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The Quality Industry Voices ManagementThe Quality Edge

Quality Edge Column

Why Process Variation Control Matters for ISO 9001 and Quality

Controlling variation is vital for product consistency, and ISO 9001 encourages standardization and continuous improvement.

By John Vandenbemden
This image shows two engineers in high-visibility safety vests and hard hats inspecting industrial machinery.
Credit: AP Chanel (E+, Royalty-free), Thailand, June 11, 2025
February 9, 2026

Previously, I discussed my concerns about organizations not properly managing corrective actions or process variation. While corrective actions were covered before, this piece focuses on variation.

“Variation” has several meanings, such as a slight change in condition or a distinct form of something. In ISO 9001, it refers to process deviations, which are either:

  1. Random Variation – unpredictable factors inherent to the process, controllable via statistical methods (SPC).
  2. Systematic Variation – predictable, identifiable sources like equipment errors, often correctable to improve quality.

Controlling variation is vital for product consistency, and ISO 9001 encourages standardization and continuous improvement. Notably, Dr. Shewhart and Dr. Deming emphasized the risks of ignoring variation.

Product variation can be positive—providing options in size, color, or material as a marketing strategy. For example, a T-shirt may come in various sizes and colors, offering multiple choices.

However, negative product variation means inconsistency: ordering three “extra large” shirts (blue, green, and red) might yield different fits due to mislabeling or poor process control, causing customer dissatisfaction.

Effective process control, including graphical monitoring techniques, is essential to ensure product quality and operational efficiency by minimizing undesirable variation.

The image displays a statistical process control chart illustrating the relationship between process variation and customer expectations
Photo courtesy of John Vandenbemden

This graphical representation demonstrates a process functioning within six standard deviations, aligned with customer specifications. Ideally, this scenario would assure the producer of consistent process performance. However, if the process is not properly controlled, alternative patterns may be evident in the graphical output, and its appearance over time can differ significantly from the example shown above.

Understanding Process Capability
Photo courtesy of John Vandenbemden

Variation can help offer different products, but if not controlled during production or providing service, it can harm customer satisfaction and increase costs.

READ MORE

  • A Moment of Random Variation 
  • Making Control Charts a Tool for Learning, Not Just Compliance 
  • Smart Performance Charts (SPC) 
KEYWORDS: continuous improvement ISO 9001 manufacturing metrology process control quality standards

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Qm 0322 professional of the year john vandenbemden

John Vandenbemden currently sits on the ASQ Standards Committee as the Inspection Division representative. He is a voting member of TC 176 and chair of the SC5, USTAG 69 and and audits for SRI and Quality Auditing. Vandenbemden is past-chair of the ASQ Inspection Division. For more information, email [email protected].

Vandenbemden is also the 2022 Quality Professional of the Year.

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