QMS Guidance Pt. 1 – ISO 9001 Clause 4

(This is a series of guidance notes to help managers to get the most out of ISO 9001 Quality Management Systems)

Clause 4 – Context of the Organisation

My aim here is not to go into the fine detail on implementation of the clause or through it line by line (if you want that kind of help then go to the bottom of the post, hit the Get in Touch button and send me an email, I’ll gladly help once we’ve agreed the arrangements and the extent of help you may or may-not need).

Clauses 4.1 & 4.2

These two clauses can in effect be dealt with together and not necessarily in the sequence provided by the standard. Firstly I find it easiest to start with the need to understand who your organisations stakeholders (‘interested parties‘ in the standard) are, and what requirements they will have of your organisation or your organisational obligations to them. The standard doesn’t mention documenting this information, BUT I think its really useful and advisable to document it. At a later time you’re going to have to review it, so having a note of what you thought and agreed with your management team is a bonus you’ll appreciate.

The thing is that ‘Quality’ per se is really an expression of what your customers experience is and so its really important if you can understand right out of the gate who can affect your Quality Management System (QMS) and who might be affected by how you operate it. So for example, you may be running a Kanban system for production control and a supplier needs 60 days notice for delivery of parts or goods for inclusion in what you’re making or providing as a service. In this case its important to know this so you can factor this in when deciding on purchasing policy where you might set re-purchase at say 70 days worth of stock level. And when there’s a known delay in materials then you’ll have to inform your sales people about this delay so they can keep the customer informed.

Later on when I get to Clause 6 the information gathered here drives the decision process when determining risk and opportunity, but more of that in a later post.

Clause 4.3

This is an exercise in thinking concerned with ‘Determining the Scope of the QMS’. In most cases this turns out to be a simple statement about what you sell and that the QMS covers this. Where this gets complicated is when your organisation has multiple sites or wants to have some products and services covered and others not. In these cases determining whats in the Scope probably requires the management team to spend a bit of time thinking about it and maybe invite the services of a consultant to help out.

So the Scope should cover what you want it to and location you want it to. You may want ISO 9001 on your engineering products but need ISO 13485 instead on your medical devices business.

The Scope statement is required to be documented, so you’ll need to write it down or record it on media and ideally everyone involved in the part of the organisation covered should at least know it exists and maybe have a good idea of what’s in it.

Clause 4.4

This clause is called ‘QMS and its Processes’ which is actually going a bit further than just the process approach advocated in the previous iteration of the standard. Basically you have to take an overview of your organisation and split it up into linked processes each of which should be managed through the bullet list of items in this sub-clause (a-g inc).

Like 4.1 & 4.2 above if it were me I’d do what’s necessary for this clause before 4.3 to make sure everything is covered off, and if you’re an adviser or consultant you really don’t want to be going back to the SMT with amendments. In any case you should end-up with a list of linked processes that describe what your organisation does and in what order and where.

Because of the ‘a-g list of requirements‘ in the clause its worth spending some time on keeping things as simple as possible because the list of requirements is a list of things you’ll have to assign to people to do to conform to the needs of the standard. So for smaller manufacturing organisations you may get this down to just one process, but for larger or more complex organisations you may end up with seven or eight or more interlinked processes. Whatever you end up with should reflect the organisation.

The key is that you should finish up with a set of controls for each process, which means measurable metrics. THEN you have to measure them, which produces data, which you can analyse and evaluate and then take action to make improvements based on evidence and not just because you get a feeling it might make things better. Like Clause 4.3, in Clause 4.4 the standard requires information to be documented so the organisation can have confidence that the processes are being carried out as planned.

Which all means that eventually you can get to 100% of products and services being 100% correct and 100% delivered on time!

The Take-Aways

So for Clause 4 then, there are 4 sub-clauses which if implemented effectively should provide the benefits listed:

Take-Away # 1 – Your organisation will fully understand and appreciate the relationship of who a stakeholder is, and their unique concerns relative to your organisation. By doing this your QMS can reflect those needs and concerns and accommodate them, recognising the limiting factors at play. Meaning your organisation should never be surprised, and always be in a position to keep on supplying great goods and services to its customers.

Take-Away # 2 – By carefully scripting the Scope of what the QMS applies to and communicating it clearly to your employees, customers, suppliers and regulators nobody should be confused about whats in the Scope and what isn’t.

Take-Away # 3 – Once you’ve understood the linked processes of your product and service offering, you then have a clear set of metrics. This means you can start to measure internally, rather than waiting for product rejections or worse still product failures and recalls. By investing in smart and meaningful metrics as close to real-time as is possible, you’ll know when processes are beginning to deviate from acceptable levels and before they become non-conformaties. All of which means you can devote more time to making improvements rather than clearing up messes.

I can appreciate this may seem like a difficult clause to understand and get to grips with but I offer that its the bedrock on which your QMS will be built and can prove to be priceless when implemented effectively.

Philip Dawson MBA | Strategy Consultant | Trainer | Systems Thinker | Growth & Innovation Enthusiast

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