ISO 9001 Certification Requirement Clause 4.3 Explained
ISO 9001 Certification requirement of Clause 4.3 – Determining the scope of the quality management system. As per ISO 9001:2015, standard clause 4 – The context of the organization has Four sub-clause
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
Where ISO Expert’s View on Understanding the organization and its context and understanding the needs and expectations of interested parties has been published by ISO Experts for enhancement of understating the requirements of these sub-clauses for implementation of Quality Management Systems in organizations for ISO 9001 Certification.
The latest publication of the Article on requirements of Understanding the organization and its context and understanding the needs and expectations of interested parties are given below as Publication Link you find the detailed requirement.
Understanding the organization and its context
Understanding the needs and expectations of interested parties
ISO Expert has taken the opportunity to explain ISO 9001 Certification Requirement Clause 4.3 in view that the user organization who are in the process of Implementation of ISO 9001:2015 to get ISO Certification are benefited.
Determining the scope of the quality management system
As per the requirement of ISO 9001:2015 – The Scope means the – Activities of the organization at the particular Place. The organization may have its Branch organization at different locations and activities may be different at each location or the same at all locations. So, while implementing ISO 9001:2015 in the organization the Scope must be addressed in detail along with Activities, Products & Services along with physical Location where the organization operates.
While deciding the scope of the organization, the following to be considered
- Issue of the organization and Limitations
- Needs and Expectations of Interested Party
As per ISO Expert’s View – the requirements given in ISO 9001:2015 are generic in nature – So will deciding the scope of the organization – the organization looks into the requirement of ISO 9001 – there is the possibility that some of the Clauses are not applicable to an organization considering the nature of Activities, Product & services of the organization. So, organizations can exclude these clauses which are not applicable to the organization.
This is all about the explanation of the requirements of clause 4.3 -Determining the scope of the quality management system ISO 9001:2015.
How implement Clause 4.3 Determining the scope of the quality management system to maintain Compliance with ISO 9001:2015
- Decide the Scope and document the same in Quality Manual
- Exclusion of Clauses – Record the Clause of ISO 9001:2015 – which are not applicable (or Excluded ) in the Quality Manual with the justification of Exclusion of Clauses considering the nature of Activities, Product & services of the organization
ISO Experts View
With the above explanation in Clause 4.3 Determining the scope of the quality management system
The organization can be able to understand the requirement of ISO 9001 Clause 4.3, which could help the organization for implementation of ISO 9001 and maintains compliance with ISO 9001 Certification.