Defining ISO 9001:2008 Scope for a Sterilization Company

C

cateen

#1
Hi

I am trying to define the ISO 9001:2008 scope for a sterilization company. They have already defined their scope as
1. Production site
2. Customer sites
3. In Transit

I need clarification on what I can include in it. Can the one certification audit cover the production site where sterilization is carried out, all customer sites (hospitals) where pre clean takes place and in transit which is carried out by a contractor.

Firstly the company sterilize medical device equipment but the first part of that process pre clean takes place at the hospital sites but by company employees based at the hospitals. There are 5 hospital in total that this company carries out sterilization work for.

Secondly the transportation of the equipment that has been pre cleaned at the hospitals by company employees is transported by a contracted transportation company.

Can all this be included in the scope and be certified to ISO 9001 under one certification audit?

Thanks
 
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