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ISO 17025 Clause Map

Quick-reference map of every ISO/IEC 17025:2017 clause leaf with its compliance status in Agrometrisis LIMS.

Summary (internal self-assessment, verified 2026-05-23):

🟡
137 Compliant0 Partial0 Gap4 N/A
This table scores how far the software covers each clause. It is our own assessment, not a

certification. Accreditation is granted to your laboratory by ΕΣΥΔ — Agrometrisis is built to

support that process, not to replace it.

Where the wording comes from. The titles in this table are our own one-line summaries, not the

text of the standard; clause numbers are cited as references. The authoritative text is the

controlled copy of EN ISO/IEC 17025:2017 your laboratory holds (§8.3) — the standard is sold by ISO

and its national members and is not reproduced here. Where our documentation quotes, it quotes

freely published guidance with attribution; see Sources.

Status symbols:

SymbolMeaning
Compliant — mechanism exists in code or in a policy document
🟡Partial — implemented with material gaps
Gap — not addressed
N/A — does not apply (e.g. testing-lab clauses about calibration certificates)

Contents


Section 4 — General requirements

ClauseTitleStatusWhere in the system
§4.1.1Impartial conduct of activitiesSettings → Laboratory Info
§4.1.2Management commitment to impartialitySettings → Quality Manual
§4.1.3Conflict of interest declarationsUsers → Confidentiality
§4.1.4Continuous impartiality risk identificationRisk Assessments
§4.1.5Mitigation of identified risksRisk Assessments
§4.2.1Legal protection of information confidentialitySettings → Security
§4.2.2Customer notification of lawful disclosureLegal Holds
§4.2.3Protection of third-party sourcesSettings → Security
§4.2.4Personnel confidentiality commitmentUsers → Confidentiality

Section 5 — Structural requirements

ClauseTitleStatusWhere in the system
§5.1Laboratory legal entitySettings → Laboratory Info
§5.2Laboratory management designationSettings → Laboratory Info
§5.3Scope of accredited activitiesAccreditation Scopes
§5.4Facilities and sampling locationsStorage Locations · Sampling Plans
§5.5Structure, responsibilities, proceduresSettings → Role Permissions · Document Control
§5.6Personnel authorization and resourcesUser Competencies · Supervised Practice
§5.7Communication and system integrityReviews · Audit Trail

Section 6 — Resource requirements

ClauseTitleStatusWhere in the system
§6.1Laboratory resource availabilityInstruments · Users · Suppliers
§6.2.1Impartial, competent personnelUsers
§6.2.2Documented competency requirementsCompetency Requirements
§6.2.3Competence to evaluate deviationsUser Competencies
§6.2.4Communicating duties and responsibilitiesSettings → Role Permissions
§6.2.5Competency procedures and recordsTraining Records · Competency Monitoring
§6.2.6Authorization for specific activitiesUser Competencies
§6.3.1Suitable facilities and environmentStorage Locations
§6.3.2Documented environmental requirementsSettings → Laboratory Info
§6.3.3Monitoring and recording conditionsEnvironmental Readings
§6.3.4Access and contamination controlStorage Locations
§6.3.5Activities outside permanent facilitiesSampling Plans · Sample Collection
§6.4.1Access to equipment and consumablesInstruments · Reagents
§6.4.2Equipment outside permanent controlInstruments
§6.4.3Handling and maintenance procedureInstruments → Maintenance
§6.4.4Compliance verification before useInstrument Validations
§6.4.5Required accuracy and uncertaintyInstruments → Calibrations
§6.4.6Equipment calibration for traceabilityInstruments → Calibrations
§6.4.7Calibration program and reviewCalibration Programmes
§6.4.8Calibration status labellingInstruments
§6.4.9Quarantine and isolation of defective equipmentInstruments
§6.4.10Intermediate quality checksInstruments → Intermediate Checks
§6.4.11Correction factors after calibrationCorrection Factors
§6.4.12Preventing unauthorized adjustmentsAudit Trail · Settings → Role Permissions
§6.4.13Equipment records and identificationInstruments · Instrument Classes
§6.5.1Documented metrological traceability chainInstruments → Calibrations
§6.5.2Traceability to the SIInstruments → Calibrations
§6.5.3Alternative routes via CRM and standardsControl Samples · Reagents
§6.6.1Suitability of external providersSuppliers
§6.6.2Supplier selection and evaluationSuppliers
§6.6.3Communicating requirements to providersSuppliers

