Safety and quality are non-negotiable in the medical devices industry, we applied quality certificate-ISO 13485:2016 as our quality management system.
Until now, we have applied ISO13485 for disposable face masks, isolation gown, coveralls, lab coats, scrub suits, bed sheets, bed covers, pillow cases, caps and sleeve cover. Will apply it for more products in next year.
According to the official explanation, “ISO 13485:2016 specifies requirements for a Quality Management System to produce ISO medical devices and related services that consistently meet customer and applicable regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services supplied by the organization”.
Most quality systems require a key component, a Quality Manual. Beyond the Quality Manual, an organization should determine the promise that they will make to ensure an environment and culture that can be consistent with putting quality first in all activities. This commitment can be captured with a policy or objective statement. The standard includes very specific requirements for both procedures and records, each of which must be fulfilled:
1. Medical device creation should be accompanied by a file that includes product specifics and guidance on intended use.
2. Plan for controlling documents.
3. Plan for controlling records.
Wuhan Youfu company strictly follow the ISO quality management system for production management. At the same time, according to customer requirements, we will provide product production photos, videos, test reports, etc. during the production process, so that customers can always grasp the production status of the order and whether the product quality meets the requirements. Meanwhile, it also helps to avoid product style, packaging, quality and other issues to the greatest extent.
We are always committed to providing quality products and thoughtful service to give customers the best purchasing experience.
