2026-09-21 · KeXinMaterials 編集チーム

ISO 45001:2018 労働安全衛生マネジメントシステム深掘り + 保護ケース B2B ガイド

ISO 45001:2018 はグローバル労働安全衛生規格。OHSAS 18001:2007 を置き換え。従業員を持つ任意の B2B 組織必須。

ISO 45001:2018 Scope + Annex SL

ISO 45001:2018 Edition 1. Annex SL structure. Replaces OHSAS 18001:2007.

ISO 45001:2018: "Occupational health and safety management systems - Requirements with guidance for use". Edition 1 (2018). Replaces OHSAS 18001:2007.

OHSAS 18001 was British Standard BS OHSAS 18001:2007. Now withdrawn. ISO 45001 is the international standard.

Scope: Generic. Applicable to any organization regardless of type, size, or industry. Demonstrates OH&S management + worker safety + prevention of work-related injuries + ill health.

Annex SL structure: 10 sections. Same as ISO 9001 + ISO 14001.

Key principles: Prevent work-related injury + ill health + safe + healthy workplaces + proactive prevention + worker consultation + participation + leadership + commitment.

OH&S policy per ISO 5.2: Top management commitment + prevention + protection + worker health + safety + compliance + continual improvement. Include worker consultation + participation.

Organization roles per ISO 5.3: Top management accountability + management representative + workers + workers representatives + contractors + visitors.

Hazard identification per ISO 6.1.2: Routine + non-routine + emergency. People (workers + visitors + contractors) + equipment + materials + environment + changes in processes + products + services.

OH&S risks + opportunities per ISO 6.1: Risk assessment + opportunity assessment. Significant OH&S risks.

OH&S objectives per ISO 6.2: Measurable + monitored + communicated. Plans to achieve them.

Worker consultation + participation per ISO 5.4 + 5.5 + 7.4 + 8.2 + 9.1 + 9.2 + 10.2: Non-managerial workers + workers representatives in decision-making. Equal with managers.

Geographic adoption: Globally adopted. EU + US + Japan + Korea + China GB/T 45001. Aligned with EU Directive 89/391/EEC (Framework Directive on Safety and Health at Work).

Hazard Identification + Risk Assessment + Hierarchy of Controls

Hazard identification per ISO 45001:2018. Risk assessment per ISO 12100 / ISO 45001. Hierarchy of controls per ISO 45001 + NIOSH.

Hazard per ISO 45001:2018 § 3.18: Source with potential to cause injury + ill health. Physical + chemical + biological + psychosocial + ergonomic.

Hazard categories: Physical (slips + falls + struck-by + caught-in + caught-between + electrical + radiation + vibration + noise + temperature). Chemical (toxic + carcinogen + sensitizer + irritant + asphyxiant). Biological (bacteria + virus + mold + bloodborne). Psychosocial (stress + violence + harassment + fatigue). Ergonomic (repetitive + manual handling + poor posture). Mechanical (crushing + cutting + entanglement + shearing).

Risk per ISO 45001:2018 § 3.21: Combination of likelihood of occurrence + severity of injury + ill health. Risk = Likelihood x Severity.

Risk assessment per ISO 12100: Iterative process. (1) Hazard identification. (2) Risk estimation. (3) Risk evaluation. (4) Risk reduction measure. (5) Re-evaluate.

Risk matrix per ISO 12100: Severity (1 Negligible + 2 Minor + 3 Moderate + 4 Serious + 5 Catastrophic) x Likelihood (1 Rare + 2 Unlikely + 3 Possible + 4 Likely + 5 Almost Certain). Risk score = Severity x Likelihood.

Risk level: 1-4 Low + 5-9 Medium + 10-15 High + 16-25 Extreme.

Hierarchy of controls per ISO 45001:2018 § 6.1.2 + NIOSH: (1) Elimination. (2) Substitution. (3) Engineering control. (4) Administrative control. (5) PPE. Most effective = elimination. Least effective = PPE.

Elimination: Physically remove hazard. Most effective. E.g., remove hazardous material from process.

Substitution: Replace hazard with less hazardous option. E.g., use less toxic solvent.

Engineering control: Isolate people from hazard. E.g., machine guarding + ventilation + enclosure.

Administrative control: Change work procedures. E.g., job rotation + training + signage + work permits.

PPE (Personal Protective Equipment): Protect worker with PPE. Last resort. E.g., respirator + gloves + safety glasses + hearing protection.

Common manufacturing hazards: Noise + dust + fumes + chemicals + vibration + heat + cold + manual handling + repetitive motion + electrical + machine + falling objects + vehicle + fire.

Safety data sheet (SDS): Per OSHA 1910.1200 + GHS (Globally Harmonized System of Classification and Labelling of Chemicals). 16-section SDS.

