QUALITY CONTROL SYSTEM

Committed to the quality of our bandages

For more than ten years, Calvo Izquierdo S.L. has been certified for the general quality standards UNE-EN ISO 9001 and for the quality of medical devices UNE-EN ISO 13485. This is combined with a continuous improvement in the manufacturing processes, with the aim of always offering bandages with the highest possible quality.

To achieve this, exhaustive quality controls are carried out from the raw materials phase, during the manufacturing phase and when the product is finished. A diligent after-sales follow-up procedure with customers is also undertaken.

Some of the standards and legislation that apply with regard to the control and assurance of product quality and safety are:

  • REGULATION 2017/745 for medical devices for human use.
  • UNE-EN ISO 14971. Application of risk management to medical devices.
  • UNE-EN ISO 12242: Determination of peel strength.
  • UNE-EN ISO 11737-1: Determination of population of microorganisms on products .
  • UNE-EN ISO 10993-5,-10: Biological evaluation of medical devices.
  • UNE-EN ISO 15223: Symbols to be used in medical devices.

In recent years, Calvo Izquierdo SL has obtained the UNE-EN ISO 14001 certification for environmental management. This involves controlling and minimizing the environmental impacts generated by our business activity, in addition to promoting environmental protection, pollution prevention and the recycling of waste generated.

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Main measures carried out by Calvo Izquierdo S.L. since obtaining this certification:

  • Reuse of certain waste such as packaging and containers.
  • Recycling of non-reusable waste by authorized waste managers.
  • Continuous training of our employees on the environment and its management.
  • Establishment of new environmental protection objectives year after year, such as the search for recycled materials or the replacement of old lights with LEDs, among others.
  • Requesting our suppliers and creditors to provide environmental responsibility declarations or certifications for the ISO 14001 standard.

For a product to be of maximum quality it must include sustainability, which for Calvo Izquierdo S.L. means safe products that are manufactured in appropriate social and environmental conditions.

For this reason, we have an Integrated Management System (IMS) which includes Quality and Environmental standards, which can be downloaded below:

DOWNLOADABLE INFORMATION