May 12, 2008

ISO 13485 vs GMP

We had an ISO 13485 audit a few weeks ago, one thing I learned is that ISO is much stricter about management review meeting content than GMP. 820.20(3)(c):

Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

That is pretty broad, while ISO 13485 5.6.2 has more specific requirements that auditors look for in a management review, like confirming if any major regulatory standards referenced in the Quality Manual have been updated or not, customer feedback, non-conformances, etc. GMP doesn't even state CAPAs must be reviewed (I suppose you could argue 820.20(3)(i or ii), but it isn't specific). A good auditor knows about 20 of these ISO/GMP differences and can focus in on them and find them in about 15 minutes. It would be a long day for the Quality department if they had any pride!


Anonymous said...

I found it the other way around. ISO13485 just a simple audit, therefore, it really depends upon the auditors on how to pursue the compliances or the non-conformances. GMP is generally much harder audit since this is a regulatory process, while ISO13485 is a peridical process. GMP is audited in a detail oriented based on a specific assignment eg Medical Devices, while ISO13485 is more into documentation process.

Peter said...


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ISO 13485 standard

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ISO 22000 Consultant said...

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ISO 13485 Consultancy said...

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Hello, I love your post. I'd like to share. Most worldwide medical device market controllers oblige manufacturers to execute a quality administration framework (QMS) as a major aspect of their item enlistment exertion. In most nations, ISO 13485 certification is the favored or obliged strategy for gathering QMS prerequisites. thanks all~ Steven Patterson

laura smith said...

Hey,The essential target of ISO 13485:2003 is to encourage corresponded medical device administrative prerequisites for quality administration frameworks. Therefore, it incorporates some specific prerequisites for medical devices and prohibits a portion of the necessities of ISO 9001 that are not suitable as administrative prerequisites. Due to these rejections, associations whose quality administration frameworks comply with this International Standard can't assert adjustment to ISO 9001 unless their quality administration frameworks adjust to all the necessities of ISO 9001.Thank you!!!
Majakel Medical

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ISO 13485 Procedures

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