Welcome to the first lesson of the ISO 9001:2015 implementation series! Today we are going to learn the basics of clause 4.1…
What is this clause all about?
A lot of organisations find the 4.1 clause a little confusing, mainly because it is a brand-new requirement in the 2015 revision, but also because there is a bit of preparation work that may not have been fully explored before.
In short, the context of the organisation is a result of identifying the external and internal issues that can impact your organisations quality management system (QMS) approach, how you plan to implement it, meeting the current strategic direction and achieving the objectives you set.
The standard requires all the information you identify and consider, to be monitored and reviewed regularly.
You may choose to do this during the scheduled management reviews to ensure you are doing this as often as you claim. However if situations change significantly that could impact your QMS i.e. compliance to legal standards like GDPR or a test standard, you may need to move the review meeting forward to address the more pressing issues.
Thankfully, as the information that needs to be considered is fairly extensive, it doesn’t have to be documented! Although you can document the information it if you choose to. Bear in mind if you do, make sure you take all the relevant steps to meet the clause requirements of 7.5 ‘documented information’.