7.5 Documented information, 7.5.1 General
“Say what you do and do what you say”? That’s the old adage, I suppose. But what does it mean, really? Does the ISO9001 standard require that we document everything we do? Has it ever required that?
The 2015 revision changes “documentation” into “documented information” for clarification. And it still does point directly to several specific areas where “documented information” is required (and therefore the absence of it would make the organization noncompliant). But the requirement of a quality manual has been removed (big deal – where are you supposed to collect your documented information if not in something similar to a quality manual?).
Many organizations have missed the opportunity all along to exercise their prerogative in the first place to deliberately consider what information the organization needs to adequately support its quality system. Too many organizations have defaulted to a boilerplate quality manual and documents and then wonder why the quality system never actually took root?
So, new users to decades old suitors of ISO9001 registration, I implore you, take a moment to ask yourself – what documented information does my organization need? Sure, be sure to tick off the specific ones required in the standard, and beyond that, just document what you think is necessary. This will make your system much more customized to fit your needs and much easier to control in the long run.
Let’s read what the standard says about documented information:
“The organization’s quality management system shall include
a) documented information required by this International Standard
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system
NOTE: The extent of documented information for a quality management system can differ from one organization to another due to:
a) the size of organizations and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons”
And there you have it! Cover the specific requirements of the standard, and then it’s up to your organization’s needs to decide about the rest!
THIS WEEK’S HOMEWORK
Take an inventory of all the documents in your organization you consider to be part of your compliance to ISO9001. Is it really required specifically in the standard? If it’s not part of the standard, why do you have it? Do you use it? Is it helpful? Is it still relevant? Does it tie in a logical fashion to the processes you’ve identified as critical to your quality system? Take the opportunity to align your documents in a process based way and clean house with the rest!
Stay involved and engaged – SUBSCRIBE!
