@oimlsmart/primmel-packages 0.1.0

package/iso-iec-17025/specification/requirements/lab.prl

@@ -0,0 +1,474 @@
+requirement_class /req/iso-17025/lab {
+  title "ISO/IEC 17025 resource requirements"
+  name "ISO/IEC 17025 laboratory resource requirements (clause 6)"
+  description "Resource requirements of ISO/IEC 17025:2017 (clause 6) on a testing or calibration laboratory: personnel acting impartially with documented and monitored competence and per-activity authorizations; equipment verified, calibrated and recorded; metrological traceability of results via a documented unbroken chain of calibrations to the SI (Annex A). The OIML-CS relies on these for Test-Laboratory competence (B 18:2025 §5.3); they are verified by assessment of the laboratory (accreditation or peer assessment), not by the type-evaluation workflow."
+  subject "Testing/calibration laboratory — personnel, equipment and metrological traceability"
+}
+
+requirement /req/iso-17025/lab/personnel-impartiality-competence {
+  name "Personnel impartiality and competence"
+  statement "All personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially, be competent and work in accordance with the laboratory's management system. The laboratory shall ensure that the personnel have the competence to perform laboratory activities for which they are responsible and to evaluate the significance of deviations."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Every person influencing laboratory activities demonstrably impartial, competent and management-system-bound"
+      - description: "Competence covers the evaluation of the significance of deviations"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment), outside the per-application certification process." }
+  source { doc "ISO/IEC 17025:2017, 6.2.1, 6.2.3" clause "" }
+}
+
+requirement /req/iso-17025/lab/personnel-competence-requirements {
+  name "Documented competence requirements per function"
+  statement "The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Competence requirements documented for every function influencing results"
+      - description: "Documentation covers education, qualification, training, technical knowledge, skills and experience"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.2.2" clause "" }
+}
+
+requirement /req/iso-17025/lab/personnel-procedure-records {
+  name "Personnel procedure and competence records"
+  statement "The laboratory shall have procedure(s) and retain records for: determining the competence requirements; selection of personnel; training of personnel; supervision of personnel; authorization of personnel; monitoring competence of personnel."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Procedure(s) in place covering all six personnel-management stages"
+      - description: "Records of selection, training, supervision, authorization and competence monitoring retained"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.2.5" clause "" }
+}
+
+requirement /req/iso-17025/lab/authorized-personnel {
+  name "Authorized personnel for specific activities"
+  statement "The laboratory shall authorize personnel to perform specific laboratory activities, including but not limited to, the following: a) development, modification, verification and validation of methods; b) analysis of results, including statements of conformity or opinions and interpretations; c) report, review and authorization of results."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Per-activity authorizations documented for every person performing 6.2.6 a–c activities"
+      - description: "Statements of conformity and opinions/interpretations released only by personnel authorized for them (feeds 7.8.6/7.8.7)"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.2.6" clause "" }
+}
+
+requirement /req/iso-17025/lab/equipment-conformity {
+  name "Equipment conformity and capability"
+  statement "The laboratory shall verify that equipment conforms to specified requirements before being placed or returned into service. The equipment used for measurement shall be capable of achieving the measurement accuracy and/or measurement uncertainty required to provide a valid result."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Conformity verification recorded before (re-)entry into service"
+      - description: "Demonstrated capability of the required accuracy / measurement uncertainty"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.4.4, 6.4.5" clause "" }
+}
+
+requirement /req/iso-17025/lab/equipment-calibration {
+  name "Equipment calibration"
+  statement "Measuring equipment shall be calibrated when: the measurement accuracy or measurement uncertainty affects the validity of the reported results, and/or calibration of the equipment is required to establish the metrological traceability of the reported results. (Equipment having an effect on the validity of the reported results includes that used for the direct measurement of the measurand, that used to make corrections to the measured value, and that used to obtain a result calculated from multiple quantities.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Every validity-affecting / traceability-required instrument calibrated"
