Inactive Total Small Business Set-Aside (FAR 19.5)

Performance Work Statement ISO License Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Introduction: This requirement is for six Department of Veterans Affairs Cooperative S... Performance Work Statement ISO License Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Introduction: This requirement is for six Department of Veterans Affairs Cooperative Studies Program sites to access three International Standards Organization (ISO) standards for the sites to use to maintain their ISO Certifications. Background: Multiple Cooperative Studies Program s sites maintain either one or both ISO 9001 and ISO 20387 certifications. One key to meeting certification requirements is to have access to the required documented standards so the organizations know what standards need to be met. Six (6) Cooperative Studies Program (CSP) centers require access for up to 8 simultaneous users and 300 people to be able to access the ISO 9000/9001 standards and one (1) site with one simultaneous user for the ISO 20387 standard. ISO Standards: STANDARD PRODUCT NAME ISO 9000:2015 Quality Management Systems - Fundamentals and Vocabulary ISO 9001:2015 Quality management systems Requirements ISO 20387:2018 Biotechnology Biobanking General requirements for biobanking Required Services Vendor will provide multi-site/user access to the following ISO standards in PDF format so sites can so CSP can post a copy on the CSP Network and CSP can print one copy per employee. ISO Standards to be accessed: ISO 9000:2015 Quality Management Systems - Fundamentals and Vocabulary ISO 9001:2015 Quality management systems Requirements ISO 20387:2018 Biotechnology Biobanking General requirements for biobanking Access Requirements ISO 9000:2015 -- (6 sites and 8 simultaneous users) ISO 9001:2015 -- (6 sites and 8 simultaneous users) ISO 20387:2018 -- (1 site and 1 simultaneous users) Information Security: In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. Other Pertinent Information or Special Considerations: Delivery of license shall be coordinated through the Chief, Quality Management located at: Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Ave SE Albuquerque, NM 87106 Period of Performance: Base Year: 07/01/2021 06/30/2022 Option Year One: 07/01/2022 06/30/2023 Option Year Two: 07/01/2023 06/30/2024 Option Year Three: 07/01/2024 06/30/2025 Option Year Four: 07/01/2025 06/30/2026