Vendor Qualification as part of DQ
As part of the design qualification process, the vendor should be qualified; the question is how should this be done? Is an established and documented quality system enough (e.g. ISO 9001), or should there be a direct audit?
The answer is that there may be situations where a vendor audit is recommended: for example, when complex computer systems are being developed for a specific user. However, this is rarely the case for balances and analytical instruments.
If equipment does not include a computer system, a good reputation, one's own experience or good references from other users - togetherwith ISO 9001 certification - can be sufficient.