4 Context T 18                           

• 4.1 The organization and its context
• 4.2 Needs and expectations of interested parties
• 4.3 Scope of the OH&SMS
• 4.4 OH&SMS

4.1 The organization and its context

External and internal issues that can influence the OH&SMS

(requirement 1, see also the quiz)

In the simplified diagram in figure 4-1, you can see the purpose of an ISO 45001 OH&Soccupational health and safety management system:

Figure 4-1. Purpose of an ISO 45001 OH&SMS

To successfully implement an OH&Soccupational health and safety management system, we must understand and evaluate everything that can influence the reason for being and business performance. You should think carefully about a few key activities:

• develop a thorough diagnosis of the unique context in which your organization exists, taking into account these issues:
  • the external environment, such as:
    • social
    • regulatory
    • economic
    • technology (new knowledge of impacts on worker health and safety)
    • competitive
    • new suppliers and contractors
  • the internal environment, such as:
    • specific aspects of the corporate culture:
      • vision
      • rationale, purpose and mission
      • core values
    • needs and expectations of:
      • workers
      • interested parties
    • products and services
    • infrastructure
    • work conditions
    • work organization
• monitor and review regularly any information relating to external and internal issues
• analyze the factors that may influence the achievement of business objectives

The results of this reflection will help us to determine the scope of the OH&Soccupational health and safety management system (OH&SMS) cf. § 4.3. 

The SWOT and PESTEL analyses can be useful for relevant analysis of business context (cf. annex 05). 

A list of external and internal issues is carried out by a multidisciplinary team. Each issue is identified by its level of influence and control. Priority is given to issues with great influence and poor control.

The OH&Soccupational health and safety management system is adapted to the corporate culture and continuously improved.

For France the CSE (Social and economic Committee) has the mission to contribute:

• to protect the health and safety of employees
• prevention of risks at work
• continuous improvement of working conditions
• strict compliance with the legal requirements for hygiene, health and safety at work
• the involvement of workers in all prevention measures

Minute of relaxation. Game: Context of the company

• diagnosis of the context includes the main external and internal issues
• the core values as part of the corporate culture are taken into account in the context of theorganization
• the results of the context analysis are widely diffused
• the SWOT analysis includes many relevant examples
• the SWOT analysis is a powerful tool for identifying the main threats and opportunities

• the issues of the context of the company, such as the competitive environment, are not taken into account
• in some cases, the corporate culture is not taken into account
• risk analysis does not take into account strategic issues
• no clear link between the SWOT analysis and the actions undertaken

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4.2 Needs and expectations of interested parties

Understand the requirements of interested parties

(requirements 2 to 4)

To understand the needs and expectations of interested parties, we must begin by determining those who may be affected by the OH&Soccupational health and safety management system, such as:

• employees and their representatives
• customers
• external providers (suppliers, contractors and subcontractors)
• owners
• shareholders
• legal authorities
• OH&S organizations
• occupational physician
• bankers
• distributors
• competitors
• citizens
• visitors
• neighbors
• social and political organizations

A list of interested parties is created by a multidisciplinary team. Every interested party is determind by its level of influence and control. Priority is given to interested parties with great influence and poor control.

Anticipating the reasonable and relevant needs and expectations of interested parties involves:

• identifying and reducing or even eliminating OH&S hazards
• preparing to address risks
• seizing improvement opportunities

A review of workers' needs and expectations is conducted to anticipate the needs and expectations that will become legal requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2).

• the list of interested parties is updated
• the needs and expectations of interested parties are established through meetings on-site, surveys, roundtables and meetings (monthly or frequent)
• the application of statutory and regulatory requirements is a prevention approach and not a constraint

• statutory and regulatory requirements are not taken into account
• the delivery time is not validated by the customer
• the expectations of interested parties are not determined
• the list of interested parties does not contain their area of activity

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4.3 Scope of the OH&SMS

Define the scope of the OH&SMS

(requirements 5 to 10 )

The scope (or in other words, the perimeter) of the OH&SMS is defined by top management. 

The specific context of the organizationa structure that satisfies a need (see also ISO 9000, 3.3.1) is taken into account to determine the scope of the OH&SMS including:

• issues (cf. sub-clause 4.1)
• operational activities of products and services
• corporate culture
• environment:
  • legal requirements
  • social
  • financial
  • technology
  • economic
• requirements of interested parties (cf. sub-clause 4.2)
• outsourced processes

The scope of the OH&SMS includes activities under the authority or influence of the organizationa structure that satisfies a need (see also ISO 9000, 3.3.1) and those that may have an impact on its performance.

