ISO 9001:2015 – Clause 4 – Context of the Organization

ISO 9001:2015 – Clause 4: Context of the Organization

By Jim Moran, BRC Quality Consultant

As you noticed in our previous article, the first 3 Clauses have the same titles as the ISO 9001:2008 version, and all of the other ISO standards you’ve ever seen. This has been standard for the International Organization for Standardization since they started writing them.

First 3 clauses:

Clause 1: Scope

Clause 2: Normative References

Clause 3: Terms and Definitions

Titles aside, you’ll notice a difference in Clause 3. The first 4 versions (87, 94, 00, and 08) did not contain any terms or definitions (except for ‘product’) but simply referenced ISO 9000. This has now changed with 22 specific definitions as of the initial draft. There are a few interesting things to note: our deliverables, (formerly  “product”) will be called “Goods and services”. The familiar term  “customer” has been replaced by “Interested Party” and includes “Stakeholder” as well. The next draft may narrow this down, but remember, you can use any terms you like to describe your activities. ISO tells you what you need to do; you decide how you want to meet the requirements.

There has been some debate around changing “continual improvement” to “improvement”.  It still means improvement of ‘the effectiveness of the management system’. You still decide what kinds of measurements and monitoring you want to do and how you want to express any improvements you’ve made.

Now let’s get into Clause 4, “Context of the Organization”.

This clause requires that we identify what kinds of external and internal conditions exist that will affect us.  We need to become aware of our ‘purpose’ as an organization and consider how our business strategy supports this concept.

This still keeps our ‘relevant interested parties’ in focus as we plan how we produce our goods and services, including our ‘Scope’. As before, you’ll list any exclusions here, limited to clauses 7.1.4 (Calibration) and Clause 8 (Operation) of ISO 9001:2015 CD1.  No surprises there!

The rest of Clause 4 provides detail about the things to consider when we determine our context. It talks about things like trends that may affect us and our ‘interested parties’, our strategies, our policies and our resources, including any outsourcing we do.

You’ll find more explanation this time on the application of the ‘process approach’ and a requirement to ‘monitor, analyze and change’ any processes that are not delivering the intended outputs. We see the first requirement to assess ‘risk’ (risks to conformity of goods and services and to customer satisfaction). There are more to come.

You can see how this supports the idea of the new ISO 9001 standard becoming a strategic consideration. Clause 4 gets us to consider quality in the context of all elements of the organization, not just the manufacturing and delivery process.

So far, so good – you will find Clauses 1 to 4 easy to handle – and quite honestly, it may help you consider elements you didn’t think of before. It’s a worthwhile and interesting exercise.

What can you start to do now to help your company prepare?