The Benefits of National
Accreditation
Steve Arms
The NELAC Institute
TNI
The NELAC Institute’s Mission
To foster the generation of environmental
data of known and documented quality
through an open, inclusive, and
transparent process that is responsive to
the needs of the community
The NELAC Institute’s
Vision for the Future
A true national accreditation program, whereby
all entities involved in the generation of
environmental measurement data within the
United States are accredited to one uniform,
rigorous, and robust program that has been
implemented consistently nationwide and
focuses on the technical competence of the
entity pursuing accreditation
TNI’s Accreditation Programs

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Designed to ensured competency
Intended to ensure environmental data of
known and documented quality
An objective way of showing clients,
the community and the government
that an organization has the
demonstrated capability to conduct
the services they provide.
National Environmental Laboratory
Accreditation Program (NELAP)
To establish and implement a program for the accreditation
of environmental laboratories
Program components:
 The recognition of accreditation bodies
 The adoption of acceptance limits for proficiency
testing
 The adoption of consensus standards for use in
the program
 The adoption of the laboratory accreditation
system
National Environmental Field
Accreditation Program (NEFAP)
To establish and implement a program for the accreditation
of field sampling and measurement organizations (FSMOs)
Program components:
 The recognition of accreditation bodies
 The development and adoption of the
accreditation system
TNI is also pursuing the development of
standards for assuring the competency
of organizations involved in stationary
source air emissions testing.
NELAP Accreditation
Unique

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Based on an internationally recognized
standard expanded to focus on unique
aspects of environmental testing
Performed with respect to a specific scope
of accreditation conducted by qualified
assessors
Involves review of results of periodic
proficiency testing performed by the
laboratory
NELAP Accreditation
Extensive

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Over 1500 accredited laboratories
Over 2000 accreditations
48 states and 1 territory
8 foreign countries
Laboratory Accreditation
System Program

Develops a system for the accreditation of
environmental laboratories:

Policies and procedures, interpretations,
guidance documents, and related tools for use
by Accreditation Bodies to implement a national
environmental laboratory accreditation program.
Reviews standards for suitability
 Subcommittee:


National Database Committee
Our Heritage . . .
SDWA
Certification
Program
Explore Self
Sufficiency
CLP De-facto
National
Program
1978
1980’s
State
Programs
expand into
other media
1995
NELAC
Restructure
1999
2001
2002
November 6, 2006
2003
2004
2003
NELAC
Standard
2006
Explore
Self
Sufficiency
The 2003 NELAC Standard
Strengths

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
Uses ISO 17025 quality system approach
Adds specificity to improve clarity and help with
consistency for environmental testing
Allows flexibility in meeting requirements
Represents best professional practice
Allows for multiple Accreditation Bodies to
implement consistently
The 2003 NELAC Standard
Weaknesses

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Refers to an organization that no longer exists
Hard to find all the laboratory requirements
Written by chemists for chemists
Some language could be improved
Not a true consensus standard
Does not incorporate ISO 17011 for
Accreditation Bodies
Muddled and outdated version of ISO 17025
A New Approach



Start with the purpose of an
accreditation program
Ensure key elements are retained
Consider the following goals:

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Easy to use and understand
Easy to grow and expand
Easy to revise and implement
Applicable to all laboratories
Basis of the New Standard

International Standards

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

ISO 17025
ISO 17011
ISO Guide 43
Work of NELAC from 1994 - 2003
Significant input from TNI membership
during consensus voting process
Benefits of New Laboratory
Standards

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Removal of outdated NELAC language
Incorporation of ISO 17011
Incorporation of current version of ISO 17025
Volume/Modular approach simplifies
understanding
Improved clarity of Technical Requirements
Increased flexibility
Very few new requirements
True consensus standard!!!
Format of the New Standard

Sector


Volume


Identifiable accreditation program with unique
requirements, e.g., NELAP
Key elements of an accreditation program for
a particular sector
Module

Specific requirements combined with other
modules to create a volume
2008 TNI Standards

Volume 1 Laboratory
Requirements
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Module 1: Proficiency
Testing
Module 2: Quality Systems
General Requirements
Module 3: Asbestos Testing
Module 4: Chemical Testing
Module 5: Microbiological
Testing
Module 6: Radiochemical
Testing
Module 7: Toxicity Testing

Volume 2 Accreditation
Body Requirements

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Module 1 – General
Requirements
Module 3 – On-Site
Assessment
Module 2: Proficiency
Testing
Volume 3 Proficiency Test
Provider Requirements
Volume 4 Proficiency
Testing Oversight
Benefits for the Public
Confidence


Health and environment are being
protected using reliable, authentic data
A recognized concept

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Hospitals
Universities
Forensic laboratories
Benefits for Data Users
Consumer Protection

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Assurance that the laboratory has been
evaluated and has met established
standards
Reduces risks associated with unreliable
data

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Expensive re-testing
Legal or financial liability
Regulatory acceptance of data
Benefits for the Profession
Advances the Field

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Uniform standards of practice
A venue to share knowledge
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Professional interaction in consensus
Forum for improvement
Benefits for Agencies
Assurance that data is adequate for use

Dependable environmental decisions based
on data that is:
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Accurate
Traceable
Reproducible
Reduced uncertainty
Increased public confidence in
governmental management of the
environment
Benefits for Agencies
Efficient allocation of resources


A single set of standards to manage
Cost effective

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Data can be used by multiple stakeholders
Redundant assessments by QA oversight
bodies can be reduced
Benefits for Agencies
Efficient allocation of resources

Reduced direct costs due to “problems”

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Less re-testing
Less re-sampling
Less lost time
Fewer false positives and negatives
Reduced effort needed to define project
expectations and requirements

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More constant baseline expectations for
environmental projects
More efficient communications regarding Data Quality
Objectives and project deliverables
Benefits for the Organization
Self-evaluation

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Improved training program and
communication
Improved processes and procedures
Improved internal consistency
Reduction in QC incidents, rejections and
complaints
Benefits for the Organization
Self-evaluation

Promotes continuous improvement
attitude
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Effective system for accountability
Reputation benchmark for maintaining
competence
Improved employee quality awareness
A Better Quality System!
Benefits for the Organization
and for Accreditation Bodies
A Nationally Consistent Standard

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An industry hindered by political
boundaries
Opportunities for reciprocity and
recognition
Removal of barriers
Reduced time and expense caused by
redundancy
The Florida Experience

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All environmental testing laboratories are
held to the same standard
Assessment consistency has improved
Marginal labs have become acceptable
Environmental decisions are now clearly
traceable to documented data
Benefits of mutual recognition realized
A Self-Nourishing Concept
Opportunities for Quality Improvements
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The TNI standards development process
encourages pooling of expertise from multiple
governmental agencies and private sector groups.
A larger scope of expertise strengthens the quality
concepts and practices upon which the standards
are based.
Having additional requirements for laboratory
assessments facilitates the expansion of the
scope of accreditation programs and improves the
abilities of the assessors.
Result: better assessments and ultimately better
laboratories and data!
Thank You!