ISO 9001 & ISO 13485 – How Do These Standards Relate and Differ?



ISO 9001 vs. ISO 13485 - similarities & differences between the two quality management standards

ISO 9001 and ISO 13485 are both recognized standards for quality management, but while one standard acts as the generic guideline across many industries and product lines, the other focuses on the specific requirements for the medical device sector. Taking the time to compare both standards is a useful exercise for many medical device manufacturers, since it will help you to pinpoint exactly where your organization can raise the bar on quality.

Taking a deep dive into both these standards will also reveal why they’re each important and will better explain the importance of adhering to ISO 13485 standards for medical device production and distribution, as opposed to just following ISO 9001 requirements.

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