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.
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.