98955 2 2022 ISO External Audit SOW_final.docx

SECTION C- DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. General

1.1 Background

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS), Center for Veterinary Biologics (CVB) seeks services for ISO 9001:2015 Certification of Registration services. This is a non-personnel services contract to provide certification and audit services. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

The USDA, APHIS, VS, CVB is committed to maintaining scientific excellence by continual improvement of the Center's program for evaluating, licensing, inspecting, and monitoring veterinary biological products. Development and continuing formal registration of a Quality Management System (QMS) confirms to the public and to the animal health world, both on a national and on an international basis, that the CVB is committed to a continually improving quality program. The CVB was initially certified to the ISO 9001 standards September 4, 2007, and is currently registered to these standards through August 25, 2022.

The CVB is located on the campus of the National Centers for Animal Health (NCAH).

1.2 Objective(s)

The objective is to contract with an internationally recognized accredited Registrar for recertification of the CVB's QMS to ISO 9001:2015 standards, with the option for two surveillance audits at yearly intervals. When it is determined that the CVB's QMS continues to meet the requirements of the current version of ISO 9001, the Registrar will issue a certificate to the CVB documenting their satisfactory compliance with the ISO 9001 Standard.

1.3 Scope of Work

Scope of the CVB Quality Management System The USDA/APHIS/VS/Center for Veterinary Biologics (CVB) is responsible for implementing the provisions of the Virus-Serum-Toxin Act (VSTA) to ensure that veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. The CVB program impacts USDA-licensed vaccines produced and distributed both in the US and Internationally. Much of the information dealt with in the CVB program is protected under the Trade Secrets Act, 18 U.S. Code § 1905, and confidentiality is critical.

The CVB is structured into 3 functional areas: Product Licensing, Product Testing, and Inspection & Compliance. These 3 functional areas are linked by and interact through a process approach system for Quality Management to assure and improve both the quality of product and the satisfaction of the customer.

CVB Product Licensing To sell or distribute either a domestically produced or imported veterinary biological product in the US, a biologics manufacturer must apply for, be granted, and maintain various kinds of licenses or permits. These licenses or permits may include a Veterinary Biologics Establishment License for a manufacturing facility, a Veterinary Biological Product License for a domestically produced product and/or a Veterinary Biological Product Permit for biological products imported into the U.S.

The review staff at the CVB is responsible for reviewing license and permit applications and assuring that the submitter has supplied all of the required documentation, and that the documentation provided is scientifically sound and in compliance with Federal laws and regulations. The Reviewer may seek additional review of study protocols and test or study results from other agent experts at the CVB. With certain agents, a Reviewer may determine that a Risk Analysis is warranted to assess the risks associated with the release of a live organism into the environment.

Additionally, the USDA has the authority to make and issue regulations to prevent the preparation and marketing of worthless, contaminated, dangerous, or harmful veterinary biologics. The licensing staff is responsible for the process of developing licensing and permit requirements, and for the process of developing and publishing program policy and procedures in regulations, standard requirements, memoranda, and notices.

CVB Product Testing The CVB Laboratory staff provides technical, laboratory expertise to the CVB program by conducting a variety of tests on master seeds, master cells, pre-license product, and post-license product. These tests are requested by the Licensing staff or by the IC staff. The results of these tests are used to assist in the determination of the fitness of a biological product for licensure, for marketing, and also for investigative purposes.

The basic test systems/methodologies for the majority of tests performed on conventional biological products at the CVB are specified in the Standard Requirements (SRs) found in the title 9, Code of Federal Regulations (9 CFR), in published Supplemental Assay Methods (SAMs) developed by the laboratory, in firm's Outlines of Production or Special Outlines, or in CVB test protocols. Non-standard tests are developed and performed as necessary on novel products or in unique situations for which there are no standardized tests available.

In addition, the CVB Laboratory staff produces and tests specific references and reagents, both for in-house testing, and to supply to biologics firms for use in required tests.

CVB Inspection and Compliance The Inspection and Compliance (IC) Unit is responsible for ensuring that veterinary biological products are prepared, maintained, and distributed in compliance with the Virus-Serum-Toxin Act and associated Federal regulations.

Licensees and Permittees of biological products are required to submit to the CVB a summary of all testing performed by them on each serial or subserial of product in order to obtain permission to sell or further distribute the product. Under certain circumstances, licensees may request additional product considerations, such as extensions of dating or reprocessing.

Licensees and distributors request Export Certificates and Certificates of Licensing and Inspection from APHIS to assist with the export and sale of U.S. licensed veterinary biological products to foreign countries. The CVB-IC is responsible for reviewing these requests and issuing these Certificates.

