Cryo Bio System | quality accreditation

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Quality Statement

It is the policy of Cryo Bio System to achieve and maintain a high standard of quality in all aspects of its operation and to continually satisfy and exceed the expectation of our customers with respect to all services offered.

The company is committed to effective Quality Management at every level within the business.

Procedures for the management of projects and contracts are laid out in the Quality Management Manual, which is designed to meet the needs of ISO 13488 and the regulatory requirements (CE mark, FDA, UL).

In providing and maintaining its service to its customers, Cryo Bio System will ensure that:

  • The quality policy is upheld and supported by management at all levels;
  • Staff responsibilities and duties are clearly identified;
  • Staff are appropriately trained to enable them to undertake their tasks and given appropriate authority within the scope of their responsibilities
  • Sufficient resources are provided to facilitate the work;
  • Quality plans are applied in the management of all projects;
  • All appropriate documentation is maintained, controlled and archived;
  • Periodic audits of staff and projects work are undertaken to ensure that standards are maintained and opportunities for improvements sought after.

Ultimate responsibility within the company rests with the Board of Directors; the Quality Manager, as management representative, is responsible for all matters pertaining to the Quality System.

 


After Sales Service - Statement

Cryo Bio System has been constantly pursuing professionalism, speed and high quality in our after sales service. We value "Customer Service" as our invariably persistent objective.

Composed of local and field engineers, our service team successfully achieves this goal through:

  • Quality control of the equipment BEFORE installation at client site;
  • Prompt on-site assistance and repair services for all type of equipment and everywhere, in accordance with the specific contract and the client application;
  • Remote tele-maintenance and regular on-site preventive visits to clients;
  • Extensive training of client personnel on all new equipment and maintenance procedures.

Beyond providing the most efficient after sales service possible to our clients, our client support team supplies feedback to our engineering department, so as to ensure continuous product improvement pertinent to clients' needs, and enhances field engineering support to exceed our customer expectations.

 


EC Approval of Medical Devices:

EC Approval of Medical Devices

U.S. F.D.A. 510(k) notification for the CBS™ Straw:

U.S. F.D.A. 510(k) notification for the CBS Straw

ISO 13485 Quality System Certification:

ISO 13485 Quality System Certification

ISO 9001 Quality System Certification:

ISO 9001 Quality System Certification

UL Compliance Certification:

UL Compliance Certification

 

 

 

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