PUBLIC NOTICE Federal Communications Commission 445 12th St., S.W. Washington, D.C. 20554 News Media Information 202 / 418-0500 Internet: http://www.fcc.gov TTY: 1-888-835-5322 DA 10-1497 August 12, 2010 Office of Engineering and Technology Provides Guidance on the Recognition of Laboratory Accreditation Bodies and Recognizes ACLASS as an Accreditation Body ET Docket No. 09-161 On September 14, 2009 the Office of Engineering and Technology (OET) identified and requested comment on certain types of information that an applicant should provide to be considered as an accreditation body of test laboratories under the Commission’s rules.1 We invited comment on (1) any information that would be useful in assessing the credentials and expertise of prospective laboratory accreditation bodies, and (2) suggestions for a streamlined set of procedures that would facilitate the recognition of future additional laboratory accreditation bodies. OET also requested comment on a request from ACLASS Accreditation Services (ACLASS), an ANSI-ASQ National Accreditation Board Company (ACLASS), to be recognized by the Commission as an accreditation body that performs accreditation of laboratories testing equipment for authorization under Parts 2, 15 and 18 of the Commission’s rules. Section 2.948 (d) of the Commission’s rules sets forth the requirements for accreditation bodies and for test laboratories,2 and specifies that any entity seeking recognition from the FCC as an accreditation body must obtain the approval of OET.3 An entity will gain OET recognition as an accreditation body based on the requirements for accreditation bodies established by the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC).4 In addition, for an applicant to function as an accreditation body for the FCC, it must be competent to assess a test laboratory’s compliance with applicable ISO/IEC standards for operating a testing laboratory and conducting tests, and of assessing the laboratory’s ability to perform testing in support of the applicable 1 Public Notice (DA 09-2049, September 14, 2009). 2 47 C.F.R § 2.948(d). 3 47 C.F.R. § 2.948(d); see also 47 C.F.R. § 0.241(f) (delegating authority to the Chief of OET to enter into agreements with the National Institute of Standards and Technology and other accreditation bodies to perform accreditation of test laboratories pursuant to section 2.948(d)). 4 Id. at § 2.948(d). The current ISO/IEC requirements for accreditation bodies are contained in ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies (2004). In 2004, ISO/IEC replaced its old set of requirements for accreditation bodies – i.e., ISO/IEC 58, Calibration and Testing Laboratory Accreditation Systems – General Requirements for Operation and Recognition, which is the set of requirements specified in Section 2.948 (d) – with ISO/IEC.17011. 2 FCC technical regulations.5 It is the responsibility of the accreditation body to review the qualifications of a test laboratory's test personnel, management systems, record keeping and reporting practices; to send recognized experts to observe testing at the laboratory; and to verify the testing laboratory’s competence to perform tests in accordance with Commission-related measurement procedures. Three parties filed comments on the type of information that applicants should provide to be considered as a recognized accreditation body of test laboratories: American Association for Laboratory Accreditation (A2LA); International Association for Radio, Telecommunications and Electromagnetics, Inc. (iNARTE); and ANSI-ASQ National Accreditation Board/ACLASS. All three parties generally agreed that the type of information identified by the Commission in the Public Notice would demonstrate an applicant’s credentials and expertise to be recognized as an accreditation body, and they made suggestions for clarifying some of the elements. Based on the comments filed in response to the September 14, 2009 Public Notice as well as its experience with the equipment authorization program and the test laboratory accreditation process, OET is providing guidance on the type of information that an applicant who desires to be recognized by the Commission as a laboratory accreditation body should provide in support of its application. An applicant must submit to the Chief of OET a letter requesting such recognition, and OET will make a determination of recognition based on the information provided in support of an application. The following types of information would provide the “best evidence” of an applicant’s credentials and qualifications to perform accreditation of laboratories that test equipment to Commission requirements, consistent with the requirements of Section 2.948 (d) of the Commission’s rules for accreditation bodies and for test laboratories: 1. Successful completion of a ISO/IEC 17011 peer review, such as being a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) or other equivalent laboratory accreditation agreement; 6 2. Experience with the accreditation of electromagnetic compatibility (EMC), radio and telecom testing laboratories to ISO/IEC 17025. This can be demonstrated by having OET staff participate in a witness audit of the accreditation body performing an assessment of an EMC/Radio/Telecom testing laboratory; or by having OET staff review the report generated by the National Institute of Standards and Technology (NIST) laboratory accreditation evaluation program conducted to support the Asia Pacific Economic Cooperation (APEC) Mutual Recognition Arrangement (MRA) for Conformity Assessment of Telecommunications Equipment.7 An applicant that offers other evidence has the burden of demonstrating that the information would enable OET to evaluate its experience with the accreditation of electromagnetic compatibility (EMC), radio and telecom testing laboratories to ISO/IEC 17025. 5 See 47 C.F.R § 2.948(d) (requiring test laboratories to comply with such ISO/IEC standards). More specifically, Section 2.948(d) requires that test laboratories be accredited based on ISO/IEC Standard 17025, General Requirements for the Competence of Calibration and Testing Laboratories. Id. 6 The ILAC Arrangement builds upon existing or developing regional arrangements established around the world. The European Cooperation for Accreditation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC) are examples of current ILAC-recognized regions with acceptable mutual recognition arrangements (MRAs) and evaluation procedures. See ILAC Arrangement at http://www.ilac.org/ilacarrangement.html. 7 Domestic laboratory accreditation bodies that successfully complete the NIST evaluation program are listed by NIST as acceptable for use by domestic laboratories seeking to be designated to foreign MRA partner economies. 3 3. Accreditation personnel/assessors with specific technical experience on the Commission equipment authorization rules and requirements; and 4. Procedures and policies developed for the accreditation of testing laboratories for FCC equipment authorization programs. In order to ensure the continued integrity of the laboratory accreditation program, OET staff will periodically review the accreditation process and maintain close coordination with each of the organizations that it has recognized to perform accreditations. OET staff will pursue opportunities to observe peer review assessments under the ILAC MRA process and to observe and/or participate in the NIST witness assessments of these laboratory accreditation bodies. This will help ensure their continued acceptable performance and provide us with information to assess periodically their credentials and expertise to maintain their status as Commission-recognized laboratory accreditation bodies. This document contains modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The OMB Control Number for this collection is 3060-0398 has been submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. Under 5 C.F.R. §1320, any agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number. The OMB control number is 3060-0398 for this information collection. For more information or questions pertaining to this document, please contact George Tannahill at (301) 362-3026, george.tannahill@fcc.gov. -OET-