+      - description: "Calibration certificates current at the time of use"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.4.6" clause "" }
+}
+
+requirement /req/iso-17025/lab/calibration-programme {
+  name "Calibration programme and status identification"
+  statement "The laboratory shall establish a calibration programme, which shall be reviewed and adjusted as necessary in order to maintain confidence in the status of calibration. All equipment requiring calibration or which has a defined period of validity shall be labelled, coded or otherwise identified to allow the user of the equipment to readily identify the status of calibration or period of validity."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Calibration programme established, reviewed and adjusted"
+      - description: "Calibration status / validity period identifiable on every instrument concerned"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.4.7, 6.4.8" clause "" }
+}
+
+requirement /req/iso-17025/lab/equipment-records {
+  name "Equipment records"
+  statement "Records shall be retained for equipment which can influence laboratory activities. The records shall include the following, where applicable: a) the identity of equipment, including software and firmware version; b) the manufacturer's name, type identification, and serial number or other unique identification; c) evidence of verification that equipment conforms with specified requirements; d) the current location; e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval; f) documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity; g) the maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment; h) details of any damage, malfunction, modification to, or repair of, the equipment."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "A retained record exists for every instrument that can influence laboratory activities"
+      - description: "Each record carries the applicable 6.4.13 a–h items"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.4.13" clause "" }
+}
+
+requirement /req/iso-17025/lab/traceability-chain {
+  name "Metrological traceability chain"
+  statement "The laboratory shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Documented unbroken calibration chain from every reported result to its reference"
+      - description: "Every link's contribution to the measurement uncertainty recorded"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.5.1" clause "" }
+}
+
+requirement /req/iso-17025/lab/si-traceability {
+  name "Traceability to the SI"
+  statement "The laboratory shall ensure that measurement results are traceable to the International System of Units (SI) through: a) calibration provided by a competent laboratory (laboratories fulfilling the requirements of this document are considered to be competent); or b) certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI (reference material producers fulfilling ISO 17034 are considered to be competent); or c) direct realization of the SI units ensured by comparison, directly or indirectly, with national or international standards. (Annex A.2.1: establishing traceability considers and ensures the specification of the measurand, a documented unbroken chain of calibrations going back to stated and appropriate references, measurement uncertainty evaluated for each step according to agreed methods, each step performed in accordance with appropriate methods with recorded results and associated uncertainties, and evidence of the technical competence of the laboratories performing the chain's steps. Annex A.3.1: internationally accepted demonstration paths include the CIPM MRA / BIPM KCDB and accreditation under the ILAC Arrangement; A.3.2: the Joint BIPM, OIML, ILAC and ISO Declaration on Metrological Traceability.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "SI traceability of every reported result via one of the 6.5.2 a–c routes"
+      - description: "Chain-laboratory competence evidence (accreditation / CIPM MRA listing) on file"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.5.2, Annex A.2.1, A.3 (Annex A informative)" clause "" }
+}
+
+requirement /req/iso-17025/lab/non-si-traceability {
+  name "Traceability when SI realization is not possible"
+  statement "When metrological traceability to the SI units is not technically possible, the laboratory shall demonstrate metrological traceability to an appropriate reference, e.g.: a) certified values of certified reference materials provided by a competent producer; b) results of reference measurement procedures, specified methods or consensus standards that are clearly described and accepted as providing measurement results fit for their intended use and ensured by suitable comparison."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Non-SI traceability demonstrated to an appropriate reference wherever SI traceability is technically impossible"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, 6.5.3" clause "" }
+}
+
+requirement /req/iso-17025/lab/conformity-only-dissemination {
+  name "Conformity-only dissemination of traceability"
