Raz Design Inc. is pleased to announce that it has achieved ISO 9001:2008, ISO 13485:2003 and EN ISO 13485:2012 certifications. This has been a 3-year process that challenged every aspect of our business.
With adherence to ISO principles, our Quality Management System is the key to controlling the functions of design, assembly, customer care and supplier management, which will help Raz consistently meet and exceed our customers’ expectations for product and services.
ISO 9001:2008 is a quality management system that is focused on meeting customer expectations and delivering customer satisfaction. It verifies, in an international-level standard, that Raz consistently operates through a series of processes that ensure the fabrication of high-quality products.
ISO 13485:2003 specifies requirements for a quality management system wherein Raz must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services
EN ISO 13485:2012 is a certification based on a European revision to the standard developed and published by the International Organization for Standardization (ISO). This revision of the ISO13485: 2003 standard was created by the European Committee for Standardization (CEN) in order to be compliant with CE-marking requirements.
Some of the benefits of ISO certification(s) are:
- Improved customer satisfaction
- Improved product design
- Improved product quality
- Increased operational efficiency
- More consistent on-time delivery
- Dedication to continual improvement
ISO certification demonstrates our commitment to our customers.