Bureaucratic burden of ISO 9001
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Also, some think that process is the same as procedure and procedure = work instructions.
Can you hear/read my frustrations?
Answer:
Being frustrated with QMS documentation is nothing new for management representatives and other quality professionals. That is the reason why this new version of the standard decreased requirements for documentation, especially for procedures (six mandatory procedures from the previous version are now gone). So, instead of applying the old "document all you do" approach it is best to focus only on those processes and activities that have the highest risk of emerging nonconfomities and also to the activities and processes that are rarely conducted so there is a higher chance for employees to make a mistake and document only those with sufficient level of information.
Besides having records to demonstrate that the certain activities are carried out, the standard has far less requirements for documenting how something is done. So you should try to make the documents as user friendly as possible and even to avoid writing procedures but rather create flow diagrams which will be sufficient for the employees to avoid nonconformities. This will make your documentation much lighter and easier to use.
For more information, see: New approach to document and record control in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
You hit the nail right on its head.
Interestingly enough, a company had written procedures and work instructions & decided to convert into flow diagrams. It was awesome as it was very easy to follow especially for operators on the production floor. It was easier to train people with flow diagrams.
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Jun 23, 2017