+  statement "Measurement standards that have reported information from a competent laboratory that includes only a statement of conformity to a specification (omitting the measurement results and associated uncertainties) are sometimes used to disseminate metrological traceability. This approach, in which the specification limits are imported as the source of uncertainty, is dependent upon: a) the use of an appropriate decision rule to establish conformity; b) the specification limits subsequently being treated in a technically appropriate way in the uncertainty budget. (Example: the use of OIML R 111 class weights to calibrate a balance.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Conformity-only dissemination relies on an appropriate decision rule"
+      - description: "Imported specification limits treated technically appropriately in the uncertainty budget"
+  }
+  verification { method deferred description "Verified by assessment of the laboratory (accreditation or OIML-CS peer assessment)." }
+  source { doc "ISO/IEC 17025:2017, Annex A.2.3 (informative)" clause "" }
+}
+
+requirement_class /req/iso-17025/process {
+  title "ISO/IEC 17025 process requirements"
+  name "ISO/IEC 17025 laboratory process requirements (clause 7)"
+  description "Clause-7 process requirements of ISO/IEC 17025:2017 — the laboratory test lifecycle from the review of requests, tenders and contracts (7.1) through reporting of results (7.8), with complaints (7.9) and nonconforming work (7.10). Each provision is enforced by the abstract process of the same lifecycle in evaluation/functional-approach.yaml (its `provisions:` binding), exactly as the OIML-CS scheme's concrete steps validate the /req/cs/* provisions."
+  subject "Laboratory test lifecycle — request review to reporting, complaints and nonconforming work"
+}
+
+requirement /req/iso-17025/process/request-review {
+  name "Review of requests, tenders and contracts"
+  statement "The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that: a) the requirements are adequately defined, documented and understood; b) the laboratory has the capability and resources to meet the requirements; c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer's approval; d) the appropriate methods or procedures are selected and are capable of meeting the customers' requirements."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Request/tender/contract review procedure in place covering 7.1.1 a–d"
+      - description: "Capability, resources and method adequacy confirmed before acceptance"
+  }
+  verification { method implicit description "Request-review step (abstract process request_review)." }
+  source { doc "ISO/IEC 17025:2017, 7.1.1" clause "" }
+}
+
+requirement /req/iso-17025/process/decision-rule {
+  name "Decision rule for statements of conformity"
+  statement "When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance), the specification or standard and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to, and agreed with, the customer."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Specification/standard and decision rule clearly defined for every requested conformity statement"
+      - description: "Non-inherent decision rules communicated to and agreed with the customer"
+  }
+  verification { method implicit description "Request-review step (abstract process request_review; the decision-rule triangle 3.7 + 7.1.3 + 7.8.6)." }
+  source { doc "ISO/IEC 17025:2017, 7.1.3" clause "" }
+}
+
+requirement /req/iso-17025/process/method-selection {
+  name "Selection of methods"
+  statement "The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data. The laboratory shall ensure that it uses the latest valid version of a method unless it is not appropriate or possible to do so; when necessary, the application of the method shall be supplemented with additional details to ensure consistent application. When the customer does not specify the method to be used, the laboratory shall select an appropriate method and inform the customer of the method chosen."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Appropriate, latest-valid-version methods in use for every laboratory activity"
+      - description: "Customer informed of the method chosen when it did not specify one"
+  }
+  verification { method implicit description "Method-selection step (abstract process method_selection)." }
+  source { doc "ISO/IEC 17025:2017, 7.2.1.1, 7.2.1.3, 7.2.1.4" clause "" }
+}
+
+requirement /req/iso-17025/process/method-verification {
+  name "Verification of methods"
+  statement "The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary. Deviations from methods for all laboratory activities shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Method verification performed before introduction and repeated on method revision; records retained"
+      - description: "Every deviation documented, technically justified, authorized and customer-accepted"
+  }
+  verification { method implicit description "Method-selection step (abstract process method_selection)." }
+  source { doc "ISO/IEC 17025:2017, 7.2.1.5, 7.2.1.7" clause "" }
+}
+
+requirement /req/iso-17025/process/method-validation {
+  name "Validation of methods"
