Application Process
A prospective laboratory should begin by completing the online application for accreditation. USLPP will provide a prospective laboratory with the necessary requirements to complete the accreditation process.
Requirements Prior to Accreditation
The most up-to-date copy of ISO / IEC 17025:2005 must possessed by the laboratory. The laboratory is required to maintain a management system that is in compliance with all applicable requirements of this standard. One 17025 Internal Audit and Management Review is required to be performed before the first on-site evaluation is performed.
- Completed Laboratory Quality Manual
- ISO/IEC 17025:2005 Document
- Minimum of One Internal Audit completed
- Minimum of One Management Review completed
Proficiency Testing
Laboratories that are accredited by USLPP must participate in scheduled Proficiency Testing is compliance with ILC/PT (ISO Guide 43). The proficiency testing the laboratory chooses to participate in must be approved by USLPP to be considered appropriate for the accreditation requirements. The PT fees are not included in your application/accreditation fees and will need to be paid separately.
Reporting Detection Limits
Laboratories will need to have guidelines and calculation for limit of detection based on the specific analysis protocol. USLPP will need to be able to review and apply the limit of detection as described by the laboratory. Where required, reporting detection limits will be review by a USLPP representative to confirm compliance.
Specific Accreditation Outline
A formal document will be provided to the prospective laboratory with specific accreditation guidelines. The guidelines for accreditation will be particular to the functions of the prospective laboratory. This document will specify the terms of the accreditation in detail.
The accreditation is based on the functions of the laboratory at the time of submitting their application. Shall the prospective laboratory modify their scope of analysis a written request for modification in accreditation will need to be submitted (USLPP form 6C) to your USLPP representative. An additional on-site assessment may be required depending on specific situation. The USLPP representative assigned to the file will decide on the best course of action based on the significance of the modification. Additional fees may be added to the fee structure due to the modification.
On-Site Assessment
The laboratory will have an on-site accreditation representative which will be matched with the laboratory’s specific field of analysis. The on-site representative will be assigned with the confirmation of the requirements met. USLPP Form 3B will need to be filled out and all supporting documents will need to be received and reviewed by your USLPP representative prior to scheduling the on-site assessment. During the on-site assessment, the accreditation guidelines specific to the laboratory will be confirmed and/or tested to ensure compliance. In order to complete the accreditation process all areas of the laboratory will need to be fully accessible to the USLPP representative assigned to the file.
Issuing Accreditation
Once the on-site assessment has been completed and the USLPP representative signs off on the specific accreditation outline, official accreditation can be issued. The accreditation will be granted for the disclosed and confirmed laboratory protocols in compliance with the USLPP requirements.
Renewal and Maintenance of Accreditation
Annual renewal applications are required. The USLPP representative assigned to your company will conduct a review of records including but not limited to the proficiency testing, ISO/IEC 17025 compliance, quality control internal audits, and management reviews. USLPP representatives may schedule a short on-site assessment if required to complete the renewal.
Every three years a full assessment is performed, which will take place of the normal renewal process. USLPP retains the right to perform these renewals within the detailed guidelines of the accreditation outline specific to the laboratory.
Reporting Detection Limits
Laboratories will need to have guidelines and calculation for limit of detection based on the specific analysis protocol. USLPP will need to be able to review and apply the limit of detection as described by the laboratory. Where required, reporting detection limits will be review by a USLPP representative to confirm compliance.
Pricing
For current Accreditation pricing, please email us at contact@nbih.org
