In my experience working in clinical diagnostic laboratories I have had to adhere to many quality control standards and guidelines. When a new device is being validated for clinical use it must have a clear quality control procedure and tracking system developed. If the quality control documentation can not be traced back to when the device was first put in use there will be discrepancies during audits which can lead to a lab losing its credentials (in extreme cases but most times if it is a small discrepancy a simple write up or a fine may be issued). More importantly, all the cases that were ran during the time of discrepancy may be deemed invalid, which can cause serious implications, especially dealing with clinical diagnosis of disease. In project management, in addition to compliance and regulations, a quality plan is what is going to ensure that your company is going to be able to output the same standard of service with its devices from day one up until the product comes off the market. For example if you’re a producer of artificial hips, a quality control plan sets the standards for the kind of product you are going to release into the market, you need to be able to state with confidence how long that hip will last. If an artificial hip produced according to the proper protocol is supposed to last 20 years, your quality program will make sure that this the kind of quality hip being produced. A good quality plan will in turn reflect positively on your company and allow the customers in the market to purchase from you with confidence.