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ISO 9001 Certification Standard – Explained

ISO 9001 Certification

ISO 9001 Certification Standard –  Explained

Context of the Organization

As per ISO 9001 Certification standard requirement, the organization has to implement the ISO 9001:2015 requirement in the organization by developing the policy, procedures, SOP and many other relevant documents & Records. ISO 9001:2015 Certification Standard in known as Quality Management System Standard – which has many requirements for implementation prior to go for ISO 9001 Certification. ISO 9001 Certification Standard – Context of the Organization is one of the key requirements of QMS.

ISO 9001 Certification Standard – Context of the Organization Explained

In this blog, Our ISO Certification Experts has explained the Context of the Organization requirement of Clause # 4, in view that user organization can get the better understanding on the Clause # 4 Context of the Organization requirement – who are in-process of Implementation of ISO 9001 for getting ISO 9001 Certified.

Context of the Organization Explained

QMS Clause # 4 – Context of the Organization has four sub clauses as given below

Clause # 4.1 Understanding the organization and its context

Clause # 4.2 Understanding the needs and expectations of interested parties

Clause # 4.3 Determining the scope of the quality management system

Clause # 4.4 Quality management system and its processes

Understanding the organization and its context -Explained

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

As per ISO 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, procedures.

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

How to maintain the Compliance of Clause # 4.1 Understanding the organization and its context

As per ISO Certification Experts View,

  • The organization has to Make the Team and Find the Internal and External issues – which are most relevant to organization activities and affective the organization’s output.
  • Record the Internal and External Issues
  • Categories the Issues – based on its impact of the performance & output of the organization
  • Take the possible necessary action on issues, which are most Significant in nature and effect to the performance of the organization.
  • Monitor the Issues on regular time interval

As per ISO Certification Expert View with the help of above explanation, the organization can able to understand the requirement of Clause :4.1 of ISO 9001:2015 Standard – which will help the user organization for Implementation of Quality Management System Standard who are in process of ISO 9001 Certification or upgrading the current organization’s Quality Management System Standards to ISO 9001:2015

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