A lot of the time when you ask companies about their ISO9000 compliance they are ever so eager to show you their quality statistics, the Xbar charts and a multitude of other charts, talk about their outgoing and incoming quality checks and of course customer returns levels. All of which is great, but that's only a part of ISO9000 and some would arg...

When I talk with people about their quality system or ISO9000 the one bit they all tell me is that they have lots of Non Conformances getting captured (which is good) or that they have just had an audit and passed with no issues (which is not so good!). What I tend to pick up though is that Non Conformances are seen as a bad thing, someti...

When you go see a movie you don't turn up a third of the way through because you know that part is pointless or skip the first 3 or 4 chapters of your book because, well the interesting stuff is always in the middle. That 1st part is the critical opening act, it's where the whole story, the basis for everything is set up, it's critical to the end o...

In our last post we pointed out that skipping the initial sections of the ISO9000 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'...

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,...

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 ...

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) ...

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 ...

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...

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...

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...

Clause 8.5.2 of ISO9001:2015 is a very brief section which outlines the need for the organisation to (it's got that Shall word in it again meaning you must) be able to identify and trace their products and services, it's brief but important, here's why.   Identification Let's start with identification since you would find it tricky to trace an...

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...

What is the signal within your organisation that your product or service is ready to be handed over to the customer? That is essentially the question that ISO9001:2015 is asking in Clause 8.6 – Release of Products and Services. Previously we have talked about verification and validation of your product or service to ensure that it meets the end use...

Unless you are operating in some mystical nirvana the reality is at some point you are going to have rework in your organisation, you have rework because you have a non-conforming output and so ISO9001:2015 has some requirements for you to meet in order to ensure that you control these adequately. The other thing that tends to happen around non-con...

When we talk to people about ISO9001 there are a few things that come up as the reasons not to do it, one is the need to document things, the other is around non-conformance and the final one is always the need for doing internal audits. Typically, I get told we fail enough external audits to know what we need to fix anyway! Or worse – we never fai...

The management review is possibly one of the most useful parts of the entire standard yet it's also one of the most underused! ISO9001:2015 Clause 9.3 is all about the requirements for that management review and the very 1st part 9.3.1 gives us a bit of a general overview of the point of the clause.   General Expectations of the Managemen...

As we have worked through all of the clauses within ISO9001 in this blog series we have highlighted a number of areas where you need a document or need to be keeping a record of things, but to be fair, it may be hard to keep track and to be honest with so many clauses it can be a little overwhelming. It's not unusual for people to believe that abso...

It's finally time, you have done all the hard yards and now it's time to actually get your new ISO9001:2015 system officially certified, so what exactly does that mean and how do you do it, there are a few steps to move through to get to that all important ISO9001:2015 certificate. In this post we will cover the 1st two steps.   Selecting a Ce...

Congratulations, you have got to the point where it is time for the stage 2 audit of your new ISO9001:2015 certification audit of your Quality Management System. You have spent many hours training all of your team on what the requirements are for running the organisation within your new system, people know where to find things, they are updati...

You have done it, the ISO9001:2015 certificate is on the wall and all that hard work of building a Quality Management System that really delivers for your organisation is behind you, so why are we talking about a journey?   Celebrate Firstly, it is important to stop for a moment and celebrate what you and the team have achieved. It says a lot ...

When an organisation makes the decision that they need to achieve the ISO9001:2015 certification there are normally a number of factors that influence the decision, because let's face it, it's not a small decision, it's one that really needs to be considered carefully since you are about to fundamentally change how your organisation functions. The ...

There is a major problem in organisations, and we need to fix it. It is a problem so major that it is going to take years to fix it, and in some organisations it will be fatal, and they just will not make it I am afraid. The challenge is that the issue is not immediately obvious, first it pops up in one area of the business and then before you know...

One of the questions I get asked a lot (and it really is a lot!) is "How does ISO define traceability?" that's always accompanied with: what do they want, what things do I need put in place, will it be expensive and but my customer doesn't care about it! The answer, initially at least is, "It depends!" Obviously, this is not overly helpful, so we n...

Even for the experienced ISO Systems manager, audits can be a nervous time. The second guessing of what you have created in your systems and what your ISO certification auditor is going to be looking for can lead to over thinking things and even on extremes the odd restless night. It does not matter if you are certifying to ISO9001 for quality mana...

The world of compliance is changing, it has had to change. The days of printing a forest worth of trees for your management systems and then keeping them, all safely tucked into a in a folder on the top shelf, is not something you can do today. COVID-19 has surely put paid to that myth once and for all? The idea of looking them it the week before a...