Lab Establishment

ISO/IEC 17025

General requirements for the competence of testing and cablibration laboratories (ISO/IEC 17025) sepcifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed uing standard methods, non-standard methods, and laboratory-developed methods.

ISO/IEC 17025 is applicable to all laboratories regardless of the  number of personnel or the extent of the scope of the testing and/or calibration activies. When a laboratory does not undertake one or more of the activires covered by ISO/IEC 17025, such as sampling and design/development of new methods, the requirements of those clauses do not appliy.

ISO/IEC 17025 is for use by laboratories in developing their management system for quality, administractive and technical operations. laboratory customers, regulatory authorities and accrediation bodies may also use it inconfirming or recognized the competence of laboratories.

USIS Inc. provides consutation services to those whom wish to establish laboratories which comply with ISO/IEC 17025.

HandBook 150-17

NIST Handbook 150-17 presents technical requirements and guidance for the accrediation of laboratories under the National Volunatory Accrediation Program (NVLAP) Cryptographic and Security Testing (CST) Laboratory Accreduation Program (LAP), formoerly known as Cryptographic Module Tesing. The Handbook is intended for information and use by accrediated laboratories assessor conducting on-site visit, laboratories seeking accrediation, laboratory accrediation systems, users of laboratory services and other needing information on the requirements for accrediation under the program.

If you wish to establish a CST Lab and been accrediated, the following process are needed

  1. Quality manual evaluation - when the laboratory is applying for initial accrediation, the assessor(s) must first determine that the management system meets the requirements.
  2. Proficiency written exam - If the assessor(s) determine that the management system meets the requirements, a written exam is then provided to the applicant laboratory, with a 5-business-day deadline for response. The laboratory shall score greater than 75% correct respnses for the accreditation process to continue and the on-site visit to be schedules.
  3. On-site visit and proficiency/round-table quize - Once the written exam is passed, an on-site visit is scheduled at a mutually agreed date and time. During the on-site visit, the laboratory's personnel will be quizzed and team dynamics observed for proficiency and experitse in the technical area for which the laboratory is applying for accreditation. The laboratory staff shall provide greater than 75% correct responses for the accreditation process to continue.
  4. Proficiency artifact and/or operational exam - Once the assessor(s) determines that the laboratory has satisfactorily completed the on-site visit, a proficency artifact and/or operational exam is provided to applicant laboratory. The laboratory shall complete the test  by the scope-dependent deadline.

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