Comparison of ISO 9001 to the CMM

The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in or considering using the CMM in the context of an FDA compliant quality and design control system.

SEI-ISO900-CMM-Comparison

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