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Do you recommend that we request a pre audit visit by our assessment organization?
During witnessing internal auditing for compliance to ISO 17025 , which clauses do you look at ?
please tell me the duration to get certification from scratch?
I'm an ET inspector - does eddy current (Eddy Current Testing or Electromagnetic Testing ) machine flaw detection unit need a third party calibration sticker? I just want to make sure that as approved Testing Facility we need to comply in all particulars that refer to ISO/IEC17025
My company doesn’t require this, but I’m trying to understand the difference between being ISO 17025 certified versus having a drug establishment license from Health Canada and letter of Compliance from the FDA. A third part lab we use does not have ISO 17025 but does have the other 2 items mentioned, they are an approved lab for Pharmaceutical testing and we manufacture for both Pharmaceutical companies and Dietary companies. Is there anything outside the requirements for a GMP license by Health Canada that ISO 17025 has that would impact the validity of the test results from a lab that doesn’t have ISO 17025. It is also not a requirement to have ISO 17025 but there can be an equivalent license. Would the Health Canada license be considered equivalent?
During a GMP audit, it was noted as a non-conformance that the third party lab (used for testing of raw materials and finished excipient products) did not have ISO 17025 accreditation. The lab is licensed by Health Canada and the FDA through on site inspections and the license indicates that chemical and microbiogical testing is authorized. Is licensing through the government bodies sufficient for testing on its own or is the lab required to have ISO 17025 certification as well?
The best simplify way of carrying out an ISO audit
Good day .What impact the laboratory would suffer in the event impartiality was to be compromised.
I was wondering if you would be willing to share some thoughts on good practices for tracking revisions and document numbering for a specific situation. We are working toward ISO accreditation and evaluating our current system of documents, especially SOPs. Our SOPs were originally set up as very topic based documents with a designated SOP number for each. For example, the topic of "Facilities" was broken into 8 separate SOPs which had topics like pest control as an individual document. As the Quality Manager this system does not feel necessary and I would rather see the content in a single document, but I'm not sure how to address the old numbers. Our owner would like to reuse the document number for new content but that seems like it would only add confusion. Any advice or opinions on that would be greatly appreciated.
I need to know if there are any differences between the FINAL DRAFT version and the one that was actually issued. So if someone uses the final draft as guidance, are there any changes that they can be held to? Thanks.