The Detailed History of the ISO 45001 Standard

As the successor to OHSAS 18001, ISO 45001 has become the global standard for Occupational Health and Safety (OH&S) Management Systems, providing organisations with a clear set of requirements for implementing and managing workplace safety and wellbeing. However, the transition from OHSAS 18001 to ISO 45001 was far from straightforward. The journey of ISO 45001 from its 2016 rejection to its publication in 2018 illustrates the challenges of international standard development.

Although the standard for Occupational Health and Safety (OH&S) Management Systems was initially touted as a promising new global standard, the initial Draft International Standard (DIS) faced significant setbacks and was not approved in its first form.

Developing any international standard requires input from a diverse group of stakeholders, including governments, industry, and labour organisations, and reconciling their differing priorities can be challenging.

This was particularly true for ISO 45001, where different stakeholder groups had conflicting priorities for how the standard should operate.

Despite these initial setbacks during the draft stages, the standard now provides a globally recognised set of requirements for establishing, implementing, and maintaining an effective OH&S management system.

We’ll explore what happened when it was rejected, why this happened and how feedback shaped the final standard when it was successfully approved in 2018.

Read about how ISO 45001 has evolved and been updated since its launch.

The process of creating or updating an ISO standard involves several key steps to meet international needs:

1. Proposal stage: A new standard or revision is proposed by a member body of The International Organisation for Standardisation (ISO)
2. Preparatory stage: A working group of experts prepares a working draft
3. Committee stage: The draft is shared with ISO members for comments and approval
4. Enquiry stage: A DIS is circulated among all ISO members for voting
5. Approval stage: If the DIS is approved, it moves to the Final Draft International Standard (FDIS) stage
6. Publication stage: The standard is published if the FDIS is approved

So, what happened in the case of ISO 45001?

The UK supported the 2016 DIS, but it failed to achieve sufficient approval overall, receiving over 1,600 comments from ISO member bodies. These concerns included unclear terminology, insufficient sector-specific applicability, and a lack of clarity around integrating OH&S into broader business management systems while safeguarding worker protections.

The initial failure to approve the DIS stage in 2016 was a significant event in the standard’s development. Despite extensive consultations and revisions, the draft was ultimately not approved because of several critical factors:

• Sector applicability: One of the main challenges was to make sure that the standard could be universally applied across various industries, from manufacturing to healthcare. Stakeholders expressed concerns that the draft did not adequately address the unique needs and risks of different sectors.
• Balancing interests: Developing a standard that equally addressed the concerns of both large corporations and organisations representing workers proved difficult. Corporate interests often focused on integrating health and safety into broader business strategies, while worker representatives emphasised direct safety measures and worker participation.
• Complexity and clarity: Feedback indicated that some of the language and requirements in the draft were seen as overly complex, particularly in areas such as leadership responsibilities, worker participation, and application of risk-based thinking, leading to varied interpretations and implementation challenges. This lack of clarity was a significant barrier to acceptance.
• Consensus building: Achieving consensus among the diverse group of international stakeholders was a formidable task. Differences in regulatory environments, cultural approaches to safety, and economic considerations contributed to the difficulty of reaching an agreement.

The need for further revisions prompted additional rounds of discussion and negotiation.

The 2016 DIS rejection highlighted the complexities of international consensus-building in standard development. The experience underscored the complexities involved in creating a standard that meets global needs while balancing diverse stakeholder interests.

Importantly, it demonstrated that achieving consensus on occupational health and safety requires balancing the need to embed OH&S within existing business processes and management systems, with the imperative of maintaining clear protections for workers.

While the initial failure to approve the draft was a setback, the second draft was later approved, marking a significant milestone in occupational health and safety management. This approval paved the way for the standard’s publication in March 2018.

The approval came after months of intensive revision work involving 67 countries, overseen by the committee ISO/PC 283. The approved draft addressed the key concerns that had led to the 2016 rejection.

Publication, initially expected in 2017, was delayed by several months. The revision process following the DIS stage extended the timeline, allowing for more comprehensive stakeholder engagement and revision processes. This shift managed the complexities involved in creating a standard that meets global needs.

The approved version incorporated substantial improvements based on the 3,000+ comments received during the 2016 consultation:

• Clearer language: Complex terminology was simplified to reduce interpretation challenges across different industries.
• Enhanced worker consultation: Stronger requirements for worker participation and consultation were integrated throughout the standard.
• Better sector applicability: The revised draft better addressed the unique needs and risks of different sectors, from manufacturing to healthcare.
• Improved consensus building: The revision process achieved broader stakeholder agreement by balancing the need to integrate OH&S into broader business management systems with worker protection priorities.
• High-level structure alignment: Better integration with ISO’s standardised framework, improving integration opportunities with ISO 9001 and ISO 14001.

Defined as a ‘transition,’ the process differed slightly from the changes made to update ISO 9001 and ISO 14001.

The approved ISO 45001 draft incorporated several significant changes from OHSAS 18001:

• Leadership with specific emphasis on worker participation and consultation.
• Extended requirements related to internal and external communication, including the need to determine what, when and how to inform.
• Systematic determination of external and internal issues, as well as the needs and expectations of workers and other interested parties. This helps to understand influencing factors relevant for the management system.
• Risk-based thinking as a basis for the management system. More focus on objectives as drivers for improvements, and related planning required to achieve the goals.
• More emphasis on control of changes and control of procurement, contractors and outsourced processes.
• More specific requirements related to performance evaluation.
• Some amendments related to emergency preparedness and response.
• A new clause related to processes for continual improvement.

ISO 45001 incorporated the Plan-Do-Check-Act (PDCA) model, which provided a cyclical framework for continual improvement of the OH&S management system.

These requirements aimed to enhance an organisation’s ability to manage risks and improve safety outcomes proactively.

Download the ISO 45001 Key Requirements.

With the DIS approved, ISO 45001 moved to the Final Draft International Standard (FDIS) stage.

Following the successful completion of this stage, the approved draft was published as an International Standard in March 2018.

It represented a significant step forward for global occupational health and safety management.

You can purchase the ISO 45001 standard requirements standard on the ISO website.

As ISO 45001 replaced OHSAS 18001, organisations with OHSAS 18001 certification were required to transition to ISO 45001 to maintain valid certification.

Following ISO 45001’s publication in March 2018, a three-year transition period was established. The original transition deadline was September 2020. This was extended to March 2021, and then later changed to 11th September 2021 due to the COVID-19 pandemic.

The approval of ISO 45001 signalled that OHSAS 18001 would be withdrawn, making ISO 45001 the new international standard for Occupational Health and Safety (OH&S) Management Systems.

OHSAS 18001 is no longer a recognised certification for occupational health and safety.

The changes brought about by ISO 45001 benefited organisations worldwide by providing a robust set of policies and procedures that supported their ability to manage risks effectively and improve safety outcomes.

Organisations may experience improved operational efficiency, better alignment with OH&S objectives, and stronger compliance where the standard is effectively implemented.

The standard’s focus on leadership and worker involvement fostered a culture of safety that extended beyond compliance, encouraging proactive safety management.

Understand the full scope and benefits of ISO 45001 by reading our detailed guide to ISO 45001.

Amtivo is a UKAS-accredited certification body providing ISO 45001 certification services for your organisation’s OH&S Management System implementation.

Request a free quote or contact our expert team today.