Manufacturing
159 regulations apply to this sector.
Written for this sector
2009/48/ECApplies directly to toy manufacturers producing goods in/for EU marketAD/CVDDomestic manufacturers petition for AD/CVD protection against foreign competitionATEXATEX regulates equipment manufactured for use in explosive atmospheresATEX Directive 2Covers equipment used in explosive atmospheres across manufacturing facilitiesBattery RegBattery manufacturers directly subject to production and labelling requirementsBE Codex WellbeingBelgian Wellbeing Codex sets occupational health and safety standards across workplacesBE ENV PERMITManufacturing facilities require environmental permits under Belgian lawBRC 9Food manufacturers must comply with BRC 9 for retailer certification.CBAMManufacturers importing steel, aluminium, fertilizers subject to CBAM.CDP ReportingManufacturers are key CDP reporters for emissions and supply chainsCE MarkingCE Marking is mandatory for manufacturers placing products on EU marketCE Marking General 2CE Marking applies broadly to manufacturers selling in EUCHIPSSemiconductor fabrication facilities are primary beneficiaries and subjectsCLPManufacturers using or producing chemicals must comply with CLPCSDDDManufacturing supply chains are a primary focus of CSDDD obligations.EC 178/2002Food manufacturers must comply with traceability and safety obligationsEMC DirectiveManufacturers of electrical/electronic products must meet EMC standards.EMC Directive 2Manufacturers must ensure products meet revised EMC requirements.ESPREcodesign rules target manufactured products' sustainability and lifecycle performance.EU Battery Regulation 2Battery manufacturers must meet sustainability, labelling and due diligence requirements.EU Conflict Minerals RegManufacturers using 3TG minerals must conduct supply chain due diligence.EU Cosmetics RegCosmetics manufacturers must comply with safety assessment and ingredient rules.EU Data ActIoT and connected product manufacturers must allow user access to generated data.EU ETSHeavy industry installations must surrender allowances for CO2 emissions.EU Forced Labour RegulationManufacturing supply chains are primary target for forced labour enforcement.EU Import/Export ControlsManufacturers exporting goods must comply with dual-use and export controls.EUDRManufacturers using timber, leather, cocoa, rubber must prove deforestation-free supply chainsFCMManufacturers of packaging and containers must comply with FCM safety requirementsFOOD_EUFood manufacturers must comply with EU general food law requirements.FSMA PCHuman and animal food manufacturers must implement preventive control plans.FSSC 22000Food and feed manufacturers use FSSC 22000 to certify safety management systems.GFSIFood manufacturers use GFSI-recognised schemes to demonstrate safety compliance.GHG ProtocolManufacturers apply GHG Protocol to measure and report operational emissions.GPSRManufacturers of consumer goods must ensure products meet GPSR safety requirements.IEC 61508IEC 61508 is the foundational functional safety standard for industrial systems.IEC 62443Industrial manufacturing control systems are a core IEC 62443 target environment.IEDIED sets industrial emissions limits for large manufacturing installations.IED RevisionRevised IED expands emission controls on industrial manufacturing sectors.ISO 14001Manufacturing widely adopts ISO 14001 for environmental impact managementISO 22318Supply chain continuity is a central concern for manufacturing operations.ISO 24748Manufacturers use lifecycle frameworks for complex product system development.ISO 45001Occupational health and safety standard primarily targets industrial workplacesISO 50001Manufacturers adopt ISO 50001 to manage and reduce energy consumptionISO 9001ISO 9001 QMS is most widely adopted in manufacturing for product quality.Machinery Reg 2Machinery regulations govern safety of machinery used in manufacturing processes.Machinery RegulationMachinery regulations govern safety of machinery used in manufacturing processes.PEDPressure Equipment Directive governs manufacture and safety of pressure equipment.PED2Updated Pressure Equipment Directive applies to manufacturers of pressure equipment.PPE RegulationPPE Regulation governs design, manufacture and certification of protective equipment.PPE Regulation 2PPE manufacturers must meet design, testing and conformity requirements.Registration, Evaluation, Authorisation and Restriction of ChemicalsManufacturers using chemicals must register and manage substances.Regulation (EU) 2023/1230 Machinery RegulationDirectly regulates safety of machinery used in manufacturing environments.RoHSApplies to manufacturers producing electronic/electrical productsRoHS 2Manufacturers must comply with updated hazardous substance restrictionsSEVESOIndustrial manufacturing sites with hazardous substances are in direct scope.Seveso IIIIndustrial manufacturing sites with hazardous substances are in direct scope.SEVESO MAPP SMSIndustrial sites with dangerous substances must implement safety management systems.WEEEManufacturers of EEE bear extended producer responsibility under WEEE rules.Also applies
