The standard has been revised heavily and now looks quite different when compared to the previous edition, ISO 9001:2008. This is due to the adoption, by the writing committee ISO/TC 176, of the so-called "Annex SL" High Level Structure.
Annex SL
Annex SL is structured around 10 headings, whereas the 2008 edition of ISO 9001 has 8. One thing that's also notable is that the heading names are quite different.
MYTH ALERT!
"We'll have to renumber our Quality Manual to map to the new structure, to show the CB auditors how we address each ISO requirement"
MYTH BUSTED:
Although the new edition doesn't make a quality manual a requirement (keep an eye open for another blog post on this topic) if an organization decides for one reason or another, to have or retain a quality manual, it doesn't need to follow the format of the 1-10 headings or clauses of ISO 9001. Indeed, even the supporting Quality Management Documents don't need to reference the new clauses of the international standard, either. It's a lot of work, doesn't add any value in real terms for the users and, more importantly, the mapping of requirements to the Quality Management System can be done much simpler and without involving a lot of work.
If a table or document tree is created (in Excel or similar) to cross reference the various documents which currently exist or have been (newly) created to meet the various clauses and sub clauses, it can be used by anyone who needs to know what's been mapped to what ISO 9001 requirement.
While we're on the topic of the Quality Manual, it's gone! Yes! There's no longer a stated requirement for the organization to have a Quality Manual. What were the Technical Committee thinking when they dreamed THAT one up?
If we reflect, for a minute, it may not have been such a bad thing. Let's face it. Most organizations have something which slavishly emulates the layout and content of the actual ISO standard itself. In many cases, just a simple substitution for key words and phrases has been made - for example replacing "The Organization" with "Company X" or something similar. Who wouldn't want to get rid of it?
MYTH ALERT!
WooHoo! We can get rid of the Quality manual. No-one reads it anyway, except for the CB auditor".
MYTH BUSTED:
Whoa there! Before you go consigning the Quality Manual to the recycling/bonfire/shredder, consider this:
Is it the Quality Manual which is the problem? Maybe it's the content which puts people off reading it. After all, if it's 30+ pages long, or uses terminology of the standard maybe THAT's the issue to address. After all, what organization calls their Engineering or Operations functions "Product Realization"? On top of that, there's some weasel words in the standard, too. "Where applicable" and similar terms are scattered throughout, so how is a reader to determine when it is applicable?
Let's revisit the whole idea of a Quality Manual for a minute - with a clean slate.
The "Context of the Organization" is key.
If we consider for one minute, a new requirement of the "Annex SL", which is termed the "Context of the Organization", we might give some thought to the position the organization holds in the market and what they have identified as the needs/expectations of their so-called "interested parties". These might include:
- Customers and their representatives
- Regulatory bodies and their representatives
- Employees
- Stakeholders
There may well be an expectation or need for some kind of quality manual to be maintained to satisfy one or more of the above. Long before ISO 9001 and certification by 3rd parties came along, it was common practice to create and maintain a document which was very like a quality manual, even if it wasn't actually called that. Furthermore, employees might find one useful, too!
Conclusion
If the context of the organization is properly understood, then creating and maintaining a document - call it a Quality Manual if you wish - which describes the organization, key processes, links to common organization-wide processes and much more may well be seen as a value proposition and not something done "to keep an external auditor happy".
