; h) date of most recent updating of each record."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Records a–h maintained for every person involved in the certification process"
+      - description: "Authorizations held (item g) traceable to the competence-management procedure"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 6.1.2" clause "" }
+}
+
+requirement /req/iso-17065/body/personnel-contract {
+  name "Personnel contract and conflict-of-interest declaration"
+  statement "The certification body shall require personnel involved in the certification process to sign a contract or other document by which they commit themselves: a) to comply with the rules defined by the certification body, including those relating to confidentiality (see 4.5) and independence from commercial and other interests; b) to declare any prior and/or present association on their own part, or on the part of their employer, with a supplier or designer of products, a provider or developer of services, or an operator or developer of processes to the evaluation or certification of which they are to be assigned; c) to reveal any situation known to them that may present them or the certification body with a conflict of interest (see 4.2). The declarations are used as input into identifying risks to impartiality (see 4.2.3)."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Signed contract/commitment for every person involved in the certification process"
+      - description: "Association and conflict-of-interest declarations feed impartiality risk identification"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 6.1.3" clause "" }
+}
+
+requirement /req/iso-17065/body/evaluation-resources {
+  name "Resources for evaluation (ISO/IEC 17025/17020/17021 delegation)"
+  statement "When a certification body performs evaluation activities, either with its internal resources or with other resources under its direct control, it shall meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents. For testing, it shall meet the applicable requirements of ISO/IEC 17025; for inspection, it shall meet the applicable requirements of ISO/IEC 17020; and for management system auditing, it shall meet the applicable requirements of ISO/IEC 17021. The impartiality requirements of the evaluation personnel stipulated in the relevant standard shall always be applicable."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Testing performed under ISO/IEC 17025-conformant resources (the OIML-CS TL tier, B 18:2025 §5.3)"
+      - description: "Impartiality requirements of the relevant standard applied to evaluation personnel"
+  }
+  verification { method deferred description "Verified by assessment of the certification body and its evaluation resources (the ISO/IEC 17025 laboratory reference package lands in TODO.roadmap/39c)." }
+  source { doc "ISO/IEC 17065:2012, 6.2.1" clause "" }
+}
+
+requirement /req/iso-17065/body/outsourcing {
+  name "Outsourcing of evaluation"
+  statement "The certification body shall outsource evaluation activities only to bodies that meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents (for testing ISO/IEC 17025, for inspection ISO/IEC 17020, for management system auditing ISO/IEC 17021). Where evaluation activities are outsourced to non-independent bodies (e.g. client laboratories), the certification body shall ensure that the evaluation activities are managed in a manner which provides confidence in the results and that records are available to justify the confidence. The certification body shall have a legally binding contract with the body providing the outsourced service (including confidentiality and conflict-of-interest provisions per 6.1.3 item c), shall take responsibility for all outsourced activities, shall maintain a list of approved providers of outsourced services, and shall inform the client in advance of outsourcing activities in order to provide the client with an opportunity to object."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Outsourced evaluation only to bodies meeting the relevant International Standards"
+      - description: "Approved-provider list maintained; client informed in advance with opportunity to object"
+  }
+  verification { method deferred description "Verified by assessment of the certification body (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17065:2012, 6.2.2" clause "" }
+}
+
+requirement_class /req/iso-17065/process {
+  title "ISO/IEC 17065 process requirements"
+  name "ISO/IEC 17065 certification process requirements (clause 7)"
+  description "Clause-7 process requirements of ISO/IEC 17065:2012 — the functional approach from application (7.2) through complaints and appeals (7.13). Each provision is enforced by the abstract process of the same name in evaluation/functional-approach.yaml (its `provisions:` binding), exactly as the OIML-CS scheme's concrete steps validate the /req/cs/* provisions."