Section 7 — Process requirements

ClauseTitleStatusWhere in the system
§7.1.1Requirements review procedureContacts → Agreements · Test Request Form (TRF)
§7.1.2Customer notification of unsuitable methodTest Request Form (TRF)
§7.1.3Conformity statement and decision ruleAcceptance Criteria
§7.1.4Resolution of differences before startContacts → Agreements
§7.1.5Customer notification of contract deviationsOrder Amendments
§7.1.6Contract amendment after startOrder Amendments
§7.1.7Customer cooperation and witnessingCustomer Witnessing
§7.1.8Retention of review recordsContract Coverage
§7.2.1.1Appropriate methods with uncertaintyMethods
§7.2.1.2Up-to-date method documentsDocument Control
§7.2.1.3Use of latest valid versionDocument Control
§7.2.1.4Lab-selected methodMethods
§7.2.1.5Verification of method execution capabilityMethod Validations
§7.2.1.6Method development as planned activityMethod Validations
§7.2.1.7Authorized method deviationsDeviations
§7.2.2.1Validation of non-standard methodsMethod Validations
§7.2.2.2Re-evaluation after changesMethod Validations
§7.2.2.3Performance characteristics fit for customerMethod Validations
§7.2.2.4Validation records retentionMethod Validations
§7.3.1Statistically based sampling planSampling Plans
§7.3.2Description of sampling methodSampling Plans · Sample Collection
§7.3.3Sampling recordsSamples → Sampling
§7.4.1Item handling procedureSamples · Aliquot Archive
§7.4.2Unambiguous identification systemSamples · Sample Receipt
§7.4.3Customer consultation at receiptSamples → Consultation
§7.4.4Storage under controlled conditionsStorage Locations · Environmental Readings
§7.5.1Technical records and original observationsAnalyses · Audit Trail
§7.5.2Tracking of record amendmentsAudit Trail
§7.6.1Measurement uncertainty contributionsAcceptance Criteria
§7.6.2Calibration uncertaintyInstruments → Calibrations
§7.6.3Uncertainty evaluation in testingAcceptance Criteria · Analyses
§7.7.1Monitoring of result validityControl Samples · Control-Chart Limits
§7.7.2Interlaboratory comparisons (PT)Proficiency Testing · Participation Plan
§7.7.3QA data analysis and correctionsControl Samples · Corrective Actions
§7.8.1.1Review and approval before releaseAnalyses
§7.8.1.2Clear and objective presentationSettings → Report Settings
§7.8.1.3Simplified report formatAnalyses
§7.8.2.1Sixteen minimum content elementsSettings → Report Settings
§7.8.2.2"As received" statementSamples
§7.8.3.1Test conditions and interpretationsObservations · Recommendations
§7.8.3.2Sampling fields on the reportSamples → Sampling
§7.8.4.1Calibration certificates (calibration labs only)
§7.8.4.2Calibration certificates (calibration labs only)
§7.8.4.3Calibration certificates (calibration labs only)
§7.8.5Sampling information on the reportSamples → Sampling
§7.8.6.1Decision rule documentation and applicationAcceptance Criteria
§7.8.6.2Identification of conformity statementAnalyses
§7.8.7.1Authorized issuance of opinionsOpinion Dialogues
§7.8.7.2Clear separation of opinion from resultsObservations · Recommendations
§7.8.7.3Record of verbal opinion communicationOpinion Dialogues
§7.8.8.1Report amendment with justificationAnalyses
§7.8.8.2Standard report-amendment statementAnalyses
§7.8.8.3New report referencing the originalAnalyses
§7.9.1Documented complaints procedureCustomer Complaints
§7.9.2Procedure availability and scope verificationCustomer Complaints
§7.9.3Receipt, investigation and appropriate actionCustomer Complaints
§7.9.4Gathering and verifying informationCustomer Complaints
§7.9.5Acknowledgement and progress reportsCustomer Complaints
§7.9.6Segregation of outcome communicationCustomer Complaints
§7.9.7Formal closure notificationCustomer Complaints
§7.10.1Nonconforming work procedureDeviations
§7.10.2Nonconforming work recordsDeviations
§7.10.3Corrective actions on recurrenceCorrective Actions
§7.11.1Access to necessary dataSettings → Role Permissions
§7.11.2LIMS validation and change controlChange Requests · Settings → System incidents
§7.11.3LIMS protection and integritySettings → Security, Backups
§7.11.4External LIMS provider complianceSettings → System incidents
§7.11.5Availability of instructions and manualsHelp → Documentation
§7.11.6Verification of calculations and transfersAudit Trail · Sync Queue

