"It is the policy of the organization to maintain and continually improve the effectiveness of the Quality Management System so that the In Vitro Diagnostic Medical Device products we design, manufacture, and distribute comply with the applicable regulatory requirements (QSR, IVDD, ISO 13485:2003, and others as appropriate) and consistently fulfill the expectations of our customers."
The organization will earn customer loyalty by providing high quality, safe and effective products. We will also provide services and interaction experiences of the highest quality and greatest value.
The organization will:
- Ensure that all of our products comply with relevant safety and regulatory requirements.
- Ensure our products meet and/or exceed their published specifications.
- Maintain and continually improve on the effectiveness of our products, services, and business management systems to conform to applicable regulatory standards and requirements or other legally required statutes as dictated by specific markets.
- Establish quality requirements for suppliers, partners, contractors, and hold them accountable to comply.