+  subject "Product certification process — application to complaints"
+}
+
+requirement /req/iso-17065/process/application-information {
+  name "Application information"
+  statement "For application, the certification body shall obtain all the necessary information to complete the certification process in accordance with the relevant certification scheme — including the product(s) to be certified, the standards and/or other normative documents for which the client is seeking certification, the general features of the client, information concerning outsourced processes that will affect conformity to requirements, and all other information needed in accordance with the relevant certification requirements (e.g. for initial evaluation and surveillance activities)."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Product(s), normative documents, client features and outsourced processes identified"
+      - description: "Information for initial evaluation and surveillance collected"
+  }
+  verification { method implicit description "Application step (abstract process application)." }
+  source { doc "ISO/IEC 17065:2012, 7.2" clause "" }
+}
+
+requirement /req/iso-17065/process/application-review {
+  name "Application review"
+  statement "The certification body shall conduct a review of the information obtained (see 7.2) to ensure that: a) the information about the client and the product is sufficient for the conduct of the certification process; b) any known difference in understanding between the certification body and the client is resolved, including agreement regarding standards or other normative documents; c) the scope of certification sought is defined; d) the means are available to perform all evaluation activities; e) the certification body has the competence and capability to perform the certification activity."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Sufficiency of information confirmed and understanding differences resolved"
+      - description: "Scope of certification defined; means, competence and capability confirmed"
+  }
+  verification { method implicit description "Application-review step (abstract process application_review)." }
+  source { doc "ISO/IEC 17065:2012, 7.3.1" clause "" }
+}
+
+requirement /req/iso-17065/process/decline-without-competence {
+  name "Decline when competence is lacking"
+  statement "The certification body shall decline to undertake a specific certification if it lacks any competence or capability for the certification activities it is required to undertake. (Where the request covers a product type, normative document or scheme with which the body has no prior experience, the body shall ensure it has the competence and capability for all the certification activities it is required to undertake and maintain a record of the justification for the decision to undertake certification, 7.3.2 / 7.3.3.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Decline path taken whenever competence/capability is lacking"
+      - description: "Justification recorded for no-prior-experience undertakings"
+  }
+  verification { method implicit description "Application-review step (abstract process application_review)." }
+  source { doc "ISO/IEC 17065:2012, 7.3.4" clause "" }
+}
+
+requirement /req/iso-17065/process/evaluation-plan {
+  name "Evaluation plan and task assignment"
+  statement "The certification body shall have a plan for the evaluation activities to allow for the necessary arrangements to be managed. The certification body shall assign personnel to perform each evaluation task that it undertakes with its internal resources (see 6.2.1). The certification body shall carry out the evaluation activities that it undertakes with its internal resources and shall manage outsourced resources (see 6.2.2) in accordance with the evaluation plan; the products shall be evaluated against the requirements covered by the scope of certification and other requirements specified in the certification scheme."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Evaluation plan in place; every internal evaluation task assigned to personnel"
+      - description: "Evaluation executed per plan against the scope of certification"
+  }
+  verification { method implicit description "Evaluation step (abstract process evaluation)." }
+  source { doc "ISO/IEC 17065:2012, 7.4.1, 7.4.2, 7.4.4" clause "" }
+}
+
+requirement /req/iso-17065/process/evaluation-results {
+  name "Nonconformity information and evaluation results documentation"
+  statement "The certification body shall inform the client of all nonconformities; if the client expresses interest in continuing the certification process, the certification body shall provide information regarding the additional evaluation tasks needed to verify that nonconformities have been corrected (the process specified in 7.4 being repeated to complete them). The results of all evaluation activities shall be documented prior to review (see 7.5)."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Client informed of all nonconformities; additional-task path offered"
+      - description: "All evaluation results documented before any review begins"
+  }
+  verification { method implicit description "Evaluation step (abstract process evaluation)." }
+  source { doc "ISO/IEC 17065:2012, 7.4.6, 7.4.9" clause "" }
+}
+
+requirement /req/iso-17065/process/review-independence {
+  name "Review independence and documented recommendation"
+  statement "The certification body shall assign at least one person to review all information and results related to the evaluation. The review shall be carried out by person(s) who have not been involved in the evaluation process. Recommendations for a certification decision based on the review shall be documented, unless the review and the certification decision are completed concurrently by the same person."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "At least one reviewer assigned; no reviewer was involved in the evaluation"
