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Clause 4 if the ISO9001:2015 standard is broken into 4 sections in a bid to make it cleared, for the user which are:
Now, here is the useful hint of the day, a lot of people would just start at 4.1 and move through the list, don't it's actually easier to shuffle it a bit and work through them in the order 4.2, 4.1, 4.4 and finally 4.3 let me explain how they fit and you'll understand why. Since the sections are quite large in terms of what you should do to cover them we'll split this to separate posts, here we will cover 4.2 next we'll cover 4.1 then 4.4 & 4.3.
First off a bit of expectation setting, assume that to get through sections 4.2 & 4.1 you will need at least a full day to a day and a half with your senior leadership team and ideally operational leaders involved in the system. Do it somewhere you can't be interrupted or dragged to the factory so an offsite location is good if you can do it & make everyone switch their cell phones to silent then put them on a table very far away from you to avoid distractions… 1st person to touch the phone during the sessions has to buy the beer!
Interested parties are, as the name suggests, is anyone who basically has interest in your company, product or service, i.e. stakeholders. That means you should be thinking about quite a few groups, for example there are customers, obviously, but also don't forget your employees, suppliers, contractors, partners, government agencies, the general public and the list goes on. Really encourage the group to rack their brains on this one, it'll surprise you when you see the list!
You need to consider if each of these names or groups actually has an impact or possibly could have an impact in the future on your quality management system (and to an extent your business ) or way of working and what that could be, do you need to do anything as a result?.
Once you have that list add next to each name or group what their needs are and then what their expectations of the company are.
I like to do this by creating a sheet of paper or on a spreadsheet that's projected up where we can have it set up in columns as follows:
There result should be a table like that shown below
By taking the time to do these steps you should be able to not only clearly understand who impacts your quality management system, and how, but also create plans on what you need to do to manage or avoid those impacts.
Of course, another by-product of this is the ability to demonstrate this to anyone who wants to audit or understand it.
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