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Clause 4.1 of the ISO9001:2015 standard is a new and can cause a fair bit of confusion, hand wringing and general bewilderment for people, I know when I first read it I thought WHAT THE!? but then I read it again (and again) and did some research and thought, actually I see what they are doing here, that's pretty helpful, I can see how any organisation would benefit from it so here's my take on it, hopefully it helps.
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.The organisation shall monitor & review information about these external & internal issues ISO 9001:2015 Clause 4.1
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.The organisation shall monitor & review information about these external & internal issues
So here is what the clause says in plain English, from my point of view.
As an organisation, you need to understand what issues / risks could impact your business & QMS both from inside the organisation and external to the organisation in both a positive and a negative way. By understanding, I mean you need to be able to know about them, explain them, assess them in terms of what the impact is and how big it is, ideally figure out a way of mitigating or preventing that risk impacting the QMS (and of course your business). Oh and you do have to keep checking on them to see understand if anything has changed over time that would change your thinking on them.
Remember that ISO9001:2015 is about your quality management system so this is where you need to focus:
There are a couple of great tools that you can use here, one tool which is really good is called PESTLE Analyses and it's a great way of really understanding the external influences on your business. Below we break it down. PESTLE is designed to help you look at the key area's that will impact your organisation externally around the following areas
Taking these headers or topics you can then think about all of the area's within that header that could have an impact on how you run your organisation and what impacts it could have on your Quality management System.
This is a great short video explaining what PESTLE Analysis is, it's on the Chartered Institute of Personnel and Development (CPID) website and their youtube and is one of the best explanations we have seen, you should certainly check out their pages for other great tips.
The good Old SWAT Analysis option where you will look at your organisations Strengths, Weaknesses, Opportunities and Threats both internally & externally to the business. It is usually helpful to do 1 SWOT for internal factors and 1 SWOT for external factors then you can combine, if you want, but I prefer to keep them separate. It's Ok if similar or the same items appear on internal & external SWOT analysis documents.
It's also important to understand the structure or hierarchy of the organisation related to the scope of the QMS, who sets policies & strategic directions, Who co-ordinates and manages the operation and who is involved in the production, service or support activities your organisation undertakes? If you outsource function, say IT you need to consider this impact as well plus communication requirements and reporting structures and how they impact your system. All sounds complicated right?.. guess what there is actually quite an easy way to do this, it's called... an Org Chart!.. yep your humble org chart can show most of these things in terms of co-ordination, management, communication flows and outsourcing and so forth with a few minor tweaks to add these things in so don't go re-inventing the wheel here are you probably already have 90% of what you need for this section.
The Standard doesn't stipulate the frequency of reviewing this data, it does say however you have to do it so you need to think about what is right for your business, it may be an annual thing you put into your company off site day for instance however this annual big bang approach is never really successful and when you really think about it that's not the intention of the standard either. What it is trying to do is get you to constantly look at your business from a risk point of view, what are the risks and what can I do with them. If you only review it once a year then your competitors could have by passed you, people could have left, laws could have changed and your business may longer be relevant or nothing could have changed and it's Ok, you just don't know. It's much wiser to take this in bite size chunks and do it as part of your monthly quality management meeting, that way you are constantly being reviewed so the risks don't blind side you and the opportunities don't get missed, it's documented as part of the minutes of your monthly meeting and you bets of all you comply with the standard.
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