AI is considered critical whenever it affects any part of the selection, determination, review, decision, attestation, surveillance, or acceptance of results.
Sometimes, the most effective quality intervention isn’t an entirely new system but a marker, a whiteboard and the willingness to stand in the middle of the floor and talk.
Bob Ferrone specializes in integrating industrial design, engineering, quality, manufacturing and environmental management systems for improving environmental and economic performance.
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.
By embracing ISO 13485, the FDA is signaling its commitment to international harmonization, reducing the burden on manufacturers and fostering a more level playing field.
The next few years mark a major convergence in quality and compliance standards. ISO 9001, the foundational global quality management system (QMS) standard, is being revised for 2026. In aerospace and defense, AS9100 is evolving into IA9100, aligning with ISO’s revisions, and incorporating tighter supply-chain and digital assurance practices.
The aerospace and manufacturing sectors are bracing for change as the IAQG (International Aerospace Quality Group) Standard Development Organization works to revise AS9101 and AS9104/1 with IA9104/1 (Requirements for Aerospace Quality Management Systems Certification Bodies) and IA9101 (Requirements for Aerospace Auditor Competence).
The most popular standard of the 27,000 standards produced by the International Organization for Standardization (often referred to as “ISO”) is ISO 9001 the standard for quality management systems – and it’s going through changes right now.