ISO9001 and the required Documents and Records

As we have worked through all of the clauses within ISO9001 in this blog series we have highlighted a number of areas where you need a document or need to be keeping a record of things, but to be fair, it may be hard to keep track and to be honest with so many clauses it can be a little overwhelming.

It's not unusual for people to believe that absolutely everything needs to be documented, controlled, reviewed, copied, stored and hoarded. The std process for changing to toilet roll really doesn't need to be included in your ISO9001:2015 documentation... honestly!! So, we wanted to give a little help here as well.

The new 2015 revision of ISO9001 is far less prescriptive and demanding in terms of documentation, the way to think about it is this, what is the basic information I need to ensure that I deliver our product or service in a way that meets our end customers needs and can help us continuously improve on how we do that. If you are about to create yet another 40-page document stop and think about how it will really be used, chances are it'll be purely to prop open a door so pause and think how useful that will be, how you would train it, implement it and of course audit it.

Remember that your Quality Manage System is only any use if it's actively getting people interacting and using it, that includes those within your organisation and other stakeholders like your customers and your suppliers. Having mammoth mountains of needless paperwork that lives on a shelf isn't going to do this and is certainly one reason many organisations are looking to more integrated online systems such as Mango for example.

The Checklist 

We have broken all the requirements down for you in terms of the must-have (required) documents and records and the optional documents and records that may make sense for you to have that tie into ISO9001:2015, remember any time ISO9001:2015 says SHALL what it means is you have no option, that's what creates the mandatory documents and records.

You may, of course, decide that you need additional lower level Standard Operating Procedures or training material to support your organisation and that is perfectly ok as well, just remember, less is more, so if you can't explain it in a few pages consider breaking it into smaller parts or go back again and ensure you really understand it.

To help you along then we thought why don't we just create a simple checklist that you can use to ensure you have things in place for all those mandatory documents and files and understand what is really optional, so that's what we did, and you can download it below for free, help yourself!