Where has all the paperwork gone?
ISO 9001:2015 no longer requires obligatory documented procedures or a quality manual. The new standard refers ‘documented information’ in practically all clauses of ISO 9001:2015.
The definition states that it concerns ‘information that the organisation has to control and maintain’. The information can be in any format and come from various sources and media. Diverse forms of evidence or documentation are therefore possible.
There is no longer any mention of ‘records’ neither, but of ‘retaining documented information’.
So what does that mean to your existing procedures?
Organisations that already have an ISO 9001 quality management system should not discard their existing procedures and documentation, of course. A good system remains a good system and you will still need a proper structure for your crucial documentation. This does give you the opportunity to critically review what you have and decide if it really is good. If not change it and get rid of the documents that don’t add any value.
If something is no longer obligatory, it doesn’t mean that you have to scrap it right away, of course. It’s better to hang on to what you are happy with and what helps your organisation to progress.
The following table is a brief summary of a number of important changes to the terminology compared with ISO 9001:2008.
ISO 9001:2008 | ISO 9001:2015 |
Documentation, quality manual, documented procedures, records, instructions Work environment Monitoring and measuring equipment Purchased product Supplier |
Products and services Documented information Environment for the operation of processes Monitoring and measuring resources Externally provided products and services External provider |