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ISO 9001 Provides a Common Language, but Does Your Team Speak It?
Following ISO 9001 doesn't automatically mean employees understand how to apply its requirements in their daily work.
AI in QMS Audits: What Must Still Remain Human?
Can artificial intelligence (AI) conduct a quality management system (QMS) audit, rather than simply assist an auditor?
Quality Professionals, Hold Yourselves to the Same Standards You Expect From Others
Quality professionals expect other departments to investigate problems thoroughly and identify their root causes.
Unrecorded Problems Are More Dangerous Than Unresolved Issues in a Quality System
An effective quality management system (QMS) depends not just on clear procedures, but on people having enough time to follow them.
Do You Need an ISO Consultant to Get Certified?
An ISO consultant is not required to achieve ISO certification, but having one can make the process easier, save time and reduce unnecessary work.
Completing Internal Audits Is Not the Same as Improving Performance
Even when an organization completes 100% of its planned internal audits, customer complaints may continue to rise, scheduled equipment inspections may be missed and the same problems may keep recurring.
The True Cost of Poor Quality Is Often Overlooked
Organizations may have systems for recording nonconformities and related expenses, but that doesn't necessarily mean they know how much poor quality is really costing them.
ISO 9001:2026 and Climate Change: Was This Really Necessary?
Climate change was already a business risk long before ISO explicitly addressed it in quality management standards.
Five Levels of Autonomy to Keep AI Agents Under Control
Just because an instruction is explicitly written into an AI system's prompt doesn't mean the system will follow it.
How Important Is QMS Maturity for Pharmaceutical Manufacturers?
Can a pharmaceutical manufacturer be fully compliant with regulatory requirements and still have an immature quality management system?
Root Cause Analysis Should Not End With Human Error
A production mistake was easy to identify.
Sometimes, Noncompliance Is Better Than Partial Compliance
Implementing only part of a requirement is not always better than leaving it unmet.
If Reminding Employees Is Your Default Corrective Action, Look Deeper
Twenty-five nonconformities identified during certification audits, and 20 corrective actions calling for the same thing: reminding employees to follow procedures.
Quality Culture Requirement in ISO 9001 Is an Admission of Failure
The new quality culture requirement in ISO 9001 is an admission that the existing quality management model has failed to deliver on its promises.
As AI's Role Grows, Auditing Faces a Fundamental Transformation
Artificial intelligence (AI) could transform the very nature of management system auditing, certification, and accreditation, along with the roles of the people involved.
No Extra Revenue, No Unnecessary Audits: Certification Body Takes a Different Approach to ISO 9001 and ISO 14001 Transitions
Certification body Interface NRM has committed to making the transition to ISO 9001:2026 and ISO 14001:2026 with minimal additional work and expense for its clients, without seeking additional revenue from the revised standards.
Three Pillars to Stop QMS Fragmentation From Hurting Manufacturers' Margins
Fragmented quality management systems (QMS) can quietly eat into manufacturers' profit margins and weaken oversight across multiple sites.
All the Terrible Ways to Make Friends as a Quality Manager
Want to make enemies at work?
Why Auditors Hate ISO/IEC 42001 (or How It's Being Implemented)
Auditing ISO/IEC 42001 can be frustrating when organizations overlook the basic requirements for managing artificial intelligence (AI) risks and impacts.
Now Is the Time to Help Shape Circular Economy Standards
In an interview with the Belgian Bureau for Standardisation (NBN), Benjamin de Ville de Goyet, Project Manager for Sustainable Systems & Consumers at CEN and CENELEC, discusses the importance of standards for the circular economy and why this is the right time for professionals to contribute to their development.
My First Audit as the Auditor: 5 Lessons for the QMSR Era
This text was written by Sagar Aedla, a senior quality engineer with more than nine years of experience in the medical device industry, an ASQ Certified Quality Engineer (CQE), and an ISO 13485 lead auditor.
Accreditation Should Not Depend on Who Shows Up
Accreditation assessment results should be consistent and based on objective evidence, not the personal interpretations or preferences of individual assessors.
Responsible AI and ISO/IEC 42001 Are Already Here, Not Just on the Horizon
Responsible AI and human accountability are already being enforced through existing quality regulations.
