An FDA audit doesn’t have to be a stressful event if companies are prepared with strong quality systems, complete documentation, and a proactive compliance culture.
Business decisions on quality are not always based on facts but on power dynamics, explainss Ekaterina Potemkina, Quality Mindset Activator, in a recent blog post.
Finance and commercial professionals should play a bigger role in management system standard (MSS) audits, writes Wilson Fernández, IMS Leader at QPro Australia Pty Ltd.
The IFRS Sustainability Standards, developed by the IFRS Foundation, are quickly becoming the global benchmark for climate related risks reporting with 36 jurisdictions already adopting them.
Michael Mills, a pragmatic quality leader and quality management systems expert, explores in his new blog post what ISO 9001’s climate change clause means for smaller companies.
Michael Mills, a quality management expert with long experience in applying standards in practice, examines whether leaders should share in sacrifices when resources run short.
Management system (MS) auditors and managers are often misunderstood in organizations, with leaders expecting them to act as problem-solvers instead of impartial evaluators.
Michael Mills of Pragmatic Quality Blog says confusion over how to audit the recent climate change amendment to ISO 9001 often stems from bad audit experiences - not the amendment itself.
Ekaterina Potemkina, a Quality Mindset Activator, reveals hidden truths about quality that rarely make it into formal training—some as surprising as its link to religion.
Real metrological traceability depends on more than just a written claim, writes Jeff Gust, a senior metrology and regulatory expert at Fluke Corporation, in part 121 of his 'Metrology Monday' blog series.
Conflicts over quality are unavoidable in product development—but managing them well can help companies improve both collaboration and outcomes, points out James Luellen, Division Process Manager at Schwarz Partners, in a recent opinion piece.