ISO 17025
Skill packages tagged with “ISO 17025”
ISO 17025 Accreditation Readiness Assessment
Assess accreditation readiness across all ISO/IEC 17025:2017 clause areas. Scans workspace for deliverables, scores each clause area 0-100%, identifies gaps, and produces an evidence index mapping documents to requirements. Readiness scorer checks document presence and completeness signals; document package checker validates evidence coverage for every clause.
ISO 17025 Complaints & Nonconforming Work
Establish complaint handling and nonconforming work procedures per ISO/IEC 17025:2017 Clauses 7.9 and 7.10. Covers the full complaint lifecycle (receipt, investigation, root cause analysis, resolution, trend analysis) and nonconforming work management (identification, impact evaluation, halt/hold/recall actions, customer notification, work resumption authority, CAPA linkage). Validates both processes for completeness and regulatory alignment.
ISO 17025 Equipment & Calibration Management
Build equipment register and calibration program per ISO/IEC 17025:2017 Clause 6.4. Covers equipment identification, calibration intervals with justification, intermediate checks, out-of-tolerance handling, and equipment lifecycle management.
ISO 17025 Externally Provided Products & Services
Build and validate procedures for managing externally provided products and services per ISO/IEC 17025:2017 Clause 6.6. Covers supplier evaluation criteria, approved supplier lists, subcontracting of tests/calibrations with customer notification, and ongoing monitoring of external providers. Extension tools validate evaluation completeness and subcontracting compliance.
ISO 17025 Facility & Environmental Conditions
Facility and environmental conditions management per ISO/IEC 17025:2017 Clause 6.3. Documents facility requirements, environmental monitoring programs with parameters, limits, and frequencies, access controls, and contamination prevention. Environmental monitoring validator checks monitoring completeness; facility layout checker validates segregation and access controls.
ISO 17025 Gap Assessment
Perform a structured gap assessment against ISO/IEC 17025:2017 clauses 4-8. Clause gap detector ensures all major clause areas are assessed; maturity rating tool validates 0-5 maturity scores for consistency with findings. Produces findings register and remediation roadmap.
ISO 17025 Impartiality & Confidentiality
Impartiality risk assessment per Clause 4.1 and confidentiality management per Clause 4.2 of ISO/IEC 17025:2017. Identifies risks from financial pressures, relationships, personnel, and organizational structure. Documents legally enforceable confidentiality commitments and information release procedures.
ISO 17025 Internal Audit Program
Establish and manage an internal audit program per ISO/IEC 17025:2017 Clause 8.8. Produces audit procedure, annual plan with schedule, clause-by-clause checklist, and report template with finding classification. Audit plan validator checks scope coverage and auditor impartiality; finding completeness checker validates report structure and evidence requirements.
ISO 17025 Laboratory Profile
Build and validate a foundational laboratory profile for ISO/IEC 17025:2017 accreditation. Captures lab identity, organizational structure and impartiality basis (Cl.4.1.5), accreditation status, scope of accreditation (disciplines, methods, measurands, ranges, scope type, CMC/uncertainty expressions), authorized signatories, key personnel, facilities, major equipment with calibration intervals, proficiency testing programme (Cl.7.7), subcontracting arrangements (Cl.6.6.3), and management commitment (Cl.8.2.2). Profile completeness checker validates all required sections; scope validator performs per-method field validation and reports failures by method ID.
ISO 17025 Management Review
Prepare and conduct management reviews per ISO/IEC 17025:2017 Clause 8.9. Compiles all required inputs (internal audits, corrective actions, PT results, risk assessments, resource adequacy), documents review decisions, and tracks action items. Review input validator checks all Clause 8.9.2 categories; action item tracker validates decisions, owners, and deadlines.
ISO 17025 Measurement Uncertainty
Estimate measurement uncertainty per ISO/IEC 17025:2017 Clause 7.6 using GUM (JCGM 100:2008) methodology. Builds uncertainty budgets with Type A/B component identification, distribution divisors, sensitivity coefficients, law of propagation of uncertainty, Welch-Satterthwaite for effective degrees of freedom, and coverage factor justification per ILAC P14:01/2020. Validates budget completeness and Clause 7.8.3/7.8.4 reporting compliance including decision rules and guard-band methods for conformity statements.
