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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.
Reflections from GFSI 2025: How Science and Trust Are Shaping the Future of Food
Lisa Kiribathgoda, Data Solutions Product Lead at MSD Animal Health, shares her experience at GFSI 2025 Conference in Dublin,
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,
ISO 14001 Revision Brings Stormproofing Model to Environmental Systems
Just like in architecture, where adaptive reuse means strengthening existing structures rather than building from scratch, the new amendments to ISO 14001:2015 aim to reinforce what’s already solid.
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.
To Strengthen ISO 27001 Audits, Balance Physical Issues With IT Risks
Many ISO 27001 audit reports focus too much on what’s easy to see, and not enough on where the real danger lies.
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.
Quality Isn’t a One-Person Job—Top Management Sets the Tone
Quality systems only work if responsibilities are clearly assigned by top management - not delegated ad hoc to quality managers.
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.
Indian Standard That Supports Renewable Energy in Rural and Remote Areas
Access to stable electricity is still a major issue in many parts of the world, and isolated renewable energy systems offer a cleaner, more reliable solution.
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.
Companies Turn to Sustainability Certifications Amid Regulatory Uncertainty
Companies across the EU are increasingly turning to sustainability certifications to navigate unclear and shifting regulations, according to financial journalist and Certified Auditor for Gender Equality Anna Zavaritt in a recent article for Il Sole 24 ORE.
The Vital Role of Information Security Management in the Digital Age
Information Security Management (ISM) is crucial for protecting data, preventing costly breaches, and maintaining consumer trust, argues a new blog post in the BSI's s Envision newsletter.
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.
