[ISO 45001 Series] Institutional Structure: Responsible Personnel and Organizational Units

Introduction

After reading the preceding articles, you may be thinking, “Ah! The author is definitely going to use the introduction to promote earlier articles again.”

Well, you are absolutely right—here they come.

In the two preceding articles, “[ISO 45001 Series] Defining External Interested Parties and External Issues” and “[ISO 45001 Series] Identifying Internal Issues in the Context of the Organization,” I offered recommendations and practical approaches for investigating the external and internal issues required by ISO 45001’s clause on the context of the organization.

In “[ISO 45001 Series] Determining the Scope of the Management System,” I brought together the ISO 45001 requirements and Taiwan’s occupational safety and health legislation to explain the criteria and basis organizations of different sizes can use to determine the system’s scope and boundaries.

Once an organization thoroughly understands its own conditions and environment and has determined the applicable scope in light of its budget and legal requirements, surely it is finally time to roll up its sleeves and start running the occupational health and safety management system—right?

No—you would be wrong. An occupational health and safety management system is extensive and must be sustained over the long term. Before it begins operating, the organization must first establish the environment and responsible units for the system and define the responsibilities and authorities of personnel in each unit, so that the management system can be embedded in the organization’s existing structure.

This part of the series therefore addresses the groundwork for the management system: establishing its institutional structure.

How ISO 45001 Addresses Institutional Structure

Most requirements concerning institutional structure are scattered across ISO 45001’s clauses on “Leadership and Worker Participation” and “Support,” while others appear under “Planning,” “Operation,” and even “Performance Evaluation.” Their scope is broad, and the details are highly fragmented.

For that reason, unlike the preceding articles, I will not begin by presenting the requirements clause by clause. I will first explain the practical operating structure I recommend for making ISO 45001 concrete, then introduce the relevant requirements within that structure so the discussion is easier to follow.

Overview of the Institutional Structure

An organization cannot devote itself exclusively to its occupational health and safety management system; it also has other tasks that serve its purpose. A more efficient arrangement is therefore to concentrate occupational safety and health work and management-system work in a designated unit responsible for formulating and planning the relevant matters, liaising across organizational levels and units, and supervising implementation by the appropriate personnel.

I therefore recommend establishing an internal unit responsible for occupational safety and health work and the occupational health and safety management system before beginning the full management-system process. Yet occupational safety and health cannot be handled by one designated unit alone; workers throughout the organization must also participate and cooperate.

The occupational safety and health work assigned to workers at different levels, together with their roles and responsibilities in the management system, must therefore be defined before the management-system process begins. In other words, the organization must establish its roles, responsibilities, and authorities.

Operating the management system depends on cooperation, participation, and consultation among people at different levels. Beyond assigning responsibilities and duties, the organization must establish communication mechanisms among its units so that they can communicate efficiently.

Education and training can create opportunities to improve occupational health and safety performance and can also allow top management to communicate its occupational health and safety policy to other workers. Its importance within the management system should not be underestimated. Because an education and training system often operates separately from the organization’s ordinary business and management-system processes, I believe it should also be established before the system formally begins operating.

Taken together, these considerations suggest that before the management-system process formally begins, the organization should establish an internal unit responsible for occupational safety and health and management-system matters and define its responsibilities and authorities. The duties and responsibilities ISO 45001 assigns to different organizational levels should then be allocated to the appropriate units within the existing organizational structure. The organization should also establish an education system that can operate alongside its ordinary business and management-system activities, as well as an effective communication system.

Given the limits of this article, I will focus here on establishing the personnel and units responsible for the management system. The other parts of the institutional structure will be addressed in later articles.

A Recommended Approach to Establishing Responsible Personnel and Units

An occupational health and safety management system involves too many matters for top management to carry out and handle all of them directly. Larger organizations, in particular, should designate a specific unit to take responsibility for the relevant work. ISO 45001 therefore permits authorities and responsibilities to be assigned to other levels, but top management retains ultimate responsibility.

In my view, an organization can build the dedicated unit responsible for implementing its management system by aligning it with the requirements in Taiwan’s Occupational Safety and Health Management Regulations concerning the occupational safety and health organizations and management personnel that business entities must establish or appoint.

Under the current legislation, safety and health management personnel serve as a bridge between a business entity and the competent or labor inspection authority. Article 33 of the Enforcement Rules of the Occupational Safety and Health Act includes the occupational safety and health affairs supervisor, occupational safety management specialist, occupational health management specialist, and occupational safety and health management personnel.

Under Article 32 of the Enforcement Rules, safety and health organizations include an “occupational safety and health management unit,” which formulates, plans, promotes, and supervises occupational safety and health matters within a business entity, and an “occupational safety and health committee,” which deliberates, coordinates, and makes recommendations on those matters.