ISO 17025 Method Selection, Verification & Validation
Build and validate method selection, verification, and full/partial validation procedures per ISO/IEC 17025:2017 Clause 7.2. Covers the Clause 7.2.1.1 method selection hierarchy, verification of standard methods, partial validation for deviated standard methods (Cl.7.2.1.4), and full validation of non-standard/lab-developed methods with track-aware performance characteristics, CRM/reference material strategy, acceptance criteria, and fitness-for-purpose conclusions. Extension tools validate protocol completeness and report compliance with track-aware minimum characteristic counts.
ISO 17025 Metrological Traceability
Establish and validate metrological traceability per ISO/IEC 17025:2017 Clause 6.5. Documents traceability chains from working standards through reference standards to NMI/SI for each measurand. Manages reference standards and certified reference materials (CRMs) with certificates, expiry tracking, and storage conditions. Extension tools validate chain completeness and reference standard register entries.
ISO 17025 Personnel Competence
Personnel competence management per ISO/IEC 17025:2017 Clause 6.2. Builds competence matrix mapping personnel to authorized methods, documents training programs, and ensures business continuity through redundant authorization. Competence matrix validator checks completeness; authorization coverage checker flags single-point-of-failure methods.
ISO 17025 Quality Manual & Document Control
Draft and validate quality management system documentation per ISO/IEC 17025:2017 Clauses 8.1–8.4. Produces a quality manual with quality policy, document control procedure, record control procedure, and master document list. Quality manual checker validates policy, structure, and clause coverage; document control validator ensures approval, revision, and distribution processes are defined.
ISO 17025 Reporting of Results
Design and validate test reports and calibration certificates per ISO/IEC 17025:2017 Clause 7.8. Creates compliant report templates with all mandatory elements (title, lab ID, unique reference, customer info, method, dates, results with units, signatures), handles opinions/interpretations per Clause 7.8.7, defines decision rules for conformity statements per Clause 7.8.6, and establishes amendment procedures.
ISO 17025 Request, Tender & Contract Review
Build and validate a procedure for reviewing requests, tenders, and contracts per ISO/IEC 17025:2017 Clause 7.1. Ensures the laboratory confirms capability, selects appropriate methods, and communicates with customers before accepting work. Covers new and repeat requests, amendments, subcontracting decisions, and dispute resolution. Extension tool validates completeness of all required procedural elements.
ISO 17025 Risk, Opportunity & Corrective Action Management
Identify and manage laboratory risks and opportunities per ISO/IEC 17025:2017 Clauses 8.5–8.7. Produces a scored risk register, corrective action procedure with root cause analysis, and CAPA tracking log. Risk register validator checks entry completeness and scoring; corrective action tracker validates procedure elements from trigger through effectiveness verification.
ISO 17025 Sampling & Test Item Handling
Build and validate sampling plans (Clause 7.3) and test/calibration item handling procedures (Clause 7.4) per ISO/IEC 17025:2017. Covers sampling methodology with statistical basis, sample receipt and registration, unique identification systems, condition assessment, handling to prevent damage and contamination, storage conditions, preparation, retention, and disposal. Extension tools validate sampling plan completeness and item handling procedure compliance.
ISO 17025 Technical Records
Establish technical records and data management procedures per ISO/IEC 17025:2017 Clauses 7.5 and 7.11. Covers recording requirements (date, personnel, equipment, conditions, observations, calculations), correction procedures (single-line strike), original observation preservation, data integrity controls, LIMS/software validation, electronic record management with audit trails, and data retention policies.
ISO 17025 Validity of Results
Design and validate a quality assurance program per ISO/IEC 17025:2017 Clause 7.7. Covers internal QC techniques (CRMs, replicates, spikes, blanks), proficiency testing and inter-laboratory comparisons, control chart monitoring (Shewhart, CUSUM), out-of-control response procedures, and performance evaluation using z-scores and En numbers. Validates QC program completeness and PT/ILC coverage for all accredited methods.