+      - description: "Review recommendation documented (or review and decision completed concurrently by the same person)"
+  }
+  verification { method implicit description "Review step (abstract process review; segregation entry review_not_evaluation)." }
+  source { doc "ISO/IEC 17065:2012, 7.5.1, 7.5.2" clause "" }
+}
+
+requirement /req/iso-17065/process/decision-independence {
+  name "Decision authority and independence"
+  statement "The certification body shall be responsible for, and shall retain authority for, its decisions relating to certification. The certification body shall assign at least one person to make the certification decision based on all information related to the evaluation, its review, and any other relevant information. The certification decision shall be carried out by a person or group of persons (e.g. a committee, see 5.1.4) that has not been involved in the process for evaluation (see 7.4). (The review and the certification decision can be completed concurrently by the same person or group of persons.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Decision authority retained by the body (never outsourced)"
+      - description: "No decider was involved in the evaluation"
+  }
+  verification { method implicit description "Decision step (abstract process decision; segregation entry decision_not_evaluation)." }
+  source { doc "ISO/IEC 17065:2012, 7.6.1, 7.6.2" clause "" }
+}
+
+requirement /req/iso-17065/process/decision-employment {
+  name "Decision-maker employment and refusal notification"
+  statement "The person(s) (excluding members of committees, see 5.1.4) assigned by the certification body to make a certification decision shall be employed by, or shall be under contract with, the certification body (see 6.1) or an entity under the organizational control of the certification body (see 7.6.4). The certification body shall notify the client of a decision not to grant certification, and shall identify the reasons for the decision."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Decision personnel employed by/contracted to the body or a controlled entity"
+      - description: "Refusals notified to the client with reasons"
+  }
+  verification { method implicit description "Decision step (abstract process decision)." }
+  source { doc "ISO/IEC 17065:2012, 7.6.3, 7.6.6" clause "" }
+}
+
+requirement /req/iso-17065/process/certification-documentation {
+  name "Certification documentation content and authorization"
+  statement "The certification body shall provide the client with formal certification documentation that clearly conveys, or permits identification of: a) the name and address of the certification body; b) the date certification is granted (the date shall not precede the date on which the certification decision was completed); c) the name and address of the client; d) the scope of certification; e) the term or expiry date of certification, if certification expires after an established period; f) any other information required by the certification scheme. The formal certification documentation shall include the signature or other defined authorization of the person(s) of the certification body assigned such responsibility."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Documentation conveys items a–f (grant date not preceding the decision date)"
+      - description: "Signature or defined authorization of the assigned person(s) present"
+  }
+  verification { method implicit description "Attestation step (abstract process attestation)." }
+  source { doc "ISO/IEC 17065:2012, 7.7.1, 7.7.2" clause "" }
+}
+
+requirement /req/iso-17065/process/attestation-preconditions {
+  name "Attestation preconditions"
+  statement "Formal certification documentation (see 7.7) shall only be issued after, or concurrent with, the following: a) the decision to grant or extend the scope of certification (see 7.6.1) has been made; b) certification requirements have been fulfilled; c) the certification agreement (see 4.1.2) has been completed/signed."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Grant/extension decision made before (or concurrent with) issuance"
+      - description: "Certification requirements fulfilled and agreement completed/signed at issuance"
+  }
+  verification { method implicit description "Attestation step (abstract process attestation)." }
+  source { doc "ISO/IEC 17065:2012, 7.7.3" clause "" }
+}
+
+requirement /req/iso-17065/process/directory {
+  name "Directory of certified products"
+  statement "The certification body shall maintain information on certified products which contains at least: a) identification of the product; b) the standard(s) and other normative document(s) to which conformity has been certified; c) identification of the client. The parts of this information that need to be published or made available upon request in a directory are stipulated by the relevant scheme(s); as a minimum, the certification body shall provide information, upon request, about the validity of a given certification."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Certified-product information (product, normative documents, client) maintained"
+      - description: "Validity of a given certification provided on request"
+  }
+  verification { method implicit description "Attestation-completion leg (abstract process attestation; the OIML-CS's public register realizes this directory)." }
+  source { doc "ISO/IEC 17065:2012, 7.8.1, 7.8.2" clause "" }
+}
+
+requirement /req/iso-17065/process/surveillance {
