Our quality management system In accordance with DIN EN ISO 9001:2008, our QM system is process-oriented and thus in full conformity with modern methods of organizational development, employs the latest information technology systems and incorporates the experience gained from ongoing process management. The QM system is evaluated for suitability and effectiveness by upper management at regular intervals, with the results summarized in a management review. The assessment is based on audit reports, information provided by the quality management representative, evaluation of complaint statistics, the status of corrective and preventive action and training measures. Our quality policy Our guiding principle is simultaneously our quality policy and is known throughout Dr. Collin GmbH. The most important principles are:
- We support the goals of our customers in a competent and professional manner, and offer innovative, creative solutions.
- We are committed to providing high-quality competitive products, first-class service and on-time delivery.
- Every employee looks beyond his or her area of responsibility and acts in the interest of our customers as well as Dr. Collin GmbH.
Quality awareness and thoughtful use of resources are our prime concern. Through continued training and education both inside and outside the company we foster the knowledge, capabilities and strengths of employees as these relate to specific tasks and personal development. We practice an open, honest and straight-forward information policy and encourage personal interaction.
Good Manufacturing Practice (GMP) Validation Master Plan Collin ® has a well-trained team to give full support to fulfill all FDA requirements during - Design
- Production and installation of the equipment
- Qualification and validation
- Documentation
The team follows the Validation Master Plan, which is tailored individually to the current project, strictly. The basic rules outlined in 21 CFR, Part 11 are observed when designing proper FDA software. Instructions for the mechanical and electrical design ensure that all FDA requirements concerning - Materials
- Surface shapes
- Surface treatments
- Electrical components
- Wiring
- Heating and cooling systems
are satisfied completely. Every detail of a Collin ® line is designed to provide easy and fast access for cleaning and maintenance. In accordance with DIN EN ISO 9001:2000, our QM system is process-oriented and thus in full conformity with modern methods of organizational development, employs the latest information technology systems and incorporates the experience gained from ongoing process management. The QM system is evaluated for suitability and effectiveness by upper management at regular intervals, with the results summarized in a management review. The assessment is based on audit reports, information provided by the quality management representative, evaluation of complaint statistics, the status of corrective and preventive action and training measures.Our guiding principle is simultaneously our quality policy and is known throughout Dr. Collin GmbH. The most important principles are: In accordance with DIN EN ISO 9001:2000, our QM system is process-oriented and thus in full conformity with modern methods of organizational development, employs the latest information technology systems and incorporates the experience gained from ongoing process management. The QM system is evaluated for suitability and effectiveness by upper management at regular intervals, with the results summarized in a management review. The assessment is based on audit reports, information provided by the quality management representative, evaluation of complaint statistics, the status of corrective and preventive action and training measures. |