|
Home
Up
Europe
| |
Quality System Tune Up:
- It’s been more than 6 months since your last Notified Body Audit,
and you can't remember if the non-conformances were corrected as you told them you would
- You started out with documents to satisfy GMPs, then went on to add just
the bare minimum to get ISO 9000 certified
- You forgot to tell the Notified Body that you added a new product line, acquired a
company, transferred operations from or to your subcontractors, etc.
- Your quality system related costs have sky-rocketed, or you don't even know or have a
good idea but don't want to document it for career reasons
The CRO Group is pleased to announce it's new service: the
Quality System Tune Up. The Tune Up has been developed to make your quality system run
like a well-oiled machine.
Our Five Point Tune Up includes the most widely needed services for the recently
certified company:
- Your CRO Group partner compares requirements from the latest standards
and legislation to your procedures. For example, new vigilance procedures have been issued
for all MDD CE marked products. Any needed additions or corrections are penned in for
appropriate document controlled changes.
- Technical files prepared since the last audit are reviewed for essential
requirements conformance.
- The last audit report is reviewed to identify problem areas and likely
elements for revisiting. We will also prepare a most likely surveillance audit plan so you
can maintain your focus.
- Your CRO Group partner will mock audit your facility taking the problem
areas and technique of your Notified Body into account.
- Finally, surveillance audit readiness training will be provided.
The cost of the two day Tune Up is minimal compared to its value. For a quote and start
dates, please contact us at qs@crogroup.com.
Many companies use The CRO Group for our Quality System Tuneup after achieving
certification on their own, or working with other consultants. Each of The CRO Group
partners have worked for manufacturers and service providers in design, development,
production, and quality assurance, before gaining valuable experience with
registrars and Notified Bodies. Our approach to procedure development and
implementation is based on the real world of lean budgets and resources, and still meets
the requirements of the standards and regulations.
|