ISO 9001: Documented Information
Digital, paper-based or both?
POSTED BY ELLEN WILLOUGHBY ON 13/03/2019 @ 8:00AM
In this series of blog posts, I will be taking a look at the main sections of ISO 9001, what they are, why they are important and a few tips on how to implement the standard ...
When developing your ISO 9001 system, you must have everything documented!
copyright: alfaphoto / 123rf
This 101 is looking at Section 7.5 Documented Information. Why is this important to my business? It doesn’t matter whether your company is all digital or paper-based, we all have documents to deal with.
"ISO9001 expects you to maintain and retain
What this means is making sure you know what are the latest procedures, forms, templates available to use and making sure you don’t accidentally use old versions. Customer and other important records (such as financial) should be prevented from deteriorating or having unauthorised changes made too.
We all have legal requirements that mean we have to keep financial records for at least seven years, we may also have other requirements which mean we have to keep other documents such as HR ones for many decades!
It is important to understand what your document requirements are and make sure you have steps in place to maintain and retain it in a suitable manner. It also helps with communication and awareness if everyone working for you is using the same template or procedure. It saves time and makes things more efficient if everyone can actually find documents they need quickly.
How do I manage this? Well, this will vary depending on your business. A one-man band with limited documentation may choose to keep it all on one computer and choose to back up the data manually every week.
All key documents may be printed out and kept in a filing cabinet securely away from dangers of flooding etc. For a larger business, an external company who provides an archiving solution may be in place if there is lots of paperwork required, whilst a digital-based company may have cloud back-up and access to all documents online with automatic revisioning. It really is up to you how you maintain and retain your documents.
The standard does not dictate how you do it. Here are some common things you need to think about when considering document control:
Documented information should include an identification and descriptions such as title, date, author and reference number
Decide what format you want your documents to be in for example, electronic, PDF, or hard copy
Make sure you understand the language requirements of your employees. If you are running a business with offices around the world, you may want to provide documents in a second language
Establish a review and approval process. If anyone can change a document then there is no control.
If you need to have both hard copies of documents and electronic ones, decide how these will be controlled for example, watermarks, coloured stamps
What kind of access will people need? For instance, finance will need different access to operations teams
What kind of information security need to be applied? What if some documents should not be shared outside the department or the company?
How are you going to ensure your documents are stored in the long term? What happens if your cloud service provider goes down and you cannot access your documents? What happens if your basement with all your paperwork in gets flooded?
How do you store documents of external origin such as trade magazines with useful articles, pieces of legislation or regulation and so forth?
Many of the companies I have worked with have found it useful to have an independent person to work with them to help understand the requirements and how to implement them.
"Would you like to know more?"
If you'd like to find out more about ISO 9001 then do give me a call on 01858 414226 or click here to ping me an email and let's see how I can help you.
Until next time ...
More about Ellen Willoughby ...
I'm Ellen, Director of All About Quality and All About Productivity. I have over 20 years experience as professional in the quality world and 17 years as a practising Buddhist. As a result of this, I have a passion for improvement. in both business and personal life.
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