- Company Wide Quality Program
- ISO 13485 Certification
- FDA21 CFR820 Compliant Quality System
- Design History Files (DHFs)
- Device History Records (DHRs)
- Device Master Records (DMRs)
To achieve this, SHL implemented a quality system that complies with FDA 21CFR Part 820 and ISO13485. This is regularly audited by leading pharmaceutical and biotech customers, and monitored by us through our internal audit procedures. Furthermore, SHL has a Corrective and Preventive Action (CAPA) program to ensure we maintain the quality of our products and services.
Supplier evaluations are conducted according to pre-defined internal procedures. We also thoroughly test all materials to comply with international safety requirements. Device History Records (DHRs) are regularly maintained, and we offer extensive experience in dealing with regulatory authorities such as the FDA.
SHL promotes a culture of continuous improvement to ensure the highest customer satisfaction. Our company-wide quality program relies on the involvement of each employee within every department. We encourage a strong feeling of commitment to providing quality products and services, resulting in a sense of pride and accomplishment throughout the organization.
*The certificates are for use of SHL’s authorized individuals, and/or companies. Any use of such certificates without SHL’s prior written authorization is strictly prohibited.