Thursday, October 22, 2015

Records, Retained Documented Information, and ISO 9001:2015

ISO 9001:2015 does a lot of things right, but using clear language is not one of them. One of the most glaring examples is the transformation of the word “records” into “retained documented information.” That’s right, they took one word and turned it into three. And the three words are not nearly as intuitive as the one word they replaced. Regardless of what you call them, records are the proof of something happening. They are historical, referring to past events. As such, they are not revised. Records might be “corrected” in some cases, but they are never revised. Only documents are revised. (We’ll address documents and their status in ISO 9001:2015 in a future article.) The primary control of records is that of housekeeping: knowing where they are stored, who is responsible, how long they’re kept, etc.

Here is a summary of records requirements in ISO 9001:2015:  
·         24 records are required in ISO 9001:2015. This is compared to 21 records required in ISO 9001:2008. Some of the 24 records required by ISO 9001:2015 are actually repeat requirements.
·         20% of all the record requirements come from section 8.3, Design and development of products and services. That amounts to 5 records, which is the same number required by ISO 9001:2008.
·         A completely new record that is required in 9001:2015 is retained information on changes: review of changes, persons authorizing the change, and necessary actions arising from change (section 8.5.6)
·         ISO 9001 continues its redundant ways. ISO 9001:2015 requires records of evidence of processes being carried out effectively TWICE, once in section 4.4.2 and again in section 8.1.e.1.
·         More redundancy: ISO 9001:2015 requires records that demonstrate conformity of products & services processes TWICE, once in section 8.1.e.2 and again in section 8.6.
·         5 of the records in ISO 9001:2015 have qualifiers. They are “to the extent necessary” and “as applicable.”
·         One item listed as “retained documented information” (i.e., record) is actually a document. That is design outputs. Design outputs are living information such as specifications, engineering drawings, recipes, formulas, and bills of material. Since they are living, they are subject to revision, meaning they are documents.
·         A handful of requirements would be virtually impossible to have evidence of without records, and yet records are not required by ISO 9001:2015. These include context of the organization (4.1), interested parties (4.2), planning of changes (6.3), and customer feedback (9.1.2).
·         One of the strangest record issues of all is the omission of calibration records in ISO 9001:2015. This has been replaced by the requirement to ‘retain information on fitness of purpose for measuring instruments,’ which would include calibration. I expect many people implementing ISO 9001:2015 will get a bit confused by this. 

Do not let anyone tell you that the “correct” terminology is retained documented information. If you like that term, then by all means use it. If you prefer the term ‘records,’ you can use that in its place. Always remember that documents are records are two different things. That one fact alone will make any QMS easier to use and understand. 

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