|Company-wide quality program||Design History Files (DHFs)|
|ISO 13485 certification||Device History Records (DHRs)|
|FDA21 CFR820 compliant quality system||Device Master Records (DMRs)|
SHL is committed to providing the highest quality products and services that meet both our customers' expectations and the international standards for medical devices. To SHL, quality means more than fulfilling minimum requirements. We build quality into every step of our development process, from the start of planning through to mass production.
To achieve this, SHL has 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 predefined internal procedures. We also thoroughly test all materials to comply with international safety requirements. Device History Records (DHRs) are 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.