Quality Assurance & Regulatory Affairs

Quality verification and validation

Quality and Regulatory Affairs, Business Units, and Facilities carry out a comprehensive system of planned and documented quality assessments to assure compliance with this manual, regulatory requirements, the Quality System Regulations (QSR), the Medical Device Directive 93/42/EEC, EN 46001, ISO 13485, and EC Directive 89/686/EEC.

Quality System

Bioteque provides a documented Quality System by which the quality policy is to be achieved and ensures that products and services conform to established and documented requirements. The Quality System is implemented as outlined in this Quality Manual and complies with appropriate statutes and guidelines.

Significant changes to the Quality System will be reviewed with DNV Product Service prior to implementation. DNV will be presented with any substantive changes to the Quality System by the Bioteque General Offices Management Representative and the Authorized EC Representative.

All Business Units and Facilities establish and maintain a documented Quality System based upon the Bioteque Quality Manual, Bioteque policies and any applicable Business Unit policies.

Regulatory Affairs

Bioteque has a Quality and Regulatory Affairs organization to plan and maintain the Quality System. Through this structure, systems and methods are in place to prevent the occurrence of non- conformances. Non-conformances are identified, documented, and the appropriate corrective action initiated. The disposition of product affected by nonconformity is determined by the quality organization.