ISO 9001 Clause 6.3 – Planning for Changes

change ahead on a black city center sign in front of a modern office building

The latest clause to come under the spotlight in this series of How to Guides for ISO 9001 is: ISO 9001 Clause 6.3 – Planning for Changes.

We take a look at what it is, and where it fits in the greater scheme of the ISO family. But first, let’s briefly set the scene with regards to the ISO 9001 standard.

In December 2021, the International Organisation for Standardisation (the main ISO body) reported “over one million companies and organizations in over 170 countries certified to ISO 9001:2015. This number continues to increase year on year, for many and varied good reasons.

Yet there’s one not-so-small catch…

ISO 9001 might just be the most confusing document in business history!

The good news is this series of articles and accompanying free factsheets are purpose designed to:

  • Cut through the jargon
  • Debunk the myths
  • Make smoother sailing of your journey to certification

Without further delay, let’s examine ISO 9001 Clause 6.3 – Planning for Changes, in closer detail.

What is the intent of this clause?

Change is inevitable. Businesses change, people change, technology changes – you get the idea.

The intent of the clause is to prompt you to look for changes in the business environment, then determine the need for changes to your quality management system (QMS) in order to adapt. It also ensures that any proposed changes are planned, presented and implemented in a controlled manner.

All changes should be planned and intentional. However ISO 9001 focuses on the significant changes, not the small tweaks. 

In other words, it does not expect a business to follow a full change management process for a minor adjustment. It focuses instead on the larger changes, such as purchasing of new equipment, significant changes in materials or overhauling an existing process.

The leadership team will need to make a judgement call about which changes need to go through a full  change management process. Just ensure that when it comes to audit, you are able to justify why you made that decision.

The Purpose of Planning for Changes

The need for a change to your QMS could be determined in many different ways. It may be identified:

  • at management review
  • by findings arising from audit
  • by a review of non-conformities
  • as a result of complaints
  • during observation of process performance
  • by changes in the context of the organisation or
  • from the changing needs of customers and other relevant interested parties.

Other areas where change management may apply are the relocation of a production line to a different site, using new technology for the ordering process, outsourcing of important processes, and of people in key roles leaving or joining the business.

Using risk based thinking can be helpful in determining the actions necessary in planning the changes. Depending on the complexity of the change, the Plan, Do, Check, Act methodology can be utilised. Complex changes may require a more structured approach such as Project Management.

change management written on a medication bottle with wording plan before use

What are the requirements of the Standard?

ISO 9001 has four distinct elements, so let’s discuss these in more detail.

1. The purpose of the changes and their potential consequences (both positive and negative)

The purpose of the change and why you are making it is normally well understood. The potential consequences however, may need more analysis. Evaluate the potential impacts of the change, so that necessary actions can be agreed to prevent any undesired effect. An example might be running a pilot, or if you are planning to change the company payroll system, you may choose to run both the old and new systems concurrently for a limited time. That will help to ensure the new system operates as intended before you switch off the old, proven one.

2. Maintain the integrity of the management system

People put a lot of work into developing a QMS. But over the course of years, the system may be forgotten and put on the shelf. ISO 9001 Clause 6.3 tells you not to forget about your management system when making changes, as the system may need to be updated following the change. You may need to write a new procedure that describes the change, modify an existing procedure, conduct training with employees or review objectives. There is no need to consider every single aspect of your QMS, but ensure that you review the key points.

3. The availability of resources

Changes in organisations generally require resources – time, money, equipment, people etc.  For change to be implemented successfully, the required resources will need to be made available.

4. The allocation (or reallocation) of responsibilities and authorities

Change needs to be owned. The business needs to define who will be responsible for each change, and who has authority. Having clear responsibilities and authorities will ensure accountability and that the change is executed as expected.

What needs to be documented?

ISO 9001 does not explicitly require documented procedures or processes for change management. However, I do recommend it as the process will be more consistent and efficient if guided by a form or procedure.  It also does not require retained information, such as records of having planned or managed changes, although it would be virtually impossible to evidence this without some a record of some sort. 

It is also worth noting that when auditors are conducting their visits, they will ask during the opening meeting what significant changes have taken place since their last visit. So maintaining a record can certainly help you answer that question confidently. 

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