Blogs Medicine / Pharmaceutical


The Compliance Puzzle: How Standards and Regulations Fit Together
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
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
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
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
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
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
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
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?
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
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
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
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
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
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
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?
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
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
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,
Quality Managers Roasted: Walking Clipboards on a Mission to Ruin Your Day
Quality Managers Roasted: Walking Clipboards on a Mission to Ruin Your Day
Muntasib Tehseen, a Quality Manager with food safety, product quality, and packaging expertise, set out to put his profession to the test - by asking ChatGPT to "roast Quality Managers" (which is a popular trend lately).
Do ISO 9001 Updates Boil Down to Linguistic Gymnastics?
Do ISO 9001 Updates Boil Down to Linguistic Gymnastics?
Quality assurance expert and QA Manager at Heineken, Mohan P V, questions whether the latest ISO 9001 updates improve quality management or merely complicate compliance.
Why Rushing ISO Certification Fails - A Consultant’s Take
Why Rushing ISO Certification Fails - A Consultant’s Take
Quality consultant Benoit Kriegel, who specializes in improving daily operations for quality and QSE professionals, shares his experience with clients who expect to achieve ISO 9001, ISO 14001, and ISO 45001 certifications within six months - an unrealistic goal.
ISO 59000 Series Unlocks the Potential of the Circular Globe Model
ISO 59000 Series Unlocks the Potential of the Circular Globe Model
The latest Circular Economy Uncovered blog post by Quality Austria explores the Circular Globe Model and the newly published ISO 59000 series, a framework designed to help organizations transition to a circular economy.
DPPs - Digital Product Passports - Are Set to Completely Reshape Business Practices in Two Years
DPPs - Digital Product Passports - Are Set to Completely Reshape Business Practices in Two Years
Starting in 2027, the European Commission will require companies to implement Digital Product Passports (DPPs) to track products from creation to recycling.
Some Organizations Hide Dysfunction Behind ISO 9001
Some Organizations Hide Dysfunction Behind ISO 9001
ISO 9001 certification is often misused, allowing companies to appear compliant while struggling with internal dysfunctions.
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