+  statement "The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall retain the following records of validation: a) the validation procedure used; b) specification of the requirements; c) determination of the performance characteristics of the method; d) results obtained; e) a statement on the validity of the method, detailing its fitness for the intended use."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Validation performed for every non-standard / laboratory-developed / out-of-scope / modified method"
+      - description: "Validation records 7.2.2.4 a–e retained"
+  }
+  verification { method implicit description "Method-validation step (abstract process method_validation)." }
+  source { doc "ISO/IEC 17025:2017, 7.2.2.1, 7.2.2.4" clause "" }
+}
+
+requirement /req/iso-17025/process/sampling-plan {
+  name "Sampling plan and method"
+  statement "The laboratory shall have a sampling plan and method when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling method shall address the factors to be controlled to ensure the validity of subsequent testing or calibration results. The sampling plan and method shall be available at the site where sampling is undertaken. Sampling plans shall, whenever reasonable, be based on appropriate statistical methods. The sampling method shall describe: a) the selection of samples or sites; b) the sampling plan; c) the preparation and treatment of sample(s) from a substance, material or product to yield the required item for subsequent testing or calibration."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Sampling plan and method available at the sampling site, statistically based whenever reasonable"
+      - description: "Method describes sample/site selection, the plan, and preparation/treatment"
+  }
+  verification { method implicit description "Sampling step (abstract process sampling)." }
+  source { doc "ISO/IEC 17025:2017, 7.3.1, 7.3.2" clause "" }
+}
+
+requirement /req/iso-17025/process/sampling-records {
+  name "Sampling records"
+  statement "The laboratory shall retain records of sampling data that forms part of the testing or calibration that is undertaken. These records shall include, where relevant: a) reference to the sampling method used; b) date and time of sampling; c) data to identify and describe the sample; d) identification of the personnel performing sampling; e) identification of the equipment used; f) environmental or transport conditions; g) diagrams or other equivalent means to identify the sampling location, when appropriate; h) deviations, additions to or exclusions from the sampling method and sampling plan."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Sampling records with the relevant 7.3.3 a–h content retained"
+  }
+  verification { method implicit description "Sampling step (abstract process sampling)." }
+  source { doc "ISO/IEC 17025:2017, 7.3.3" clause "" }
+}
+
+requirement /req/iso-17025/process/item-handling {
+  name "Handling and identification of items"
+  statement "The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the item and to protect the interests of the laboratory and the customer; precautions shall be taken to avoid deterioration, contamination, loss or damage, and handling instructions provided with the item shall be followed. The laboratory shall have a system for the unambiguous identification of test or calibration items; the identification shall be retained while the item is under the responsibility of the laboratory and shall ensure that items will not be confused physically or in records, accommodating, if appropriate, a sub-division of an item or groups of items and the transfer of items."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Item-handling procedure covering transport to disposal/return with integrity precautions"
+      - description: "Unambiguous identification retained for the whole period of laboratory responsibility"
+  }
+  verification { method implicit description "Item-handling step (abstract process item_handling)." }
+  source { doc "ISO/IEC 17025:2017, 7.4.1, 7.4.2" clause "" }
+}
+
+requirement /req/iso-17025/process/item-receipt-storage {
+  name "Item receipt deviations and storage conditions"
+  statement "Upon receipt of the test or calibration item, deviations from specified conditions shall be recorded. When there is doubt about the suitability of an item for test or calibration, or when an item does not conform to the description provided, the laboratory shall consult the customer for further instructions before proceeding and shall record the results of this consultation; when the customer requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report indicating which results may be affected by the deviation. When items need to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Receipt deviations recorded; doubtful items consulted on before proceeding"
+      - description: "Storage/conditioning conditions maintained, monitored and recorded; disclaimer where applicable"
+  }
+  verification { method implicit description "Item-handling step (abstract process item_handling)." }
+  source { doc "ISO/IEC 17025:2017, 7.4.3, 7.4.4" clause "" }
+}
+
+requirement /req/iso-17025/process/activity-records {
+  name "Technical records of laboratory activities"
