News

New MEDDEV 2.5/10 EAR

6-Feb-2012 New MEDDEV guidance on European Authorized Representatives
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Season greetings

20-Dec-2011 - We wish you a Merry Christmas and a Happy New Year in good health.
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Successful surveillance audit

26-Oct-2011 - We congratulate one of our clients with a successful ISO13485 surveillance audit today. No nonconformities were observed.
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Supplier audits

Another type of audits are supplier audits. The 'quality management system' of your supplier is checked against the ISO 9001 or ISO 9001 standard. We can focus in the services that they provide to you. This will give your supplier opportunities to improve its processes which will support your relationship with the supplier.

You demonstrate your interest in your supplier by working together on a long-term relationship. This investment in your supplier will benefit your mutual relationship. The return on investment will exceed the time spent on searching new suppliers.

The reporting format for supplier audits most often happens in a template provided by the client. Often specific attention points are provided to the auditor for review during the audit.

Please feel free to contact us to find out what we can do for you.

 

DEKRA Certification BV

We are working as a contractor for DEKRA Certification BV (formerly KEMA Quality BV) as Lead auditor for ISO 9001, ISO 13485 and as a Notified Body auditor for the European medical devices directive.




We are working as a contractor for SQA services Inc, USA, for the performance of supplier evaluations at European suppliers in the medical and pharmaceutical sector.


+31 642 31 95 05

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