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Context of the Organization Requirements

Management systems (which could be ISO 9001:2015, ISO 14001:2015 and the pending ISO 45001) are now based on the ISO High Level Structure (HLS).

High Level Structure – Context of the organization requirements

Management systems (which could be ISO 9001:2015, ISO 14001:2015 and the pending ISO 45001) are now based on the ISO High Level Structure (HLS). 

Benefits of the HLS:

  • Provides identical structure, text and common terms and definitions for management systems of the future.
  • Ensures streamlined integration with other ISO Management Systems as a simpler process
  • The HLS uses core text which will be in every management system standard as they are revised
  • Contextualized text is then used depending on what the management system is – whether it be Quality, Safety or Environment
Management systems (which could be ISO 9001:2015, ISO 14001:2015 and the pending ISO 45001) are now based on the ISO High Level Structure (HLS).

Context of the organization:

The HLS states the following requirements for clauses 4.1 and 4.2

Clause 4.1 Understanding the organization and its context

This clause states that the organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its management system.  The organization shall monitor and review the information about these external and internal issues.

Clause 4.2 Understanding the needs and expectations of interested parties

This clause states that due to their impact or potential impact on the organization ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements….

What does this mean?

Together clauses 4.1 and 4.2 require the organization to determine the issues and requirements that can impact on the planning of the management system. 


  • An understanding of the issues that have or can have an affect (either positively or negatively), on the way the organization manages its responsibilities in relation to the management system.
  • Issues may include characteristics or changing circumstances that can affect the management system, products or services.
  • These issues may be from external and/or internal influences.

External issues

External issues, may be:

  • The cultural, social, political, legal, financial, technological, economic, natural surroundings and market competition, whether international, national, regional or local.
  • Introduction of new competitors, new technologies, new laws and the emergence of new occupations.
  • Key drivers and trends relevant to the industry or sector having impact on the objectives of the organization.
  • Relationships with and perceptions and values of its external interested parties.
  • Changes in relation to any of the above.

Internal issues

Internal issues, may be:

  • Governance, organizational structure, culture, roles and accountabilities.
  • Policies and objectives, and the strategies that are in place to achieve them.
  • The capabilities of the organization, understood in terms of resources and knowledge (people, processes, systems and technologies).
  • Information systems, information flows and decision-making processes (both formal and informal).
  • Relationships with, and perceptions and values of, its internal interested parties.
  • Standards, guidelines and models adopted by the organization.
  • The organizations culture.


Aims of these clauses are to:

  • Assist an organization in determining its risks and opportunities.
  • Developing or enhancing its policies.
  • Effectively setting and reviewing objectives.
  • Determining its approach to maintaining compliance with its customers, interested parties and applicable legal and other requirements.
  • To continually monitor and review changes in internal and external context and apply these to the established management system.

What an auditor looks for:

In many instances organizations will already have a business plan which will include both internal and external issues.

There are many Management tools which organizations use to help with this and they include things such as;

  • SWOT analysis: Strengths Weaknesses, Opportunities, Threats
  • Porter’s five forces: New entrants, Suppliers, Customers, Buyers and Competitors
  • The Boston Consulting Group Growth-Share Matrix: Stars, Question marks, Cash cows, Dogs

As auditors we need to look at what the organization is already doing and keep an open-mind as to what methods are used to determine these internal and external issues and interested parties.  The above methods and tools may be used however it could also be as simple as being stated in management meeting minutes.

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