ISO Quality System Reviews
If you are initiating or implementing an ISO 9001 / ISO 13485 Quality system, an audit of your current operations can identify additions and changes required for registration. PharmOut has experienced consultants who can perform such an audit.
The consultant will:
- Document and review the list of issues found during the audit. They can then be added to the Project Plan and assigned to various project team members or areas of the organization; and
- Provide sample templates and techniques for addressing the required changes.
PharmOut will provide technical assistance as needed to project members as they prepare assigned documentation (quality manual, policies, procedures, flow charts, etc.). We will also conduct a review of the completed documentation and help you improve them.
PharmOut will provide a report on the progress and update the Project Plan as needed. This report will be circulated to senior management at an agreed frequency.
Back to Practical Implementation of ISO 9001 and 13485.
Who will benefit?
Medical Device, Pharmaceutical and Veterinary Product manufacturers wanting to implement ISO or quality systems.
To learn more:
Please contact us to discuss your needs.
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Validation
GMP Compliance
Drug / Medical Device Registration
