ISO 9001 Certification Requirement of Clause 4 Explained

ISO 9001 Certification Requirement Clause 4 Explained

ISO 9001 Certification requirement of Clause 4 – Context of the organization is very much important for understanding for the user organization who are into the process of Implementation of Quality Management System Standard or already ISO 9001 Certified. As ISO Experts View – understanding the Requirement of Clause 4 -Context of the organization provide the base of Risk Based Thinking to organization – when designing, development and Implementation of Quality Management System of the organization.

ISO 9001 Certification Requirement Clause 4

The clause # 4 -is 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 below link the ISO Expert View on Understanding the organization and its context is provided in more depth for user understanding. See the Link below

Understanding the organization and its context

 

 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 organization’s ability to meets consistent requirements of products and service. As per ISO Experts View this clause did not say any client products requirements (For Example – Product dimensions, specification, Test requirement etc).  When organization addressing the clause Understanding the needs and expectations of interested parties – Organization has looked in the Clients and Interested party needs & Expectations from organization other than the specific technical requirement. For Examples the Need and Expectation could be – There should be no failure of products during use or services, The price of product can be reviewed 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 Maintaining the Compliance for Understanding the needs and expectations of interested parties during Implementing ISO 9001:2015.

  • Communicate with Client find the Needs and Expectations of product and services other than product technical requirements
  • Find any regulatory requirements are applicable to your products and services – if any – then maintain the compliance of regulatory requirements
  • Record the above two points and monitor the same time to time to ensure that the needs and expectations of Interested Party  meets.

Benefits of implementation Context of the organization

  • Help the organization to meets to Compliance requirement of ISO 9001:2015
  • The organization take the proactive action by Risk Based Thinking to enhance the overall performance of the organization
  • Get ISO 9001 Certified

ISO Experts View

ISO Experts believed that Quality Management System implementation not only help the organization for ISO 9001 Certification, but it also helps the organization other way by enhancing the overall performance and productivity of the organization.  So, it is advices to user organization to implement the Quality Management System standard to get benefits of ISO 9001 Certification.

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