If you are familiar with the ISO9001:2008 standard you will know that it had a customer focus requirement so the need for it in ISO9001:2015 shouldn't be a surprise and it's similar. So what are the changes and why do you care? Again it is about stressing that top management needs to care about and be focused on the customer, they are responsible f...

The quality policy is one of those documents that is ubiquitous to ISO9001, we have all seen them, pinned to noticeboards inside the company handbooks and, if your really lucky, as part of a presentation at your induction. That is, for most, the extent of the involvement with the Quality Policy which is bizarre as it is the fundamental document of ...

For a lot of companies having crystal clear roles and responsibilities along with clarifying who has authority for what is something which is perhaps not the highest of priorities, which to me seems strange, don't you want your people to know what's going on and who does what? There is sometimes the fear that if you define things too much then...

As we have mentioned before  ISO 9001:2015 is very much focused on understanding the Risks in your Quality Management System and to your organisation and obviously how you will handle them. Clause 6.1 - Actions to address risk and opportunities is really focused on helping you do this, it's also got that keyword "SHALL" in the clause whic...

It's time to talk about your Quality Objectives which is ISO 9001: 2015's Clause 6.2 and is another of the sections which is a "shall" i.e. you must do this to comply with the standard. This time however it doesn't say "Top Management", it says "The Organisation" which means that you really should pull in as much of the organisation to develop obje...

Your Quality Management System must be a living and evolving system which means that over time you will make changes to the system either because of a business change, a new system, new staff or as a result of a management review of a process, it doesn't matter how you come to the decision, but you will want to change things as you go along. After ...

ISO9001:2015 Section 7, Support, has had a few changes, Clause 7.1 – Resources especially, it goes from only 31 words in the 2008 version of the standard to 2 pages! Resources required around your Quality Management System have always been a bit subjective and varied wildly, now, however, the ISO9001:2015 version of the standard puts some much-need...

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...