While many ISO 13485:2003 requirements are taken directly from ISO 9001:2000, the two certifications are unique. The most important difference is that ISO 9001:2000 is a continual improvement process, where ISO 13485:2003 is medical industry-specific and emphasizes the documentation, implementation and maintenance of processes, procedures and requirements. Although the two ISO levels share some requirements, they are significantly different and certification for one cannot apply for the other.
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