ISO9001:2015 Section 7.1.5 is all about the how you look after measuring devices, calibration and measurement traceability. It's not a massive change from the previous standard but what does it mean and what do you have to do? Resources Firstly, you need to ensure that you have the resources required to carry out the measurements required by your o...

Clause 7.1.6 of the ISO9001:2015 Standard – Organisational Knowledge is a new section and can be a bit of a challenge for some. It's not uncommon for organisations to have differing views internally about what organisational knowledge is, add in the external auditor's 3rd viewpoint and you can have some very interesting discussions about it. As an ...

ISO9001:2015 has split out Competency and Awareness which were combined in the 2008 standard, I'm not sure if this is a good or a bad thing as you can't possibly have any Competency without Awareness (or Communication!) but for simplicity sake we'll take each of the new sections in turn so in this post let's talk about Competency and how ISO9001:20...

Although ISO9001:2015 splits out Awareness (Clause 7.3) and Communication (Clause 7.4) it seemed wrong not to cover them together since when you think about it is, is it possible to have awareness without communication? Here's what the new ISO9001:2015 standard looks for in these clauses. ISO9001:2015 Clause 7.3 – Awareness  This section of th...

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...