+  statement "The laboratory shall ensure that technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original. The technical records shall include the date and the identity of personnel responsible for each laboratory activity and for checking data and results. Original observations, data and calculations shall be recorded at the time they are made and shall be identifiable with the specific task."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Per-activity records enable repetition under near-original conditions and identify affecting factors"
+      - description: "Date, responsible personnel and data/result checkers identified; original observations recorded when made"
+  }
+  verification { method implicit description "Test-execution step (abstract process test_execution)." }
+  source { doc "ISO/IEC 17025:2017, 7.5.1" clause "" }
+}
+
+requirement /req/iso-17025/process/record-amendments {
+  name "Amendments to technical records"
+  statement "The laboratory shall ensure that amendments to technical records can be tracked to previous versions or to original observations. Both the original and amended data and files shall be retained, including the date of alteration, an indication of the altered aspects and the personnel responsible for the alterations."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Amendments trackable to previous versions/original observations"
+      - description: "Original and amended data retained with date, altered aspects and responsible personnel"
+  }
+  verification { method implicit description "Technical-records discipline (abstract process technical_records)." }
+  source { doc "ISO/IEC 17025:2017, 7.5.2" clause "" }
+}
+
+requirement /req/iso-17025/process/measurement-uncertainty {
+  name "Evaluation of measurement uncertainty"
+  statement "Laboratories shall identify the contributions to measurement uncertainty; when evaluating measurement uncertainty, all contributions that are of significance, including those arising from sampling, shall be taken into account using appropriate methods of analysis. A laboratory performing calibrations, including of its own equipment, shall evaluate the measurement uncertainty for all calibrations. A laboratory performing testing shall evaluate measurement uncertainty; where the test method precludes rigorous evaluation of measurement uncertainty, an estimation shall be made based on an understanding of the theoretical principles or practical experience of the performance of the method. (Following a well-recognized test method that specifies limits to the values of the major sources of measurement uncertainty and specifies the form of presentation of the calculated results satisfies 7.6.3.)"
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "All significant MU contributions identified, including sampling contributions"
+      - description: "MU evaluated for all calibrations and for testing (estimated where the method precludes rigour)"
+  }
+  verification { method implicit description "Measurement-uncertainty step (abstract process measurement_uncertainty)." }
+  source { doc "ISO/IEC 17025:2017, 7.6.1, 7.6.2, 7.6.3" clause "" }
+}
+
+requirement /req/iso-17025/process/validity-of-results {
+  name "Ensuring the validity of results"
+  statement "The laboratory shall have a procedure for monitoring the validity of results; the resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed (including, where appropriate, use of reference materials, alternative traceable instrumentation, functional checks, check standards with control charts, intermediate checks, replicate tests, retesting of retained items, correlation of results, review of reported results, intralaboratory comparisons and blind-sample testing). The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate, including participation in proficiency testing and/or interlaboratory comparisons other than proficiency testing. Data from monitoring activities shall be analysed, used to control and, if applicable, improve the laboratory's activities; results outside pre-defined criteria shall lead to appropriate action to prevent incorrect results from being reported."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Validity-monitoring procedure with trend-detectable recording, planned and reviewed"
+      - description: "Interlaboratory comparison / proficiency testing participation where available and appropriate"
+      - description: "Out-of-criteria analysis followed by action preventing incorrect reporting"
+  }
+  verification { method implicit description "Validity-monitoring step (abstract process validity_monitoring)." }
+  source { doc "ISO/IEC 17025:2017, 7.7.1, 7.7.2, 7.7.3" clause "" }
+}
+
+requirement /req/iso-17025/process/results-review-release {
+  name "Review and authorization of results before release"
+  statement "The results shall be reviewed and authorized prior to release. The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling), and shall include all the information agreed with the customer and necessary for the interpretation of the results and all information required by the method used. All issued reports shall be retained as technical records."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Review and authorization of results recorded before every release"
