Quality System Audits
Auditing is the on-site verification activity — inspection or examination of a process or quality system — to ensure compliance to requirements. FDA requires establishments to periodically perform an internal audit; DAMAS requires an audit at minimum annually. SafeLink can perform these audits.
The purpose of an audit is to establish conformance with the FDA Quality System Regulation — and with DAMAS or ISO specifications if applicable. Each audit verifies that the Quality System has been correctly communicated and is practiced, and is followed by a written Audit Report indicating any non-conformances. SafeLink Consultants perform these audits with an ASQ Certified Quality Auditor on staff, and SafeLink is an Approved DAMAS Certification Auditor. SafeLink is proud to be recognized as the 2016 NADL Supplier of the Year.
Audit Types SafeLink Performs
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Our compliance advisors are ready to help you stay ahead of inspections, regulatory changes, and the evolving risk landscape. Whether you need a one-time assessment or a long-term advisory partner, SafeLink will build a solution that fits your industry, your team, and your budget.
Serving businesses nationwide since 1991 including dental practices, dental laboratories, medical, device manufacturers, and general industry.