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 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...

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...

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 ...

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...

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...

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...

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 ...

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...

In ISO9001:2008 we had Management Responsibility, in ISO9001:2015 however we have Leadership as a clause, surely, it's just a simple name change, branding if you like. Actually no, it's quite a deliberate distinction they have made in the standard and it's aimed at engaging more of the company. Previously a company would hire a Quality Manager and ...

ISO9001:2015 Clause 4.3 is all about the scope of your Quality Management System, of what parts of your organisation will be included within your Quality Management System, in other words what are the boundaries of the Quality System. By completing ISO9001:2015 Clauses 4.1(Context of the Organisation) , Clause 4.2(Interested parties) ...

ISO 9001:2015 Clause 4.4 is an interesting one, it says that you shall establish, implement, maintain and continually improve a quality management system. It says you should  include the processes needed & their interactions as well, its your job to determine the processes that are needed to meet the standard. It doesn't say anywhere ...

Clause 4.1 of the ISO9001:2015 standard is a new and can cause a fair bit of confusion, hand wringing and general bewilderment for people, I know when I first read it I thought WHAT THE!? but then I read it again (and again) and did some research and thought, actually I see what they are doing here, that's pretty helpful, I can see how any organisation would benefit from it so here's my take on it, hopefully it helps.

Clause 4 if the ISO9001:2015 standard is broken into 4 sections in a bid to make it cleared, for the user which are: 4.1 Understanding the Organisation & its Context4.2 Understanding the needs & expectations of interested parties4.3 Determining the scope of the quality management system4.4 quality management system & it's processes Now,...

In our last post we pointed out that skipping the initial sections of the ISO9001 standard is dumb, it's like walking into the movies after the first 30 minutes and hoping you know what's going on, so if you haven't read our post on the initial clauses pop back there and have a read, we'll wait.    ISO9000 and The Initial Clauses (the one...