Leading Change and Improvement

Leading Change and Improvement

Having been involved in Quality and Compliance since the early 80’s I sometimes wonder why we still get bad products and services, despite ISO 9001 et al. One of the issues is definitely weak and inconsistent auditing from certification bodies. But I have a feeling...
Covid 19, PPE and ISO 13485

Covid 19, PPE and ISO 13485

We’ve been working with companies in the medical device market for over ten years. Gaining approval to ISO 13485, (the quality system standard required for by a medical device business) isn’t easy. It often takes over a year from start to certification for even...