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Frequently Asked Questions (FAQs)

Where do I start to get accredited?
How can I get help?
What happened to NELAC, NELAP?
What kind of records do I need to keep?
Does everything have to be perfect in order to get accredited?
I have a suggestion for improving a TNI or NELAC Standard, what can I do?
What do I do if I disagree with an audit finding in my laboratory?
If I get accredited for pH only, can I say my lab is NELAC accredited?


Where do I start to get accredited?

Review the Flow Chart TNI has developed to help you. Review the list of recognized Accreditation Bodies.

If your laboratory is located within one of these 12 states you must go to that state for accreditation. If your laboratory is in another state or country, you can choose to apply to any state. But, be careful of these facts:

- Some states only offer accreditation in some areas, e.g., only drinking water.
- Some states will not accredit out-of-state laboratories.

Review the scope of the accreditation program of each state relative to your scope of services and select a state to apply to for primary accreditation.

Read the state-specific rules and regulations for how to apply within that state.

Read the 2003 NELAC Standards, especially Chapters 2-5 and implement a program to comply with the requirements.

Note: For laboratories that have never been accredited, this is usually a 12-18 month process.


How can I get help?


There are several ways to find help.

First, the TNI web site has an accreditation help center that has a good start with a Quality Manual template, and SOP templates. It will be populated with more and more good stuff as the year goes on.

Secondly, there are private consultants to help you through the whole thing. Look through the members directory for consultants.

Third, join TNI. There are many members who love to share their experiences!

Fourth, attend the biannual conferences where everyone is available to discuss issues and concerns.

Fifth, call your Accreditation Body (the state that you are going to get accreditation from) and ask.

What happened to NELAC, NELAP?

The National Environmental Laboratory Accreditation Conference (NELAC) was established on February 16, 1995 by State and Federal officials as an accreditation standards setting organization. The primary objective of NELAC was to develop and adopt laboratory accreditation standards to support a National Environmental Laboratory Accreditation Program (NELAP). NELAC was established as a voluntary program for States because of the absence of existing Congressional authority to establish a Federal accreditation program. The USEPAs initial intentions were an eventual transition to a fiscally self-sufficient program.

Initially, eleven (11) states received recognition as NELAP accrediting authorities. The goal of NELAP was to unify existing State and Federal accreditation standards through a cooperative process between various states and other governmental agencies. Standards approval authority was limited to representatives of State and Federal agencies.

Two significant events hastened the transition to self-sufficiency. The National Technology Transfer and Advancement Act (NTTAA) of 1996, which is mandatory for Federal agencies, increased the reliance of Federal agencies on voluntary consensus standards. Federal agencies were directed to adopt private sector standards, wherever possible, in lieu of creating proprietary, non-consensus standards. The revised OMB Circular A-119 of February 1998 established policies on Federal use and development of voluntary consensus standards and on conformity assessment activities.

NELAC did not meet the OMB Circular A-119 definition of a voluntary consensus organization. In 2002, they amended their Constitution and By-Laws to change the function of the conference to a standards adoption body only, receiving and considering standards that have been developed by standards development organizations that use a consensus process as defined in OMB Circular A-119. NELAP was unaffected by this change.

In 2001, the Institute for National Environmental Laboratory Accreditation (INELA) was formed with a mission of developing OMB A-119 compliant consensus standards for NELAC and other organizations to use. Standards development transitioned from NELAC to INELA in 2002 when the NELAC Constitution and By-Laws were amended.

In 2005, the USEPA initiated a five-year plan to transition NELAC into a self-sufficient program. This was accomplished on November 6, 2006 when The NELAC Institute (TNI) was created which recombined accreditation standards development and laboratory accreditation within the same organization.

The activities of NELAC and NELAP were systematically transitioned into TNI. NELAC remained an active conference until all previously existing functions were transitioned. NELAP was transitioned to TNI late in 2007 and now exists as a Board of accreditation bodies within the organization. Their objective is to establish and implement a program for the accreditation of environmental laboratories including the formal recognition of accreditation bodies, the adoption of acceptance limits for proficiency testing, and the adoption of the laboratory accreditation system developed by the Laboratory Accreditation System Committee (LASC). To ensure that the program is implemented effectively and to address the needs of the stakeholder community, the NELAP Board is expected to work in cooperation with other key committees within TNI.

In January 2008 NELAC officially discontinued operations following the successful transition of all program elements to TNI.

 

What kind of records do I need to keep?

All quality records (any documentation that may affect the quality of the data is considered a quality record) must be kept for a minimum of 5 years. In addition to the laboratory QA manual and SOPs, these records include, but are not limited to:

  • laboratory project files (procurement documents, correspondence, project quality plans)
  • log-in, sample tracking and handling records (including sending out bottles/preservatives for sampling);
  • sample preparation records (digestion/extraction logs);
  • traceability records for all standards and reagents;
  • all records related to sample analysis (instrument maintenance logs, calibration files, analysis logs/bench sheets, raw data (instrument output), and worksheets);
  • records associated with data review and reporting (review checklists, data and QC summary forms, LIMS reports, and client data reports);
  • audit results and regulatory compliance records;
  • training files (DOCs, certifications, transcripts, any additional training); and
  • miscellaneous QA records (refrigerator temperature logs, annual balance service, balance weight, thermometer, and pipette checks, and LOD/LOQ summaries).


Does everything have to be perfect in order to get accredited?

  • The accreditation process is stepwise and iterative within some steps in some cases. So not everything has to be perfect to start. However, the application has to eventually be complete and any deficiencies with it, such as with the quality manual, need to be addressed and fixed before the next step can happen.
  • The lab needs to satisfactorily participate in two proficiency tests for the relevant fields, one of which must have occurred with the six months immediately preceding the lab's application.
  • Some labs need more than two studies, but the lab needs to get 2 of the most recent past 3 studies scored satisfactory for the applied FOAs in order to be granted approval.
  • Then there is the on-site assessment. Most labs usually have some deficiencies to correct. The lab will have up to two responses after which, if satisfactory, final approval is granted.


If I have a suggestion for improving a TNI or NELAC Standard, what can I do?

The TNI standards are developed through an open consensus process. This means any TNI member can have meaningful input into the development and approval of all standards. It is really up to each individual how much they want to be involved. The standards development process is described in detail in the "Procedures Governing Standards Development" on the TNI Website, and the following is a summary of that process. First, any member who doesn't like an existing standard or who believes a new standard should be developed can provide input to the Expert Committees (EC), who may then develop a Working Draft Standard (WDS) for consideration and public discussion by the membership. As a result of that input the ECs appropriately modify the WDS to produce a Voting Draft Standard (VDS).

Every member has an equal voice in voting, and may submit comments that have to be resolved by the ECs before the VDS can pass to become the final TNI Standard.

 

What do I do if I disagree with an audit finding in my laboratory?

You have to go to the Accreditation Body (the state you applied to). You cant go to TNI. However, if the TNI standard is being misinterpreted, that is a TNI issue that should be brought up at the biannual meeting in the Assessment Forum session. You may also complete a Standards Interpretation Request.

 

If I get accredited for pH only, can I say my lab is NELAC accredited?

Yes, but only for pH by the analytical method tested.