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ISO9001:2015 Clause 8.3 is all about how your organisation carries out it's design and development of products and services. Now obviously if you do not actually carry out any design or development work then this section is not applicable to you and you are allowed to exclude it from your ISO9001:2015 system, however your request for exclusion will have to pass the sniff test, assuming it does you can skip this section, if not, read on!
This section of the clause is a single sentence, not that big a deal, 24 words in total, can't be that big a deal, right? Wrong, like most initial elements to a clause this sets the scene of what is to come, and it contains one of the mightiest words in the IOS9001:2015 lexicon... "SHALL". Remember shall is ISO9001 speak for you must do it or we won't give you a certification.
Thankfully the ISO9001:2015 authors aren't that mean, they are going to give you a framework to develop your systems around and it starts as usual with planning (remember that underpinning Plan, Do Check Act principle way back at the beginning of the standard, well it's at play here as well).
As we mentioned, for all these areas you need to be able to consider how it would impact your process. There isn't a requirement in the standard to document any processes or procedures you come up with as a result only that you can prove that you considered at least these elements. However, lets be honest, you would be a bit remiss as an organisation not to develop the associated procedures to ensure consistency of approach.
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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