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This is a Performance Work Statement (PWS) for annual ISO 17025 accreditation services for the Biological Operations Laboratory at Aberdeen Proving Ground – Edgewood Area, located in Building E3401.

The contractor shall provide on-site and off-site assessments of the laboratory and management system in accordance with ISO/IEC 17025:2017 standards. On-site assessments are required every other year in years 1, 3, and 5, while off-site assessments occur in years 2 and 4. Following each assessment, the contractor must deliver a detailed assessment report identifying any deficiencies with required correction timeframes. Upon successful remediation of deficiencies, the contractor shall issue a Certificate of Accreditation and accompanying Scope of Accreditation certificate. The contract period consists of a base year plus four one-year options, with performance occurring at Aberdeen Proving Ground, Maryland. All contractor personnel must possess minimum qualifications including formal accreditation/auditing training and at least one year of direct experience performing accreditation/auditing to ISO 17025 standards. Personnel must provide proof of training before the contract effective date. The contractor shall work independently as a non-government agent and comply with all applicable federal and local safety regulations, as well as Army security requirements including background checks, personal identity verification (FAR clause 52.204-9), and installation access procedures. A Quality Assurance Surveillance Plan is attached for government oversight of contractor performance.

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PERFORMANCE WORK STATEMENT

Annual ISO 17025 Accreditation of Biological Operations Laboratory at Aberdeen Proving Ground

1.0 SCOPE. The contractor shall provide all personnel, support the Biological Operations Laboratory as defined in this Performance Work Statement (PWS). The services to be conducted by the contractor are to include on- and off-site assessments of the laboratory and management system located at DEVCOM-CBC Building E3401, Aberdeen Proving Ground – Edgewood Area.

1.1 Background. Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence. The criteria are based on the internationally accepted standard (ISO/IEC 17025) requirements developed with regulators and specifiers. Laboratory accreditation bodies use the ISO/IEC 17025 standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test results.

These factors include technical competence of staff, validity and appropriateness of test methods, calibration and maintenance of test equipment, and quality assurance of test data. Laboratory accreditation to ISO/IEC 17025 covers the same quality management system principles that are addressed in ISO 9001 registration.

Successful accreditation inspires customer confidence and minimizes customer risk knowing the laboratory meets certain standards.

1.2 Objective. The objective of this contract is to provide a yearly assessment and audit of the laboratory and management system and accredit the Biological Operations Laboratory to the ISO 17025 standard.

2.0 APPLICABLE DOCUMENTS.

2.1 ISO 17025:2017 standard found at www.iso.org.

3.0 REQUIREMENTS. The contractor, as an independent contractor and not as an agent of the Government, shall perform the following work:

3.1 Offsite assessment. The contractor shall perform an off-site assessment of the Biological Operations Laboratory management system in accordance to the ISO 17025 standard every other year (years 2 and 4). At the conclusion of the assessment, the contractor will deliver an assessment report detailing any deficiencies found during the assessment, along with the time frame required for correction. Upon successful completion of those deficiencies, the contractor shall deliver a Certificate of Accreditation and accompanying Scope of Accreditation certificate.

3.2 Onsite assessment. The contractor shall perform an on-site assessment of both the Biological Operations

Laboratory and its management system in accordance to the ISO 17025 standard every other year (years 1, 3 and 5). At the conclusion of the assessment, the contractor will deliver an assessment report detailing any deficiencies found during the assessment, along with the time frame required for correction. Upon successful completion of those deficiencies, the contractor shall deliver a Certificate of Accreditation and accompanying Scope of Accreditation certificate.

4.0 TECHNICAL REQUIREMENT.

4.1 The contractor, as an independent contractor and not as an agent of the government, shall provide sufficient personnel possessing the skills, knowledge, training, and experience to perform the required tasks. All training, education and certification will be accomplished outside of this contract.

4.2 All contractor personnel performing services under this contract must be contractor trained in accreditation/auditing before the effective date of this contract. Contractor shall provide proof of this training to the appropriate accreditation standard specified in the contract. Personnel must have a minimum of one (1) year experience performing accreditation/auditing to the appropriate accreditation standard covered in the contract in accordance with the PWS.

5.0 PERIOD OF PERFORMANCE. Base Year and Four (4) One (1) Year Options.

6.0 PLACE OF PERFORMANCE. Aberdeen Proving Ground, MD.

7.0 SAFETY CONSIDERATIONS. While on–site the contractor will follow all applicable Federal and Local regulations. Specifically, the contractor will abide by all Biological Operations Laboratory specific safety and health requirements for entry into and assessment of the Biological Operations Laboratory facilities/laboratories.

8.0 SECURITY CONSIDERATIONS. Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. Contractor and all associated subcontractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. For contractors that do not require a CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and processes using the National Crime Information Center Interstate Identification Index (NCIC- Ill) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/ facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

9.0 Quality Assurance Surveillance Plan (QASP). SEE ATTACHED

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