ISO 13485 certification in Iraq is a standard by ISO which specifies requirements for a quality management system for the organizations who provide medical devices and related services that continuously meet customer and applicable legal regulatory requirements. The standard is also applicable to the organizations involved in one or more stages of the life-cycle, including production, storage and distribution,design and development, servicing or installation of a medical device.
The organizations irrespective of their size have realized the benefits of ISO 13485 Certification in Iraq. Any how the benefits cannot be exaggerated but significantly can help organizations to open doors to untapped domestic and international business opportunities and reap the benefits
The structure of ISO 13485 Certification in Iraq is divided into 8 sections, the first 3 sections are just for introduction and remaining 5 contains mandatory requirements.
Section 4: This section is all about Quality Management Systemand documentation requirements
Section 5: Demonstrates top management commitment in providing directions and responsibility
Section 6: This section covers resources, including human resources, buildings, infrastructure and the working environment.
Section 7: Design and development, product requirement review and controlling the equipment used to monitor and measure the product or service. This section is not applicable for companies who do not design any product
Section 8: The last section includes assessing customer satisfaction, internal audits, dealing with non-conforming product and corrective and preventive actions .