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Registrars/Notified Bodies
Besides preparing you for quality systems certification, The CRO Group can assist
you in selecting the best registrar. Have you already established certification with
a registrar? We can assist you in transferring to one which more closely meets your
needs. We use the following criteria:
- Expertise - You don't want your registrar to be on the
"learning curve" during your certification audit. Similarly, you don't
want a well established registrar using your audit as a "training audit" for a
novice auditor not familiar with your products or production process. Although the
registrars with the most expertise generally come in with higher quotes, the savings in an
audit that takes less time, and is less disturbing to your operations are more
significant.
- Notification/Accreditation Scope - If you require European
quality systems certification in a regulated industry (medical, in vitro diagnostic, etc.)
for CE Mark, it may not be sufficient to select a registrar claiming to be "a
notified body." For example, there are over 40 registrars/Notified Bodies
for the European Medical Devices Directive. However, less than half are notified
for an Annex III Type Examination for an active medical device. Also, a Notified
Body for one EU DIrective is not necessarilly notified for other related directives.
Less than a quarter of the Notified Bodies for the MDD are also notified for the
IVD Directive.
- Cost - Most registrars/Notified Bodies base their
prices on the number of employees. The more employees, the more operations, and the
more to be audited. Also, depending on the registrar (and sometimes the country of
his accreditation), the followup audits may occur twice a year, doubling the annual
overhead travel expenses and "interruption factor" on your operations.
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