Clause 7.5 - Documented Information is a new section within the ISO9001:2015 standard, this section highlights what is required when creating and controlling documentation that is required to support your Quality Management System and the requirements have obviously changed since technology has moved on significantly since the last iterat...

If you think about the first 7 clauses of the ISO9001:2015 as building the framework of your Quality Management System then section 8 - Operation is very much about putting some substance on that framework. Section 8.1 - Operational Planning and Control, that we will discuss here, gives the requirements for the organsiation to put into place the&nb...

How often have you got into the manufacture or design of a product and realise that you really don't either understand exactly what you should be making or that you are not capable of making it? ISO9001:2015 clause 8.2 Requirements for Products and Services is really aimed at avoiding this situation from happening. It's important then, that you do ...

One of the questions I get asked a lot about ISO9001:2015 is what they heck is the difference between a Process, a procedure and Work Instructions (sometimes also called Standard Operating Procedures). It's surprising how much gnashing of teeth, squabbling among teams and dents in office walls this issue causes, so here is you nice and simple break...

ISO9001:2015 Clause 8.3 is all about how your organisation carries out it's design and development of products and services. Now obviously if you do not actually carry out any design or development work then this section is not applicable to you and you are allowed to exclude it from your ISO9001:2015 system, however your request for exclusion will...

In this second part of the discussion about ISO9001:2015 Section 8.3 we are going to look at section 8.3.3 of ISO9001:2015 which is all about the Design & Development Inputs to your product or service. The aim of this clause is simple, lets make sure you have considered everything you need to when designing your product or service  8.3.3 D...

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....