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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.

Read the full post.