FBODaily.com | FedBizOpps: FILE | 70 | VA258-16-N-0193 ISO 9001 License - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 14, 2016 FBO #5196
DOCUMENT

70 -- VA258-16-N-0193 ISO 9001 License - Attachment

Notice Date: 2/12/2016
Notice Type: Attachment
NAICS: 541611 — Administrative Management and General Management Consulting Services
Contracting Office: Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
ZIP Code: 85014
Solicitation Number: VA25816N0193
Response Due: 2/11/2016
Archive Date: 4/11/2016
Point of Contact: Derrick Fletcher
E-Mail Address: 602-795-4339<br
Small Business Set-Aside: Total Small Business
Description: ?.## SOW This posting is for a sources sought only with respect to any Small Business interest. This posting is not a solicitation. Please contact Derrick Fletcher by e-mail at derrick.fletcher@va.gov if you can deliver the items listed on the SOW by the requested date. STATEMENT OF WORK (SOW) 1.SCHEDULE OF SERVICES AND/OR SUPPLIES. Base Year: March 1, 2016- February 28, 2017 CLINDescriptionEst. Qty.UnitUnit PriceEstimated Amount 0001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR 0002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people1YR 0003ISO 9001:2008 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR TOTAL ESTIMATED COST Option Year One (1): March 1, 2017- February 28, 2018 CLINDescriptionEst. Qty.UnitUnit PriceEstimated Amount 1001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR 1002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people1YR 1003ISO 9001:2008 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people NOTE: This Line Item WILL NOT be renewed after this option is exercised1YR TOTAL ESTIMATED COST Option Year Two (2): March 1, 2018- February 28, 2019 CLINDescriptionEst. Qty.UnitUnit PriceEstimated Amount 2001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR 2002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people1YR TOTAL ESTIMATED COST Option Year Three (3): March 1, 2019- February 28, 2020 CLINDescriptionEst. Qty.UnitUnit PriceEstimated Amount 3001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR 3002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people1YR TOTAL ESTIMATED COST Option Year Four (4) : March 1, 2020- February 28, 2021 CLINDescriptionEst. Qty.UnitUnit PriceEstimated Amount 4001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people1YR 4002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people1YR TOTAL ESTIMATED COST 2.CONTRACT TITLE. Cooperative Studies Program ISO 9001 Multi-user Site License (Current 2015 and Former 2008 standard) for Albuquerque, Boston, Hines, Palo Alto, Perry Point, and West Haven and CSP CRPCC ISO 15378:2015 for Albuquerque 3.BACKGROUND. ISO 9000 is a set of standards for quality management systems. The International Organization for Standardization maintains the ISO 9001 standard, and conducts periodic updates to improve or clarify quality standards. The ISO 9001 was updated in September 2015 and the new standard is currently ISO 9001:2015. The organization also approves certification bodies to administered accreditation to the ISO standard. CSP (Albuquerque, Boston, Hines, Palo Alto, Perry Point, and West Haven) contracted with an accreditation body and is currently ISO 9001:2008 registered. In addition, Albuquerque is also registered to a Good Manufacturing based ISO standard, 15378:2011. ISO 15378:2015 was updated and reissued in October 2015. Registration to an ISO 9001 standard certifies that formalized quality management processes are being employed consistently to meet customer and regulatory requirements; those processes are continually improved to enhance customer satisfaction; and a third party has validated those processes. CSP's quality program is surveilled and monitored to the ISO standard annually. CSP must now update their Quality Management Systems (QMS) to adhere to the new 2015 standards by 2018. Moreover, the Registrar's auditor must see that CSP is making a good faith effort and planning to conform to the new standard in the interim years. As part of that effort, CSP needs access to both the new and old standard in an electronic format to ensure proper Center wide analysis and updates to current system processes. While individual copies could be purchased for a few, vendors prohibit sharing. All employees should be able to access the standard for robust deployment of the QMS. A multi-user site license for ISO 9001:2008 and ISO 9001:2015 posted on a CSP SharePoint site is more cost effective. 4.SCOPE. The purpose of this procurement is to provide electronic multi-user site license access to the needed standards (ISO (001:2008, ISO 9001:2015 for CSP (Albuquerque, Boston, Hines, Palo Alto, Perry Point, and West Haven) and ISO 15378:2015 for Albuquerque on a CSP SharePoint site. 5.SPECIFIC TASKS. The vendor must deliver ISO 9001:2015 and ISO 9001:2008 multi-user site licenses for the 6 Centers, up to 8 simultaneous users, for 300 people in an electronic format that can be uploaded to the CSP SharePoint site. Access to ISO 9001:2008 ends after option year 1 when all site are registered to ISO 9001:2015. The vendor will also deliver ISO 15378:2015 multi-user site licenses for the Albuquerque location, up to 6 simultaneous users, for 100 people in an electronic format that can be uploaded to the local intranet. 5.1Task 1 - ISO 9001:2015 Quality management system- The vendor will provide an electronic PDF copy of the ISO 9001:2008 product that can be installed on the CSP network and CSP may print one copy of the product per employee. The required electronic capability is for 300 people at 6 centers with 8 simultaneous users to access ISO 9001:2015 (for base plus 4 years) 5.2Task 2- ISO 15378:2015 Primary packaging materials for medicinal products- Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) - The vendor will provide an electronic PDF copy of the ISO 15378:2015 product that can be installed on the CSP Albuquerque network. CSP may print one copy of the product per employee. The required electronic capability is for 100 people at one center with 6 simultaneous users for ISO 15378:2015 (for base plus 4 years). 