Management Systems World
All on Quality and other Standards in one place since 2010. Now Worldwide.
Blogs
Please note that you have to be a registered member with paid membership in order to see full articles.
Become a Member
How ISO 13485, ISO 14971 and IEC Standards Combine To Build Safer Medical Devices
ISO 13485, ISO 14971 and key IEC safety standards work together as one system to make medical devices safe and compliant.
Rising Importance of Internet of Things Demands Better Standards and Interoperability
The growing importance of the Internet of Things (IoT) is changing how data is collected, shared and used,
Six Red Flags in Certification Readiness You Should Not Ignore
Certification readiness matters because a management system must work in real operations, not only in documents.
Why Quality Placebo Shapes How A Product Is Judged
A quality product or service is essential, but that alone is not enough, because customers also judge what they buy through signals that shape their expectations and emotions.
Why Standardization Fails: “Original Sins” That Turn Certification Into a Lie
Standardization often fails for the same recurring reasons, and a new analysis revisits these “original sins” that weaken quality systems from the start.
New Revision, Old Mistakes: ISO 9001 Draft Repeats Problems Seen in 2015
The draft of ISO 9001:2026 has triggered strong debate, with many experts warning that it repeats the same unclear wording and weak audit criteria that caused problems in the 2015 revision.
ISO 14060 Moves Net Zero Toward Credible And Practical Action
International standards are emerging as a way to restore trust in net zero claims,
Stricter Global Rules Shaping Pharma and Therapeutic Goods GMP in 2025
As the Quality Systems Now blog post notes, the most important feature of today’s GMP landscape for pharmaceutical and therapeutic goods manufacturers is the impact of stricter global rules, rapid digital change, and complex supply chains,
Expert Offers Guidance to Newcomers: Things I Wish I Had Known at the Start of My Quality Career
Pankaj Bhatia, a quality leader with more than 28 years of experience in medical devices and automotive, shares valuable insider lessons for newcomers to the profession.
Five Steps to Reduce the Burden of Social Audits
A new blog post by Dr. Thijs Willaert, Global Director Sustainability Services at DQS, explains that social audits run more smoothly when companies take simple steps that ease pressure on suppliers and build cooperation.
When the Quality Manager Goes Silent, the System Is Already Failing
Mercy Kagendo, Head of QAFS at Farmer’s Choice Limited and Plant Operations Manager at Choice Meats Limited, shares a personal reflection on what it truly means when a quality manager stops speaking up.
When Reviewers Become Technical Previewers, Audit Impartiality Is Compromised
Cornelis van Elst, Founder of QAssurance, warns in his blog post that impartiality in certification audits is being compromised as technical reviewers become “technical previewers”.
Lost in Translation: Making Quality Speak the Language of Business
Quality professionals often struggle to show their real impact because they focus on procedures instead of outcomes, writes Lokman Hossain in his blog post.
Checklist Parades, QMS Theater and Fee Pressures: ISO 9001 Systemic Issues
Drawing from his experience in auditing and quality management, Johnathon Grumelot, president of JAG Business Consulting, outlines several systemic issues he believes are inherent in ISO 9001.
When Buying QMS Software, Implementation Makes the Difference
Buying quality management system (QMS) software can save time, money, and risk - if implemented correctly.
Knowing How to Ask Questions Turns Audits Into Collaboration
Consultant and auditor Agata Lewkowska, Ph.D., from QualityWise, reflects on how the tone and phrasing of audit questions can decide whether an audit builds trust or tension.
When Certification Bodies Cross the Line Between Auditor and Advisor
When certification bodies provide gap analyses, pre-audits, or training, they risk compromising their impartiality and creating conflicts of interest.
Time to Rethink the Global Claim of GFSI Standards
Cornelis van Elst, Founder of QAssurance and its iMIS Food compliance operating system, challenges the long-held belief that Global Food Safety Initiative (GFSI) standards form a true global baseline for food safety.
ISO 9001 Revision Broken Down and Torn Apart
The first draft of the revised ISO 9001 standard has drawn a wave of attention from quality professionals,
Reconnecting With Core Principles in the Current ISO 9001 Revision
In an interview with Quality Magazine, ISO 9001 consultant and writer at ISO Tracker QMS Software Michael Mills described the ongoing revision of the main quality management system standard as a chance to reconnect with the principles behind quality management, rather than just modify its structure or vocabulary.
Bad Decisions Are the Real Cause of Quality Issues
Quality expert Ekaterina Potemkina, who advises organizations on transforming their quality management systems into reliable delivery systems,
True Quality Leader Is More Like an Architect Than a Firefighter
Most quality leaders spend their time reacting to problems, but true progress comes from designing systems that prevent them,
ISO 9001 Revision Adds Nothing but Profit for Consultants
Frédéric Mayer, QHSE and CSR Director at Casino 2000, offers a scathing critique of the draft of the upcoming ISO 9001:2026 revision,
