Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Linah, Nov 15, 2017.
Hello, would like to clarify on the level 3 document. Is it a compulsory to have it.
Nope. They don't even talk in terms of document levels anymore.
ISO 9001:2015 doesn't make reference to any "level" of documents or anything called work instructions, if that's what you are asking about being mandatory. Your customer and/or management might decide differently.
If you would refer to the statements below:
Clause 4.4.2a - "To the extent necessary, the organization shall...maintain documented information to support the operation of its processes";
Clause 7.5.1b - "The organization’s quality management system shall include...documented information determined by the organization as being necessary for the effectiveness of the quality management system";
Clause 8.1e - "determining and keeping documented information to the extent necessary";
Clause 8.5.1a.1 - "Controlled conditions shall include, as applicable...the availability of documented information that defines...the characteristics of the products to be produced, the services to be provided, or the activities to be performed".
All mentioned subjective statements like "to the extent necessary", "determined as being necessary", and "as applicable". These are not mandatory or compulsory.
There wasn't in the past, either. It's a system which was created by someone's interpretation of what the 1987 requirements were. The "pyramid" of documentation was a myth.
The terms applicable and appropriate are among the concepts that are not well defined in the 9001 or 9000 standards. But applicable means, if it applies to the organization then the organization must do it. Appropriate gives the organization the right to determine necessity. I hope this helps.
The answer to this OP is to consider the "Context of the Organization" and those internal and external issues. Debating the words "applicable and "appropriate" won't work without consideration of these issues and the needs of interested parties. As with just about all of the ISO 9001:2015 requirements you must consider what the principles of quality management and assurance are: Consistently meeting requirements, through process control. If these results aren't being met then one way to achieve control is through some form of documentation which defines (some of) those controls (I won't debate what they are called, as it's not important)
Exactly: what's applicable is customer requirements, regulatory requirements, and other relevant interested party requirements (4.2) as well as factors that make the controls, via documentation, worthwhile (4.1). Such factors can include having a work force (less-educated, and in some cases more educated yet unaware of customer and program expectations) that needs explicit instructions do consistently deliver satisfactory outputs, and/or to be held accountable to.
I point to definitions to make this point clear in persons who otherwise would think they get to decide if and when to have process documentation at all. First we must understand what we are doing, but if we are to certify we are to also understand the standard.
In determining the type and extent of documented information, organizations should also apply risk-based thinking.
Refer to the 3rd paragraph of Annex 4 of ISO 9001:2015 as stated below:,
The risk-based thinking applied in this International Standard has enabled some reduction in prescriptive
requirements and their replacement by performance-based requirements. There is greater flexibility
than in ISO 9001:2008 in the requirements for processes, documented information and organizational
including the 4th paragraph of clause 4.4.2 of ISO/TS 9002:2016 as stated below:
It is up to the organization to specify the different types of documented information needed to support
the operation of its processes and its quality management system. In determining the type and extent
of documented information needed, the organization should evaluate its own needs and apply riskbased
thinking. It should also give consideration to its size, activities, types of products or services,
complexity of its processes, resources, etc., as well as the potential consequences of nonconformities.
For understanding of the word "as applicable", you can also refer to the ISO 9000 Glossary for additional guidance. This document can be searched from this link: https://www.iso.org/search/x/query/glossary
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