Quality Assurance

Quality Assurance Policy

NEL is committed to providing analytical testing services, and generating scientifically valid data of known and documented quality as well as compliance with and adherence to the NELAC, A2LA, and ISO 17025 standards.

All policies and procedures referenced in this LQAP have been established to meet the requirements of the NELAC, A2LA, and ISO 17025 standards.

It is the laboratory’s policy to conduct all projects in a timely manner using USEPA, FDA, ASTM, AOAC, and other Standard Reference Methods as well as state of the art technology/instrumentation. To achieve this end, this document was prepared and a copy distributed to each section of the Laboratory.

All personnel are required to familiarize themselves with this document and implement the policies and procedures in their work. The owners and management of NEL are committed to complying with the NELAC, A2LA, and ISO 17025 standards and to continually improve the effectiveness of the management system.

NEL is also committed to good professional practice and to the quality of its testing and calibration in servicing its customers

Media Quality Control Statement

Northeast Laboratory Services produces and packages microbiological culture media at a facility inspected by the Food and Drug Administration for compliance with the current Good Manufacturing Practices regulations for Medical Devices and Diagnostic Products, CFR 21, Part 820.

Compliance with the CLSI Standard M22-A3, Quality Assurance for Commercially Prepared Microbiological Culture Media is a criterion for release of invitro diagnostic products. Products must meet the characteristics specified in the CLSI Standard before shipment release to your laboratory.

NEL also offers customized quality control testing. Product specific organisms and growth challenge levels are available to meet specific requirements, including procedures which follow USP recommended guidelines. Sterility confirmation testing with specified temperature and duration may also be designed to meet unusual needs.

All product testing is certified on product/lot specific certificates of analysis (COA), which are available for each manufactured lot.

Your satisfaction with our service and the quality of our products is the primary goal of the NEL staff. Any questions or concerns you may have regarding NEL products should be addressed to the Quality Assurance Department (X317) or our very friendly Customer Service Department (X304).