ISO 45001 — Standard

About the Standard

Scope title: occupational health and safety management system

ISO 45001 is a standard published by International Organization for Standardization (ISO). The international standards organisation; it publishes the widest body of management system, test method and product standards.

See the other 310 codes from ISO

Coverage areas

Certification — How Does This Scheme Work?

The section below describes the field that code ISO 45001 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Certification schemes establish, through third-party assessment, that a system, a product or a person conforms to defined requirements. What distinguishes them from testing is the output: a test produces a measurement result, certification produces a DECISION, and that decision is recorded in a certificate.

Schemes are separated by their scope, and this separation determines which accreditation is valid. Management system certification assesses the organisation's processes (quality, environment, occupational health and safety, information security, food safety, energy). Product certification assesses the product itself and the consistency of production. Personnel certification addresses the competence of an individual.

The competence of the certification body is itself subject to its own standard, and this is the most confused point in the field: management system certification falls under ISO/IEC 17021-1, product certification under ISO/IEC 17065 and personnel certification under ISO/IEC 17024. The scopes are independent of one another; accreditation in one does not cover another. A body being "accredited" does not mean it is accredited for the scheme you need.

The process typically follows the same steps: application and scope determination, document review, stage one audit (readiness assessment), stage two audit (implementation assessment), closure of non-conformities, the certification decision and then periodic surveillance audits. The validity of the certificate depends on surveillance audits being maintained; without them the certificate is suspended.

THE SCOPE OF THE CERTIFICATE is as important as the certificate itself. A certificate is valid for the organisation's defined activities and defined sites. A quality certificate that excludes design activity is not sufficient for a manufacturer responsible for design; relying on a certificate in a tender without reading its scope is a common mistake.

Most management system standards share a common high-level structure (Annex SL): context, leadership, planning, support, operation, performance evaluation and improvement. This makes it possible to manage several systems in an integrated way; quality, environmental and occupational safety systems can be run under a single documentation framework.

Product certification differs structurally from management system certification: product testing, technical file review and factory production control auditing run together. The certificate is tied to that product type and that place of manufacture; a design change requires the certificate to be reviewed.

Sector schemes form a separate body of work and have become effectively mandatory in supply chains: IATF 16949 in automotive, AS/EN 9100 in aerospace, IRIS in rail, GFSI-recognised schemes in food and ISO 13485 in medical. These schemes add the sector's own requirements on top of the general standards and their audits are markedly more detailed.

Method groups in this field

Application and scope
The activities, sites and headcount to be certified are established; the number of audit days is calculated from this information.
Document review
Policies, procedures, risk assessment and the structure of records are reviewed.
Stage one audit
It is assessed whether the system has been established and is ready for implementation; gaps are closed before stage two.
Stage two audit
It is verified through records and interviews that the system is actually implemented on site.
Non-conformity management
Findings are classified by severity; root cause analysis and corrective action are required.
Certification decision and surveillance
The certificate is issued upon approval by an independent decision maker; periodic surveillance and recertification audits are maintained.

Commonly confused in this field

A certificate should not be relied on without reading its scope; an activity excluded from the scope cannot be evidenced by the certificate.
Accreditation scopes are independent; a body accredited under ISO/IEC 17021-1 is not accredited for product certification.
A management system certificate does not demonstrate product conformity; a CE declaration or product approval runs separately.
If surveillance audits are not carried out the certificate loses its validity; the date on the certificate is not sufficient information on its own.
A certificate issued by a non-accredited body is not accepted in many tenders and supply chains.
Sector schemes do not replace the general standard, they sit on top of it; for IATF 16949 the ISO 9001 requirements are also met.

Which decisions these results support

Meeting customer and tender requirements
Gaining acceptance in the supply chain
Making processes systematic and traceable
Meeting the system obligations imposed by legislation
Defining the scope of the certificate correctly

Structure of the Code

Published by: ISO
Serial number: 45001
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Certification

Related Tests and Services

Of the 1 pieces of content this code is referenced in, the 1 with their own published page are listed below.

Certification · 1

Occupational Health and Safety Management – ISO 45001

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

(AB) 2018/858Vehicle Type-Approval FrameworkApproval of motor vehicles and their components. Component and separate technical unit approval run under this framework; the E mark arises from it.
UNECEUNECE 1958 AgreementType-approval under component-specific UNECE regulations (e.g. R10 EMC, R30/R54 tyres, R43 glazing).
UNECE R10UNECE R10Electromagnetic compatibility approval for vehicles and their components.
2011/65/EURoHSRestriction of hazardous substances in electrical and electronic equipment.
2000/53/ATELVEnd-of-life vehicles. Sets heavy-metal restrictions and recoverability targets.
(EU) 2017/745MDRThe Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
(EU) 2017/746IVDRThe In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
(AB) 2017/745 art. 33EUDAMEDThe European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
2006/42/ATMachinery Directive (overlap)Relevant essential requirements also apply to medical devices that also qualify as machinery.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC and becomes mandatory on 20 January 2027 with no further transition period. Requires notified-body involvement for Annex I high-risk machinery.
2014/35/EULVDThe Low Voltage Directive. Governs electrical safety in the 50–1000 V AC range.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Emission and immunity are covered together.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
2000/14/ATNoise EmissionNoise emitted into the environment by outdoor equipment. Machinery within scope requires a sound-power-level declaration and marking.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
(EU) 2024/573F-GasRefrigerant type, GWP value and leak-tightness obligations for systems containing a refrigerant.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(EU) 2023/1542Batteries RegulationBattery obligations and a removability requirement for toys containing a battery.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2023/988GPSRThe General Product Safety Regulation. The safety framework for consumer products not covered by sector-specific legislation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(EU) 2024/3110Construction Products RegulationDeclaration of performance and CE marking for construction products. Most provisions apply from 8 January 2026; it progressively replaces (EU) 305/2011.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(EU) 2023/1115Deforestation (wood-based)A deforestation-free supply declaration for wood and derived construction materials.
(AT) 1223/2009Cosmetic Products RegulationThe Cosmetic Products Regulation. Appointing a responsible person, the product information file (PIF), the safety assessment (CPSR) and CPNP notification are mandatory; there is no product approval, and responsibility rests with the manufacturer.
(AT) 1223/2009 Annexes II-VIProhibited and Restricted SubstancesLists of prohibited substances, restricted substances, and permitted preservatives, colorants and UV filters.
(AT) 1223/2009 art. 16Nanomaterial NotificationA separate notification six months before placing on the market for products containing nanomaterials.
(AT) 1223/2009 art. 18Animal Testing BanA ban on animal testing of finished products and ingredients, and on placing animal-tested products on the market.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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Frequently Asked Questions

Is this standard mandatory for my product?

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