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ISO9001 and The Initial Clauses (the ones everybody skips)

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 of the story. So why do it with your ISO9000 implementation?

For many people when they launch a new process or system, they want to dive right into the getting stuff done part, then using it part. Spending all that time reading the pointless instructions is just getting in the way of the doing. It's the same with ISO9000, so many people just jump right over those 'pointless' initial clauses, we're talking about clauses 0.1 to 0.3 and 1 to 3 in ISO 9001:2015 but that's the important opening act of the process you need to really understand it.

We thought it may be a good idea to give you a few key gems from those initial clauses to convince that you really need to go back and reread them and truly understand them, in this post we'll talk only 0.1 – 0.3 and cover 1-3 in our next post.

Clause 0.1 – General 

This is about actually making the clear strategic decision that you are going to implement the ISO9000 Quality Management System. As a leadership team, you need to have had those great, and sometimes heated, discussions about the benefits to your organisation that it will bring.

Discuss how wide your quality management system will be, for example, most companies see it as purely managing the product quality but it's about your business systems so think about how your finance, sales & marketing or R&D sections will fit into your QMS & make it an integrated system. This, in part, is where the uniformity comes in, it's not about your quality system being like your last companies one, they will be vastly different but inside your company, the process approach should be universal amongst your departments.

You don't actually have to number your quality system to line up with ISO 9000, it's not a requirement and in the past, it's been pretty hard to do but in the ISO9000:2015 std it's a lot better and if you can then you certainly should line them up.

Product or service, the ISO9000:2015 std doesn't really care, think about them as the same thing and just swap out the words you don't want to use.

You should use your ISO9000 certification logo in everything you share with clients or potential clients, so all your sales & marketing information, emails, letterheads not forgetting of course forms, policies & procedures!

There are some key definitions to remember at the end of this clause:

  • "shall" indicates a requirement; (i.e. you must do it)
  • "should" indicates a recommendation; (i.e. you should do it)
  • "may" indicates a permission; (i.e. you can do it if you want & it adds value)
  • "can" indicates a possibility or a capability. (i.e. think of this as an outcome or a result)

Clause 0.2 Quality Management Principals 

There are 7 quality management principals to be aware of, it's the whole basis of the system and you need to figure out how you integrate these 7 principals into your business and make them auditable, are you ready? Here they are:

  • Customer Focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management

A daunting list isn't it? Don't worry we have posts on these coming along soon but I bet you are doing more here than you think!

Clause 0.3 – Process Approach

The process approach is one of those non-negotiable things in ISO9000 that you need to incorporate. Here we are talking about the Plan-Do-Check-Act (PDCA) cycle and of course your risk-based thinking approach. We talked about the process approach here:

For your Risk-Based thinking, it's important to look at both the positive & negative risks. Your brain is hard-wired to look for negativity first, it's what kept us alive as cavemen, so you need to put effort into the risk from a positive side, for example, if you improved in X then the risk is you double your sales!

It also talks about the need to 'adopt various forms of improvement" so these may be big bang breakthrough change improvements, kaizen style events, innovation or even a change to your organisational structure that yields an improvement in some way. Build it into your system from the start.

That's' a lot of thinking just for a few short, 'simple' clauses that I bet you skipped over so here's your homework, go back and reread them, at least twice, get your colleagues to do it as well and then compare notes, only then can you move forward.


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ISO9001 and The Scope (and fine print)
ISO 9001 and The Improvement Clause

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Tuesday, 16 July 2019

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