Job hazard analysis (JHA): Per OSHA 3963. Step-by-step task analysis. Identify hazards + control measures for each step.

Lockout/tagout (LOTO): Per OSHA 29 CFR 1910.147. Control of hazardous energy during service + maintenance. Required for any service on energized equipment.

Emergency Preparedness + Incident Investigation

Emergency preparedness per ISO 45001:2018 § 8.2 + OSHA 29 CFR 1910.38. Incident investigation per OSHA + root cause analysis.

Emergency preparedness per ISO 45001:2018 § 8.2: Plan + respond + prevent + mitigate OH&S impacts from emergency situations. First aid + fire + spill + natural disasters + medical emergency + active shooter.

Emergency plan per OSHA 29 CFR 1910.38(a): Required for all employers. Emergency action plan with evacuation + alarm + reporting + rescue + medical + fire prevention.

Fire prevention plan per OSHA 29 CFR 1910.157: Required for fire brigades + fire watch + flammable liquid handling. Alarms + detection + suppression + evacuation.

First aid per OSHA 29 CFR 1910.151: Trained first aid provider + first aid supplies + medical care + eyewash + shower for chemical exposure. ANSI Z308.1 first aid kits.

Eyewash + emergency shower per ANSI Z358.1: Required for chemical exposure. Tepid water (16-38 °C). 15 minutes of continuous flow. Weekly testing.

Process safety management (PSM) per OSHA 29 CFR 1910.119: For highly hazardous chemicals. Process hazard analysis + mechanical integrity + operating procedures + training + contractors + emergency response + incident investigation + compliance audit.

Hazard communication (HazCom) per OSHA 29 CFR 1910.1200: GHS-aligned. Container labeling + safety data sheets (SDS) + worker training + written program.

Incident reporting per OSHA 29 CFR 1904: Recordable injuries + illnesses. Fatalities within 8 hours. Severe injuries (amputation + eye loss + hospitalization) within 24 hours.

OSHA recordable injuries: Death + days away from work + restricted work + transfer + medical treatment beyond first aid + loss of consciousness + significant injury + occupational illness.

DART (Days Away, Restricted, or Transferred) rate: Per 100 employees per year. TRIR (Total Recordable Incident Rate) = 200,000 x recordable injuries / total hours.

Root cause analysis per OSHA 3960 + ISO 45001: Identify root causes not symptoms. 5-Why + Ishikawa (fishbone) + Apollo root cause + TapRooT + Fault Tree Analysis (FTA) + Bowtie analysis.

Bowtie analysis: Per ISO 45001 + ISO 31000. Hazard + threats + preventive controls + top event + consequences + mitigating controls. Visual risk management.

5-Why analysis: Toyota Production System. Ask Why 5 times to reach root cause. E.g., Worker fell. Why? Slippery floor. Why? Water spill. Why? No drain. Why? Drain blocked. Why? No maintenance. Root cause: maintenance gap.

Incident classification per ISO 45001: Near miss + first aid + medical treatment + lost time + severe + fatality. Required reporting + investigation + corrective action.

CAPA (Corrective + Preventive Action): Per ISO 45001 § 10.2. Investigate + root cause + corrective action (eliminate cause) + preventive action (eliminate potential cause) + effectiveness check.

Safety observation: Per behavioral-based safety (BBS). Direct observation + feedback + coaching + reinforcement + goal setting + metric analysis.

Worker Consultation + Participation + ILO + OSHA

Worker consultation + participation per ISO 45001 + ILO Convention 155 + OSHA framework + safety culture.

Worker consultation per ISO 45001:2018 § 5.4 + 5.5: Non-managerial workers + workers representatives consulted in OH&S decisions. Equal participation with managers.

Worker participation per ISO 45001:2018: Direct involvement in hazard identification + risk assessment + controls + incident investigation + audit + corrective action.

Safety committee: Per ISO 45001 + OSHA + national regulations. Joint management + worker representatives. Meet regularly. Review incidents + hazards + safety performance + audit findings + corrective actions.

Safety representative: Per ILO Convention 155 + national regulations. Elected by workers. Right to refuse unsafe work + right to stop work + right to investigate + right to be consulted.

Right to refuse unsafe work: Per OSHA + national regulations. Worker can refuse work that poses imminent danger of death or serious injury. Protected from retaliation.

Right to stop work: Per some national regulations. Worker or safety representative can stop work that poses imminent danger. Investigate + mitigate + restart only when safe.

ILO Convention 155: Occupational Safety and Health Convention. 1981. International Labour Organization. Foundation convention on OH&S.

ILO Convention 161: Occupational Health Services Convention. 1985. Comprehensive OH services to workers.

ILO Declaration on Fundamental Principles + Rights at Work: 1998. Freedom of association + collective bargaining + forced labor + child labor + discrimination. OH&S not included but related.

