Thanks for the replies.
For clarity we are a label manufacturer, so no direct contact with food and other hygiene sensitive materials. On the basis of risk we have required ISO9001 + the aforementioned hygiene questionnaire and been fine. My interpretation of the new clause is that we can get rid of the hygiene questionnaire and just have a declaration of conformity alongside the ISO9001 - again based on risk and no food contact etc etc.
Tony - you mention that ISO9001 'would be fine if you add traceability.' This is actually a discussion I've had with auditors in the past and has been accepted by them, but wanted to know if others have had similar experiences:
I've always referred to 8.5.2 from ISO9001 which states "8.5.2 Identification and traceability. The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability."
I suppose the potential problem here is the wording "when traceability is a requirement." Again though, I've had the discussion with auditors in the past who have subsequently accepted that ISO9001 does include traceability