Blogs
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From Stress to Success: The Right Preparation for FDA Audits
An FDA audit doesn’t have to be a stressful event if companies are prepared with strong quality systems, complete documentation, and a proactive compliance culture.
Psychological Safety Is Key to Honest and Effective Audits
Auditors often face pressure to soften their findings or avoid raising uncomfortable issues,
How Companies Benefit from Participation in Standardization Committees
Active participation in standardization committees can help companies shape industry developments,
A Decade of Change in Standards for Building Industry
Building standards have undergone significant transformation over the past ten years,
Top 5 Reasons Laboratories Face Nonconformities
Most laboratories struggle to complete assessments without issues,
When Power Dynamics Outweigh Rational Decisions in Quality
Business decisions on quality are not always based on facts but on power dynamics, explainss Ekaterina Potemkina, Quality Mindset Activator, in a recent blog post.
Logistics Failures Can Trigger Major Quality Problems
A recent post by Michael Mills, a QMS expert writing on the Pragmatic Quality blog,
The Most Typical Communication Pitfalls in Quality Management and How to Avoid Them
Clear communication is one of the most important success factors in quality management, yet it is often the point where good systems fail.
Certification Alone Ensures Neither Compliance nor Conformance
A certified management system is only as strong as the leadership and culture that sustain it.
Solutions to Shift India’s Global Reputation from Low Cost to High Quality
India’s manufacturing sector is expanding, but its products are still viewed globally as affordable rather than reliable,
Finance Brings Balance to MSS Audits by Connecting Risks to Business Impact
Finance and commercial professionals should play a bigger role in management system standard (MSS) audits, writes Wilson Fernández, IMS Leader at QPro Australia Pty Ltd.
Because I Am a Quality Manager: Motivation and Mindset to Succeed
Quality managers often work under pressure, facing resistance from teams, short deadlines, and a culture that sees “just enough” as acceptable.
Why IFRS Standards Gain Ground as Others Stall in Climate Related Risks Reporting
The IFRS Sustainability Standards, developed by the IFRS Foundation, are quickly becoming the global benchmark for climate related risks reporting with 36 jurisdictions already adopting them.
Quality Pros Still Undervalued and Seen as Failed Engineers
Quality professionals remain undervalued in many organizations, according to an opinion piece by Rai Chowdhary, founder and CEO of The KPI System.
ISO 9001 Asks Small Firms to Weigh Climate Relevance, Not Save Polar Bears
Michael Mills, a pragmatic quality leader and quality management systems expert, explores in his new blog post what ISO 9001’s climate change clause means for smaller companies.
ISO 9001 Revision Focuses on Resilience, Digitalization and Sustainability
The long-awaited draft of ISO 9001:2026 is now available for comment,
Europe’s Microelectronics Ecosystem Under Pressure, VDE Warns
Standardization and certification of tamper-proof microprocessors and microcontrollers are seen as vital for Europe’s industry,
Ten Tips to Make the Most Out of ISO 9001
ISO 9001 is the most widely used international quality management standard,
EU Updates GMP Documentation Rules for Medicines in Largest Overhaul Since 2011
The European Union has released draft revisions to Chapter 4 of the Good Manufacturing Practice (GMP) guideline on documentation, part of EudraLex Volume 4 for medicinal products.
AFNOR White Paper: Quality Culture Barometer Shows Link to Performance and Safety
More than 80% of business leaders view quality culture as a key driver of performance, according to a new white paper from AFNOR.
Agentic AI Set to Reshape Quality Management
Agentic artificial intelligence (AI), made up of autonomous agents that act on goals and make decisions, is expected to reshape quality management in the future.
Quality and Shared Sacrifice: A Tale of Two Management Approaches
Michael Mills, a quality management expert with long experience in applying standards in practice, examines whether leaders should share in sacrifices when resources run short.
Solution for Managing Special Responsibilities in QMS
Special responsibilities in a quality management system (QMS) are specific tasks that require competence - such as equipment calibration - that do not fit under standard job titles.