Blogs Medicine / Pharmaceutical


Three Strengths Every Manufacturing Quality Manager Needs
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.
Audit Programs Should Focus on Risks, Not Just Schedules
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
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
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
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 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
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
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
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
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.
Every Friend Group Needs a Quality Manager
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
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
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.
Can DAkkS Reform Deliver Real Change?
Can DAkkS Reform Deliver Real Change?
The German Accreditation Body (DAkkS) has moved from planning to implementation of a major reform effort, but questions remain about its ability to produce meaningful results.
Investment, Not Expense: Travel Can Preserve Company Culture
Investment, Not Expense: Travel Can Preserve Company Culture
Travel is often viewed as a business expense, but Michael Mills argues that, in the right circumstances, it can be a worthwhile investment in company culture.
Unpacking the Major Changes in ISO/IEC 17020:2026
Unpacking the Major Changes in ISO/IEC 17020:2026
Inspection bodies preparing for future accreditation assessments will face new expectations under ISO/IEC 17020:2026, the first major revision of the standard in more than a decade.
Get Every Department Involved in Quality, Or Pay for It
Get Every Department Involved in Quality, Or Pay for It
Quality depends on more than just the quality department.
Lessons From ASQ's World Conference on Quality and Improvement
Lessons From ASQ's World Conference on Quality and Improvement
Mike Richman, Exemplar Global's Manager of Communications, reflects on the ideas and conversations that stood out to him at the American Society for Quality (ASQ) World Conference on Quality and Improvement (WCQI).
The Hidden Cost of Cheap IMS Consulting
The Hidden Cost of Cheap IMS Consulting
Companies looking to implement an integrated management system (IMS) may be attracted by what appears to be a bargain.
Don't Expect Your QMS Engineer to Be a Superman
Don't Expect Your QMS Engineer to Be a Superman
A single Quality Management System (QMS) engineer cannot be expected to handle every quality responsibility alone.
Is Your QMS Delivering Results or Digitizing Dysfunction?
Is Your QMS Delivering Results or Digitizing Dysfunction?
Quality management systems should lead to measurable improvements in organizational performance, not simply documented processes.
ISO 17024:2026 Treats AI Based on Its Role in Certification
ISO 17024:2026 Treats AI Based on Its Role in Certification
ISO/IEC 17024:2026 requirements for AI use in personnel certification depend on the role tools play in certification activities and decision-making.
No Point Pretending - Experienced Auditors Will See Through It
No Point Pretending - Experienced Auditors Will See Through It
Experienced auditors can often tell within minutes whether a quality management system (QMS) is genuinely embedded in the organization or simply polished for audit day.
The Power to Change Things Matters More Than the Title
The Power to Change Things Matters More Than the Title
The ability to actually change things is what many people working in quality ultimately want from their careers, argues quality mentor Ekaterina Potemkina.
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