Category Archives: ISO 13485 – Medical Devices

Document Revision Criteria

Question Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485?  Some organization don’t revise the documents for a period of more than 2-3 years.  The reason provided by the organization is that … Continue reading

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Terminology for Inspected Material (GMP, ISO 13485)

Q: There is often confusion with the labeling of purchased materials  after they have been “inspected, tested and/or verified” according to good manufacturing practice (GMP) requirements.  Once out of quarantine, are purchased materials labeled as accepted, approved or released?  I’ve … Continue reading

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Establishing and Maintaining a CAPA System

Q: We have a Corrective Action and Preventative Action (CAPA) system, and we find that CAPAs are almost always completed late — even though we do have an extension request form for CAPAs, and the system sends automated reminders to  employees in … Continue reading

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ISO standard audit and confidential information

Q: During an external audit, what records are we allowed to keep confidential – e.g. human resources records? Certain records pertaining to new business leads or accounting matters? Specifically, my question is related to audits to the ISO 9001:2008 Quality … Continue reading

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ISO 9001:2008 impact on ISO 13485:2003

Q: Why does Annex B of ISO 13485:2003: Medical devices — Quality management systems — Requirements for regulatory purposes address ISO 9001:2000? Shouldn’t it be ISO 9001:2008 Quality management systems–Requirements? A: ISO 9001 is “controlled” by Technical Committee (TC) 176 while ISO 13485 … Continue reading

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