The Israeli Standards Institute granted Plastomold Ltd. two ISO standards for quality system management in the company and medical organizations.
Plastomold, which specializes in the production of injection molded plastic products in Israel and China, received two certifications from the Standards Institute
Importance:
ISO 9001:2008 - a standard for managing a quality system for company processes
ISO 13485:2003 - a quality system management standard adapted to organizations in the medical industry.
These standards indicate that the company has the ability to consistently provide a product that meets the customer's requirements and applicable legislative requirements, strives to increase the satisfaction of its customers through the effective implementation of the quality management system in the organization, and implements processes for continuous improvement of the system by ensuring compliance with the customer's requirements and applicable legislative requirements.
The ISO13485 medical standard is actually an extension of the ISO9001 standard and includes higher level traceability, risk survey, process validation (validation), etc. It allows the company to produce products for the medical market and includes most of the American FDA requirements.