ISO 9001 Certification Requirement Clause 4.4 Explained
ISO 9001 Certification requirement of Clause 4.4 Explained– Quality management system and its processes. As per ISO 9001:2015, the standard Designing Quality Management and its process is the basic requirement for the Quality Manual and procedures which are required to be developed during the implementation of ISO 9001:2015 in the organization with a view to getting ISO Certified.
As per ISO 9001:2015 Standard – clause 4 – The 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 have taken the opportunity to explain the requirements of sub-Clause 4 of ISO 9001:2015, as it was the new requirement in comparison to ISO 9001:2008 Standards. So that any organization who are already certified for ISO 9001, can take the explanation of the advantages of ISO 9001:2015 requirements to upgrade its implemented Quality Management System Standard to New requirements. Also, those organizations who are planning for implementation of ISO 9001:2015 for getting ISO 9001 Certification. So, taking the view of all user organizations benefits their understanding. ISO Experts team is continuously publishing the ISO 9001:2015 requirement clause-wise. In the 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 Past Articles on the requirements of ISO 9001 Clause 4, can go to the below link to know more detailed requirements on the 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 Explained – Quality management system and its processes
Quality Management System and Its Process – As per the requirements of this clause 4.4, the organization
- Look at each process/activity and determine the Inputs and output of each process/ Activity
- Sequence the process as per the 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 process with the QMS of the organization.
- Look into the Customer requirements – accordingly – an organization can set the Criteria of each Internal process and method of monitoring. So that while processing of products 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 the production or delivery of services.
- Review the Internal process from 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 Explained – 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 processes and their Interactions.
- Develop the Criteria and Monitoring System for each process
- Ongoing Basis maintain the record of Monitoring of process, Input & Output result of the 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 better understand the Requirement for Implementation and maintain the compliance of QMS to getting ISO 9001 Certification.