ISO 9001 Certification Requirement Clause 4.4 Explained

ISO 9001 Certification Requirement Clause 4.4 Explained

ISO 9001 Certification requirement of Clause 4.4 – Quality management system and its processes. As per ISO 9001:2015 standard Designing the Quality Management and its process is the basic requirement for Quality Manual and procedures which is required to be developed during the implementation of ISO 9001:2015 in the organization with view for getting ISO Certified.

As per ISO 9001:2015 Standard – the clause 4 – Context of the organization has Four sub-clauses

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

The ISO Experts has taken the opportunity to explain the requirements of sub-Clause 4 of ISO 9001:2015, as it was the new requirement in comparison of ISO 9001:2008 Standards.  So that any organization who are already certified for ISO 9001, they can take the advantages explanation on ISO 9001:2015 requirements to upgrade their implemented Quality Management System Standard to New requirements. Also, those organization who are planning for implement of ISO 9001:2015 for getting ISO 9001 Certification. So, taking the view of all user organization benefits of their understanding. ISO Experts team are continuously publishing the ISO 9001:2015 requirement clause wise. In past few articles ISO Experts Team has published the requirements of

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

If the user organization has not viewed to past Articles on the requirements of ISO 9001 Clause 4 , can go to below link  to know more detailed requirements on above 3 sub- clauses – 4.1 , 4.2 & 4.3

Understanding the organization and its context

Understanding the needs and expectations of interested parties

Determining the scope of the quality management system

 

ISO 9001 Certification Requirement Clause 4.4 – Quality management system and its processes

Quality Management System and Its process – As per the requirements of this clause 4.4, the organization

  • Look in each process / activity and determine the Inputs and output of each process/ activity
  • Sequence the process as per process flow chart – also look into the Interactions of each process. As per Expert View – each process needs Inputs to deliver the output – So there must be an Interaction processes with the QMS of the organization.
  • Look into the Customer requirements – accordingly – organization can set the Criteria of each Internal process and method of monitoring. So that while processing of product at each stage of activities meets the requirements. So that at End Final products meets customer requirement.
  • As per Customer requirements resources are made available for production or delivery of services.
  • Review the Internal process time to time – if necessary, make the necessary changes for better output.

 How to Maintain the Compliance of ISO 9001 Certification Requirement Clause 4.4 – Quality management system and its processes

  • In the Quality Manual – Define the Inputs & outputs of the Process.
  • In Quality Manual – documents and Established the Sequence of process and its Interactions.
  • Develop the Criteria and Monitoring system for each process
  • On-going Basis maintain the record of Monitoring of process, Input & Output result of process

ISO Experts View

As per Experts view  the  explanation provided  on ISO 9001:2015 Standard – Requirement on Clause 4 – Context of organization – will help the organization for better understanding the Requirement for Implementation and maintain the compliance of QMS to getting ISO 9001 Certification.

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