+      - description: "Issued reports retained as technical records"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.1.1, 7.8.1.2" clause "" }
+}
+
+requirement /req/iso-17025/process/report-common-content {
+  name "Common report content"
+  statement "Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse: a) a title; b) the name and address of the laboratory; c) the location of performance of the laboratory activities, including when performed at a customer facility or at sites away from the laboratory's permanent facilities, or in associated temporary or mobile facilities; d) unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end; e) the name and contact information of the customer; f) identification of the method used; g) a description, unambiguous identification, and, when necessary, the condition of the item; h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to the validity and application of the results; i) the date(s) of performance of the laboratory activity; j) the date of issue of the report; k) reference to the sampling plan and sampling method used by the laboratory or other bodies where these are relevant to the validity or application of the results; l) a statement to the effect that the results relate only to the items tested, calibrated or sampled; m) the results with, where appropriate, the units of measurement; n) additions to, deviations, or exclusions from the method; o) identification of the person(s) authorizing the report; p) clear identification when results are from external providers. The laboratory shall be responsible for all the information provided in the report, except when information is provided by the customer; customer-provided data shall be clearly identified and a disclaimer placed on the report when it can affect the validity of results; where the laboratory has not been responsible for the sampling stage, it shall state in the report that the results apply to the sample as received."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Every report carries the 7.8.2.1 a–p content (or documented valid reasons)"
+      - description: "Customer-provided data identified and disclaimed; sample-as-received statement where applicable"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.2.1, 7.8.2.2" clause "" }
+}
+
+requirement /req/iso-17025/process/test-report-content {
+  name "Test-report specific content"
+  statement "In addition to the requirements listed in 7.8.2, test reports shall, where necessary for the interpretation of the test results, include the following: a) information on specific test conditions, such as environmental conditions; b) where relevant, a statement of conformity with requirements or specifications (see 7.8.6); c) where applicable, the measurement uncertainty presented in the same unit as that of the measurand or in a term relative to the measurand when it is relevant to the validity or application of the test results, when a customer's instruction so requires, or when the measurement uncertainty affects conformity to a specification limit; d) where appropriate, opinions and interpretations (see 7.8.7); e) additional information that may be required by specific methods, authorities, customers or groups of customers."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Test reports carry the 7.8.3.1 a–e content where necessary for interpretation"
+      - description: "MU reported in measurand units or relative terms when validity-relevant, customer-required, or conformity-affecting"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.3.1" clause "" }
+}
+
+requirement /req/iso-17025/process/conformity-statements {
+  name "Statements of conformity"
+  statement "When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule. (Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.) The laboratory shall report on the statement of conformity, such that the statement clearly identifies: a) to which results the statement of conformity applies; b) which specifications, standards or parts thereof are met or not met; c) the decision rule applied (unless it is inherent in the requested specification or standard)."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Decision rule documented (risk taken into account) and applied"
+      - description: "Statement identifies the results covered, the specifications met/not met, and the decision rule"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.6.1, 7.8.6.2" clause "" }
+}
+
+requirement /req/iso-17025/process/opinions-interpretations {
+  name "Opinions and interpretations"
+  statement "When opinions and interpretations are expressed, the laboratory shall ensure that only personnel authorized for the expression of opinions and interpretations release the respective statement; the laboratory shall document the basis upon which the opinions and interpretations have been made. (Opinions and interpretations are to be distinguished from statements of inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC 17065, and from statements of conformity as referred to in 7.8.6.) The opinions and interpretations expressed in reports shall be based on the results obtained from the tested or calibrated item and shall be clearly identified as such. When opinions and interpretations are directly communicated by dialogue with the customer, a record of the dialogue shall be retained."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Opinions/interpretations released only by personnel authorized for them (6.2.6 b)"
