Iso 17025 Accredited Labs List In India
Iso 17025 Accredited Labs List
Iso Accredited Labs

The U.S. Food and Drug Administration (FDA) is proposing to establish a program for the testing of food by accredited laboratories as required by the FDA Food Safety Modernization Act (FSMA). The laboratory accreditation program, once established, will require that the testing of food in certain circumstances be conducted by laboratories that voluntarily become accredited under this program.

Accreditation is the formal recognition that an organisation is competent to perform specific processes, activities, or tasks which are detailed in a scope of accreditation in a reliable, credible and accurate manner. ISO 17025 is the international standard on which accreditation is based and sets out the requirements that laboratories must meet. List of Accredited Laboratories According to ISO/IEC 17025 To see the scope of any accredited laboratory, please click at its accreditation number C A L I B R A T I O N L A B O R A T O R I E S. PJLABS offers Laboratory Accreditation in ISO 17025, DOD ELAP, EPA NLLAP, CPSC, Energy Star, FSMO, and Food and Medical Marijuana Testing. Search PJLA’s Listing of Accredited Labs Skip to primary navigation. The accreditation bodies that are signatories to the ILAC MRA have been peer evaluated in accordance with the requirements of ISO/IEC 17011 to assess and accredit conformity assessment bodies according to the relevant international standards, including calibration laboratories using ISO/IEC 17025, testing laboratories using ISO/IEC 17025, medical testing laboratories using ISO 15189. ISO/IEC 17025 Laboratory Accreditation ISO/IEC 17025 accreditation can help move your organization toward global recognition, consistent operations, and a competitive advantage. ANAB assessors evaluate the laboratory’s ability to produce precise, accurate test and calibration data.

Laboratories that become accredited under this program will be required to follow model standards and will be subject to appropriate oversight. Establishing such a program will help FDA ensure the safety of the U.S. food supply and protect U.S. consumers by helping ensure appropriate oversight of certain food testing that is of importance to public health. It will also ensure that the testing is done in accordance with appropriate model standards which will help produce consistently reliable and valid test results.

Key Features

Overview
- establish the framework and requirements for accreditation bodies (ABs) seeking recognition by the FDA, as well as requirements for laboratories seeking accreditation;
- incorporate by reference existing voluntary consensus standards for accreditation bodies and laboratories that industries are familiar with; and
- require food testing by accredited laboratories in the following specific circumstances, consistent with FDA’s FSMA mandate:
  - to provide evidence to support the admissibility of imported food into U.S. commerce;
  - under an import alert through successful consecutive testing;
  - to address an identified or suspected food safety problem and presented to FDA as part of evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;
  - in response to a food testing order (a new procedure proposed by this rule to address an identified or suspected food safety problem); and
  - to comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests for shell eggs, bottled water, and sprouts)
- require results of the food testing conducted under this program to be sent directly to the FDA, as FSMA specifies;
- establish a pathway for an accredited laboratory with a successful track record in the FDA program to streamline their submissions;
- enable FDA to monitor program activities and to revoke an AB’s recognition or revoke a laboratory’s accreditation under certain circumstances, or place either ABs or laboratories on probation; and
- establish a publicly available list of recognized ABs and laboratories accredited under this program.
Requirements for Recognized Accreditation Bodies
The FDA is proposing that:
- ABs must be signatories of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement (ILAC-MRA), by which they agree to maintain conformity with ISO/IEC 17011:2017 “Conformity Assessment—Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies,” Second edition, November 2017 and ensure that all laboratories they accredit comply with appropriate laboratory standards;
  (ISO/IEC stands for the International Organization for Standardization and the International Electrotechnical Commission, which have issued voluntary international consensus standards.);
- recognized ABs take certain steps to safeguard against conflicts of interest;
- ABs follow procedures to accredit laboratories, as well as for withdrawing accreditation or limiting a laboratory’s scope of work;
- ABs follow certain requirements for submitting reports and notifications to FDA; and
- ABs follow specific requirements for maintaining records.
Requirements for Accredited Laboratories
- Accredited laboratories meet model standards. These standards require a laboratory to:
  - demonstrate they are capable of conducting each method of food testing for which each laboratory seeks to be accredited by, among other things, complying with most aspects of ISO/IEC 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories,” Third Edition, November 2017;
  - use appropriate analytical procedures and certify its reports of analysis as true and accurate;
  - establish and maintain internal quality systems;
  - establish procedures to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and,
  - assign individuals qualified by training and experience to conduct the analyses.
- Accredited laboratories submit to FDA analytical reports, either full or abridged, as applicable, for food testing conducted under this program. A full analytical report must include all original compilation of raw data, identify and describe negative and positive quality controls, and include all calculations, among other documentation. An abridged analytical report would include certain more limited information describing the analysis.
- To obtain permission to submit abridged analytical reports to FDA on an ongoing basis, accredited laboratories must not be on probation or disqualified from submitting analytical reports, and they must meet the following criteria:
  - They must submit 10 consecutive full analytical reports to FDA under this program.
  - Those submissions must include at least one full analytical report relating to each major food testing discipline in the accredited laboratory’s scope of accreditation for which it seeks to submit abridged analytical reports. (Examples of “major food testing disciplines” include microbiology, chemistry and physical.)
  - None of the consecutive full analytical reports can demonstrate any substantive material shortcoming in the food testing.
  - The consecutive full analytical reports must not contain repeated administrative deficiencies.
For more information about submitting an abridged analytical report see the Abridged Analytical Reports Flowcharts
- Examples of the types of laboratories that may be accredited under this program are private laboratories; laboratories run and operated by federal agencies, states, localities; and foreign laboratories.
- Laboratories accredited under this program will be required to establish, control, and maintain records relating to their food testing activities under this program.
- FDA may consider invalid any test results, analytical reports and related documents, or associated analyses containing deficiencies or otherwise indicating that any aspect of the food testing i

Iso 17025 Accredited Laboratories List