Think about clause 8.3.4 Design and Development Controls within ISO9001:2015 as the Check section of the Plan Do Check Act (PDCA) loop. In earlier clauses of section 8.3 – (Design & Development of Products & Services) the organisation was required to carry out some detailed design & development planning and to look at the assorted input...

ISO9001:2015 clause 8.3.5 Design and Development Outputs can sometimes cause confusion on it's purpose. It is not about the actual product that is being designed but about the outcome of the design process, a design drawing or CAD model for example. Requirements of the Design & Development Output Clause   The aim of this section is to ensu...

ISO9001:2015 takes a fairly decent step forward in how it handles or rather requires you to handle your Supplier Management within your Quality Management System. It used to be that you just needed a list of your suppliers and to be honest not too much else, it's changed a bit from that. Clause 8.4 is all about the new requirements on organisations...

 ISO9001:2015 Clause 8.4.2 is all about expanding on what type of controls and the extent that you need to manage these controls on your suppliers to ensure that they meet the necessary requirements to deliver you good products or services in line with your requirements and that their processes don't adversely impact your products or services....

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...

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...

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...

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% ...

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, ...

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...