ISO 9001 - Context of the Organization -Explained

 


ISO 9001 Context of the Organization -Explained

When the organization implements this QMS Clause 4, the organization looks into the Internal and External Issues of the organization as per the nature of products and Services of the organization.  The issues which are affecting the organization’s performance and output.

As per ISO 9001 Certification Experts View,

 

Internal Issue - The Internal issues of the organization could be – Knowledge, overall organizational performance, the culture and practices of the organization, Governance, Role & Responsibility, policy, and procedures.

 

External Issues – The External issues are not in the control of the organization, but to meet the organizational performance and output the organization has to address the issues by taking the necessary steps while implementing the QMS in the organization. As per ISO Expert View Examples of External issues are - social and cultural, political, legal, regulatory, financial, technological, economic, natural, and competitive environments, whether international, national, regional, or local


Internal and External Issues are very much important for the organization to Identify, review, and analysis. After the Analysis of Internal & External Issues, the organization takes necessary action on Significant issues which are affection organizational performance.  Also, it is advised to the organization to develop a team of management personnel who review the Issues from time to time and do the proper analysis .

This will helps the organization for further productivity enhancement and ISO 9001 Certification compliance.

After Implementation of ISO 9001 -Context of the organization, Clause 4 of QMS Standard. The organization develops an SOP for Issues Identification, Review, and analysis. Also set the review frequency, Responsibility. The Risk Analysis and its control measure implementation must be referred to in the Management Review meeting and the record shall be maintained by the organization as evidence of compliance with ISO 9001 Certification requirements.




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