Occupational Health and Safety Management Systems — Requirements with Guidance for Use
Specifies requirements for an occupational health and safety management system, built on the same high-level structure as ISO 9001 and ISO 14001 — context, leadership, planning, support, operation, performance evaluation and improvement — with worker participation and consultation as distinctive requirements.
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Scope & applicability
Occupational health and safety for workers and others affected by an organisation’s activities. In a regulated site it shares rooms, people and procedures with the quality system without sharing its objectives: gowning that protects the operator and gowning that protects the product are the same act performed for opposite reasons, and where they conflict the conflict is real.
Key requirements
- Clause 4.1 — determination of external and internal issues, including whether climate change is relevant (Amendment 1:2024)
- Clause 5.4 — consultation and participation of workers, including non-managerial workers
- Clause 6.1.2 — hazard identification and assessment of OH&S risks and opportunities
- Clause 8.1.2 — elimination of hazards and reduction of risks following the hierarchy of controls
- Amendment 1:2024 adds climate-action considerations; a revision is at Draft International Standard stage
Implementation tips
- Integrate the risk assessment with the GMP one rather than running two: the same operation is being assessed and the controls interact, most obviously in containment and gowning
- The hierarchy of controls is the part that transfers directly into quality thinking — eliminating a hazard by design beats a procedure, for the same reason it does in contamination control
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
ISO 45001:2018: frequently asked questions
Quick answers to common questions about ISO 45001:2018.
What is ISO 45001:2018?
ISO 45001:2018 — Occupational Health and Safety Management Systems — Requirements with Guidance for Use — is a standard issued by the International Organization for Standardization. Specifies requirements for an occupational health and safety management system, built on the same high-level structure as ISO 9001 and ISO 14001 — context, leadership, planning, support, operation, performance evaluation and improvement — with worker participation and consultation as distinctive requirements.
Who does ISO 45001:2018 apply to?
Occupational health and safety for workers and others affected by an organisation’s activities. In a regulated site it shares rooms, people and procedures with the quality system without sharing its objectives: gowning that protects the operator and gowning that protects the product are the same act performed for opposite reasons, and where they conflict the conflict is real.
What are the key requirements of ISO 45001:2018?
ISO 45001:2018 requires, among other things: Clause 4.1 — determination of external and internal issues, including whether climate change is relevant (Amendment 1:2024); Clause 5.4 — consultation and participation of workers, including non-managerial workers; Clause 6.1.2 — hazard identification and assessment of OH&S risks and opportunities; Clause 8.1.2 — elimination of hazards and reduction of risks following the hierarchy of controls.
When was ISO 45001:2018 last updated?
The current version of ISO 45001:2018 dates from March 2018.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.