21 CFR 111Manufacturers of dietary supplements must comply with GMP requirements21 CFR 117Food manufacturing facilities must implement preventive controls and GMP21 CFR 210/211Pharmaceutical manufacturing facilities must meet FDA GMP standards21 CFR 806Medical device manufacturers must report and document corrections/removals21 CFR 807Medical device manufacturers must register establishments with FDA21 CFR 820Medical device manufacturers must implement quality management systems per FDA21 CFR Part 11Medical device and regulated manufacturers must complyACEManufacturers importing raw materials or exporting products use ACEADRManufacturers shipping hazardous materials must package and label per ADRAEOManufacturers engaged in international trade apply for AEO statusAI ActAI in safety components of machinery falls under high-risk provisionsBasel ConventionManufacturers generating hazardous waste subject to Basel trade controlsBE WhistleblowingLarge manufacturers must comply with whistleblowing channel requirements.Biocides RegulationIndustrial biocide use in manufacturing processes regulated.BIS Export LicenseManufacturers exporting controlled goods need BIS licenses.Canada Controlled Goods RegulationsManufacturers of controlled goods must register and complyCMMCDefence manufacturers must comply with CMMC for DoD contractsCMMI DEVManufacturers adopt CMMI DEV to improve development process capabilityCodex AlimentariusFood manufacturing must comply with Codex standards and guidelinesCOSO 2013Large manufacturers use COSO for SOX compliance and internal controlsCOSO ERMLarge manufacturers implement COSO ERM for enterprise risk programmesCRAManufacturers of connected devices must meet CRA security obligationsCSRDLarge manufacturers required to report sustainability information under CSRD.CSRD/ESRSManufacturers apply ESRS environmental and social topic standards.CTPATManufacturers exporting to the US participate in CTPAT for supply chain security.Cyber Resilience ActManufacturers placing digital products on EU market must meet CRA obligations.DFARS 7012Defence manufacturers processing controlled information subject to DFARS 7012.EARManufacturers exporting controlled goods must comply with EAREC 852/2004Food manufacturing facilities must comply with hygiene requirements.EC 853/2004Animal product processing plants must meet specific hygiene rules.EIALarge industrial plants must complete EIA before construction.ELDIndustrial manufacturers subject to environmental liability obligations.EU Allergen RegulationFood manufacturers must identify and label allergens in production processes.EU DUCManufacturers using cattle, soy, palm oil, timber etc. face due diligence obligations.EU GMPContract manufacturers producing regulated goods must comply with GMP.EU IPRManufacturers rely on IPR protection for designs and industrial processes.EU POPSIndustrial manufacturers must eliminate POPs from production processes.EU TaxonomyManufacturers must assess taxonomy alignment for sustainable finance access.EU Textile Labelling RegTextile manufacturers must produce compliant labels for EU market products.Euro 1 Step 1Engine and component manufacturers must comply with emission standardsFCC Equipment AuthorizationManufacturers of electronic equipment must comply with FCC authorization proceduresFCPAManufacturers operating internationally must maintain FCPA compliance programsFDA 21 CFR 210/211Contract manufacturers producing drugs must comply with pharmaceutical GMP rulesFDA 21 CFR 803Medical device manufacturers must establish MDR reporting systems and proceduresFDA 21 CFR 806Device manufacturers must track and report field corrections and market removalsFDA FSVPForeign food manufacturers must meet FDA safety standards verified by importers.FDA QMS 820Applies to manufacturers producing FDA-regulated medical devicesFGASManufacturers of equipment containing F-gases must comply with quotas and reportingFood Fraud RegulationFood manufacturers