Variation is normal -  an ISO 9001 business management system needs to accommodate it

If we try to control every variable in a process, we could be trying to create something that no-one is going to be able to reproduce every single time.  Perhaps a better approach would be to identify which variations are significant, and then establish means to manage these variations.  

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In other words, we should expect mistakes to happen.  What we need to do is work out which mistakes are particularly important to the whole process, and put in place mechanisms to pick up on them and correct them when they happen.

Let's not sweat the small stuff, as they say!  If tolerances are wide, why worry?  If they are critical, focus on them, and make provision for the times when they are outside what is required.

Based on an article in Quality World, November 2016, p10 

If you are using ISO 9001 as a management system and would like help with maintaining it, or would like to implement the new ISO 9001:2015 or ISO 14001:2015 Standard in your business, why not talk to us about your requirements?

 

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What is an ‘agile’ QMS?stethoscope_11.jpg

The NHS Blood and Transplant service has been facilitated to use an agile QMS concept to move them from their previous ‘waterfall’ approach.  This former approach laid the process open to delivering results out of step with their stakeholder requirements.  By the time the end results were delivered, the needs of those involved had often changed.  The ‘agile’ development approach is based on “specifying and developing smaller chunks of requirements, so you have a better chance of delivering results rapidly and more efficiently.”*

Both internal and external stakeholders had to be involved in the research and development of this scaled agile framework concept.  Because of the highly regulated environment required within this NHS service, it was not possible to find anyone else using this technique in quite the same way, against whom they could benchmark their work.  Many elements of the existing QMS, such as user requirement specifications, change control and validation had to be redesigned to make sure that compliance could be maintained.  The regulators, such as the Medicines and Healthcare Regulatory Authority (MHRA) and the Human Tissue Authority (HTA) had to be kept on board.  Regular meetings with them ensured that they were happy that safety was being maintained.

*Ian Bateman, Director of Quality NHS Blood and Transplant


Based on an article in Quality World, November 2016, p24

If you are using ISO 9001 as a management system and would like help with maintaining it, or would like to implement the new ISO 9001:2015 or ISO 14001:2015 Standard in your business, why not talk to us about your requirements?