Management Systems World
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Cutting Corners Today Can Break Your Quality System Tomorrow
Cutting corners may seem efficient in the moment, but it erodes quality systems and creates long-term risks, writes Julius DeSilva in his latest blog post.
Misclassified Events in Pharma and Medtech Can Trigger Penalties and Waste—Here’s How to Prevent That
Misunderstanding the difference between deviation and nonconformance can lead to costly quality mistakes in pharma, biotech, and medical device industries.
Why Cutting CI and Quality Teams Is a Costly Mistake for Businesses
Managers often make the wrong call by laying off continuous improvement (CI) and quality professionals to cut costs—missing their vital role in long-term success.
AI Set to Transform Quality Control With Predictive Maintenance and Smarter Testing
AI could reshape how industries manage quality by preventing defects, predicting equipment failures, and automating root cause analysis, according to Akli Adjaoute, CEO of Exponion.
What ISO 9001 Gets Right—and Misses—in the From Lead to Order Process
The “From Lead to Order” process is essential for turning business interest into confirmed customer orders,
The Compliance Puzzle: How Standards and Regulations Fit Together
Understanding the difference between standards and regulations is essential for businesses navigating compliance and safety in industries like manufacturing, healthcare, and technology.
When Frustration Becomes Leadership: The Tipping Point in Quality
The moment quality professionals decide to stop waiting for permission and start leading is often their real turning point, according to Ekaterina Potemkina - a Corporate Quality Manager, Independent Assessor, and ISO Auditor whose goal is turning quality into growth and profitability of a business.
Why QSE Managers Should Step Back to Move Systems Forward
Surprisingly, improving a Quality, Safety, and Environment (QSE) management system isn't about getting the QSE manager more involved.
16 Hard Truths To Unlock High-Impact Quality
Quality professionals don’t get better by waiting for leadership to care—they improve by acting like business partners.
Medical Device QMS Success Depends on Knowing ISO 13485 Clause Differences
Some parts of ISO 13485 may not apply to all medical device manufacturers, but knowing which clauses can be left out—and why—is essential to building a compliant and effective quality management system.
The Biggest Lie About ISO Certification Exposed
“Passing an ISO audit” doesn’t mean a company delivers quality - just that it met the minimum standard.
From Chaos to Quantum: The Funny Evolution of Quality
Anthony Lenarz, Product Quality Specialist at GE Vernova, shares a witty take on how quality practices have changed over time - from chaotic beginnings to today’s tech-driven systems.
Tips for Gaining Full Management Commitment to Quality Systems
Brian Newbery, Quality Operations Manager at Medicom and founder of Fast Track QMS Consultants, shares tips in a practical document on how to secure full management commitment and engagement in a medical device company’s quality management system (QMS).
Apart From Dining and Travelling, What Do Quality Consultants Even Do?
Jasmina Šerifović, a food safety and sustainability consultant and auditor, explains in her blog post that the job of consultants and auditors is far from the carefree image of fine dining and having the opportunity to travel - a common misconception people have when learning about what she does.
Pharma and Medical Leaders Must Integrate Quality Management Maturity and Operational Excellence
Quality Management Maturity (QMM) and Operational Excellence (OpEx) are crucial frameworks pharmaceutical and medical device leaders must adopt to enhance product safety, comply with regulations, and improve overall efficiency.
New Approach to Quality Management Must Embrace Breakthrough Improvements
Claude Roger Dione, a quality consultant and certified auditor specializing in ISO standards (ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17065), emphasizes in a recent blog post that true quality management requires more than just incremental improvements.
Context of Organization Should Tell Your Story, Not Complicate Things
Organizations often struggle with analyzing their context because they focus too much on complicated methods instead of simply telling their own story, writes Jasmina Šerifović, a quality consultant and Executive Director at Šušnić poslovno savjetovanje (Šušnić Business Consulting), in a recent opinion piece.
Don't Listen to False Experts—There Is No Quality Management Without Business Leadership
Andre Dytz, a seasoned executive with a 40-year international career in senior management, argues that what is advertised as quality management often fails to address business leadership.
Human Fire Extinguisher or Adult Babysitter: How to Explain What Quality Managers Do
Explaining the job of a Quality Manager often leads to confusion or polite nods.
Barriers Still Hinder Growth of Personnel Certification, IAF Global Survey Finds
A 2024 survey by the International Accreditation Forum (IAF) gathered insights from 49 accreditation bodies (ABs) worldwide on the implementation of ISO/IEC 17024, the standard for certifying persons.
Are Standards Key to Cutting Bureaucracy?
Bureaucratic hurdles slow down innovation, add costs to businesses and governments, and reduce efficiency in administrative processes.
How ISO 56000 Defines Innovation Using Outdated Concepts
In January 2025, the International Organization for Standardization (ISO) released ISO 56000, a standard aimed at defining the key terms and concepts of innovation management.
Fixing GxP Audit Failures Takes More Than Pointing Out Faults
Gustavo Oliveira, a trilingual professional specializing in pharmaceutical quality assurance, discusses the challenges faced when suppliers are unprepared for GxP audits,