+  name "Surveillance per the scheme"
+  statement "If surveillance is required by the certification scheme, or as specified in 7.9.3 or 7.9.4, the certification body shall initiate surveillance of the product(s) covered by the certification decision in accordance with the certification scheme (the criteria and process for surveillance activities are defined by each certification scheme). When surveillance utilizes evaluation, review or a certification decision, the requirements in 7.4, 7.5 or 7.6, respectively, shall be fulfilled."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Surveillance initiated wherever the scheme requires it"
+      - description: "Surveillance re-using evaluation/review/decision fulfils 7.4/7.5/7.6 respectively"
+  }
+  verification { method implicit description "Surveillance step (abstract process surveillance)." }
+  source { doc "ISO/IEC 17065:2012, 7.9.1, 7.9.2" clause "" }
+}
+
+requirement /req/iso-17065/process/surveillance-marked-products {
+  name "Mandatory surveillance for continued mark use"
+  statement "When continuing use of a certification mark is authorized for placement on a product (or its packaging, or information accompanying it) (for process or service, see 7.9.4) of a type which has been certified, surveillance shall be established and shall include periodic surveillance of marked products to ensure ongoing validity of the demonstration of fulfilment of product requirements. When continuing use of a certification mark is authorized for a process or service, surveillance shall be established and shall include periodic surveillance activities to ensure ongoing validity of the demonstration of fulfilment of process or service requirements."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Periodic surveillance established wherever a certification mark continues in use"
+  }
+  verification { method implicit description "Surveillance step (abstract process surveillance)." }
+  source { doc "ISO/IEC 17065:2012, 7.9.3, 7.9.4" clause "" }
+}
+
+requirement /req/iso-17065/process/changes {
+  name "Changes affecting certification"
+  statement "When the certification scheme introduces new or revised requirements that affect the client, the certification body shall ensure these changes are communicated to all clients, shall verify the implementation of the changes by its clients, and shall take actions required by the scheme. The certification body shall consider other changes affecting certification, including changes initiated by the client, and shall decide upon the appropriate action. The actions to implement changes affecting certification shall include, if required: evaluation (see 7.4), review (see 7.5), decision (see 7.6), issuance of revised formal certification documentation (see 7.7), and issuance of certification documentation of revised surveillance activities — completed in accordance with the applicable parts of 7.4, 7.5, 7.6, 7.7 and 7.8, with records (see 7.12) including the rationale for excluding any of these activities."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Scheme changes communicated to all clients; implementation verified"
+      - description: "Change actions run per 7.4–7.8; exclusions' rationale recorded"
+  }
+  verification { method implicit description "Changes step (abstract process changes)." }
+  source { doc "ISO/IEC 17065:2012, 7.10.1, 7.10.2, 7.10.3" clause "" }
+}
+
+requirement /req/iso-17065/process/termination {
+  name "Termination, reduction, suspension or withdrawal"
+  statement "When a nonconformity with certification requirements is substantiated, either as a result of surveillance or otherwise, the certification body shall consider and decide upon the appropriate action (e.g. continuation under specified conditions, reduction of the scope of certification, suspension pending remedial action, or withdrawal). When the appropriate action includes evaluation, review or a certification decision, the requirements in 7.4, 7.5 or 7.6, respectively, shall be fulfilled. If certification is terminated (by request of the client), suspended or withdrawn, the certification body shall take actions specified by the certification scheme and shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure it provides no indication that the product continues to be certified; if a scope of certification is reduced, the reduced scope shall be clearly communicated to the client and clearly specified in certification documentation and public information."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Substantiated nonconformity decided upon; 7.4/7.5/7.6 applied when re-entered"
+      - description: "No indication of continued certification after termination/suspension/withdrawal/reduction"
+  }
+  verification { method implicit description "Termination step (abstract process termination)." }
+  source { doc "ISO/IEC 17065:2012, 7.11.1, 7.11.2, 7.11.3" clause "" }
+}
+
+requirement /req/iso-17065/process/records {
+  name "Records"
+  statement "The certification body shall retain records to demonstrate that all certification process requirements (those in this International Standard and those of the certification scheme) have been effectively fulfilled (see also 8.4). The certification body shall keep records confidential; records shall be transported, transmitted and transferred in a way that ensures confidentiality is maintained (see also 4.5). If the certification scheme involves complete re-evaluation of the product(s) within a determined cycle, records shall be retained at least for the current and the previous cycle; otherwise, records shall be retained for a period defined by the certification body."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Records demonstrating fulfilment of all certification process requirements retained"
