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Clause 4.1 of ISO 9001:2015 standard says ‘’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 result(s) of its quality management system.’’

Determining the external and internal issues involves: 

  • Studying the influences of various elements affecting the organization directly or indirectly.
  • Understanding how the elements affect the management system.
  • Studying the risks and opportunities regarding the business.

These elements are referred to as the interested parties with their attending issues, internal or external to the system and/or the organization.


  • Interested parties – Who qualifies?

Interested parties are entities that are directly or directly concerned with the performance of an organization’s quality, occupational health & safety, environmental safety or food safety systems. They are the individuals, organizations or group that can influence or be influenced by your organization’s processes or activities. They include the organization’s management, community, contractors, and shareholders. These parties are qualified as interested parties for the management systems.

  1. Management & Shareholders: These people are connected to all the business functions and strategic decisions affecting the well-being of the business. They set directions and take the lead in implementing the strategic goals of the organization.
  2. External Providers, Contractors & Service Parties: The role of this group is also very important for the effectiveness of a management system since they can also be a source for introducing food safety risk in the supply chain of food (for FSMS). The organization should develop proper controls to manage their performance to enhance the effectiveness of the system.
  3. Government, Regulatory or Legislative Bodies: In the case of the fulfilment of legal requirements, these parties become interested in authority over organizations.
  4. Customers: Customers are the most important interested party of a management system. They should purchase products of high quality, which should be manufactured in hygienic condition. In the absence of proper controls, they will suffer the negative impact of these products on health, including acute diseases.

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Internal & External Issues

  • Internal Issues

Internal issues of an organization make up the internal context of the organization. They are actions or products and services within the organization that may affect an organization’s management systems performance. 

Organizations have so much intensive and complex issues to consider when planning for the operation of their management system. When analyzing the business context, they should consider some common internal issues such as these:

  • The competence of the organization’s workforce for ensuring effective management system implementation.
  • The commitment of the workforce regarding food safety, health & safety, quality etc.
  • Organization’s communication channels and means for the management system and their significance.
  • The readiness to collaborate and remain within the declared scope of the management system.


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  • External Issues

External issues refer to factors influencing the organization’s business and operations from the outside. They include legal, economic, social, or political issues susceptible to damage an organization’s business and operational performance. 

The following are some examples of external issues that an organization should consider while planning its management system.

  • Legislation & regional laws: Legislation and regional laws are important to the organization’s performance. The organization need to make their processes compliant with these laws. They should have a system in place to upgrade with any new laws as well.
  • Economic & Political Situations: Both economic and political conditions of the sector in which an organization operates impact their business processes. While they may not be able to control the situation, they can adapt and respond to such changes in political and economic space. Response should go to the level in which organization can maintain its effectiveness for business and the management system itself. These should be addressed in policy, objectives, and programs. 
  • Shareholders Interest: The expectations of the stakeholders must be taken care of. Since they are also concerned about business and the system performance.
  • Updates from International agencies: They might need a restructuring of your business parameters for your specific system. An example is the FDA banning the usage, sales and distribution of seven artificial food flavorings (benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone, or pyridine).

Haven determined the internal and external issues affecting an organization documenting the analysis of business context is recommended to to serve as an evidence to auditors and other stakeholders. Also, a consistent review of the issues should regularly be conducted to address changes in changing world.

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About the Author

Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB), Digital Manufacturing Professional and Management Systems Lead Auditor (ISO 9001, 45001 & ISO 22000) with strong experience leading various continuous improvement initiative in top manufacturing organizations. 

You can reach him here.

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