Quality management systems for IVDs
There are many different requirements with which in vitro diagnostic manufacturers have to comply in order to place products on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. This is certainly not a new requirement for companies. Philip B. Crosby said “Quality Management is a systematic way of guaranteeing that organized activities happen the way that they are planned… Quality management is needed because nothing is simple anymore, if indeed it ever was.” Although this quote is now nearly 40 years old, it is as true today as it was then. Companies still need a system in place to ensure that activities happen according to plans, especially as the environment continues to get more complicated with increasing regulation, customer expectations and product complexity.
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Our whitepapers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.
- The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016
- Requirements for vigilance reporting and post-market surveillance?
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