+      - description: "Basis documented; clearly identified as based on the tested/calibrated item's results; dialogues recorded"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.7.1, 7.8.7.2, 7.8.7.3" clause "" }
+}
+
+requirement /req/iso-17025/process/report-amendments {
+  name "Amendments to reports"
+  statement "When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report. Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement \"Amendment to Report, serial number... [or as otherwise identified]\", or an equivalent form of wording, and shall meet all the requirements of this document. When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Post-issue changes only via an identified amendment document or a uniquely identified replacement report"
+  }
+  verification { method implicit description "Reporting step (abstract process reporting)." }
+  source { doc "ISO/IEC 17025:2017, 7.8.8.1, 7.8.8.2, 7.8.8.3" clause "" }
+}
+
+requirement /req/iso-17025/process/complaints {
+  name "Complaints"
+  statement "The laboratory shall have a documented process to receive, evaluate and make decisions on complaints; a description of the handling process shall be available to any interested party on request. Upon receipt of a complaint, the laboratory shall confirm whether the complaint relates to laboratory activities that it is responsible for and, if so, shall deal with it; the laboratory shall be responsible for all decisions at all levels of the handling process. The process shall include at least: a) a description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it; b) tracking and recording complaints, including actions undertaken to resolve them; c) ensuring that any appropriate action is taken. The laboratory receiving the complaint shall be responsible for gathering and verifying all necessary information to validate the complaint. Whenever possible, the laboratory shall acknowledge receipt of the complaint, and provide the complainant with progress reports and the outcome; the outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question. Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Documented receive/validate/investigate/decide process with tracking and recording"
+      - description: "Outcomes decided or reviewed/approved by individuals not involved in the original activities"
+  }
+  verification { method implicit description "Complaint-handling step (abstract process complaint_handling)." }
+  source { doc "ISO/IEC 17025:2017, 7.9.1, 7.9.2, 7.9.3, 7.9.4, 7.9.5, 7.9.6, 7.9.7" clause "" }
+}
+
+requirement /req/iso-17025/process/nonconforming-work {
+  name "Nonconforming work"
+  statement "The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer. The procedure shall ensure that: a) the responsibilities and authorities for the management of nonconforming work are defined; b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; d) a decision is taken on the acceptability of the nonconforming work; e) where necessary, the customer is notified and work is recalled; f) the responsibility for authorizing the resumption of work is defined. The laboratory shall retain records of nonconforming work and actions as specified in 7.10.1 b) to f). Where the evaluation indicates that the nonconforming work could recur, or that there is doubt about the conformity of the laboratory's operations with its own management system, the laboratory shall implement corrective action."
+  obligation shall
+  acceptance_criteria {
+    type: "qualitative"
+    items:
+      - description: "Nonconforming-work procedure with risk-based actions, significance evaluation and acceptability decision"
+      - description: "Records retained; corrective action implemented where recurrence is possible"
+  }
+  verification { method implicit description "Nonconforming-work step (abstract process nonconforming_work)." }
+  source { doc "ISO/IEC 17025:2017, 7.10.1, 7.10.2, 7.10.3" clause "" }
+}
+

package/iso-iec-17025/terminology.prl

@@ -0,0 +1,72 @@
+term impartiality {
+  label "impartiality"
+  definition "presence of objectivity"
+  section "3.1"
+  note "Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory. (SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — \"the certification body\" replaced by \"the laboratory\" in Note 1, and \"independence\" deleted from the list in Note 2.) Identical wording to ISO/IEC 17065:2012, 3.13; ISO/IEC 17000:2020, 5.3 differs — see the file header."
+  source "ISO/IEC 17025:2017, 3.1"
+}
+
+term complaint {
+  label "complaint"
+  definition "expression of dissatisfaction by any person or organization to a laboratory, relating to the activities or results of that laboratory, where a response is expected"
+  section "3.2"
+  note "SOURCE: ISO/IEC 17000:2004, 6.5, modified — \"other than appeal\" deleted; \"a conformity assessment body or accreditation body, relating to the activities of that body\" replaced by \"a laboratory, relating to the activities or results of that laboratory\"."
