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ISO 9001 and The Improvement Clause

When I talk with people about their quality system or ISO9000 the one bit they all tell me is that they have lots of Non Conformances getting captured (which is good) or that they have just had an audit and passed with no issues (which is not so good!). What I tend to pick up though is that Non Conformances are seen as a bad thing, sometimes they are even weaponized by different departments against each other or against suppliers to make them do what you want. 

That's clearly not the intention of Clause 10 of the ISO9000 Standard - Improvement, and it's called Improvement for a reason : if you are not continuously improving then you are going backwards, there isn't any standing still here because you competition is passing you as you sit there twiddling your thumbs thinking about doing what ever it is you will do to avoid improving. This clever little improvement section, is probably one of the most powerful value drivers in the entire quality system form my point of view, it's the ACT part of the Plan-Do-Check-Act cycle from our friend Mr Deming.

Positive, Valuable Improvement

​It wouldn't be the 1st time where I have seen someone being given an annual objective of raising at least 10 non conformances or 5 improvement proposals or even both! Which is dumb on a number of fronts, firstly, a "non conformance" and an "opportunity to improve" are the same thing when you really think about it, secondly by setting targets like this you get people just raising anything to meet the number and perhaps not thinking about how that improvement request will add genuine value to your process, product or customer experience. This is a shame, because real Improvement, continuous improvement and implementing corrective actions are real game-changers for your business.

Be Selective

The organisation shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

ISO9000: Clause 10.1

You can't Pick & Choose your improvement  actions! .. Well actually... Clause 10.1 kinda suggests that maybe you should, here's what is says:

Ok So Determine & select, certainly sounds like choice to me, it means you need to look at what opportunities you have to improve of close out the non conformance and make a choice about what is right for your customer and of course your business (but aren't they the same?) 

These improvements may come, according to the standard ,from:

  • improving products or services to meet current and future needs (yep FUTURE needs! so you can plan in advance what the right thing to do it
  • Corrective of Preventative actions or from steps to reduce undesired effects
  • actually improving the effectiveness of your own quality management system, so when you start ripping out all that non longer required red tape and make your system simple it counts !

Of course now you have all these options you need to look at them as a business and set a priority for them, which will you do 1st, 2nd & 3rd and which will you say No to.. yes you actually will have to say no to something and that's OK, as long as you can explain why you say no to them and it's reasonable of course not just because you couldn't be bothered.​

Manage Your System

 Check out the great help you get in section 10.2, it's all about how you manage your nonconformities and then put some corrective action in place to correct them. So why is this a great section, well simply if you follow the handy hints it gives you you have an improvement process right there! here are the steps you should put in place for those improvement oppertunities

  1. Take action to control the nonconformity, correct it and then deal with the consequences;
  2. Evaluate the need for action to eliminate the cause of the nonconformity;
  3. Implement any corrective action;
  4. Review the effectiveness of any corrective action;
  5. Update the risk register;
  6. Finally make changes to the quality management system, if required.


Now the standard does want you to keep records of all this stuff that your doing, ​and why wouldn't you? If you put an improvement in place you want to be able to go back and verify that what you documented would happen actually happens. If it doesn't solve the problem when it's probably helpful to know what your intention was so you can adjust your approach (it's that pesky PDCA approach again!). Thats what the standatrd wants to know, what did you do, did it work and was there anything else you had to do.

Now you can do this on a spreadsheet, I know many many companies that do it this way, but I have to say it's not the best way, for a start it needs a heck of a lot of manual intervention, you never capture everything, it normally comes down to 1 person chasing everyone right before the quality management meeting or the corrective action meeting to see what has been done and getting useful stats out of as spreadsheet is always a little harder than it needs to be. The other option is you head for a dedicated QMS system like MANGO which is designed to make life easier for you, it'll let anyone capture the improvement opportunity in the handily names Improvement Module which is then whisked away to the right person to follow through on it. It'll send you reminder emails to make sure people do what they need to do, it'll let the person raising the improvement opportunity keep track of where it's at so no more black holes! best of all it involves people in the process far more than a spreadsheet ever could.

Continuously Improve

The organisation shall continually improve the stability, adequacy and effectiveness of the quality management system.

ISO9000 Section 10.3

Improvement is or should never be a 1 time hit as I've said before. Actually don't take my word for it, ISO9000 section 10.3 actually tells you that you need to keep improving and again why would you not? Your competition certainly is.

Of course getting continuous improvement isn't a 5 minute job, it's about embedding the desire in everyone in the company, it's about embedding it into the company culture and then restating it every chance you get at every level.

And here's a thought, the next time you have an audit, that you pass with no improvement opportunities or non conformances or what ever the audit labels them...why not ask them to go back and look harder.


Get In Touch

If you need any support in developing or improving your ISO or Quality Systems we'd love to hear from you, just click here to make an appointment and find out how we can help you Make Things, Better

You can also call John on 0211649739 to set up a meeting 

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Monday, 20 May 2019

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