I realized that many people are confused about the companies that typically get involved when a factory wants to get its quality management system (QMS) certified to ISO 9001 or ISO 13485. Let's break it down into the logical steps to get to a certification. 1. Gap analysis You need to know what the gap is. This is necessary in order to draw a QMS implementation plan (along with a budget). You may call in a certifying body (more on them in section 4, below). But, if there … [Read more...]
Quality Assurance, Product Development, and Purchasing Strategies in China