Understanding Section 6.3

Planning of changes

This is an educational article on Section 6.3 of ISO 9001, entitled “Planning of changes”.

The purpose of this article is to give you an understanding of what Section 6.3 requires.

This article is directed towards:

• Those responsible for compliance to section 6.3.
• Those responsible for change management activities generally.
• Others interested in understanding the requirements of section 6.3.

Section 6.3 requires you to:

• Ensure that changes to the QMS are carried out in a planned manner.

When making changes to the QMS, you are required to consider:

• The purpose of the changes and their potential consequences,
• The integrity of the quality management system,
• The availability of resources, and
• The allocation or reallocation of responsibilities and authorities.

The first two of these are clearly directed at avoiding unforeseen adverse consequences of the change.

The second two seem to be directed towards ensuring effective follow-through for the change to be effective.

Change management is crucial to maintaining a quality management system in working order, however, there are many levels of change that call for varying degrees of controls.

Consider treating QMS changes differently, depending on their breadth of impact. Breadth refers to how many other departments, systems, or processes would be impacted by the change.

For example, consider creating a different procedure for changes that impact a single department as opposed to changes that impact many departments.  

Consider treating QMS changes differently, depending on their depth of impact. Depth refers to the extent of change occurring to your processes and systems and the extent of behavioral change that will be required to pull it off effectively.

Consider creating a different procedure for changes requiring all new processes, systems, and training as opposed to those requiring only slight modifications in current systems or processes.

Some changes would clearly require input from a cross section of relevant parties in order to truly:

• Avoid adverse consequences,
• Preserve integrity of existing processes and systems,
• Ensure availability of resources, and
• Ensure proper reallocation of responsibilities.

Ensure that all relevant parties are included in the change process.

On the other hand, other changes may only require the decision of a single manager in order to ensure quality results.

Some changes are so extensive that a full-scale change management project may need to be undertaken.

Some changes would be relatively quick fixes such as a quick revision to a document.

In such cases, you may simply integrate the requirements of section 6.3 into your document control procedure.

In any case, ensure that your policy or procedure provides a plan involving the following considerations in all change processes:

• The purpose of the changes and their potential consequences,
• The integrity of the quality management system,
• The availability of resources, and
• The allocation or reallocation of responsibilities and authorities.

For more information on how to manage changes to the QMS, see our implementation video for section 6.3, and review our template library for various implementation examples.