ISO9001 in 2021 Week by Week - Week 24 – 7.5.2 Creating and updating 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!

7.5.2 Creating and updating (documented information)

Last week, I emphasized the point that documented information should be used leanly and deliberately, to prevent making a management system that is too complex or user-UNfriendly and difficult to maintain.  I want to continue on that theme focusing on the word “purposefully” as well.  When deciding what to document, (or when reviewing what you have documented), be sure to consider whether you’re using it. 

PLEASE DO NOT think (or worse yet, say) "We need to document EVERYTHING we do to comply with ISO9001".  This simply isn't true.  We need to document what we need in order to share information with the people who need it.  Another way to think of it is to ask "what is the risk of someone not doing the thing correctly if it's not documented in some way"?   If you're not going to use it to guide actions around your processes or management system, why have it?  For an auditor?  NO.  Do it for the organization ONLY.  The best written procedure in the world isn’t of any value if it isn’t used to communicate information to the appropriate user.  If it’s never seen by anyone, it doesn’t communicate anything.  So, keep that in mind when you’re considering what documents to create/keep. 

A key tip – also look out for duplicate documents.  Many organizations have “training materials” that are used to train people how "we really do the work".  And then there are also management system procedures and work instructions, presumably for the quality department or third-party auditor.  Not only is this wasteful, but it also creates a lot of risk for error when both sources of information are not managed properly. 

Make sure to have clear and well controlled documents wherever an ISO standard requires it as well as wherever your organization needs it. 

ISO9001:2015 changes terminology from “documents” to “documented information” in an attempt to clarify to the last remaining users who have yet to pry their paper documents out of their hands in favor of the wide assortment of other media available for use in support of a quality management system.  Most all organizations use other forms of media in their daily operations, communications, training, etc, but do not consider them “documented information” and therefore do not manage them the same as their other documentation.  This clause casts an umbrella over all forms of documentation and requires they be managed in some way.

The use of document management tools like “SharePoint”, “Googledocs”, “OneDrive”, etc add a measure of control, and now our horizons are starting open up about the many different ways to document and share our information.  

The standard includes the following simple requirement:

“When creating and updating documented information the organization shall ensure appropriate:

a)  identification and description (e.g. a title, date, author, or reference number);

b)  format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

c)  review and approval for suitability and adequacy.”

So, this clause restates the obvious about having a standard process for creating and updating documents.  (The discussion of control comes next week, so we’ll talk more about that then).  For now, it’s simply about deciding how documented information will be created and included.  Then identifying a format (perhaps even defining some structure like templates, masters, etc).  And finally, defining a process for review and approval.

Now back to the less obvious point here – what else may be considered a document, and therefore be subject to these requirements?  Do you use videos, audio, web-based training or instructions?  If they support the quality management system (ie – if they are necessary for any of the key processes you’ve identified), they should be included and managed with these requirements in mind.

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.  Beyond this list, your organization must decide WHAT OTHER documents it needs to maintain the integrity of the quality management system.  This means what other documents you need to disseminate information and knowledge to the appropriate people within your company.

THIS WEEK’S HOMEWORK

Review your quality system.  Does it address the creation of documents?  Does it tick all the boxes above?  Does it apply to all the types of media in use in your organization (or have some things been missed or not yet captured)?  Look for other types of documents you may not have previously considered “documents” per se.  Are there guidelines on how they are created?  What they should (or shouldn’t) contain?  Has that been communicated within your organization?  Make any adjustments you feel necessary to improving this part of your quality management system.  We’ll talk control – distribution, storage, control of changes – next week.  Stay tuned!

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And, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE or VIRTUALLY for IMPLEMENTATION of ALL ISO9001 Clauses.  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!

Or perhaps your organization is more advanced and is ready for some training that will transform your organization and start solving problems and diving deep into identifying and reducing your risks:

• Problem Solving Training - We'll teach your team 3 powerful problem solving techniques ("5 Why", "Fishbone" and "Pareto") with a workshop to solve one of your organization's REAL LIFE problems
• FMEA Failure Mode & Effects Analysis - We'll lead a dynamic, hands-on workshop to teach your team how to perform an FMEA and how that tool can be leveraged to launch powerful lean, Six Sigma and Continuous Improvement

And the options don't stop there.  

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!