ISO 9001 Certification requirement of Clause 4 Explained– The context of the organization is very much important for understanding the user organization that is in the process of Implementation of Quality Management System Standard or is already having ISO 9001 Certification. As ISO Experts View – Understanding the Requirement of Clause 4 -Context of the organization provides the base of Risk Based Thinking to the organization – when designing, developing, and Implementation of Quality Management System of the organization.
ISO 9001 Certification Requirement Clause 4
Clause # 4 -in the Context of the organization, this clause has 4 Sub Clauses
Sub-Clause #4.1 Understanding the organization and its context
Sub-Clause #4.2 Understanding the needs and expectations of interested parties
Sub-Clause #4.3 Determining the scope of the quality management system
Sub-Clause #4.4 Quality management system and its processes
Understanding the organization and its context
We have explained the requirement of clause 4.1 – Understanding the organization and its context in our last blog – so if you wanted to see the requirement of this clause – kindly go to the below link the ISO Expert View on Understanding the organization and its context is provided in more depth for user understanding.
Understanding the needs and expectations of interested parties
Understanding the needs and expectations of interested parties – As per ISO 9001:2015 requirement Understanding the needs and expectations of interested parties in view to effect or potential effects on the organization’s ability to meet consistent requirements of products and services. As per ISO Experts View this clause did not say any client product requirements (For Example – Product dimensions, specification, Test requirement, etc). When the organization addresses the clause Understanding the needs and expectations of interested parties – Organization has looked into the Clients and Interested parties’ needs & Expectations from the organization other than the specific technical requirement. For Example, the Need and Expectation could be – There should be no failure of products during use or services, The price of the product can be reviewed from time to time to meet the economic condition and meet the market competition, Products and services delivered by the organization meets the compliance requirement of regulatory Body (if any)
How to Maintain Compliance for Understanding the needs and expectations of interested parties during Implementing ISO 9001:2015.
- Communicate with the Client to find the Needs and Expectations of products and services other than product technical requirements
- Find any regulatory requirements are applicable to your products and services – if any – then maintain compliance with regulatory requirements
- Record the above two points and monitor the same from time to time to ensure that the needs and expectations of the Interested Party meet.
Benefits of Implementation Context of the organization
- Help the organization to meet to Compliance requirements of ISO 9001:2015
- The organization takes proactive action by Risk Based Thinking to enhance the overall performance of the organization
- Get ISO 9001 Certified
Overview of the importance of Clause 4
As we have understood clause – 4 – in the context of the organization covering many key requirements while planning for Quality Management System implementation and further forb ISO 9001 Certification. The requirements given in this class are based on the QMS of the organization. which set the base to meet the objective of QMS of the organization, such as
- Internal and External Issues – Identification – Risk Analysis and further to take control measures for significant issues at the time of planning of QMS
- identifying the Applicability
- Understanding the expectation of an Integrated party – generally, it is not said in specific (sometimes) requirements – may help the organization to address them in advance to enhance the performance of the organization and meets the overall objective of the organization.
- Establishing the QMS Process
ISO Experts View
ISO Experts believed that Quality Management System implementation not only helps the organization for ISO 9001 Certification, but it also helps the organization in another way by enhancing the overall performance and productivity of the organization. So, it is advised to the user organization to implement the Quality Management System standard to get the benefits of ISO 9001 Certification.