Inspections (in-depth, follow-up, and special) are conducted by Biologics Specialists at biologics manufacturing facilities and distribution sites to determine if the products have been produced and tested by competent people using acceptable facilities, equipment, and methods. There are approximately 121 US and 22 foreign inspection facilities and sites.

The CVB-IC is also responsible for conducting Veterinary Biological Investigations (VBI) to prove or disprove violations of the VSTA when a credible complaint or concern is raised regarding a licensed or an unlicensed firm or product.

The current CVB organizational chart identifies approximately 122 program positions.

1.4 Period of Performance

Recertification of the CVB's QMS to ISO 9001:2015 standards, with the option for two surveillance audits at yearly intervals. The period of performance shall be for one (1) Base Year of 12 months and two (2) 12-month option periods,

1.5 Place of Performance

The CVB is located at the NCAH, 1920 Dayton Avenue, Ames, IA 50010.

2.0 Specific Requirements/Tasks

2.1 The Registrar shall provide documentation of current and continual accreditation by an IAF (International Accreditation Forum) member and signatory; provide documentation that their certificate of accreditation for ISO 9001 includes a unique, physical street location; and provide documentation demonstrating experience in providing ISO 9001:2015 certification services in a health sciences setting, especially as related to veterinary specialties. This documentation is to be included in the proposal.

2.2 The Registrar shall provide documentation confirming that all auditors employed in providing the services required of this contract have Exemplar Global certification (previously RABQSA, the Registration Accreditation Board and Quality Society of Australasia), or an equivalent certification. (Del 1)

2.3 The Registrar shall submit the credentials of all auditors employed in providing the services required of the contract documenting experience working successfully with other governmental agencies within 10 calendar days of award. (Del 2)

2.4 The Registrar shall submit a detailed work plan outlining the proposed audit/certification process within 10 calendar days of award; including, but not limited to: (Del 3)

2.4.1 The process and timeframes for the on-site audits, including entry and exit briefings, and draft deficiency reports

2.4.2 Time frames associated with the initial audit reports, the final audit reports, certifications, and registrations

2.4.3 The media (hard copy, electronic, etc.) through which official information (audit reports, etc.) will be provided to the CVB.

2.4.4 List of proposed surveillance audit dates or timeframes, such that there is no lapse (where possible) in certification for the CVB (currently certified through August 25, 2022) provided that the CVB's QMS conforms to the ISO 9001:2015 Standards.

2.5 Within 10 calendar days after award the Registrar shall identify a qualified individual to coordinate the audit process, including selection of the most appropriate auditor(s) and determination of the audit dates and audit report timeframes, in consultation with the CVB Quality Management Leader. This individual shall also work with the CVB Quality Management Leader when matters of clarification arise regarding the audit process or corrective actions, and in the resolution of disagreements should disputes arise regarding the interpretation of the most current ISO 9001 Standard and the applicability of the CVB QMS. (Del 4)

2.6 The auditor(s) shall recognize and follow all safety and security requirements in place while working at the laboratory location. (Del 5)

2.7 All information regarding the CVB's QMS and all information and results obtained through the reviews/audits shall be maintained as confidential and shall not be shared by the Registrar/auditors/assessors with anyone outside of the CVB, with the exception of that information required for certification/registration. The Registrar's policy for maintaining confidentiality and managing confidentiality breaches, including the timeframe for alerting entities whose information has been breached or misdirected, shall be provided. (Del 6)

2.8 An oral report of the findings shall be provided to the CVB management by the auditor at the conclusion of the on-site audit, and a written report shall be provided no later than 30 calendar days following the conclusion of the on-site audit. (Del 7)

2.9 Upon completion by the CVB of a satisfactory assessment, the Registrar shall provide, within 30 calendar days, a certificate stating that the CVB QMS is in compliance with the most current version of ISO Standard 9001. (Del 8)

2.10 The Registrar shall comply with the requirement that all auditors employed providing the services required of this contract shall sign a VS Memo 800.2 regarding Confidential Business Information on or before the day of arrival at the NCAH. (Del 9)

3.0 Deliverables

Deliverables are as described in Section 2.0 (Specific Requirements/Tasks), above, and as summarized in Section 8.0 (Performance Requirements Summary), below.

4.0 Meetings

Meetings will be held as outlined in the work plan for performing the proposed audit/certification activities or as needed to communicate key information related to the audit/certification process.

