QMSR QuickTake #2: Building Good Practices, Not Just Fixing Nonconformances

QMSR’s goal isn’t just to correct bad outcomes. It’s to strengthen the practices that prevent them using a risk-driven approach aligned with ISO 13485.

Consider how FDA responded to a seemingly narrow question about product preservation in storage , whether ISO 13485 adequately prevents a manufacturer from using obsolete product.

Comment #14 in the preamble of QMSR¹ raised this exact concern, noting that ISO 13485 did not appear to cover the requirement found in §820.150 of the current QSR.

FDA’s answer was yes - and much more. Clause 7.5.11 of ISO 13485 already addresses product preservation, but FDA used the opportunity to clarify that the true objective of QMSR extends beyond preventing obsolete product from use. A QMSR-adherent system must identify and correct poor practices - improper training, failure to follow procedures, inadequate controls - before they result in product issues.

This marks a shift from managing nonconformances to managing quality system health. The goal isn’t firefighting - it’s building reliable processes that prevent the fire in the first place.

So, think about this question and share your opinion in the poll below:

👉 Where is most of your energy focused today under your current QMS?

1. Federal Register: Medical Devices; Quality System Regulation Amendments, FDA response to Comment #14, Published February 2, 2024.