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.
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.
Special responsibilities in a quality management system (QMS) are specific tasks that require competence - such as equipment calibration - that do not fit under standard job titles.
Management system (MS) auditors and managers are often misunderstood in organizations, with leaders expecting them to act as problem-solvers instead of impartial evaluators.