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Have you ever had one of those days when you are working through something you have done many times before only for someone to say, oh hey we changed how we do that, or we don't use those parts now we changed that? Frustrating isn't it? It's also pretty wasteful as it can create a bunch of rework or worse useless products or services no one wants or will pay for. This is what the ISO9001:2015 clause 8.5.6 Control of Changes Clause is about, it's to ensure that everyone is working on the right thing and just as importantly, everyone knows when something has changed.
This clause also requires you to hold on to the documented information i.e. records of the changes that you have made for the product or service. Typically an organisation may have a dedicated Change Form (sometimes called an Engineering Change Request or Change Notice) that will capture all of the required information you need in one place that can be communicated and referenced by the organisation or suppliers or customers as required.
The record does need to have some specific things captured:
It's also a good idea to keep a register of the changes as a quick reference this can also serve as the source of a reference number to attach to the change to ensure that it is easily traceable within the system.
To help meet the requirements of this clause why not grab a couple of our free resources by clicking below:
This clause, 8.5.6 of the ISO9001:2015 standard is really focused on helping you better control changes (and so variability) within your products or service provision. Keeping track of what has changed, when and why is vital to be able to track any adverse effects on the expected function of the product or service and ensure that it always meets the original requirements.
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