A preliminary OH&Soccupational health and safety analysis makes it possible to:

• identify the hazards
• assess the risks
• identify the legal requirements
• analyze existing processes and documented information
• evaluate the history of emergencies, incidents and nonconformities
• define the necessary resources
• create a training program
• set objectives

The scope of the OH&SMS is available to any interested party as documented information. 

• the scope is relevent and available upon request
• non applicable requirements are justified in writing

• some products are outside the scope of the QMS without justification
• the paint shop is not included in the scope of the QMS
• the requirements of a customer are not accepted and no justification is present
• the scope is obsolete (a new subsidiary is not included)

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4.4 OH&SMS

OH&SMS requirements, processes and interactions

(requirement 11)

Prevention always costs less

Top management of the organizationa structure that satisfies a need (see also ISO 9000, 3.3.1) defines and implements an occupational health and safety management system (OH&SMS). The purpose is the development of a safe work environment, incident prevention, risk reduction and the overall protection of workers and all interested parties. For that:

• the occupational health and safety management system is:
  • established
  • documented (a simple and sufficient documentary system is implemented)
  • applied and
  • continually improved
• the OH&S manager (prevention referent) is appointed
• OH&S policy, objectives, resources and the work environment are determined
• the hazards are identified
• risks are assessed and actions to reduce them are established
• the legal requirements of the sector concerned are identified
• actions to implement the policy and achieve the objectives are planned
• the history of emergencies, incidents and nonconformities are evaluated
• the training program is created
• core processes required by the OH&SMS are controlled:
  • the corresponding resources are insured
  • the input and output elements are determined
  • the necessary information is available
  • owners are appointed (responsibilities and authorities defined)
  • sequences and interactions are determined
  • each process is measured and monitored (established criteria), objectives are established and performance indicators are analyzed
  • process performance is evaluated regularly
  • the necessary changes are introduced to obtain the expected results
  • actions to achieve continual improvement of processes are established
• the bare minimum ("as necessary") documented process information is maintained and retained ( , )

The OH&Soccupational health and safety manual is not a requirement of ISO 45001, but it is always an opportunity to present the organizationa structure that satisfies a need (see also ISO 9000, 3.3.1), its OH&SMS and its processes (see annex 07). 

The ISO guide “The integrated use of management system standards” of 2018, contains relevant recommendations on the integration of management systems.

 Pitfalls to avoid:

• going overboard on quality: 
  • a useless operation is performed without adding value and without the customer asking for it - it is a waste, cf. quality tools D 12
• having all procedures written by the OH&S manager: 
  • responsibility is everybody's business, "the staff is conscious of the relevance and importance of each to the contribution to OH&S objectives", which is even more true for department heads and process pilots
• forgetting to take into account the specificities related to the corporate culture: 
  • innovation, luxury, secrecy, authoritarian management (Apple)
  •  strong culture related to ecology, action and struggle, while cultivating secrecy (Greenpeace)
  • fun and quirky corporate culture (Michel & Augustin)
  • liberated company, the man is good, love your customer, shared dream (Favi)

The requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) of the ISO 45001 standard are shown in figures 4-2:  

Figure 4-1. The requirements of the ISO 45001:2015 standard

• the process mapping contains enough arrows to show who the customer is (internal or external)
• many arrows (multiple customers) are used for processes (no customer is forgotten)
• during the process review, the added value of the process is well revealed
• process performance analysis is an example of evidence of continual improvement in the effectiveness of the OH&SMS
• top management regularly monitors objectives, indicators and action plans
• the purpose of each process is clearly defined

• some process outputs are not set correctly (customers not considered)
• process efficiency criteria are not established
• the process owners are not formalized
• real activities are not identified in any process
• sequences and interactions of certain processes are not determined
• criteria and methods for ensuring effective processes are not determined
• the OH&SMS is not updated (new processes are not determined)
• the threats and weaknesses identified in the SWOT analysis remain without actions

The rest of the T 18v18 ISO 45001 readiness version 2018 training is accessible on this page.

See also the training T 38v18 Internal audit ISO 45001 and the training package ISO 45001.

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