EU Directive 89/391/EEC (Framework Directive on Safety and Health at Work): EU framework. Risk assessment + prevention + information + training + consultation + participation.

EU Directive 2009/104/EC (Use of Work Equipment): Equipment used at work. Minimum safety + health requirements.

EU Directive 2004/37/EC (Carcinogens + Mutagens at Work): Exposure to carcinogens + mutagens. Limit values + protection measures.

OSHA framework (US): Occupational Safety and Health Administration. Federal enforcement. State OSHA plans. Standards 29 CFR 1910 (general industry) + 29 CFR 1926 (construction).

Safety culture per ISO 45001: Beyond compliance. Genuine concern for worker well-being + proactive prevention + open communication + continuous improvement + leadership commitment.

DuPont Bradley Curve: 4 stages. Reactive (accidents blame workers) + Dependent (manager-driven compliance) + Independent (worker-owned safety) + Interdependent (team safety + coaching).

B2B relevance: For B2B protective cases, require supplier ISO 45001:2018 + hazard identification + risk assessment + hierarchy of controls + emergency preparedness + worker consultation + ILO + OSHA + safety culture.

B2B Procurement Workflow + Manufacturing Case Design

OH&S B2B procurement per ISO 45001 + OSHA + EU framework. Worker safety + manufacturing safety + case design.

Common manufacturing hazards: Injection molding (high temperature + pinch points + noise + fumes). CNC machining (sharp tools + coolant + chips + vibration). Foam cutting (dust + fumes + sharp tools + manual handling). Assembly (ergonomic + repetitive + manual handling). Painting (fumes + VOCs + fire). Soldering (fumes + lead + rosin + ergonomic). Testing (electrical + mechanical + radiation + ergonomic). Packaging (repetitive + manual handling + ergonomic). Storage (heavy lifting + falling objects + fire).

OSHA citation examples for manufacturing: Machine guarding + LOTO + HazCom + PPE + electrical + noise + falls + manual handling + ergonomics + emergency preparedness.

Workstation ergonomics per OSHA + ANSI/HFES 100-2007: Chair + desk + monitor + keyboard + mouse + lighting + space + reach. Repetitive task + force + posture + vibration + duration.

Manual handling per OSHA + EU Manual Handling Directive 90/269/EEC: 25 kg male / 15 kg female maximum lifting under ideal conditions. Risk assessment + mechanical aids + team lifting + training.

Noise per OSHA 29 CFR 1910.95 + EU Directive 2003/10/EC: 85 dB(A) action level + 90 dB(A) PEL (OSHA) / 87 dB(A) ELV (EU). Hearing protection + audiometric testing + engineering controls.

Chemical exposure per OSHA + EU REACH: PEL (OSHA) / ELV (EU) + OEL + monitoring + medical surveillance + engineering controls (ventilation + enclosure) + PPE.

Working at heights per OSHA 29 CFR 1910.28 + EU Directive 2001/45/EC: Fall protection + guardrails + safety nets + personal fall arrest systems (PFAS) + training. Required > 1.8 m (US) or > 2 m (EU).

Confined space per OSHA 29 CFR 1910.146 + EN 60079-10: Permit-required confined space. Atmospheric testing + ventilation + rescue + training + communication.

Hot work per OSHA 29 CFR 1910.252: Welding + cutting + brazing. Permit + fire extinguisher + fire watch + 30-minute fire watch after work.

Electrical safety per OSHA 29 CFR 1910.331-335 + NFPA 70E: Qualified persons + arc flash + LOTO + PPE + grounding + GFCI.

Powered industrial trucks per OSHA 29 CFR 1910.178: Forklifts + pallet jacks. Operator certification + daily inspection + maintenance + travel speed + load capacity.

Fire safety per OSHA + NFPA + local fire code: Fire extinguishers + fire alarm + sprinkler + exit lighting + emergency exits + fire drills.

Lockout/tagout (LOTO) per OSHA 29 CFR 1910.147: Energy isolation. Authorized employees + written program + annual inspection + training.

Safety training per OSHA + ISO 45001: New hire orientation + task-specific + refresher + toolbox talks + safety meetings + supervisor training.

B2B procurement workflow: (1) Verify supplier ISO 45001:2018 + scope. (2) Verify hazard identification + risk assessment per ISO 12100. (3) Verify hierarchy of controls + emergency preparedness. (4) Verify worker consultation + participation. (5) Verify ILO Convention 155 alignment. (6) Verify OSHA compliance + audit findings.

B2B recommendation: For B2B protective cases from manufacturing, require ISO 45001:2018 + scope + hazard identification + risk assessment + hierarchy of controls + emergency preparedness + worker consultation + ILO + OSHA compliance + safety culture + audit findings + corrective actions.

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