5.0 Required Travel and Other Direct Costs (ODCs)

The government will award a Firm Fixed Price Purchase Order.

6.0 Government Furnished Property/Equipment/Information

The Registrar shall be responsible for safeguarding all government equipment, information and property provided for Registrar use.

7.0 Special Instructions

7.1 Security Requirements

7.1.1 Personnel Security Requirements: The Registrar shall comply with the requirement that all auditors employed providing the services of this contract shall meet the NCAH security clearance requirements for access.

7.1.2 Physical Security Requirements: The Registrar shall comply with the requirement that all auditors employed providing the services required of this contract shall sign a VS Memo 800.2 regarding Confidential Business Information on the day of arrival at the NCAH. (See Del 8)

7.2 Other

7.2.1 Type of Contract: The government will award a Firm Fixed Price Purchase Order.

7.2.2 The CVB shall designate a representative(s) to schedule the audit dates; to escort the auditor(s) and coordinate the on-site aspects of the review and auditing; to coordinate audit finding responses; and to verify completion of the registration process.

7.2.3 Contracting Officer Representative (COR): The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; maintain written and oral communications with the Contractor concerning technical aspects of the contract; monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; oversees availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

7.2.4 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

7.2.5 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests* (OCI). The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor's mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

*Described in the Federal Acquisition Regulations System, subpart 9.5

8.0 Performance Requirements Summary (PRS)

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

PRS # 1 (Del 1)

2.2 The Registrar shall provide documentation confirming that all auditors employed in providing the services required of this contract have Exemplar Global certification (previously RABQSA, the Registration Accreditation Board and Quality Society of Australasia), or an equivalent certification.

PRS #2 (Del 2)

2.3 The Registrar shall submit the credentials of all auditors employed in providing the services required of the contract documenting experience working successfully with other governmental agencies.

PRS # 3 (Del 3)

2.4 The Registrar shall submit a detailed work plan outlining the proposed audit/certification process including, but not limited to:

2.4.1 The process and timeframes for the on-site audit, including entry and exit briefings, and draft deficiency reports

2.4.2 Time frames associated with the initial

audit reports, the final audit reports, certifications, and registrations

2.4.3 The media (hard copy, electronic, etc.)

through which official information (audit reports, etc.) will be provided to the CVB.

2.4.4 List of proposed surveillance audit dates or timeframes, such that there is no lapse (where possible) in certification for the CVB (certified through August 25, 2022) provided that CVB's QMS conforms to the ISO 9001:2015 Standards.

The proposed work plan must be provided within 10 calendar days after contract award.

PRS # 4 (Del 4)

2.5 The Registrar shall identify a qualified individual to coordinate the audit process, including selection of the most appropriate auditor(s) and determination of the audit dates and audit report timeframes, in consultation with the CVB Quality Management Leader. This individual shall also work with the CVB Quality Management Leader when matters of clarification arise regarding the audit process or corrective actions, and in the resolution of disagreements should disputes arise regarding the interpretation of the most current ISO 9001 Standard and the applicability of the CVB QMS.

PRS # 5 (Del 5)

2.6 The auditor(s) shall recognize and follow all safety and security requirements in place while working at the laboratory location.

The auditor(s) shall follow all safety and security requirements while working at the laboratory location.

PRS # 6 (Del 6)

2.7 All information regarding the CVB's QMS and all information and results obtained through the reviews/audits shall be maintained as confidential and shall not be shared by the Registrar/auditors/assessors with anyone outside of the CVB, with the exception of that information required for certification/registration. The Registrar's policy for maintaining confidentiality and managing confidentiality breaches, including the time frame for alerting entities whose information has been breached or misdirected, shall be provided.

PRS # 7 (Del 7)

2.8 An oral report of the findings shall be provided to the CVB management by the auditor at the conclusion of the on-site audit, and a written report shall be provided no later than 30 calendar days following the conclusion of the on-site audit.

PRS # 8 (Del 8)

2.9 Upon completion by the CVB of a satisfactory assessment, the Registrar shall provide, within 30 calendar days, a certificate stating that the CVB QMS is in compliance with the most current version of ISO Standard 9001.

Within 30 calendar days, a certificate stating that the CVB QMS is in compliance with the most current version of ISO Standard 9001.

PRS # 9 (Del 9)

2.10 The Registrar shall comply with the requirement that all auditors employed providing the services required of this contract shall sign a VS Memo 800.2 regarding Confidential Business Information on the day of arrival at the NCAH.

Signed VS Memo

800.2 regarding Confidential Business Information· on the day of arrival.

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