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QUALITY ASSESSMENT

  

To increase the efficiency, quality and competitiveness of small and medium sized enterprises through the implementation and certification according to ISO 9000 series.

 

  Equipment and Process Quality Audit

  • Project management of different retrospective or prospective qualification in chemical (API) or pharmaceutical units.
  • Description of each modification and realization of the global URS (User Requirements)
  • Realization of each DQ of the appropriate modification. (Design Qualification)
  • Feasibility, Technical specifications, First design drawing, Final design drawing, Calls for tender, Negotiation with Purchase Service, Planning management and coordination on site of each supplier in case of revamping or new project.
  • Qualification plan of each modification or new component with:
    • FAT (Fabrication Acceptation Tests)
    • SAT (Site Acceptation Tests)
    • IQ/OQ (Installation and Operational Qualification)
    • PQ (Performance Qualification)
    • QR / QPR (Final Qualification Report)
    • Collect of the as-built documentation.

  Procedure Quality Audit

The objective is to increase the efficiency, quality, and competitiveness of small and medium sized enterprises through the implementation and certification according to ISO 9000 series

  • ISO 9000 is a generic standard. It can be applied to any organization which intends to set up a quality management system, whether the organization is small or large, for-profit or governmental, whatever the service or product. The certification is now implemented by thousands of companies around the world. Many countries have taken it as their national standard.
  • Organization of Auditor Training Course and Forms and Management training for employees.  
  • Assistance during the implementation, the certification and after sales services.