Congratulations, you have got to the point where it is time for the stage 2 audit of your new ISO9001:2015 certification audit of your Quality Management System. You have spent many hours training all of your team on what the requirements are for running the organisation within your new system, people know where to find things, they are updati...
It's finally time, you have done all the hard yards and now it's time to actually get your new ISO9001:2015 system officially certified, so what exactly does that mean and how do you do it, there are a few steps to move through to get to that all important ISO9001:2015 certificate. In this post we will cover the 1st two steps. Selecting a Ce...
As we have worked through all of the clauses within ISO9001 in this blog series we have highlighted a number of areas where you need a document or need to be keeping a record of things, but to be fair, it may be hard to keep track and to be honest with so many clauses it can be a little overwhelming. It's not unusual for people to believe that abso...
The management review is possibly one of the most useful parts of the entire standard yet it's also one of the most underused! ISO9001:2015 Clause 9.3 is all about the requirements for that management review and the very 1st part 9.3.1 gives us a bit of a general overview of the point of the clause. General Expectations of the Managemen...
When we talk to people about ISO9001 there are a few things that come up as the reasons not to do it, one is the need to document things, the other is around non-conformance and the final one is always the need for doing internal audits. Typically, I get told we fail enough external audits to know what we need to fix anyway! Or worse – we never fai...
Let's face it if you are working through ISO9001:2015 you already know that you need to monitor, measure, analyse and evaluate your quality management system, we talked about it way back in Clause 4.4 and again in Clause 6.2. You already understand why it's important so why is it here again in ISO9001:2015 Clause 9.1.1? I guess you could look at th...
Unless you are operating in some mystical nirvana the reality is at some point you are going to have rework in your organisation, you have rework because you have a non-conforming output and so ISO9001:2015 has some requirements for you to meet in order to ensure that you control these adequately. The other thing that tends to happen around non-con...
What is the signal within your organisation that your product or service is ready to be handed over to the customer? That is essentially the question that ISO9001:2015 is asking in Clause 8.6 – Release of Products and Services. Previously we have talked about verification and validation of your product or service to ensure that it meets the end use...
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 o...
ISO9001:2015 clause 8.5.5 – Post Delivery Activities is as the name suggests, all about how you support your customers after they get their hands on your products or services. Before going too much further just pause for a second and think about the time when you have bought say a car or a new cell phone and you wanted to follow up support for it, ...
Preservation may sound like an unusual thing to talk about when it comes to ISO9001:2015 but that's exactly what clause 8.5.4 is all about and as is the tendency for this standard it's a small clause, only 20 words in fact, and a short note to give some hints, surely that can't be a big deal then?... well it is and here's why. Clause 8.5.4 is 100% ...
When I worked in subcontract electronics, we build products for a great range of organisations and a great range of industries. One of the challenges there is making sure you test things properly before you ship them both electrically and mechanically where a specific fit is required. Sometimes we would build the test gear and sometimes the custome...
Clause 8.5.2 of ISO9001:2015 is a very brief section which outlines the need for the organisation to (it's got that Shall word in it again meaning you must) be able to identify and trace their products and services, it's brief but important, here's why. Identification Let's start with identification since you would find it tricky to trace an...
Up till now Section 8 of ISO9001:2015 has been really dealing with the planning of the provision of your products and services, in clause 8.5 however that changes to the actual delivery of your products and services and there is a bit to think about here, thankfully you have been working through all the previous clauses in which case this part is e...
How many times have you had issues with your suppliers or contractors and the root cause of that issue turned out to be that they just didn't have the right information or clear information from your organisation? It happens more often than people care to admit yet there is no need for this to happen if you actually take a bit of time and think abo...
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