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My First Audit as the Auditor: 5 Lessons for the QMSR Era
My First Audit as the Auditor: 5 Lessons for the QMSR Era
This text was written by Sagar Aedla, a senior quality engineer with more than nine years of experience in the medical device industry, an ASQ Certified Quality Engineer (CQE), and an ISO 13485 lead auditor.
Accreditation Should Not Depend on Who Shows Up
Accreditation Should Not Depend on Who Shows Up
Accreditation assessment results should be consistent and based on objective evidence, not the personal interpretations or preferences of individual assessors.
Principles Behind the Strongest Quality Organizations
Principles Behind the Strongest Quality Organizations
Quality organizations create the greatest value when they go beyond compliance and help businesses make better decisions.
From Quality Control to Quality Assurance: Doing Better With a Smaller Team
From Quality Control to Quality Assurance: Doing Better With a Smaller Team
A smaller quality team can be more effective when routine checks are shared across the business, allowing quality professionals to focus on preventing problems rather than simply finding defects. 
Buying ISO Standards for a Fraction of the Usual Price
Buying ISO Standards for a Fraction of the Usual Price
Organizations buying ISO standards may be able to pay far less than expected.
Quality Pros Juggle Audits, Problems, People and Everything in Between
Quality Pros Juggle Audits, Problems, People and Everything in Between
As experience shows, quality professionals can end up carrying far more than the usual demands of the quality management system (QMS).
The CQO Question Exposes a Mismatch in How Companies Treat Quality
The CQO Question Exposes a Mismatch in How Companies Treat Quality
ISO 9001:2026 has prompted a renewed question about who owns quality at the highest level of an organization.
When Quality Reports to Operations, Who Can Say Stop?
When Quality Reports to Operations, Who Can Say Stop?
An organisational chart may show a Head of Quality. The real test comes when a quality decision threatens a shipment, a production target or a budget.
10 Fundamentals of Quality, Simplified Into a Practical Framework
10 Fundamentals of Quality, Simplified Into a Practical Framework
What does quality come down to once the standards, procedures and terminology are stripped away?
What Separates Auditor Training, Qualification, Authorization and Demonstrated Competence?
What Separates Auditor Training, Qualification, Authorization and Demonstrated Competence?
Are organizations developing competent auditors or placing too much emphasis on training courses, qualifications and certificates?
Reported Cost of Poor Quality Is Only the Tip of the Iceberg
Reported Cost of Poor Quality Is Only the Tip of the Iceberg
Poor quality may be costing organizations far more than their reports show, and that gap can lead to misguided business decisions.
The Trap of Accumulating Too Much Responsibility in Quality
The Trap of Accumulating Too Much Responsibility in Quality
Quality departments risk taking on more and more responsibility for issues that other parts of an organization should own.
Auditors, Your Opinions Are Not Nonconformities
Auditors, Your Opinions Are Not Nonconformities
An auditor cannot report a nonconformity just because something seems wrong.
How SDGs, ISO Standards and ESG Work Together for Companies
How SDGs, ISO Standards and ESG Work Together for Companies
The Sustainable Development Goals (SDGs), ISO management system standards and environmental, social and governance (ESG) practices can work together to connect broad sustainability ambitions with the way companies set priorities, manage operations and measure results.
Seven Criteria for Choosing an eQMS That Fits Your Operations
Seven Criteria for Choosing an eQMS That Fits Your Operations
The growing number of electronic quality management systems (eQMS) on the market can make choosing the right platform more difficult, especially when many come with similar features and promises.
When Quality Fails, Look at the System Before Blaming the Culture
When Quality Fails, Look at the System Before Blaming the Culture
When quality problems keep returning, management often concludes that the organization has a culture problem.
Rise of Customer Service Apps: How Product Degradation Is Sold as Empowerment
Rise of Customer Service Apps: How Product Degradation Is Sold as Empowerment
As customer service apps become more common, Pragmatic Quality Leader Michael Mills asks whether replacing human support with self-service technology really represents an advance in product Quality.
Seven-Figure Penalty for Deepak Jain, but Questions Over AiNET’s Other Certificates Remain
Seven-Figure Penalty for Deepak Jain, but Questions Over AiNET’s Other Certificates Remain
Deepak Jain faced a seven-figure penalty after federal investigators found that he fabricated letters claiming AiNET’s data center had been certified as Tier IV under TIA-942, the highest tier level for reliability, availability and security.
What DAkkS Is Changing After Industry Criticism Over Accreditation Speed, Cost and Service
What DAkkS Is Changing After Industry Criticism Over Accreditation Speed, Cost and Service
The German Accreditation Body (DAkkS) has come under pressure from industry groups including the Federation of German Industries (BDI), TÜV Association and VUP over slow accreditation, high costs and service problems, while a wider reform process is now under way.
Exempting Accreditation Bodies From Supplier Controls Creates a Double Standard
Exempting Accreditation Bodies From Supplier Controls Creates a Double Standard
A recent ISO Committee on Conformity Assessment (ISO/CASCO) clarification on ISO/IEC 17025 has triggered a forceful critique from Christopher Paris, founder and vice president of operations at Oxebridge. 
Tips for Surviving an ISO Audit
Tips for Surviving an ISO Audit
Auditors can sometimes stray into consultancy, turning personal preferences about how a control should be implemented into something that sounds like a requirement.
Quality’s ‘New Baseline’ Brings the Cost of Bad Decisions Into the Executive Room
Quality’s ‘New Baseline’ Brings the Cost of Bad Decisions Into the Executive Room
Quality leaders should trace operational failures back to the business decisions that created them and bring their full financial consequences into executive discussions before the damage spreads across the organization.
Preparing Your Management System for the ISO 2026 Updates
Preparing Your Management System for the ISO 2026 Updates
Several major ISO management system standards are changing in 2026, and organizations should start assessing the impact now rather than wait for certification transition timelines. 
What CEOs Need Instead of Another Quality Report
What CEOs Need Instead of Another Quality Report
CEOs do not need another report listing nonconformities, defects, or complaints without showing why they matter.
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