Our services include both consulting and development assistance in the following and other related areas:

ISO – ISO 9000-2000 Pre-assessment Audits; Compliance Assistance; Procedural Development; Transition from ISO 9000-1994 (9001, 9002, 9003); ISO 9000-2000; ISO-14385; Assistance with the Selection of an Appropriate Registrar

FDA – QSR (GMP/cGMP) Compliance Audits; Design Control; Procedural Development; Complaint Investigation; Quality Systems Development, Remediation and Implementation; Facilitation Assistance

Quality Assurance – Quality Policy; Quality Manual; Internal Auditing; Document Control; TQM Implementation; Corrective Action; Material Review Board

Supplier Quality – Supplier Audits; Selection and Qualification; Rating Programs; Partnership Programs. Provide technical support to your own suppliers as a neutral and objective third-party.

Quality Engineering – Statistical Process Control; Qualification Test Methods; Failure Analysis Methodology