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:
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 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.
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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:
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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.
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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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.
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