+      - description: "Confidentiality preserved; retention covers at least current and previous cycle where applicable"
+  }
+  verification { method implicit description "Records step (abstract process records)." }
+  source { doc "ISO/IEC 17065:2012, 7.12.1, 7.12.2, 7.12.3" clause "" }
+}
+
+requirement /req/iso-17065/process/complaints-process {
+  name "Complaints and appeals process"
+  statement "The certification body shall have a documented process to receive, evaluate and make decisions on complaints and appeals, and shall record and track complaints and appeals, as well as actions undertaken to resolve them. Upon receipt of a complaint or appeal, the certification body shall confirm whether the complaint or appeal relates to certification activities for which it is responsible and, if so, shall address it. The certification body shall acknowledge receipt of a formal complaint or appeal, and shall be responsible for gathering and verifying all necessary information (as far as possible) to progress the complaint or appeal to a decision."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Documented receive/evaluate/decide process with recording and tracking"
+      - description: "Receipt acknowledged; responsibility confirmed; information gathered and verified"
+  }
+  verification { method implicit description "Complaints step (abstract process complaints)." }
+  source { doc "ISO/IEC 17065:2012, 7.13.1, 7.13.2, 7.13.3, 7.13.4" clause "" }
+}
+
+requirement /req/iso-17065/process/complaint-resolution-independence {
+  name "Complaint-resolution independence"
+  statement "The decision resolving the complaint or appeal shall be made by, or reviewed and approved by, person(s) not involved in the certification activities related to the complaint or appeal."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "No complaint-resolution decider/reviewer/approver was involved in the related certification activities"
+  }
+  verification { method implicit description "Complaints step (abstract process complaints; segregation entry complaint_resolution_not_case)." }
+  source { doc "ISO/IEC 17065:2012, 7.13.5" clause "" }
+}
+
+requirement /req/iso-17065/process/complaint-consultancy-bar {
+  name "Two-year consultancy bar on complaint resolution"
+  statement "To ensure that there is no conflict of interest, 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 by the certification body 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."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "No complaint-resolution reviewer/approver within two years of consultancy for or employment by that client"
+  }
+  verification { method implicit description "Complaints step (abstract process complaints; segregation entry complaint_consultancy_two_year_bar)." }
+  source { doc "ISO/IEC 17065:2012, 7.13.6" clause "" }
+}
+

package/iso-iec-17065/terminology.prl

@@ -0,0 +1,103 @@
+term client {
+  label "client"
+  definition "organization or person responsible to a certification body for ensuring that certification requirements, including product requirements, are fulfilled"
+  section "3.1"
+  note "Whenever the term \"client\" is used in this International Standard, it applies to both the \"applicant\" and the \"client\", unless otherwise specified."
+  source "ISO/IEC 17065:2012, 3.1"
+}
+
+term consultancy {
+  label "consultancy"
+  definition "participation in a) the designing, manufacturing, installing, maintaining or distributing of a certified product or a product to be certified, or b) the designing, implementing, operating or maintaining of a certified process or a process to be certified, or c) the designing, implementing, providing or maintaining of a certified service or a service to be certified"
+  section "3.2"
+  note "In this International Standard, the term \"consultancy\" is used in relation to activities of certification bodies, personnel of certification bodies and organizations related or linked to certification bodies. The consultancy bars of 4.2.10 and 7.13.6 are the segregation constraints this term anchors."
+  source "ISO/IEC 17065:2012, 3.2"
+}
+
+term evaluation {
+  label "evaluation"
+  definition "combination of the selection and determination functions of conformity assessment activities"
+  section "3.3"
+  note "The selection and determination functions are specified in ISO/IEC 17000, Clauses A.2 and A.3. This is the term the activity_kind multi-kind tag [selection, determination] on the evaluation abstract process encodes."
+  source "ISO/IEC 17065:2012, 3.3"
+}
+
+term product {
+  label "product"
+  definition "result of a process"
+  section "3.4"
+  note "Four generic product categories are noted in ISO 9000:2005: services (e.g. transport), software (e.g. computer program, dictionary), hardware (e.g. engine, mechanical part), and processed materials (e.g. lubricant); many products comprise elements belonging to different generic product categories. Products include results of natural processes, such as growth of plants and formation of other natural resources. Adapted from ISO/IEC 17000, 3.3."
+  source "ISO/IEC 17065:2012, 3.4"
+}
+
+term process {
+  label "process"
+  definition "set of interrelated or interacting activities which transforms inputs into outputs"
+  section "3.5"
+  note "Examples: welding engineering processes; heat treatment processes; manufacturing processes requiring confirmation of process capability. Adapted from ISO 9000:2005, definition 3.4.1."
+  source "ISO/IEC 17065:2012, 3.5"
+}
+
+term service {
+  label "service"
+  definition "result of at least one activity necessarily performed at the interface between the supplier and the customer, which is generally intangible"
+  section "3.6"
+  note "Adapted from ISO 9000:2005, definition 3.4.2."
