What is Auditing? Auditing is the on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements.
An audit can apply to an entire organization or might be specific to a function, process, or production step. Reasons for auditing include evaluation of your competitive edge, pre-audit assessment, and continuous improvement.
Results of audits are used to identify problems, reduce costs, assess personnel competency, review equipment maintenance programs, provide visible management support, ensure adherence to process standards, determine system effectiveness, and identify system inefficiencies.
FDA requires that establishments periodically perform an Internal Audit. DAMAS requires that establishments perform an audit at a minimum annually. SafeLink Consultants can perform these audits.
Results of audits are used to identify problems, reduce costs, assess personnel competency, review equipment maintenance programs, provide visible management support, ensure adherence to process standards, determine system effectiveness, and identify system inefficiencies.
FDA requires that establishments periodically perform an Internal Audit. DAMAS requires that establishments perform an audit at a minimum annually. SafeLink Consultants can perform these audits.
The purpose of the audit is to establish conformance with the FDA Quality System Regulation and conformance with the DAMAS Specifications if applicable. The audit will verify that the Quality System has been correctly communicated and is practiced. The audit will be followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your Quality System are being practiced.
FDA requires that a Quality System Internal Audit be performed annually. The purpose of the Quality System Internal Audit is to establish conformance with the FDA Quality System Regulation – QS/GMP’s. The Quality System Audit will verify that the Quality System has been correctly communicated and is practiced. The Quality System Audit is followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your Quality System are being practiced. SafeLink Consultants can perform these audits with an ASQ Certified Quality Auditor on staff.
DAMAS requires that establishments perform a Third-party Audit annually . The purpose of the DAMAS Audit is to establish conformance with the DAMAS Specifications. The Third-party Audit will verify that the DAMAS specification has been correctly communicated and is practiced. The DAMAS Audit is followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your DAMAS specifications are being practiced. SafeLink Consulting is an Approved DAMAS Certification Auditor.
Learn more about DAMAS Certification.
ISO requires that establishments perform a Second-Party Audit and Third-party Audit annually. The purpose of the ISO Audit is to establish conformance with ISO Specifications. The Third-party Audit will verify that the ISO specification has been correctly communicated and is practiced. The ISO Audit is followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your ISO specifications are being practiced.
SafeLink Consulting is proud to be recognized as the 2016 NADL Supplier of the Year.
DAMAS requires that establishments perform a Third-party Audit annually . The purpose of the DAMAS Audit is to establish conformance with the DAMAS Specifications. The Third-party Audit will verify that the DAMAS specification has been correctly communicated and is practiced. The DAMAS Audit is followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your DAMAS specifications are being practiced. SafeLink Consulting is an Approved DAMAS Certification Auditor.
Learn more about DAMAS Certification.
ISO requires that establishments perform a Second-Party Audit and Third-party Audit annually. The purpose of the ISO Audit is to establish conformance with ISO Specifications. The Third-party Audit will verify that the ISO specification has been correctly communicated and is practiced. The ISO Audit is followed up with a written Audit Report that will indicate any non-conformances. This report provides you a checklist to ensure that the standards established by your ISO specifications are being practiced.
SafeLink Consulting is proud to be recognized as the 2016 NADL Supplier of the Year.
