Documented Information (ISO 9001:2015)

Posted by vivek 30/01/2017 0 Comment(s) Quality System,

In ISO 9001:2008 version the words like documents, records, quality manual, documented procedures, quality plan have been mentioned at various places. The new revised version of ISO 9001 quality systems standard (ISO 9001:2015) has introduced a new term 'documented information'. Thus words 'documents' and 'records', both have been replaced throughout the text by ‘documented information’. The 'documented information' is required be maintained and retained.



An annex to the new standard (A.6) says that "Where ISO 9001:2008 would have referred to documented procedures...this is now expressed as a requirement to maintain documented information”, and "Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information".



The type and extent of the documented information will depend on the relevance i.e.  requirement of organization’s products, processes, the level and extent of formal communication needed, and the organizational culture, the need to preserve and spreading across the organization’s experiences etc. The documented information may be maintained and retained in any form such as paper, magnetic, electronic, optical computer disc, photograph etc.



Wherever, the word 'retain' has been used in the new standard, it requires the information to be collected in a structured manner (e.g. controlled record format) and retained.  Wherever the documented information is required to be 'maintained', it requires the document to be controlled and possibly 'retained' also. The duration of 'maintaining' and 'retaining' will depend upon the nature, relevance and importance of the documented information.

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