ISO 9001 extent of process documentation
My understanding is that ISO 9001:2015 allows significant latitude for organizations to determine the extent of process documentation they feel is required to maintain their QMS. However, it seems like trying to navigate a certification audit with very sparse process documentation would be to say the least challenging. The small to medium sized company I represent has very sparse process documentation and I am concerned about our odds of successfully navigating the certification audit. What are your thoughts or recommendations?
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ISO 9001:2015 as you say does not make mandatory many documents. However, there are still several mandatory records - Consider this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
I understand your concern, but as long as you know that common documents used by other quality management systems are not mandatory, you can defend your position.
I, as an auditor, do not like to prescribe what kind or number of documentations an organization should have. I, as an auditor, look into an organization’s complexity level, look into staff turnover figures, look into the quality and extent of the training program and, above all, look into organization’s performance before I raise an opportunity for improvement about the number or quality of an organization’s quality management system documents.
You can find more information about documentation below:
- How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
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Nov 02, 2020