must implement anti-fraud controls in production.FSVPForeign food manufacturers supplying US market must meet FSVP-verified standards.GRIManufacturers use GRI to report on emissions, labour, and supply chains.GS1 StandardsManufacturers implement GS1 standards for product coding and supply chain.HACCP CodexFood manufacturing facilities require HACCP plans as standard.IEC 60601Medical device manufacturers must design to IEC 60601 electrical safety standards.IEC 62366Medical device manufacturers must integrate usability processes per IEC 62366.IFRSListed manufacturers must comply with IFRS for financial statements.IFRS S1Manufacturers report sustainability information relevant to financial decisions.IFRS S2Manufacturers report climate risks affecting financial performance.IIA StandardsLarge manufacturers apply IIA Standards in internal audit departments.IMDG CodeManufacturers exporting hazardous materials by sea apply IMDG Code.ISO 10993Manufacturers of medical device components must comply with biocompatibility requirementsISO 13485Manufacturers producing medical devices or components must comply with ISO 13485ISO 14971Medical device manufacturers implement ISO 14971 for product risk managementISO 15288Applied to engineered product lifecycle management in manufacturingISO 19011Manufacturing QMS audits commonly follow ISO 19011 guidelinesISO 22000Applies to food manufacturing facilities and production environmentsISO 22301Manufacturers use ISO 22301 to protect supply chains and production continuity.ISO 22317Manufacturers apply BIA to assess financial and operational disruption impacts.ISO 22361Manufacturing leaders use crisis frameworks to manage major operational disruptions.ISO 23053Manufacturers deploying ML for quality and process control reference this standard.ISO 27033Manufacturers apply it to secure operational and IT networksISO 27036Manufacturers apply it to manage ICT supplier security risksISO 30414Large manufacturers track workforce metrics using this standardISO 31000Manufacturers apply risk management to operations and supply chainsISO 31010Manufacturing uses risk assessment techniques for process safety and qualityISO 37001Manufacturers with global supply chains apply anti-bribery managementISO 42001Manufacturers deploying AI in production adopt AI management systemsISO 55001Manufacturers adopt asset management systems for plant and equipmentISO 56002Manufacturers use ISO 56002 to structure R&D and product innovationITARManufacturers of controlled defense components must comply with ITAR.IVDRManufacturers of IVD devices must comply with IVDR conformity requirements.KanbanKanban originated in manufacturing for lean production flow control.KanbanKanban originated in manufacturing for lean production flow control.KanbanKanban originated in manufacturing for lean production flow control.LVDManufacturers placing electrical equipment on EU market must comply with LVD.LVD2Manufacturers placing electrical equipment on EU market must comply with LVD.MDRManufacturers producing medical devices must comply with MDR requirements.Montreal ProtocolManufacturers using refrigerants or solvents subject to ODS restrictions.NIS2Critical manufacturing included as important entity category under NIS2.NIST CSFManufacturing sector applies NIST CSF to operational technology security.NIST IoT CSFIndustrial IoT in manufacturing environments covered by this framework.REDManufacturers of radio equipment must demonstrate conformity.RED CyberManufacturers of IoT and connected devices must embed security by design.Regulation (EU) 2021/697 European Defence FundDefence manufacturing capability development is supported through EDF.SASBManufacturing sectors covered by industry-specific SASB standardsSOX ITGCListed manufacturers must implement IT controls supporting financial reporting integrity.Stockholm ConventionManufacturers must eliminate or restrict POPs in production processesTAPA FSR TSRManufacturers shipping high-value goods must meet TAPA facility standardsTARICManufacturers importing raw materials must comply with TARIC classificationsToy Safety DirectiveToy manufacturers must meet chemical, mechanical and electrical safety standardsWaste FWDManufacturers are major waste producers subject to framework directive requirements.TRIZ for Manufacturing
Worked contradictions and resolutions for this sector.
Seveso TRIZ
Process TRIZ
Green Field Industrial Projects TRIZ
Chemical Industry TRIZ
Automotive TRIZ
Brown Field Industrial Projects TRIZ
Food Production Management TRIZ
AI & Robotics TRIZ
Manufacturing TRIZ