How to Achieve ISO 9001 Certification: Clauses 4.1, 4.2, 4.3 and 4.4

Posted by Craig Thornton

Part 10: Clauses 4.1, 4.2, 4.3 and 4.4 – Context, Interested Parties, Scope, QMS

We have discovered that when it comes to trying to meet the clauses in 4.1 to 4.4 of ISO 9001:2015 there’s an important thing you should know – it’s actually best to start with clause 4.2.  Then move onto clause 4.1.  Then work on 4.4 and then finally tackle clause 4.3.

This process requires some good planning with Senior Management’s involvement.  

Let me walk you through it.

First, you must determine who will participate in this process, where the process will take place, and what data is necessary.

Here at Mango, the Management Team devoted an entire day to meeting the requirements of clauses 4.1 and 4.2.  To avoid any distractions we completed this task off site and banned the use of communication devices.


Interested Parties (4.2)

We discussed Mango’s interested parties by first highlighting those who influence our operations and those who are affected by them.  As you can imagine there were quite a few.  These included customers, employees, partners, suppliers, contractors, government, registrar, public etc. 

We considered how each party has an impact or could have an impact on our quality management system or on our product and meet customer requirements in the future.  We documented their needs and expectations on a simple spreadsheet.

Context of the Organisation (4.1)

With the interested parties as a starting point we then discussed the context of the organisation (clause 4.1).   

For many years we have used Brand Compasses to describe our vision, mission and our values.  The compasses cover:

  • Our core promise
  • Our values
  • Our unique buying proposition
  • The benefits of using Mango
  • What customer insight we have
  • What our target market is
  • What brand anchors we use
  • How we will behave

We have a compass for our end-users and a compass for our partners.  In situations where we strike uncertainty around a business decision we refer to our brand compasses to determine whether it aligns with our company’s purpose. 

We then fleshed this out some more with a SWOT analysis.  This analysis is a review of our strengths and our weaknesses, as well as the opportunities and threats to the business.  In other words, we were doing - and documenting - some risk-based thinking.

This analysis helps us understand our business environment by identifying internal and external factors, both positive and negative, that could have an impact on our product.  This provided us with a 360 degree view of our organisation and much valuable insight into the big picture.

We discussed techniques and processes that we have used in the past. Throughout the discussions we realised that we actually had a large portion of a these clauses in place, but we lacked some structure.  ISO 9001 was going to give us the structure.

Once these three processes were documented we were able to distill this information and turn it into our key business strategies.  These business strategies have taken into consideration all aspects of our organisation’s context.  They are focused on meeting customer requirements and on continuous improvement. 

Here are Mango's key business strategies are:

  1. Develop business processes to accommodate the expected growth.
  2. Improve the efficiency and effectiveness of the core processes.
  3. Personnel to be capable of delivering the growth for the business.
  4. Grow market share in all markets.

To ensure we meet our key business strategies, we will create meaningful objectives and targets for each area of the business that are specific, measurable, achievable, realistic and time-based (SMART).

This context of the organisation process should never be seen as an annual “document and forget it” requirement.  This process should be viewed as a pot of gold.  It provides your organisation with a wealth of information that can be used to identify areas of improvement.  It’s a process that could help change the strategic direction and overall success of your organisation.  Yes, it’s that powerful, and as such, should be frequently monitored and reviewed by management.  Don’t leave it sitting in a forgotten folder.

Here at Mango, we have made it a process to continually monitor and review our processes outlined above, and we’ve made a commitment to act on areas where improvement can be made.  This has been incorporated into the agenda of our monthly management meetings.  To provide evidence of this taking place, we record the monthly review in the minutes of the meeting. 


Quality Management System (4.4)

The next discussion was around what the quality management system (QMS) should look like and how should it be documented.

The ISO 9001:2015 standard doesn’t require a documented system.  But as an team we determined that we will document the QMS.  The benefits of a document system far outweighs bot having a documented system. The QMS will hold many years of insight and knowledge; information that was hard-earned and is incredibly valuable to us.  We want to preserve it.

We then decided on some of the core business processes that will be described in our QMS.  The following procedures were placed on the whiteboard as the first cut of the operations that make us successful:

  • Marketing
  • Sales
  • Client Setup
  • Implementations
  • Design and Development
  • Test and Release
  • Support
  • Finance
  • Governance

Scope (4.3)

Now that we have documented 4.1, 4.2 and 4.4, we are now in a place to determine the scope of our QMS.

Our first cut scope will be “the provision of quality, health and safety and environmental management software”.  This scope will be edited and refined over the next couple of months.


The steps to meeting clauses 4.1 to 4.4 of ISO 9001:2015 are:

  1. Determine the needs and expectations of your interested parties (4.2)
  2. Review your purpose, vision and mission with reference to your interested parties (4.1)
  3. Conduct a SWOT analysis (4.1).
  4. Develop your Key Business Strategies (4.1).
  5. Sketch out your QMS and document as you go along(4.4).
  6. Determine the scope of the QMS (4.3).


View previous blogs in this series "How to Implement a QMS and Achieve ISO 9001 Certification":

How to Implement a QMS and Achieve ISO 9001 Certification - Part 1: Introduction

How to Implement a QMS and Achieve ISO 9001 Certification - Part 2: Customer Focus

How to Implement a QMS and Achieve ISO 9001 Certification - Part 3: Leadership

How to Implement a QMS and Achieve ISO 9001 Certification - Part 4: Engagement of People

How to Implement a QMS and Achieve ISO 9001 Certification - Part 5: Process Approach

How to Implement a QMS and Achieve ISO 9001 Certification - Part 6: Improvement

How to Implement a QMS and Achieve ISO 9001 Certification - Part 7: Evidence Based Decision Making 

How to Implement a QMS and Achieve ISO 9001 Certification - Part 8: Relationship Management

How to Implement a QMS and Achieve ISO 9001 Certifiaction - Part 9: Clauses 0.1, 0.2, 0.3, 1, 2 and 3 of ISO 9001:2015


Tags: Quality Management, ISO 9001, ISO 9001 certification, ISO 9001 accreditation