ISO 9001 Basics Lesson #7 – Clause 4: Context

The video below offers an explanation of Clause 4. Watch the video and use your pdf workbook to follow along with different action steps to help you document how your organization meets each requirement.

Below is a short summary of each of the subclauses that are discussed at length in the video.

Clause 4.1 Understanding the Organization and its Context (see the ‘Note’ section below the clauses).

You need to determine internal and external ‘Issues’ in order to determine your context.

I prefer the word ‘conditions’ rather than ‘issues’. Note 1: Issues (or conditions) can be positive or negative.

Note 2: External context includes things like: Legal requirements, cultural issues, competitors, market situation, social aspects, economic environments and your whole market area.

Note 3: Internal conditions need to consider things like: culture, values. employee knowledge, skill levels, access to appropriately skilled labour.

Clause 4.2 Understanding the Needs and Expectations of Interested Parties
Interested parties are people or a group of people who can affect or be affected by your management system. You also need to understand what they want from your organization.

Clause 4.3 Scope
This is stated on your ISO certificate if you have one. If you don’t, your scope is simply a description of the products and services you provide.

Clause 4.4 Quality Management System and its Processes
This section describes how your system is structured – this is the ‘big picture’ you’ve seen a few times in this presentation – ‘the overview’.

Clause 4.4.1 Establish, Implement, Maintain and Improve your system
a) Identify the processes you need to satisfy customers. Determine inputs and outputs b) Show the interactions of your processes (a flowchart does both a and b)
c) Determine measurement methods
d) Provide resources
e) Plan responsibilities (organization chart)
f) Address risks and opportunities
g) Evaluate effectiveness of your system
h) Improve the effectiveness of your system

Clause 4.4.2

Decide on how much documentation you need – at least make sure you have met all the requirements in the Standard and requirements of any regulatory bodies. It’s customized to every organization and there are no specific requirements except for records (retain documented information).

Describe what your organization does to meet these requirements

Ask to have a look at the Scope, Context and Interested Parties for your organization. Become familiar with the parts of your management system that you’ll be using.