SUPPLEMENTARY INFORMATION:

Background

The United States Department of Homeland Security (DHS) requested that NIST establish a laboratory accreditation program for laboratories that test radiation detection instruments used in homeland security applications. In response to the request from DHS, and after consultation with interested parties through public workshops and other means, the National Voluntary Laboratory Accreditation Program (NVLAP) has established an accreditation program for laboratories that test radiation detection instruments.

This notice is issued in accordance with NVLAP procedures and general requirements, found in Title 15 Part 285 of the Code of Federal Regulations.

Technical Requirements for the Accreditation Process

NVLAP accreditation criteria are established in accordance with the Code of Federal Regulations (CFR, Title 15, Part 285), NVLAP Procedures and General Requirements. NVLAP accreditation is in full conformance with the standards of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), including ISO/IEC 17025.

Accreditation is granted to a laboratory following successful completion of a process, which includes submission of an application and payment of fees by the laboratory, an on-site assessment by technical experts, resolution of any non-conformities identified during the on-site assessment, and participation in proficiency testing. The accreditation is formalized through issuance of a Certificate of Accreditation and Scope of Accreditation.

General requirements for accreditation are given in NIST Handbook 150, NVLAP Procedures and General Requirements. The specific technical and administrative requirements for the program for accreditation of laboratories that test radiation detection instruments are given in NIST Handbook 150-23, Homeland Security Applications—Radiation Detection Instruments. Laboratories must meet all NVLAP criteria and requirements in order to become accredited. To be considered for accreditation, the applicant laboratory must provide a completed application to NVLAP, pay all required fees, agree to conditions for accreditation, and provide a quality manual to NVLAP (or a designated NVLAP assessor) prior to the beginning of the assessment process.

Application Requirements

(1) Legal Name and full address of the laboratory;

(2) Ownership of the laboratory;

(3) Authorized Representative's name and contact information;

(4) Names, titles and contact information for laboratory staff nominated to serve as Approved Signatories of test or calibration reports that reference NVLAP accreditation;

(5) Organization chart defining relationships that are relevant to performing testing and calibrations covered in the accreditation request;

(6) General description of the laboratory, including its facilities and scope of operations; and

(7) Requested scope of accreditation.

In addition, the laboratory shall provide a copy of its quality manual and related documentation, where appropriate, prior to the on-site assessment. NVLAP will review the quality management documentation and discuss any noted nonconformities with the Authorized Representative before the on-site visit. Laboratories that apply for accreditation will be required to pay for NVLAP fees and undergo on-site assessment and shall meet proficiency testing requirements before initial accreditation can be granted.

PRA Clearance

This action contains a collection of information requirements subject to review and approval by the Office of Management and Budget (OMB) under ( printed page 15865) the Paperwork Reduction Act (PRA) of 1995. Collection activities for NVLAP are currently approved by OMB under control number 0693-0003. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information unless it displays a currently valid OMB Control Number.