ISO9001 in 2021 Week by Week - Week 23 – 7.5.1 Documented information

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

“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?

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, to everyone seeking 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”

First of all, “NOTE”s are for clarification, and are not requirements.  So that leaves us with only two categories of things we must document.

1 – the things required by ISO9001 and

2 – the things we also think we need

And the things required by ISO9001 are only approximately 20 items, and most of those are records (as in filled out forms), NOT procedures or work instructions.

Click here to receive a FREE DOWNLOAD  list of what’s really required by ISO9001.  You’ll be shocked at how short the list actually is. 

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

Get the FREE DOWNLOAD List of Required Documents and 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!

This weekly series is a DIY guide including lots of FREE STUFF like templates, examples and tutorials.  So, SUBSCRIBE today and we’ll keep it coming to your inbox weekly.

But, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE or ON LINE for IMPLEMENTATION of  ISO9001.  We’ll lead your team and build a fully compliant foundation for your quality system so you and your team can understand the requirements and have the confidence to continue forward on your ISO9001 journey toward BETTER QUALITY.   World Class Quality, ISO9001 certification, lower costs and higher yields are just the beginning of the benefits of a robust quality system.  Connect with us today and LET'S GET STARTED!

And if you’re in the US in the state of Michigan, I’m offering a great summer SPECIAL with no travel reimbursement for projects completed between US Memorial Day and US Labor Day anywhere in the lower peninsula of Michigan!

 Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

We look forward to continuing this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

And join me on my journey to always keep improving!