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 known as Quality Management System Standard – has many requirements for implementation prior to going 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 a better understanding on 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 implements this QMS Clause, the organization looks into the Internal and External Issues of the organization as per the nature of the 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, and procedures.
External Issues – The External issues which are not in control of the organization, but to meet the organizational performance and output of the organization have 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
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 the organization’s activities and affect the organization’s output.
- Record the Internal and External Issues
- Categories The Issues – based on their impact of the performance & output of the organization
- Take the possible necessary action on issues, which are most Significant in nature and affect the performance of the organization.
- Monitor the Issues at regular time intervals
As per ISO Certification Expert View with the help of the 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 the 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