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Moving From Quality Minimum to Business Excellence
Many quality functions succeed at keeping the business under control, but far fewer are designed to help it achieve business excellence.
Why Qualified Aerospace Auditors Are Becoming Harder to Find
A shortage of qualified aerospace lead auditors is becoming a growing challenge for AS9100 certification, Christopher Paris argues in an opinion article.
AI Doesn't Change the Fundamentals of ISO 9001 Auditing
The use of artificial intelligence (AI) in a quality management system (QMS) does not change the fundamentals of ISO 9001 auditing.
For Auditors, Adaptability Is as Important as Evaluating Systems
ISO auditing is not just about evaluating management systems.
Independent Oversight at Every Level Is What Gives ISO Certification Its Credibility
A "second pair of eyes" reviews every stage of accredited certification to ISO management system standards.
Auditors Face More Unpaid Work as SMETA 7.0 Reporting Demands Grow
Growing reporting expectations under SMETA 7.0 are leaving auditors with more uncompensated work.
Three Strengths Every Manufacturing Quality Manager Needs
Finding the right Quality Manager has become one of manufacturing's toughest hiring challenges because the role requires a combination of strengths that are rarely found in one person.
Using Auditor Judgment to Target the Underlying System Failure
Auditor judgment does not end with identifying a nonconformity. It also shapes how auditors determine which standard requirement best reflects the evidence.
Audit Programs Should Focus on Risks, Not Just Schedules
An effective audit program should focus on the risks that matter most, not simply ensure every area is audited according to plan.
Proving Certification of Person Value Requires Better Evidence
The demand for evidence showing the real-world value of certifications is growing, but certification bodies often lack data on what happens after individuals earn their credentials.
When Optimization Starts to Undermine Resilience
Systems that perform exceptionally well under normal conditions can become difficult to change when circumstances shift.
Same Standards, Different Lessons Across U.S. States
Auditing organizations across U.S. states can vary considerably, sometimes to the point of feeling like auditing different countries.
The Most Frustrating Quality Work Often Teaches the Most
The tasks nobody clearly owns are often the ones that reveal how organizations really function and provide some of the biggest opportunities for professional growth.
Avoiding the Assumption Trap in Root Cause Analysis
When production stops unexpectedly, the pressure to find a quick explanation — and the pull of confirmation bias — can be just as dangerous as the problem itself.
Turning Audit Nonconformities Into Opportunities for Improvement
Organizations often gain the greatest value from audit findings when they view them as opportunities to strengthen their operations rather than as criticism or punishment.
How 'As Appropriate' Creates Flexibility in ISO 13485
The phrase “as appropriate” in ISO 13485 gives organizations flexibility to build a quality management system (QMS) that reflects their products, activities and risks rather than requiring every requirement to be applied in the same way.
How to Recognize an Effective Quality Manager
Appraising what a good quality manager actually is is not an easy task, but Taiwo Olagoke, Quality Improvement Manager at PZ Cussons, offers a practical framework for doing it.
AI Can Support Audits, but Humans Remain Accountable
The use of artificial intelligence (AI) in internal audits is increasing, but not every approach will satisfy external auditors.
Every Friend Group Needs a Quality Manager
There is a saying that everyone benefits from having friends in key professions such as doctors, lawyers, tax advisers and police officers.
Knowing Where to Invest to Protect Quality and Where Costs Can Be Cut
Not every system, tool or resource deserves the same level of investment because the consequences of failure are not the same.
Questions That Reveal Which Medical Device Quality Professionals to Hire
Hiring decisions for medical device quality and regulatory roles often involve reviewing qualifications, certifications and experience.
Waste Reduction Reflects the Maturity of Food Management
Food waste is increasingly being viewed as a sign of how well an organization manages food safety and quality.
Food Safety Lessons Not Learned at University
Many organizations believe a food science degree is enough to prepare employees for food safety roles,
