COFRAC
Certification
What it is:
The assessment audit enables you to assess the quality of your suppliers and/or partners, detect associated risks and involve them in a shared approach to continuous improvement.
These audits are carried out in accordance with the applicable regulatory standards:
Eudralex, USP, ICHQ7, Veterinary products, IPEC PQG, ISO 9001, ISO 22 716, Medical devices...
The service aims to:
-> Measure the application of the standards,
-> Evaluate the organization of the quality system and quality risk management,
-> Measure the effectiveness of the rules implemented to comply with the relevant standards.
For whom/why?
Evaluation audits are intended for:
-> Pharmaceutical companies :
- To audit their suppliers of finished products, active pharmaceutical ingredients, excipients, cos- metics, packaging material, medical devices, etc., worldwide;
- To evaluate potential suppliers
-> -> Manufacturers of active pharmaceutical ingredients or finished products who wish to assess the level of their quality system in relation to the relevant standard.
MUTUALIZING AUDITS
Mutualizing audits offers a number of advantages for both customers and suppliers:
- Reduced costs and travel expenses
- Optimization for audited sites, with a reduction in the number of audit days
- Respect for the anonymity of each customer
BUSINESS ORGANIZATION
- Receive audit requests from each customer
- If customer agrees to mutualize their audits, sharing of planned audit list
- How the service is provided (see diagram below)
- Specific audit report for each client
Assessment Audit Cost :
Contact us to receive a quote :
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