Clarifying QMS Relevancy: Why We Need Industry Guidance Now

In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for interpretation when it comes to what is considered “QMS-Relevant.” This ambiguity can lead to inconsistent supplier qualification practices, compliance risks, and even quality blind spots.

That’s why our team discusses QMS Relevancy and hopes to establish clear, practical guidance on what products and services within our industry should be considered QMS-Relevant—and therefore require supplier quality management.

🧭 Why QMS Relevancy Matters

At its core, QMS Relevancy is about risk-based thinking. It asks: Does this product or service directly impact the quality, safety, or regulatory compliance of our final product? If the answer is yes, then it should fall under the umbrella of QMS oversight.

But without a shared framework, teams are left to make judgment calls. And that’s where things get murky.

🧪 A Real-World Example: Cleanroom HVAC Filters

Let’s take a seemingly mundane example: HVAC air filters in a cleanroom. Are they QMS-Relevant?

✅ Yes, if the filters directly affect air purity, which in turn impacts product sterility or contamination risk.

❓ But what about the service team that installs or replaces those filters? If improper installation could compromise cleanroom integrity, then their work is just as critical.

Under current regulatory language, these decisions are often left to interpretation. One company might qualify the filter supplier and the service team rigorously, while another might treat them as general vendors. This inconsistency can lead to gaps in quality assurance and regulatory exposure.

🛠️ What Guidance Could Look Like

To bring clarity, we suggest developing a QMS Relevancy Decision Matrix—a tool that helps teams assess whether a product or service should be subject to supplier quality management. It could include:

  • Impact on product quality or safety
  • Regulatory requirements
  • Risk of failure or contamination
  • Frequency and criticality of use
  • Direct vs. indirect involvement in production

This matrix wouldn’t replace regulatory standards—it would complement them by translating abstract principles into actionable criteria.

📣 Call to Action

It’s time we stop relying on subjective judgment and start building a shared understanding of QMS Relevancy. By doing so, we can:

  • Strengthen supplier oversight
  • Reduce compliance risks
  • Improve product quality
  • Align cross-functional teams

Let’s move from ambiguity to clarity—because in quality management, precision isn’t just preferred, it’s essential.

This blog post is a product of Rx-360’s Supplier Quality Working Group. Find out if you work for a member organization – and can join our working groups now – or consider leading the initiative to join Rx-360 on behalf of your company. Inquire at info@rx-360.org.