Most of the companies are under increasing pressure to reduce costs. However, when savings are made in quality management, it’s worth taking a close look at the long-term effects. Quality is not an end in itself. It stands for safe products and regulatory compliance enabling international sales. Reducing resources in this area often creates risks that only become apparent later – but are all the more serious for it. You probably noticed that I started to push your attention already to pragmatic and cost-efficient quality solutions. Over the last weeks I talked about simplification of process validation and software validation. I will continue posting about opportunities to right-size the QMS in medical device industries. While standards and regulations are thanksfully starting to calm down (no upcoming changes to ISO 13485 and ISO 14971; proposals for a very relaxed MDR; FDA applying ISO 13485) it is our task now to simplify our internal quality systems. Let me know if you will need an external look into your procedure to spot potentials for cost-savings.
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