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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 assessment results should be consistent and based on objective evidence, not the personal interpretations or preferences of individual assessors.
Responsible AI and ISO/IEC 42001 Are Already Here, Not Just on the Horizon
Responsible AI and human accountability are already being enforced through existing quality regulations.
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
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
Organizations buying ISO standards may be able to pay far less than expected.
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
ISO 9001:2026 has prompted a renewed question about who owns quality at the highest level of an organization.
Getting the ISO 9001:2026 Transition Right
The ISO 9001:2026 transition can be handled as little more than a set of tasks to complete, but that risks missing what the process should achieve: understanding what has changed, what those changes mean for the organization, and whether they work in practice.
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
What does quality come down to once the standards, procedures and terminology are stripped away?
How Software Validation Safeguards Quality Under ISO 13485
Clause 4.1.6 of ISO 13485 is an often-overlooked requirement covering the validation of software used in a quality management system.
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
Poor quality may be costing organizations far more than their reports show, and that gap can lead to misguided business decisions.
ISO 9001’s Turning Point From Quality Assurance to Quality Management
Is ISO 9001 a quality assurance standard or a quality management standard?
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
An auditor cannot report a nonconformity just because something seems wrong.
Buying ISO 27701 Twice for One Usable Copy
Buying a standard to implement a management system across an organization sounds like the easy part.
The Problem With Making Quality Culture an Explicit ISO 9001:2026 Requirement
Making quality culture an explicit requirement in ISO 9001:2026 may create more questions than it resolves.
QMS Gaps Often Hide in Broken Connections, Not Missing Documents
Quality management system (QMS) gaps can remain hidden even when procedures, records and other expected elements are all in place.
ISO 9001:2026 Changes at a Glance
With ISO 9001 revised for the first time since the 2015 edition, one of the immediate questions for quality teams is what has actually changed.
China Is Gaining Ground in ICT Standardization, but What Is Driving It?
A Humboldt University of Berlin study of 1,128 information and communication technology (ICT) companies takes a closer look at what may be giving China an increasingly strong position in international standardization.
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.