Under Article 11, Paragraph 1 of the Occupational Safety and Health Management Regulations then in force, the occupational safety and health committee was to include the employer; occupational safety and health personnel; managers, supervisors, and directing personnel from the entity’s departments; engineering and technical personnel connected with occupational safety and health; medical and nursing personnel engaged in labor health services; and labor representatives.

The Occupational Safety and Health Management Regulations set different requirements for occupational safety and health management units, committees, and management personnel according to organizational size. I organized the requirements in the following table.

Where an organization establishes an occupational safety and health management body, its occupational safety and health management personnel may be assigned to that body.

The 2022 Rules and the Current Requirements after the 2026 Amendments

Rules in Force When This Article Was Published in 2022: At that time, Article 32 of the Enforcement Rules of the Occupational Safety and Health Act defined an occupational safety and health management unit as an organization that formulates, plans, promotes, and supervises occupational safety and health matters within a business entity. It defined an occupational safety and health committee as an organization that deliberates, coordinates, and makes recommendations on those matters. The safety and health personnel listed in Article 33 included the occupational safety and health affairs supervisor, occupational safety management specialist, occupational health management specialist, and occupational safety and health management personnel. Article 11 of the Occupational Safety and Health Management Regulations then listed the committee members as the employer; occupational safety and health personnel; managers, supervisors, and directing personnel from the entity’s departments; engineering and technical personnel connected with occupational safety and health; medical and nursing personnel engaged in labor health services; and labor representatives. The preceding table was prepared from the rules in force when this article was published.

What Changed in 2026: Following the amendments to the Occupational Safety and Health Act promulgated on December 19, 2025 and effective July 1, 2026, the Ministry of Labor amended the Enforcement Rules of the Occupational Safety and Health Act on June 26, 2026 and the Occupational Safety and Health Management Regulations on June 29, 2026; both amendments took effect on July 1, 2026. The amendments did more than revise general risk assessment and management-plan requirements. They directly affected the institutional structure discussed here: the Enforcement Rules added assessment to the functions of the occupational safety and health committee; the Management Regulations reorganized committee membership, specified the duties of occupational safety and health organizations and personnel, persons responsible for workplaces, and supervisors at all levels more clearly, and amended the staffing requirements in Schedule 2 to Article 3.

Current Requirements after the Amendments: Under current Article 32 of the Enforcement Rules of the Occupational Safety and Health Act, the occupational safety and health management unit formulates, plans, promotes, and supervises occupational safety and health matters. The occupational safety and health committee deliberates, coordinates, assesses, and makes recommendations on those matters. The safety and health personnel listed in Article 33 remain the occupational safety and health affairs supervisor, occupational safety management specialist, occupational health management specialist, and occupational safety and health management personnel.

Current Article 11 of the Occupational Safety and Health Management Regulations requires a committee of at least seven members. The employer serves ex officio. Depending on the entity’s needs, the employer designates departmental managers, supervisors or directing personnel; occupational safety and health personnel; labor health service personnel; and other relevant professionals. Labor representatives make up at least one-third, but the employer does not appoint them: where there is a union, it nominates them; otherwise the labor-side representatives at a labor-management meeting select them, or the workers jointly select them if neither body exists. Article 5-1 also separately specifies the duties of the management unit, committee, occupational safety and health affairs supervisor, occupational safety management specialist, occupational health management specialist, occupational safety and health management personnel, workplace person in charge, and supervisors at each level. These duties provide a clearer legal basis for planning, promoting, supervising, auditing and carrying out safety and health management.

Because Schedule 2 to Article 3 was also amended in 2026, the original figure in this article must be treated as a historical summary of the 2022 rules. It must not be used directly to determine current staffing. When establishing management units, committees, and management personnel, an organization must check each requirement against the business category, number of workers, Schedule 2, and all other applicable provisions in force at the relevant time._[1][2][3]

In light of the legislation above and the current requirements following the 2026 amendments, I believe that where an organization is legally required to establish an occupational safety and health management unit and committee, it can incorporate management-system matters into those bodies’ statutory duties and organizational operations. Where an organization is not legally required to establish those two bodies, the occupational safety and health management personnel appointed in accordance with law can undertake the relevant work. Under either arrangement, assigning work to another unit or individual does not relieve top management of its responsibility for the effectiveness of the management system.

Conclusion

ISO 45001 does contain many requirements concerning the institutional structure needed before an occupational health and safety management system begins operating. They are simply scattered across different clauses. When I first encountered ISO 45001, the requirements felt fragmented, and I found it difficult to see the overall direction.

To make ISO 45001 more concrete, I gathered the requirements related to institutional structure from their different clauses and reorganized them outside the standard’s original clause structure. I proposed this separate “institutional structure” stage in the hope that organizations seeking to establish an occupational health and safety management system can understand the requirements more clearly. I also drew on the applicable occupational safety and health legislation to propose a practical method for establishing responsible personnel and units under current law.

The next few articles will continue with practical recommendations for the other parts of the institutional structure. I will see you in the next article : ).