A Need For Change
According to the California State Water Board, regulation prior to the implementation of the proposed TNI 2016 regulations, "were established in 1994. Over time, the requirements for operation of the accreditation program have become outdated, and criteria for determining the competency of a laboratory performing environmental testing has not kept up with the fundamental elements of accreditation standards. Examples of fundamental elements that are lacking in the current regulations include quality system requirements, ethics and integrity policy requirements, data traceability requirements, method validation requirements, sample handling policies, and enforcement. "
"The inadequate requirements in the current regulations have resulted in an ineffective accreditation program and a laboratory community that operates without effective regulatory oversight. Furthermore, the lack of specificity and detail in the current regulations has impacted ELAP’s ability to consistently assess the quality and competency of laboratories. Similarly, differing interpretation of the current regulations has created an unequal playing field where laboratories operate to different standards and can gain an unfair business advantage over other laboratories. This jeopardizes the validity of the data produced by accredited laboratories and creates a lack of trust in data used to make decisions regarding human health and the environment. "
"As listed on the the NELAC Institute website, "after resolution of appeals, TNI Standards are considered to be final, and the standard may be used by any organization. However, for use within TNI’s National Environmental Laboratory Accreditation Program (NELAP), the TNI Laboratory Accreditation System Executive Committee (LASEC) reviews the adopted TNI Standard and develops supplementary documents (guidance, SOPs, etc.), when needed. The LASEC then forwards the standards to the TNI NELAP Accreditation Council for this program group to adopt the standard for use by all Accreditation Bodies (ABs). "
"TNI expects most NELAP ABs will require a lead time of about two years to amend regulations and implement the a new standard. Because However, modifying regulations is restrictive and time-consuming, the current and NELAP ABs may possibly continue to accredit laboratories to the 2003 NELAC any version of the standards until the year 2010, when their proposed regulations are finalized to allow accreditation to the TNI standard. The listing of NELAP ABs shows which standard each AB is using. "
Update : Oct 11th 2019:
The California State water Board has released a Notice of Proposed Rulemaking stating that, "the costs to implement and maintain compliance with the 2016 TNI Standard are assumed to comprise the main economic impacts a laboratory may experience from implementation of the proposed regulations. Although the proposed regulations do not specifically require the purchase of new technology or laboratory equipment, hiring new personnel, or any additional investments to comply, the State Water Board is assuming for the purposes of the economic impact assessment that laboratories will hire new personnel and/or a laboratory consulting firm to help with the implementation process. Based on those assumptions, the State Water Board estimates the cost to implement the proposed regulations for a typical laboratory ranges from $40,000.00 to $77,334.40."
You can purchase the TNI 2016 Standard here:
A Note From the NELAC Institute
"Prices have been established for members of TNI and for the general public. You may join TNI and purchase the standards at the discounted member prices. Any Patron or Sponsor level organizational member of TNI will receive a single-use version of each Standard as part of their annual membership fee. An organization participating at the Partner, Corporate, or Consulting level may select one free single-use volume each year. Individual members may purchase copies of the Standards at member rates. A single-use copy means that you may install one copy of the standards on, and permit access to it by, a single computer owned, leased or otherwise controlled by you. You may not copy the standards onto a network. You may view the standards on screen and may print a single paper copy. A network-use copy or Site License Subscription mean that the Standards may be stored at a single location in digital form accessible by employees of your organization at that location. Your employees shall have the right to electronically display the Standards on their own computer and may print a copy of the Standards."
Please read the complete Single-Use Licensing Agreement (PDF), the Network-Use Licensing Agreement, and the Site License Subscription Licensing Agreement for additional information.
Sources:
Commentaires