Skill Packages
Browse ready-made AI workflow skills for document elaboration, review, and structuring.
ISMS Scope Statement (ISO 27001 Clause 4.3)
Define and validate the ISMS scope boundaries (physical, organizational, technical) with justified exclusions and no Shadow IT gaps. Includes boundary integrity checker and exclusion logic validator for audit-ready scope statements.
Learn MoreISO 14001 EMS Documentation
Draft ISO 14001:2015 Environmental Management System documentation: organization environmental profiling, gap assessment against clauses 4-10 with maturity ratings, and environmental policy creation. Includes tools for aspect significance evaluation, profile completeness checking, maturity scoring, remediation prioritization, and policy validation.
Learn MoreISO 14971 Risk File Author
Guided elaboration of risk management file for medical devices per ISO 14971: hazard identification, risk analysis, risk control, residual risk acceptability, and benefit–risk rationale. Flags risks above acceptability thresholds without control or justification.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn MoreISO 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.
Learn More