![]() ![]() Similarities Between ISO 9001 and ISO 13485 Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications. Clearly there are structural differences, but you may be wondering-how different are they? While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.
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