+  source "ISO/IEC 17025:2017, 3.2"
+}
+
+term interlaboratory-comparison {
+  label "interlaboratory comparison"
+  definition "organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions"
+  section "3.3"
+  note "SOURCE: ISO/IEC 17043:2010, 3.4. With proficiency testing (3.5), the 7.7.2 performance-monitoring instrument."
+  source "ISO/IEC 17025:2017, 3.3"
+}
+
+term intralaboratory-comparison {
+  label "intralaboratory comparison"
+  definition "organization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory in accordance with predetermined conditions"
+  section "3.4"
+  note "The single-laboratory counterpart of 3.3; one of the 7.7.1 monitoring techniques."
+  source "ISO/IEC 17025:2017, 3.4"
+}
+
+term proficiency-testing {
+  label "proficiency testing"
+  definition "evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons"
+  section "3.5"
+  note "SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry deleted."
+  source "ISO/IEC 17025:2017, 3.5"
+}
+
+term laboratory {
+  label "laboratory"
+  definition "body that performs one or more of the following activities: testing; calibration; sampling, associated with subsequent testing or calibration"
+  section "3.6"
+  note "In the context of this document, \"laboratory activities\" refer to the three above-mentioned activities. The definition added at the 2017 revision; the OIML-CS Test Laboratory is the laboratory of this package (B 18:2025 §5.3)."
+  source "ISO/IEC 17025:2017, 3.6"
+}
+
+term decision-rule {
+  label "decision rule"
+  definition "rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement"
+  section "3.7"
+  note "The decision-rule triangle this term anchors: 3.7 (definition) + 7.1.3 (contract-stage definition and agreement with the customer) + 7.8.6 (documented, risk-informed application and identification in the report) — the normative basis a Test Laboratory relies on when converting OIML-Recommendation MPE verdicts into statements of conformity (corpus audit, Corpus E §3)."
+  source "ISO/IEC 17025:2017, 3.7"
+}
+
+term verification {
+  label "verification"
+  definition "provision of objective evidence that a given item fulfils specified requirements"
+  section "3.8"
+  note "SOURCE: ISO/IEC Guide 99:2007 (VIM), 2.44. When applicable, measurement uncertainty should be taken into consideration. Verification in legal metrology, as defined in VIML, and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification certificate for a measuring system. Verification should not be confused with calibration; not every verification is a validation (3.9). COLLISION: ISO/IEC 17000:2020, 6.6 defines a different, conformity-assessment sense — see the file header."
+  source "ISO/IEC 17025:2017, 3.8"
+}
+
+term validation {
+  label "validation"
+  definition "verification, where the specified requirements are adequate for an intended use"
+  section "3.9"
+  note "SOURCE: ISO/IEC Guide 99:2007 (VIM), 2.45. The method-validation requirement of 7.2.2 is stated in this term."
+  source "ISO/IEC 17025:2017, 3.9"
+}
+

package/iso-iec-17065/package.primmel

@@ -0,0 +1,10 @@
+package {
+  id iso-iec-17065
+  kind core
+  title "OIML SMART iso-iec-17065 layer package"
+  description "ISO/IEC 17065:2012 reference package — the product-certification-body competence model: the /req/iso-17065/* body requirements (legal entity, impartiality management, personnel competence and records, evaluation resources per ISO/IEC 17025/17020/17021, records, complaints), the clause-7 functional approach as abstract processes classified against the ISO/IEC 17000 activity taxonomy, and role segregation as machine-checkable constraints (review/decision personnel disjoint from evaluation personnel; complaint-handler independence with the two-year consultancy bar). Composed into each Recommendation via `uses: [iso-iec-17065]` after iso-iec-17000 and ahead of oiml-cs."
+  uses { iso-iec-17000 }
+  requires { iso-iec-17000 }
+  provides { iso-iec-17065 cb-requirements-17065 ca-terminology-17065 }
+  default_spelling eng-Latn
+}