ISO 9001 - A Change of Plans

ISO 9001 - Planning of Changes (6.3)

ISO 9001:2015, clause 6.3 requires that “when the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4)”.
 
What Does This Mean?
 
To fully understand this requirement of ISO 9001:2015, let’s first begin with the literal definitions of the key word(s) used. Almost all of the wording used in the ISO 9001:2015 standard is purposeful, with very specific intention.
 

• Determine is to ascertain or establish exactly by research or calculation. (https://en.oxforddictionaries.com).
• Change is to make the form, nature, content, future course, etc., of (something) different from what it is or from what it would be if left alone (www.dictionary.com).
• Planning is the process of thinking about and organizing the activities required to achieve a desired goal (www.wikipedia.org).

 
How Does This Apply?
 
Next, let’s clarify the application of this requirement, by looking to ISO 9001:2015, clause 4.4, Quality management system and its processes. This particular clause of ISO 9001:2015 requires the organization to determine the processes needed for the quality management system, as well as their sequence and interaction, the inputs required, outputs expected, monitoring and measurement, responsibilities, resources, etc.
 
Stated in Different Terms
 
Finally, with both definitions and application established, let’s completely reword this requirement of ISO 9001:2015 as follows:
 
When the organization ascertains or establishes the need to alter the form, nature, content or future course of the quality management system, its processes, required inputs or desired outputs, resources, or responsibilities, etc., the organization shall establish and organize those activities required.
 
Practical Application
 
This requirement of ISO 9001:2015 is intended to address those changes which may have a direct impact on Quality Management System, or the subsequent achievement of its specified outcomes. In the practical application of this requirement, we can use to the Plan-Do-Check-Act model, which is referred to throughout this standard:
 
Plan

• Identify the need for change
• Identify the type of change required
• Determine the best approach
• Determine the potential implications of the change

 
Do

• Implement change as planned

 
Check

• Monitor the change while in process
• Determine the overall effectiveness of the change
• Identify any new risks or opportunities

 
Act

• Address the results of “checking” above
• Take action if goals are not met
• Standardize
• Share successes stories

 
Typically, when we’re talking about the planning of changes at a management systems level, we don’t consider those day-to-day changes related to contractual amendments, engineering changes, purchasing modifications, product deviations, alterations or changes to other work-specific deliverables and outputs, which would be considered a normal part of operations and more appropriately, covered under other requirements.
 
Is documented information required for the planning of changes? Typically, when the words “determined” and “planned” are used in ISO 9001:2015, I’d consider this to be implied. Without objective evidence being retained, there’s no proof that any of the above has actually occurred.
 
Note also, that not all alterations, modifications or adjustments to a management system require the planning of change. Examples of this could include changing line employees, replacing worn equipment, replenishing inventory, editorial revisions to documents, etc. In most cases, these types of changes can be considered substitutions.
 
The intent of the change process should not be to prevent anyone from taking immediate steps to protect the health and safety of employees, the environment, company or customer property, etc. during an emergency or unplanned event. However, any changes made under such circumstances should be immediately followed up with an appropriate evaluation once the emergency situation has been resolved.​