Life Sciences ISO 45001 – Occupational Health and Safety Management Systems (OHSMS)
ISO 45001 certification – reduce risk and promote occupational health and safety (OH&S) by working with SGS to migrate to the new standard.
An Occupational Health and Safety Management System (OHSMS) is a fundamental part of an organization's risk management strategy. Implementing an OHSMS enables an organization to:
- Protect its workforce and others under its control
- Comply with legal requirements
- Facilitate continual improvement
ISO 45001 is expected to be the new international standard for an OHSMS. While its ethos is similar to that of OHSAS 18001, ISO 45001 has been aligned with Annex SL – the required framework for all new and revised ISO management system standards. Therefore, the final version of ISO 45001 will be aligned with other management systems standards, such as ISO 9001:2015 and ISO 14001:2015.
ISO 45001 is currently at the FDIS comment and ballot stage of the development process.
The final version is planned for publication in Q1 2018, providing the forthcoming ballot returns a successful outcome. If no majority is returned, it is anticipated that a second FDIS will be developed and issued for further ballot. The target date for this would be July, with a final publication date of Q3 2018.
ISO/DIS 45001 Standard – Key Areas and Organization Context
The ISO/FDIS 45001 standard places a strong focus on an organization’s context. It requires the organization to consider what stakeholders expect from it in terms of occupational health and safety management.
The intent of ISO/FDIS 45001 is to provide an organization with a high level, conceptual understanding of the important issues that can affect it either positively or negatively and how it manages its responsibilities towards its workers and their representatives, where relevant.
Issues of interest are those that affect the organization’s ability to achieve its intended outcomes. These include the objectives it has set for its OHSMS, such as meeting its OHS policy commitments and preventing risk.
The organization must determine which interested parties are relevant to its OHSMS, and it must also determine the relevant requirements of those interested parties.
Top management must now demonstrate its involvement and engagement with the OHSMS through direct participation, taking OHS performance into account in strategic planning. It must communicate the importance of having an effective OHSMS and conforming to its requirements.
Top management must also contribute to the effectiveness of the OHSMS by playing an active role in directing and supporting individuals in all functions and promoting and leading organizational culture with regard to the OHSMS.
This new standard emphasizes top management's responsibility and accountability for its OHSMS. This is to ensure that ultimate responsibility cannot be delegated to health and safety or other managers within an organization.
Participation and Consultation
The standard requires the organization’s processes to encourage consultation with, and participation from workers and their representatives, as these are key factors in OH&S Management.
Consultation implies two-way communication – dialogue and exchanges – and involves the timely provision of the information that workers and their representatives require before the organization can make a decision.
The OH&S management system depends on worker participation, which enables workers to contribute to decision making regarding OH&S performance measures and provide feedback on proposed changes.
The organization must encourage workers at all levels to report hazardous situations, so that preventive measures can be put in place and corrective action taken. Workers must also be able to report and suggest areas of improvement without fearing dismissal, disciplinary action or similar reprisals.
Risk Based Approach to the OHSMS
Closely aligned with the focus on organizational context is the requirement to adopt a risk based approach when developing and implementing an OHSMS. An organization must identify the risks and opportunities that it must address to ensure that the OHSMS can achieve its intended outcomes. These include those relevant to, or determined by its organizational context. The organization must plan actions that address these risks and opportunities and then integrate and implement them into its OHSMS processes. Finally, it must evaluate the effectiveness of these actions.
The standard requires an organization to ensure that outsourced processes affecting its OHSMS are defined and controlled. When outsourced products and/or services supplied are under the control of the organization, supplier and contractor risk must be managed effectively.
The term "documented information" is used instead of "documents and records", which was present in OHSAS 18001. Evidence from processed information not held in a formal document system, such as electronic information held on smart phones and tablets, will now be accepted.
Migrating from OHSAS 18001 to ISO 45001
If your organization currently holds accredited OHSAS 18001 certification, you will have three years from the formal publication of the new standard in which to migrate to the new ISO 45001 standard.
How can SGS help?
We can provide awareness training to help you to understand the requirements of ISO 45001, Annex SL, risk based thinking and empowering leadership. On request, we will provide a gap analysis that can highlight the changes to be made for migration from OHSAS 18001 to ISO/FDIS 45001 certification.
National member bodies of ISO are currently in the middle of a three month review period for the FDIS text of the standard. If the outcome is positive, the next step will be the publication of the first International Standard.
A copy of the ISO/FDIS 45001 standard can be purchased from the ISO Store.
The official ISO 45001 Working Group (ISO/PC 283) is responsible for developing and publishing the ISO 45001 standard.
Further news and updates regarding the development of ISO 45001 and its publication schedule will be issued as they become available.