5.3Task 3 -ISO 9001:2008 Quality management system- The vendor will provide an electronic PDF copy of the ISO 9001:2008 product that can be installed on the CSP network and CSP may print one copy of the product per employee. The required electronic capability is for 300 people at 6 centers with 8 simultaneous users to access ISO 9001:2008 (for base plus one year). Deliverables: Delivery of ISO standards in PDF format for network posting: "ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people for networking on CSP SharePoint site "ISO 15378: 2010 Multi-user Site license for Albuquerque Center, 6 simultaneous users and 100 people "ISO 9001:2008 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people for networking on CSP SharePoint site " 6.PERFORMANCE MONITORING. TaskStandardAcceptable Quality LevelSurveillance Method Delivery of ISO 9001:2015Accessible for useAccess within 30 days after contract awardDirect Observation Delivery of ISO 15378:2015Accessible for use Access within 30 days after contract awardDirect Observation Delivery of ISO 9001:2008Accessible for useAccess within 30 days after contract awardDirect Observation 7.SECURITY REQUIREMENTS. THE C&A REQUIREMENTS DO NOT APPLY AND A SECURITY ACCREDITATION PACKAGE IS NOT REQUIRED. 8.GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). The contractor will not use GFE or need GFI to perform tasks identified above. Contractor may use government facilities to conduct report briefings to CSP employees and specified training. 9.OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. Vendor's electronic networking ISO standards must be copyright protected and ensure it cannot be merged, adapted, translated, modified or that users cannot remove any proprietary notice or labels appearing on any of the Products described in section 7. 10.RISK CONTROL. None 11.PLACE OF PERFORMANCE. Product (electronic site licenses to post PDF for ISO 9001:2008, ISO 9001:2015, ISO 15378:2015) to be delivered to Albuquerque CSPCRPCC for internal staff to post on CSP network (ISO 9001) and Internal network (ISO 15378) 12.PERIOD OF PERFORMACE. This request is for a multi-year contract (base year plus four option years): Base Year:March 1, 2016- February 28, 2017 Option Year (1) OneMarch 1, 2017- February 28, 2018 Option Year (2) TwoMarch 1, 2018- February 28, 2019 Option Year (3) ThreeMarch 1, 2019- February 28, 2020 Option Year (4) FourMarch 1, 2020- February 28, 2021 13.DELIVERY SCHEDULE. SOW Task #Deliverable TitleFormatNumberCalendar Days After CO Start 0001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people Electronic format1 Network site license1 March 2016 0002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people Electronic format1 Network site license1 March 2016 0003ISO 9001:2008 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people Electronic format1 Network site license1 March 2016 1001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people Electronic format1 Network site license1 March 2017 1002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 people Electronic format1 Network site license1 March 2017 1003ISO 9001:2008 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 people NOTE: This Line Item WILL NOT be renewed after this option is exercised Electronic format1 Network site license1 March 2017 2001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 peopleElectronic format1 Network site license1 March 2018 2002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 peopleElectronic format1 Network site license1 March 2018 3001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 peopleElectronic format1 Network site license1 March 2019 3002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 peopleElectronic format1 Network site license1 March 2019 4001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 peopleElectronic format1 Network site license1 March 2020 4002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 peopleElectronic format1 Network site license1 March 2020 5001ISO 9001:2015 Multi-user Site license for 6 Centers, 8 simultaneous users, for 300 peopleElectronic format1 Network site license1 March 2021 5002ISO 15378:2015 Multi-user Site license for 1 Center 6 simultaneous users and 100 peopleElectronic format1 Network site license1 March 2021 14.ACRONYMS. A.CO - Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. B.COR - Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. C.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. D.VAMC - Department of Veterans Affairs Medical Center E.NMVAHCS - New Mexico Veterans Affairs Healthcare System
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25816N0193/listing.html)
Document(s): Attachment; File Name: VA258-16-N-0193 VA258-16-N-0193_3.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2557863&FileName=VA258-16-N-0193-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2557863&FileName=VA258-16-N-0193-000.docx; File Name: VA258-16-N-0193 TP01 QUALITY ASSURANCE SURVEILLANCE PLAN - 01-11-12.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2557864&FileName=VA258-16-N-0193-001.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2557864&FileName=VA258-16-N-0193-001.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: VA CSPCRPCC;2401 Centre Avenue, SE;Albuquerque, NM; Zip Code: 87106-4180
Record: SN04019714-W 20160214/160212234616-134913b01b3369ce42bd595af958c20d (fbodaily.com)
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70 -- VA258-16-N-0193 ISO 9001 License - Attachment