Compliance in the Semiconductor Industry



Semiconductor operations intersect with safety, environment, product quality, export controls, facilities engineering, and cleanroom discipline. This Compliance Hub organizes the core standards, regulations, and audit practices that fabs, OSATs, suppliers, and equipment makers must meet across global jurisdictions.


Domain Standards Map

Domain Standard / Regulation Scope Typical Enforcer / Registrar Notes
Quality Management ISO 9001 QMS for organizations (design, manufacturing, service) Accredited registrars Baseline QMS; many customers mandate as supplier prerequisite
Automotive Quality IATF 16949 Automotive-specific QMS for parts and electronics IATF-recognized certification bodies Often required for Tier-1/2 auto semiconductor suppliers
Environment ISO 14001 Environmental management systems Accredited registrars Pairs with emissions, wastewater, waste minimization programs
Energy Management ISO 50001 Energy policy, targets, measurement & verification Accredited registrars Useful for fab power optimization and microgrid integration
Occupational Health & Safety ISO 45001 OH&S management systems Accredited registrars Complements OSHA compliance and SEMI S2 safety reviews
Information Security ISO/IEC 27001 ISMS for protecting IP, mask data, customer data Accredited registrars Critical for foundry portals, EDA flows, tape-out data
Functional Safety (Industrial) IEC 61508 SIL lifecycle for safety-related systems Notified bodies / cert labs Applies to tools, gas cabinets, safety PLCs
Functional Safety (Automotive) ISO 26262 ASIL for road vehicles (chips, IP, safety mechanisms) Automotive cert labs, OEM audits For automotive-grade microcontrollers, SoCs, PMICs
Semiconductor EHS (Equipment) SEMI S2 EHS guidelines for semiconductor manufacturing equipment Third-party SEMI S2 evaluators Often required for tool acceptance at fabs
Semiconductor Ergonomics SEMI S8 Ergonomic guidelines for equipment Third-party SEMI evaluators Reduces operator risk; influences tool layout
Power Quality / Voltage Dips SEMI F47 Voltage sag immunity for fab equipment SEMI testing labs / fab acceptance tests Key for fabs with sensitive litho/etch tools
UPW Materials Purity SEMI F57 (and related F-standards) High-purity polymer components for UPW & CMP slurries SEMI conformance testing Limits extractables/particles from wetted parts
Cleanrooms ISO 14644-1/-2 Cleanroom classification & monitoring Accredited testing firms Defines particle counts (Class 1–9), testing cadence
U.S. Worker Safety OSHA 29 CFR (e.g., 1910, PSM 1910.119) General industry, process safety management OSHA / state plans Hazardous chemicals, gas distribution, LOTO, PSM
U.S. Fire / Electrical Codes NFPA 70 (NEC), 70E, 79, 318 Electrical safety, industrial machinery, semiconductor fabs AHJ, fire marshal, insurers (FM Global) NFPA 318 specific to semiconductor fabrication facilities
Hazard Communication GHS / CLP Chemical classification & labeling OSHA (HazCom), EU authorities SDS, pictograms, training requirements
U.S. Environmental EPA (CAA, CWA, RCRA, TSCA) Air permits, wastewater discharge, hazardous waste EPA, state environmental agencies Includes PFC/NF3/SF6 reporting, solvent waste, stormwater
EU Environmental REACH, RoHS, WEEE Substances registration, product hazardous restrictions ECHA, national authorities Material declarations for components & finished goods
Export Controls (U.S.) EAR (BIS), ITAR (DDTC) Dual-use and defense-related items U.S. Dept. of Commerce / State Controls for advanced nodes, lithography, EDA flows
Building / Seismic IBC / local codes Facility structural, seismic bracing Local AHJ Tool anchorage, gas racks, chemical rooms
Reliability of Equipment SEMI E10/E79 OEE, MTBF/MTTR metrics for fab tools SEMI-aligned audits Feeds uptime SLAs and capacity models

Audit Readiness Checklist

  • Scope & Applicability Matrix: Which standards apply by site, tool set, product line, and region.
  • Document Control: QMS/EHS manuals, SOPs, work instructions, and revision control (ISO 9001).
  • Training & Competence: Role-based curricula, chemical handling, LOTO, cleanroom protocols.
  • Hazard & Risk Assessments: HAZOP/What-If, SIL/ASIL, machine safeguarding, arc-flash studies.
  • Permits & Licenses: Air permits, wastewater discharge, hazardous waste generator status.
  • Cleanroom Compliance: ISO 14644 classification records, particle trending, gowning compliance.
  • Equipment Compliance: SEMI S2/S8/F47 reports, CE/UL/NRTL marks, lockout points, safety PLCs.
  • Chemicals & Gases: SDS library, inventories, gas detection & interlocks, GHS labels, TSCA/REACH declarations.
  • Emissions & Abatement: PFC/NF3/SF6 inventories, destruction efficiency data, CEMS logs, EPA reporting.
  • Waste Management: RCRA manifests, satellite accumulation areas, vendor qualifications.
  • Incident & CAPA: Near-miss tracking, root-cause analyses, corrective/preventive action closure.
  • Supplier Controls: OSAT/tool vendor S2 certifications, material declarations (RoHS/REACH), change notices (PCN).
  • Security & Export: EAR/ITAR screening, access controls to mask data and EDA repositories.
  • Management Review: KPIs, audit findings, resource plans, continual improvement records.

Roles & Responsibilities (RACI Snapshot)

Activity Responsible Accountable Consulted Informed
SEMI S2 Equipment Review Tool Vendor EHS Fab EHS Manager Facilities, Production Procurement
ISO 14001 Certification Site EMS Lead Plant Manager Utilities, Maintenance Corporate ESG
Export Control Screening Trade Compliance Chief Compliance Officer Legal, Program Mgr Sales, Logistics
Cleanroom Certification (ISO 14644) Cleanroom Ops Facilities Director EHS, Tool Owners All Production

Authoritative Bodies (for Primary References)

  • SEMI (S2, S8, F47, E10/E79, F57, and other fab/tool standards)
  • ISO / IEC (9001, 14001, 45001, 50001, 27001, 61508, 26262, 14644)
  • U.S. OSHA, EPA, DHS/CFATS; State environmental agencies; Local AHJ & fire marshal
  • NFPA (NEC 70, 70E, 79, 318), IBC, FM Global
  • EU: European Commission, ECHA (REACH), RoHS/WEEE authorities
  • U.S. Department of Commerce BIS (EAR), U.S. State Department DDTC (ITAR)

Compliance Program KPIs

  • Audit Closure: % of findings closed on-time; CAPA cycle time
  • EHS Performance: TRIR, near-miss rate, emissions intensity (kg CO2e/wafer start)
  • Training: Completion & effectiveness; retraining interval compliance
  • Supplier Conformance: % with valid S2, ISO certs, RoHS/REACH declarations
  • Utilities & Abatement: PFC/NF3 destruction efficiency; power quality (SEMI F47 pass rate)


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