+  source "ISO/IEC 17065:2012, 3.6"
+}
+
+term certification-requirement {
+  label "certification requirement"
+  definition "specified requirement, including product requirements, that is fulfilled by the client as a condition of establishing or maintaining certification"
+  section "3.7"
+  note "Certification requirements include requirements imposed on the client by the certification body (usually via the certification agreement, see 4.1.2) to meet this International Standard, and can also include requirements imposed on the client by the certification scheme; they do not include requirements imposed on the certification body by the certification scheme. Examples that are not product requirements: completing the certification agreement, paying fees, providing information about changes to the certified product, providing access to certified products for surveillance activities."
+  source "ISO/IEC 17065:2012, 3.7"
+}
+
+term product-requirement {
+  label "product requirement"
+  definition "requirement that relates directly to a product, specified in standards or in other normative documents identified by the certification scheme"
+  section "3.8"
+  note "Product requirements can be specified in normative documents such as regulations, standards and technical specifications."
+  source "ISO/IEC 17065:2012, 3.8"
+}
+
+term certification-scheme {
+  label "certification scheme"
+  definition "certification system related to specified products, to which the same specified requirements, specific rules and procedures apply"
+  section "3.9"
+  note "Adapted from ISO/IEC 17000, 2.8. A \"certification system\" is a \"conformity assessment system\" (ISO/IEC 17000, 2.7). The rules, procedures and management for implementing product, process and service certification are stipulated by the certification scheme. General guidance for the development of schemes is given in ISO/IEC 17067, in combination with ISO/IEC Guide 28 and ISO/IEC Guide 53."
+  source "ISO/IEC 17065:2012, 3.9"
+}
+
+term scope-of-certification {
+  label "scope of certification"
+  definition "identification of the product(s), process(es) or service(s) for which the certification is granted, the applicable certification scheme, and the standard(s) and other normative document(s), including their date of publication, to which it is judged that the product(s), process(es) or service(s) comply"
+  section "3.10"
+  source "ISO/IEC 17065:2012, 3.10"
+}
+
+term scheme-owner {
+  label "scheme owner"
+  definition "person or organization responsible for developing and maintaining a specific certification scheme"
+  section "3.11"
+  note "The scheme owner can be the certification body itself, a governmental authority, a trade association, a group of certification bodies or others."
+  source "ISO/IEC 17065:2012, 3.11"
+}
+
+term certification-body {
+  label "certification body"
+  definition "third-party conformity assessment body operating certification schemes"
+  section "3.12"
+  note "A certification body can be non-governmental or governmental (with or without regulatory authority)."
+  source "ISO/IEC 17065:2012, 3.12"
+}
+
+term impartiality {
+  label "impartiality"
+  definition "presence of objectivity"
+  section "3.13"
+  note "Objectivity is understood to mean that conflicts of interest do not exist, or are resolved so as not to adversely influence the activities of the body. DEFINITION DIVERGENCE: ISO/IEC 17000:2020, 5.3 defines impartiality as \"objectivity with regard to the outcome of a conformity assessment activity\" — the 2020 revision postdates this International Standard; in composed trees this entry deep-merges over the 17000 register's (see the header note)."
+  source "ISO/IEC 17065:2012, 3.13"
+}
+

package/iso-iec-17067/package.primmel

@@ -0,0 +1,10 @@
+package {
+  id iso-iec-17067
+  kind core
+  title "OIML SMART iso-iec-17067 layer package"
+  description "ISO/IEC 17067:2013 reference package — the product-certification scheme taxonomy: the clause-5 scheme types (1a/1b/2/3/4/5/6) as a machine-queryable register (determination/attestation/surveillance facets per Table 1; surveillance presence per 5.3.1) and the §6.5.1 a)–v) scheme-content checklist as /req/iso-17067/scheme-content/* provisions verified by assessment of the scheme corpus. The resolution register for the scheme_type facet a scheme layer declares (the OIML-CS declares type_1a — B 18:2025 §1.3). Composed into each Recommendation via `uses: [iso-iec-17067]` after iso-iec-17025 and ahead of oiml-cs."
+  uses { iso-iec-17000 }
+  requires { iso-iec-17000 }
+  provides { iso-iec-17067 scheme-content-requirements-17067 ca-terminology-17067 }
+  default_spelling eng-Latn
+}