Section 8 — Management system

ClauseTitleStatusWhere in the system
§8.1.1Management system establishmentDocument Control
§8.1.2Option A — coverage of §§8.2–8.9Document Control
§8.1.3Option B — ISO 9001 (Option A adopted)
§8.2.1Quality policies and objectivesSettings → Quality Manual
§8.2.2Competence, impartiality, consistencySettings → Quality Manual
§8.2.3Management commitment and improvementReviews
§8.2.4Documentation linked to systemDocument Control
§8.2.5Personnel access to documentationDocument Control
§8.3.1Control of internal and external documentsDocument Control
§8.3.2Document approval, review, identificationDocument Control
§8.4.1Maintenance of legible recordsAudit Trail · Retention Policies
§8.4.2Identification and storage controlsRetention Policies · Pending Disposition
§8.5.1Addressing risks and opportunitiesRisk Assessments
§8.5.2Action planning and effectivenessRisk Assessments
§8.5.3Actions proportional to impactRisk Assessments
§8.6.1Identification of improvement opportunitiesImprovement Backlog
§8.6.2Customer feedbackCustomer Surveys
§8.7.1Corrective actions for nonconformitiesCorrective Actions
§8.7.2Suitability of corrective actionsCorrective Actions
§8.7.3Records of nonconformities and actionsCorrective Actions
§8.8.1Conducting internal auditsAudits
§8.8.2Audit programme, criteria, and reportingAudit Programme
§8.9.1Management review at planned intervalsReviews
§8.9.2Review inputs (a–o)Reviews
§8.9.3Outputs, decisions, and actionsReviews

Sources

The sources below are freely published and allow reproduction with attribution. Where the Agrometrisis documentation quotes text for a requirement, it takes it from here — never from the standard itself.

SourceWhat it covers
ΕΣΥΔ ΚΟ-ΔΕΙΓΜSampling criteria — the Greek wording the assessor actually applies
ΕΣΥΔ ΚΟ1-ΚΡΙΤΕLaboratory accreditation criteria, including calibration intervals
ILAC-G8Statements of conformity and decision rules (§7.8.6)
ILAC-P9Participation in proficiency testing and interlaboratory comparisons (§7.7.2)
EA-4/18Level and frequency of participation in proficiency testing
Eurachem/CITAC CG4 (QUAM)Quantifying uncertainty in measurement (§7.6)
Eurachem MUCMeasurement uncertainty and compliance statements
UKAS LAB 48Decision rules in practice

EN ISO/IEC 17025:2017 is sold by ISO and its national members, ΕΛΟΤ in Greece. Every accredited laboratory must hold its own controlled copy — Agrometrisis does not replace it.