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From version < 9.1 >
edited by SuperUwe Trueggelmann
on 2024/03/30 20:47
To version < 10.1 >
edited by SuperUwe Trueggelmann
on 2024/04/02 19:14
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64 64  1. If the subcontractor Company B does not maintain their own CQM Certificate covering IL production, then during the audit of Vendor A as an IL Vendor, the subcontracted production at Company B shall be audited as if it were a separate IL manufacturing site of Company A, and hence must undergo a complete CQM Audit, except for the processes conducted by Company A, in our example development and qualification of the IL.
65 65  
66 66  Note: The times above are the times to assess the Vendor's Subcontractor so that the Vendor can receive the respective label. These are not the times needed if the Subcontractor wants to aquire their own CQM label.
67 +
68 += Q7) I have a CSI letter for my Product. Does CQM still apply? =
69 +
70 +CSI is not a replacement for CQM. CSI is independent from CQM.
71 +
72 +CQM will verify if certain things are covered by a CSI letter:
73 +
74 +* Certain products must be covered by a CSI letter, in addition to be covered by a CQM label.
75 +* Non-conformities determined during CQM qualification, that the vendor fails to remedy.
76 +
77 +Both cases require that the vendor obtains a CSI letter, but this does not replace CQM certification, and the need for the vendor to conduct full qualification testing against the applicable CQM requirements.
78 +
79 +
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