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ISO 9001 Revision Unpacked: What Changes in Clauses 8–10 on Operations, Performance and Improvement
As the quality community awaits the upcoming update to ISO 9001, John Watt, Owner of Many Caps Consulting, provides a detailed analysis of proposed changes in the draft ISO 9001:2026.
Certifying Large Companies Requires A Different Approach
A question raised by Kyle Chambers during a podcast prompted Michael Mills to explain how large, complex organizations can be certified to standards like ISO 9001, pointing to the need to carefully define the scope of certification.
Product Carbon Footprint Needs Standards for Reliable Comparison
The Product Carbon Footprint (PCF) is becoming central to climate goals such as the European Green Deal, but questions remain about how reliable and comparable these values really are.
Five Early Signs That Reveal How a QA Audit Will Unfold
Early signs can show how a QA audit will unfold, and experienced auditors know how to read them.
Does AI Improve Auditor Judgment Or Create New Blind Spots In Food Safety?
AI is already reshaping food safety and quality audits, but the key issue is whether it improves how auditors see risk or creates new blind spots.
Too Messy Or Just More Useful? Rethinking QM Documentation Formats
Stephan Joseph, founder of Joseph Beratung, challenges a familiar concern in an opinion piece:
Transition from ISO 9001 to ISO 13485 Requires Deep System Changes
Companies transitioning from ISO 9001 to ISO 13485 to enter the medical device field should expect significant changes in their quality management system (QMS),
Thinking Like An Auditor Starts With Questions Not Checklists
Carlos Manuel Pereira da Cruz, a consultant, auditor, trainer, author, and ISO 9001 expert, explains in a video lesson that effective audits begin with the right questions rather than clauses or checklists.
Why Quality Fails in Manufacturing Despite More Inspection And Supervision
Focusing on inspection instead of preventing problems before they occur allows defects to keep coming back in manufacturing,
Systems, Not People, Determine Results: Deming’s Red Bead Lesson Still Ignored
Most performance problems come from the system that produces results, not from the people working within it,
Why Recurring IATF 16949 Trouble Spots Continue To Drive Most Nonconformities
Imran Khan, Ph.D., Principal Consultant at Omnex Inc, highlights that recurring IATF 16949 problem areas continue to drive a large share of nonconformities because organizations do not adjust their systems in response.
When Written Procedures Do Not Match Daily Work, Certified Systems Fail
Many companies obtain ISO certification expecting business benefits, but real-world experience shows that written procedures often do not match daily work, limiting the value of the system.
Quality Managers, Stop Absorbing Dysfunction And Reclaim Your Role
Many quality managers stay too long in environments that do not support strong quality practices, gradually adapting to issues they should be challenging.
From Five Audits to One: How MDSAP Simplifies Global Medical Device Compliance
One audit covering five regulators is significantly reducing the burden of medical device compliance under the Medical Device Single Audit Program (MDSAP),
Mentoring Could Solve The Auditor Pipeline Problem
The ISO auditing field faces a growing talent pipeline problem as demand for certification rises while fewer new auditors enter the profession.
A Step-by-Step Approach To ISO 27001 Internal Review Preparation
Preparing for an ISO 27001 internal independent review is not difficult in itself.
What Changes For Healthcare Under The Revised ISO 14001
Healthcare organizations will face broader environmental responsibilities when the revised ISO 14001 is published on April 15,
Building Expertise in Food Safety Standards: An Auditor’s Career Journey
Cemal Gurkan Kara, Chief Strategy Officer at AGFOCERT, shares how he built his expertise in food auditing across different standards, countries, and challenges as his career developed.
AI Is Not Just A Tool As It Redefines The Role Of Quality
AI is no longer just a support tool in quality work, as it begins to redefine which tasks matter and what roles are built around.
Things You Should Know Before Moving From Corporate Regulatory Affairs To Consulting
Moving from corporate regulatory affairs (RA) roles to independent consulting changes how work is found, delivered, and experienced day to day.
The High Cost Of False Security In ISO 13485
Many medtech companies feel secure behind ISO 13485 certification until an FDA inspection exposes weaknesses in how their quality system actually works.
What U.S. Food Safety Actions Mean For Latin America Exporters
Recent actions by the FDA and USDA FSIS are shaping how companies in Latin America exporting to the U.S. approach food safety.
As Geopolitical Risks Rise, ISO 28000 and CTPAT Support Supply Chain Security Governance
Rising tensions in the Middle East are increasing global supply chain risks, exposing vulnerabilities in energy supply, shipping routes, and cross-border trade,
