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Back to the Future: Why Continuous Development Outperforms Annual Reviews
Ideas that feel modern in performance management are often older than they appear.
Enabling Others Marks the Shift From Quality Engineer to Quality Manager
Moving from Quality Engineer to Quality Manager is less a technical step and more a change in mindset.
Quality Paradox: The Best Manager Is Almost Invisible
Strong quality systems work quietly in the background, argues Adrian Bazior, which can make the person responsible for quality seem invisible.
Management Review as the Key Aspect of Your QMS
Because no organization gets its management system right the first time, regular management review is what matters most in a Quality Management System, explains Michael Mills, Pragmatic Quality leader, in a recent blog post.
Future Auditors Face Higher Expectations and Need Broader Skills
Auditors will need broader skills as expectations rise and audits become more complex.
Half of Quality Work Is Defending the System, Selling It Over and Over
Quality workers spend only half of their day on real QA tasks, and the other half goes to explaining why those tasks matter,
Revised ISO 19011 Marks a Major Shift in How Modern Audits Are Run
ISO 19011, the global guideline for auditing management systems, is being revised, with the updated version scheduled for release in early 2026.
A Way Forward for Small Quality Teams Stuck in a Seemingly Unwinnable Situation
A two-person quality team at a small medical device company is facing a nightmare scenario of overload and constant pressure.
AI Cuts ISO Paperwork in Seconds, Bureaucracy Loses
Artificial intelligence was pitted against bureaucracy to see who would win, showing just how useful AI can be inside a management system.
A Defining Realization: Medical Quality Is the Final Barrier for Patients
Medical quality shifted from being about audits, CAPAs, and deadlines to something far more serious for Dr. Harold E. Braustein when he realized he is the last barrier between a patient and a possible failure.
Auditors Should Care about ISO 42001 Since AI Is Already Inside Audits
Auditors are already reviewing AI-driven decisions without clear rules for who controls them, which is why ISO/IEC 42001 now matters, as pointed out by Jackie Stapleton, Director of Auditor Training Online.
When Details Cloud the View, the Big Picture About Quality Gets Lost
An opinion piece by Michael Mills, a quality expert who uses risk-based thinking to streamline management systems,
PDCA Drives Companies Forward but Certification Bodies Still Lag Behind
Companies put strong effort into Plan Do Check Act (PDCA), but Certification Bodies often do not apply the same approach to themselves, argues Cornelis van Elst, owner of QAssurance and a long-time practitioner working toward real-time food assurance.
ISO Order Falls Short Against Parenting Morning Chaos
Danny Lee, director of OneSystemMgt Ltd and a former Senior Quality Manager in the Royal Air Force,
Avoiding Common Mistakes In IFS Logistics 3 Audits
The most common mistakes in IFS Logistics 3 audits stem from recurring gaps in preparation, and a new post by International Featured Standards (IFS) explains what these issues are and how they can be avoided.
Useful Audits Avoid Nit-Picking and Focus on Context
Auditors should look at what really happens in an organization instead of searching for small paperwork errors,
Revised ISO 10993 Unpacked And Why Industry Is Not Ready For It
The release of the revised ISO 10993-1:2025 , the key standard for the biological evaluation of medical devices, has sparked wide discussion.
Why Quality Placebo Shapes How A Product Is Judged
A quality product or service is essential, but that alone is not enough, because customers also judge what they buy through signals that shape their expectations and emotions.
How ISO 13485, ISO 14971 and IEC Standards Combine To Build Safer Medical Devices
ISO 13485, ISO 14971 and key IEC safety standards work together as one system to make medical devices safe and compliant.
Why Standardization Fails: “Original Sins” That Turn Certification Into a Lie
Standardization often fails for the same recurring reasons, and a new analysis revisits these “original sins” that weaken quality systems from the start.
Rising Importance of Internet of Things Demands Better Standards and Interoperability
The growing importance of the Internet of Things (IoT) is changing how data is collected, shared and used,
Six Red Flags in Certification Readiness You Should Not Ignore
Certification readiness matters because a management system must work in real operations, not only in documents.
New Revision, Old Mistakes: ISO 9001 Draft Repeats Problems Seen in 2015
The draft of ISO 9001:2026 has triggered strong debate, with many experts warning that it repeats the same unclear wording and weak audit criteria that caused problems in the 2015 revision.
