In the latest amendment of the Directive (2007/47/EC) the following was added to Annex II 3.2c:
“where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party”

I am working at a Medical Device facility, which will become a virtual manufacturer. This means that we are registered as the legal labelled manufacturer for the products but the design, development, manufacturing, labeling, and packaging will be carried out by other legal entities of our franchise. We do have the same quality system. What methods of monitoring the efficient operation of the quality system and in particular the type and extent of control should be applied to our sister companies?

As I understand it, this was added to allign with the ISO13485 emphasis on outsouricing (4.1). Just keep your ISO13485 controls for outsourced processes.

I would like to refer ISO 13485:2003: Maintaining Control of Outsourced Processes (http://www.devicelink.com/mddi/archive/06/08/029.html) and Outsourcing: A Blueprint for GMP Compliance (http://www.devicelink.com/mddi/archive/08/03/020.html)

The issue is more complicated than just supplier/purchasing control according ISO 13485:2003 par 7.4.
Our sister companies manufacture, label and package the product and perform all inspections including final release according frachise procedures and procedures defined in the Design Master Record. However:
- what level of control is required for change management for the design specification (please remind design control is not performed by us as legal labeled manufacturer); production process specification; quality control methods; packaging and labeling specifications
- what should our minimum level of control be for risk assessments in case of product non-conformities or customer feedback
- should we audit our sister companies whereas they are already internally audited per our shared franchise audit procedures
- what level of control should we apply on suppliers which supply items affecting our products