VA RFQ: Cooperative Studies Program (CSP) ISO

Notice ID:  36C24524Q0350

The VA Cooperative Studies Program (CSP) is the Division of VA Research and Development that is responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies in the Department of Veterans Affairs. To achieve this mission, The CSP has a clinical research infrastructure that operates under the management of Central Office in Washington, D.C. The CSP is comprised of a CSP Central Office, and professional experts at five data and statistical Coordinating Centers (CSPCCs).

The CSP and its coordinating centers in ongoing efforts to ensure regulatory proficiency utilize the ISO 9001 Quality Management System (QMS) to meet and exceed regulatory and quality requirements.  ISO 9001 is a set of standards for quality management systems. The International Standards Organization (ISO) maintains the ISO 9001 standard and approves certification bodies to administered accreditation.

On a task order basis and funds availability to the vendor may be requested to provide non-customized training and consultation to any center to achieve certification or conformance on ISO standards audited, this will be requested through the COR to the CO, then to the Vendor.

This SOW addresses only ISO 9001:2015, any proposals or bids are based on these established standards and prior experience with Research Clinical Trials.

Vendor requirements:

Certifying Body (CB) Registration Audits:

1. The Vendor shall provide a certifying body auditor (CB auditor) who is experienced with audits of Government Organizations, Clinical Trials and related activities conducted at a clinical trial Coordinating Centers.
2. The CB auditors shall travel to and perform a registration audit and/or surveillance audits at all six Centers for conformance to the designated scope of services for the ISO 9001:2015.
3. The CB auditor shall interview all levels of Center personnel at each location to determine and evaluate the extent of deployment of the Quality Management System, and the Quality Manual.
4. The Vendor will provide the audit schedule at least 30 days prior to the start of the registration audit at the first Center with subsequent schedules delivered at least 30 days before each scheduled audit at the remaining Centers.
5. The CB auditor shall provide an opening meeting to discuss their audit process and address any center questions regarding the audit activities.
6. After the scheduled audit at each Center, the CB auditor shall conduct a closing meeting to summarize results, note difficulties and give at least a draft report with recommendations as part of the closing meeting.
7. When only a draft report is provided at the conclusion of an audit, a final report must be provided to the Center Director and Quality Management Specialist of the Center within one week of the audit. Each Center will have at least 30 calendar days to provide response to any findings.
8. Have the capability to perform teleconferencing to perform Audits, updates and reviews. Currently the preferred VA teleconferencing medium is Microsoft Teams…

The estimated period of performance is for three years.

This is a total small business set aside.

Read more here.

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