To run a successful business, you want to make and distribute products that are at the right quality standard and that comply with the regulations of the countries of sale. I guess nobody will argue with that. But what do “Quality and Compliance” mean, in practice?
They are often separated under different functions inside the same company. Why?
Let’s look at these 2 concepts in the context of manufacturing products and importing them.
“Quality with a capitalized Q” includes compliance
For example, quality management systems standards such as ISO 9001 and, to a greater extent, ISO 13485, emphasize the need to collect both customer requirements and regulatory requirements.
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