Blogs Medicine / Pharmaceutical


‘Human Error’ Is Not a Valid Root Cause, Experts Confirm
‘Human Error’ Is Not a Valid Root Cause, Experts Confirm
The most engaging post from EU MDR Compliance in 2024 - titled 'HUMAN ERROR' is not a valid root cause! - sparked wide discussion, with 2,833 reactions, over 60 comments, and more than 550 reposts.
What Should Medical Device Makers Pay Attention to Under New EU Rules?
What Should Medical Device Makers Pay Attention to Under New EU Rules?
The European Medical Device Regulation (MDR) requires manufacturers to closely monitor their products after they reach the EU market.
Strategies for Quality Professionals to Lead Through Influence Alone
Strategies for Quality Professionals to Lead Through Influence Alone
For quality professionals, leadership often depends on influence rather than formal authority.
C-Suite, Take Notice: Quality Managers Drive Business Success
C-Suite, Take Notice: Quality Managers Drive Business Success
In a recent blog post, renowned Corporate Quality Manager and ISO Auditor Ekaterina Potemkina delivers a powerful message to executive leaders: the lasting success of their business is in the hands of their quality teams.
Quantum Technologies Will Drive the Next Breakthroughs in Metrology - But Not Yet
Quantum Technologies Will Drive the Next Breakthroughs in Metrology - But Not Yet
Jeff Gust, Chief Corporate Metrologist at Fluke Corp., shares his perspective on how quantum technologies will shape the future of metrology in the 102nd Metrology Monday blog post.
Unlocking Smarter Cities Through Education about Standards
Unlocking Smarter Cities Through Education about Standards
In a blog by the IEC, the growing trend of urbanization and digitalization is underscored as cities strive to become smarter and more sustainable.
How to Build and Sustain Successful Process Improvements
How to Build and Sustain Successful Process Improvements
Organizations embarking on process improvement need a solid foundation to ensure success.
China Emerges as a Leader in International Standards Development
China Emerges as a Leader in International Standards Development
Tom Barrett, Research Associate for Emerging Technology at the United States Studies Centre,
Too Many Standards or Not? Deciding Factors Explained
Too Many Standards or Not? Deciding Factors Explained
Jean-Marie Reilhac, an experienced QSE auditor, EFQM assessor, and Lean Management expert, offers his perspective on what determines if there are too many standards.
How to Shine in Quality Audits with Three Key Preparation Steps
How to Shine in Quality Audits with Three Key Preparation Steps
Lydia Mandah-Malan, a seasoned quality management expert and certified ISO 9001 Lead Auditor, shares her practical advice on how to excel during a quality audit in her latest blog post.
Serious Career, Funny Perks: 10 Reasons to Become an Auditor
Serious Career, Funny Perks: 10 Reasons to Become an Auditor
Michael Mills, a seasoned quality consultant specializing in ISO 9001, ISO 14001, and ISO 45001 standards, revisited the topic of why individuals choose to become auditors in his latest blog post.
Unlearning 15 Quality Habits That Are Holding Us Back
Unlearning 15 Quality Habits That Are Holding Us Back
Rethinking quality management often requires letting go of entrenched habits that no longer serve us.
Six Key Methods in Focus: How Z540.3 Handbook Clarifies Compliance with Measurement Risk
Six Key Methods in Focus: How Z540.3 Handbook Clarifies Compliance with Measurement Risk
In the 98th part of the Metrology Monday blog series, Jeff Gust talks about conformity assessment, decision rules, and measurement decision risk, focusing on the Z540.3 Handbook.
Avoiding Common CAPA Mistakes in Medical Device Quality Management
Avoiding Common CAPA Mistakes in Medical Device Quality Management
The CAPA (Corrective and Preventive Action) process for medical devices is at times threatened by common mistakes, but there are strategies to avoid them.
How to Prepare Your Quality Management System for AI
How to Prepare Your Quality Management System for AI
Artificial Intelligence (AI) is transforming industries worldwide, and Quality Management Systems (QMS) are no exception.
Building Excellence: ISO’s Guide to Quality Management Principles
Building Excellence: ISO’s Guide to Quality Management Principles
Quality management principles are essential for businesses striving to achieve organizational excellence.
Optimizing Production With Predictive Maintenance and IEC 63270-1
Optimizing Production With Predictive Maintenance and IEC 63270-1
The blog post by IEC highlights the transformative role of predictive maintenance in manufacturing, powered by AI (Artificial Intelligence) and IoT (Internet of Things).
Why Process-Based Auditing Enhances Organizational Excellence
Why Process-Based Auditing Enhances Organizational Excellence
TOP Quality Consulting, highlights the importance of process-based auditing over traditional compliance-focused audits in its blog post.
Bridging Engineering and Quality: Key Strategies for Organizational Success
Bridging Engineering and Quality: Key Strategies for Organizational Success
Abdur Rahman Farooq, an expert in ISO standards, lean methodologies, and process improvement, shares transformative insights from his engineering management studies.
30 Everyday Actions That Show You Already Practice Quality
30 Everyday Actions That Show You Already Practice Quality
In a thought-provoking blog post, Ekaterina Potemkina shares 30 relatable ways people unknowingly practice quality in their daily work.
Qualiopi and Technology Alone Cannot Ensure Quality Training
Qualiopi and Technology Alone Cannot Ensure Quality Training
Jean-Christophe Thibaud critiques Qualiopi certification and technology's role in professional training in France.
ISO 9001 Revision Criticized for Diluting Quality Standards
ISO 9001 Revision Criticized for Diluting Quality Standards
Jean-Marie Reilhac, founder of QleanRSE Consulting, shared a personal critique of the proposed revision of ISO 9001.
The ISO Paradox: Essential Standards Behind Paywalls
The ISO Paradox: Essential Standards Behind Paywalls
A blog post by TOP Quality Consulting highlights the growing tension between the increasing importance of ISO standards and their restricted access due to paywalls and court decisions.
Quality Professionals Eye ISO 9001 Updates Amid Controversy
Quality Professionals Eye ISO 9001 Updates Amid Controversy
A blog post by "TOP Quality Consulting" examines the delayed revision of ISO 9001, a major topic in the quality management field.
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