What Are the Documentation Requirements?
Between the previous (2008) version and the latest, current version, ISO 9001: 2015, there was considerable change to the requirements for documentation. The earlier version included a requirement for a quality manual and mandated written procedures in 6 areas. Both of these have now been dropped.
There is much (mis) information being propagated, including the complete falsehood of 'now we don't need to have any documents at all'! Not true.
The changes are positive in my opinion, as the intent is to make it more flexible, and put even more power into the hands of organisations to choose what they need. But for people who want to know 'exactly' what they have to have, it could take a while to understand them. And for any old-fashioned auditors wanting the list of mandatory procedures, it is going to be a learning curve.
In a nutshell, you need:
- the documents that you decide are necessary in order to plan, operate, improve and maintain your quality system (see what I mean about broad? mind you, it was similar in the 2008 version too)
- the documents required by the Standard. It specifically requires: a written scope for your system, a written quality policy and written quality objectives. But beyond this, it also calls for 'written information' in a number of clauses. Figuring out where this applies to you and how can be a bit tricky if you're new to the whole thing.
Do be aware that there is a big difference between how the previous version (2008) and the latest, now current version (2015) treat 'documents'.
Naturally, there is plenty of guidance and simple examples of how to meet the requirements in a practical and simple way in my DIY ISO 9001 Kit.
Or, if you're making the transition to the 2015 version, there is practical, clear and concise advise and guidance in the DIY Transition Kit.
ISO has also published a Guidance document.
Author: Jane Bennett