Understanding 7.5 Documented Information | Documents Required for ISO 9001 2015 | Know QMS Documents
This video focuses on understanding 7.5 documented information requirement of ISO 9001 2015 standard. We will continue exploring element 7.5.2, creating and updating documented information. We will see how to show not only signatures of review and approval of changes but how to demonstrate the suitability and adequacy of the documents.
In the previous video, I shared a survey showing considerable user dissatisfaction with the quality of their management system documents. Among concerns were documents being too wordy, poor quality of writing, complicated content, and others. These issues result from a lack of validating documents before the release. So, what is validation? ISO 9000 2015, Quality management systems — Fundamentals and vocabulary, clause 3 8 13 defines validation as confirmation through the provision of objective evidence …, that the requirements … for a specific intended use or application have been fulfilled. In simple language, you showed that your design, product, or service meets users' requirements. This is part of understanding 7.5 documented information clause of the standard.
For example, If your customer asks you to design a train with a three thousand 500 horsepower motor, you have to prove that the motor meets this specification. If your pool requires a pH of 7.4 plus or minus 0.2, you will use a pH meter to show that the pH is in the required range or needs to be adjusted. The validation process in these examples looks straightforward: here are the specification numbers, and here are the test records. But what about documents? How can we demonstrate that our procedures are not too long, or writing is literate, or the content is straightforward? Well, it is not difficult. How do we know that ice cream is tasty? Well, if by the end of the day, we sold all coffee cream, it means it was tasty for our customers. How do we know if our office is clean? We do not walk around with a dust meter; we just look around and see if it is clear. And finally, our documents: how do we know that what we just wrote meets our user's requirements? The same thing: we ask our customers. We take the procedure to the production floor and ask operators if they understand the document, if it is easy to follow, and so on. Unfortunately, only very few companies validate their documents before the release. This results not only in users complaining about many deficiencies in documents but also repetitive corrections of previous mistakes. I have seen this re-work or changes due to mistakes in documents between some 10 and 30 percent of all document changes. Understanding the 7.5 documented information clause helps you realize that validating your documents before release is very important.
7.5.2 (1) Creating and updating documented information, video 1
• 7.5 Documented Information Explained | Con...
7.5.2 (2) Creating and updating documented information, video 2
• Understand 7.5 Documented Information | Wh...
Lean Procedures – Fighting Wastes playlist
• Lean ISO Documentation | Eliminate Excess ...
Lean ISO Management Systems YouTube Channel
/ @leanisomanagementsystems3375
Free quality management system templates
https://www.leanisomanagementsystems....
Amazon - ISO Management Systems: The Lean Revolution
https://www.amazon.com/ISO-Management...