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Certificate of Good Manufacturing Practices
 
ISO 9001 Certificate
 
ISO 13485 Certificate

 

QUALITY ASSURANCE

Laboratorios Yermedic SAC has 3 quality certifications internationally recognized for almost 10 years, having been the national laboratory disposable medical equipment manufacturer, pioneer ISO 9001 Certified.

CERTIFICATE GMP

Certificate issued by the ANM (national drug authority) warrant that which manufacturing operations are our laboratory in uniform controlled by international quality standards for medical use products, thus ensuring quality and thus avoid risk of contamination of products made.

The BPM records written demand that:

  • Manufacturing processes defined revised approved and constantly

  • Qualified and trained constantly

  • Infrastructure, space, equipment and services appropriate

  • Materials, containers and labels right

  • Proper storage and transport

  • Quality control laboratory full go to approving the distribution of a lot

  • Complete history of each lot, from input supply, manufacture, storage, and distribution quality control

  • System to make possible the removal of any products market, any complaint study, causes and remedies adoption

 

ISO 9001 Certificate

Certificate issued by international certification entities authorized, to verify compliance with requirements for systems of quality management in an organization in order to satisfy efficient legal requirements and their customers.

Requirements are focus on customer exceed expectations, leadership for workers involved in achieving the objectives of the organization and resources manage activities as a process to be more efficient, see the process as a continuous improvement system applying, based on the analysis of data (all registration process) and mutually beneficial relationship with supplier

This must be for making a quality manual include scope management system quality, documented procedures and description of the interaction between system processes. You must wear a control of documents and records. Should appoint a representative of the steering system responsible for ensuring quality management


ISO 13485 Certificate

Certificate issued by international certification entities authorized, to verify compliance with requirements for systems of quality management, may be used by an organization for the design and development, production, installation and service of medical devices and the design, development and provision of related services


INDUSTRIAL PLANT

Laboratorios Yermedic SAC has approved areas for manufacturing disposable medical supplies, such as assembly areas with air classification system Class 100,000, Chambers of ethylene oxide sterilization for industrial batch production tooling area for mold making injection and extrusion for new product development, injection machines and plastic extrusion machines to manufacture components and non toxic medical material tubes.

It also has warehouses that comply with Good Storage Practices, including filtered air systems, both inputs warehouse, packaging materials, packaging materials, components locally manufactured and imported to integrate the manufacture, goods in process, finished products, products in quarantine, and counter signs Quality Control area.

It also has areas of quality control laboratory physical chemistry, functionality,
and microbiological latter with air classification system Class 100.

 
 
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