Clause 4 of ISO 9001:2008 QMS Standard mentions requirements of ‘quality management system’ that has following sub-clauses:
4 Quality management system
4.1 General requirements
4.2 Documented requirements
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
Now the working draft for forthcoming ISO 9001 mentions clause 4 as ‘Context of the organization’ instead of ‘Quality management system’ as in ISO 9001:2008 QMS Standard. Clause 4 of the working draft issued by ISO/TC 176 Sub-committee 2 mentions requirements of ‘context of the organization’ that has following sub-clauses:
4 Context of the organization
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
Understanding the organization and its context
This is a new addition that requires:
- Organization to determine internal and external issues relevant to the organization’s purpose and that can affect organization’s ability to achieve desired results
- Organization to consider such issues for determining risks and opportunities
Understanding the needs and expectations of interested parties
This time understanding the needs and expectation of interested parties is included that requires:
- Organization to determine interested parties relevant to organization’s quality management system
- Organization to determine QMS related requirements of such interested parties
Determining the scope of the quality management system
Clause 1.1 of ISO 9001:2008 QMS Standard discusses the scope in general but now to determine the scope for the QMS will be a requirement to establish organization’s QMS scope. Organization needs to determine boundaries and applicability of its QMS by considering internal and external issues, needs and expectations of interested parties. It is now a requirement to mention the scope and also any exclusion in the documented information.
Quality management system
Requirements mentioned in the working draft is more or less similar to clause 4.1 of ISO 9001:2008 QMS Standard, however following additional requirements have been added in the working draft:
- Organization to determine risks to quality performance where unintended output is produced and/or process interaction is not effective.
- Organization to allocate responsibilities and authorities for particular processes or set of processes.
- Organization to ensure that (new or revised) processes continue to deliver desired results.
We will post more articles on ISO 9001 QMS Standard revision.
Please also read my earlier articles ‘Revision of ISO 9001:2008 QMS Standard’ and ‘Revision of ISO 9001:2008 QMS Standard – Working Draft has 10 clauses’ posted in this blog. I will be happy to have your comments and reaction to the write-up.
With best wishes,
Keshav Ram Singhal
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