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of many different management system approaches and suggested seed language and topics for the subsequent development of the ILO OHSMS (24).

      While the ILO and IOHA were performing these background efforts, two developments occurred. First, ISO elected for a second time to not develop an ISO OSHMS. Second, the BSI published OHSAS 18001:1999, which generally followed the structure of ISO 14001:1996 (13, 19). This document was published specifically for use as an auditable standard. In its introduction, OHSAS 18001:1999 stated that the document was developed “in response to urgent customer demand for a recognizable occupational health and safety management system standard against which their management systems can be assessed and certified.”

      In 2000, in the United States, the AIHA solicited the ANSI to form a committee to develop an ANSI standard for OHSMS. The Z10 committee held its first meeting in 2002 and issued a final standard in 2005 (15). This standard was revised in 2012, shortly after which the American Society of Safety Engineers (ASSE) assumed the leadership of the Z10 standard activities. A revision of Z10 was underway at the time of this publication.

      3.1 ISO and Standards Making

      Management system standards and guidelines are developed and published by a range of organization types. These include: NGOs, such as ISO; national standards bodies, such as ANSI and BSI; professional organizations, such as the American Chemistry Council (ACC) and the AIHA; and, national regulatory‐bodies, such as OSHA in the United States. The ILO is of course an international organization that is part of the United Nations structure; it has also been active in the OHSMS arena.

      The dominant organization in the standards development space has been ISO which was formed in 1926 as the International Federation of the National Standardizing Associations (ISA), and was later renamed ISO following a brief operating gap during WWII.

      ISO is a voluntary organization whose members are recognized standard authorities, each representing one country. ISO standards are produced by volunteers who represent the national standards institutes of over 160 member national standards institutes (25). For example, ANSI is the United States representative to ISO. These volunteers participate on technical committees, subcommittees, and working groups each headed by a Secretariat from one of the member organizations. Each of these groups work to produce or update technical guidance in a specific area. Generally, a specific consensus standard is the ultimate work product, such as ISO 9001, 14001, and 45001.

The difference between standards and guidelines is important. The term standard, typically refers to documents that are “shall” based as opposed to “should” which is often used in guidelines. Use of shall, means that the issue at hand is required, versus the use of should that means that the issue at hand is a recommendation or good idea.

      Standards rarely have the force of law unless specifically adopted by a regulatory agency or legislative body. Thus, most standards are voluntary until referenced by regulation or judicial process. However, the line between voluntary and required begins to blur as more organizations adopt these standards and begin requiring conformity by their suppliers. For example, few governments require ISO 9001 or ISO 14001 certification but it is almost impossible to be a global supplier without them. Third‐party certification to the standards such as these has become a de facto requirement in many markets.

      3.2 ISO's High‐Level Management System Structure (MSS)

      In an effort to bring uniformity to its management system efforts, ISO's Technical Management Board (TMB) formed the ISO Ad Hoc Group on Management System Standards shortly after ISO 14001:1996 was published. This group published Guidelines for the Justification and Development of Management System Standards (ISO Guide 72) in 2001 (26). This guide presented common MS elements as:

      1 Policy;

      2 Planning;

      3 Implementation and operation;

      4 Performance assessment;

      5 Improvement; and

      6 Management review

      These elements followed the structure of ISO 14001:1996 and were found in many nation‐specific approaches at that time.

      In the early 2000s, the Ad Hoc Group on Management System Standards recommended the formation of the Joint Technical Coordination Group (JTCG) to work on establishing consistency between ISO's various management system standards; the TMB subsequently formed the JTCG on MSS. This group developed ISO Guide 83, High Level Structure, Identical Core Text and Common Terms and Core Definitions for use in MS Standards (27). This document was never formally adopted, but was issued in December 2011. In it was the recommendation to establish what is often referred to as ISO's “high‐level MSS structure.” These recommendations where subsequently adopted, and published in 2013, in Annex SL of ISO's Directives (also referred to as the ISO Supplement). Annex SL formally presented the new high‐level and generic MSS that all revisions and future ISO MSSs were required to follow (28). This high‐level MSS structure has 10 sections, these are:

      1 Scope;

      2 Normative references;

      3 Terms and definitions;

      4 Context of the organization;

      5 Leadership;

      6 Planning;

      7 Support;

      8 Operation;

      9 Performance evaluation; and

      10 Improvement

      ISO 45001:2018 follows this outline as have all ISO MS standards since 2013, including ISO 14001:2015 and ISO 9001:2015.

4 FOUNDATIONAL CONCEPTS

At their most basic level, systems are typically described as having four elements: input, process, output, and feedback. The relationship between these four elements is depicted in Figure 2.

      A question that often comes up when talking about an OH&S management system is “what is the difference between a system and program?” One way to describe this difference is in terms of an information feedback loop, that is, feedback in a system is essential and an integral component of the system. Conversely, this is not the case with programmatic approaches where feedback is not necessarily part of a structural design.

      A system can be further characterized as being either open or closed. In the case of open systems, there are identifiable pathways whereby the system interacts – exchanging information with and gaining energy – from its external environment. This phenomenon is readily observed in biological systems. Conversely, closed systems do not have such pathways, and thus limit their ability to adapt or respond to changing external conditions.

      ISO's guidelines on the development of management system standards defines a management system as a “system to establish policy and objectives and to achieve those objectives” (26). This ISO guideline states that

FIGURE 2 Basic system depiction.

“management systems are used by organizations to develop their policies and to put these into effect via objectives and targets, using: an organizational structure with roles, responsibilities, authorities, etc., of people defined; systematic processes and associated resources to achieve the objectives and targets; measurement and evaluation methodology to assess performance against the objectives and targets, with feedback of results used to plan improvements to the system; and, a review process to ensure problems are corrected and opportunities for improvement recognized and implemented when justified” (26).

      ISO 45001:2018 defines a management system (§3.10) as a “set of interrelated or interaction elements of an organization

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