The Benefits of National Accreditation

Steve ArmsThe 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’sVision for the FutureA 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

Designed to ensured competency Intended to ensure environmental data

of known and documented quality

An objective way of showing An objective way of showing clients, the community and clients, the community and

the government that an the government that an organization has the organization has the

demonstrated capability to demonstrated capability to conduct the services they conduct the services they

provide.provide.

National Environmental Laboratory Accreditation

Program (NELAP)

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

To establish and implement a program for the accreditation of environmental laboratories

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 AccreditationUnique

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 AccreditationExtensive

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

1978

State Programs expand

into other media

CLP De-facto National Program

19951999

2002

2004

2003

2001

2006

NELAC Restructur

e

Explore Self

Sufficiency

Explore Self

Sufficiency

2003 NELAC

Standard

November 6, 2006

1980’s

The 2003 NELAC StandardStrengths

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 StandardWeaknesses

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:

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 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

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 Identifiable accreditation program with

unique requirements, e.g., NELAP Volume

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 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

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 PublicConfidence

Health and environment are being protected using reliable, authentic data

A recognized concept Hospitals Universities Forensic laboratories

Benefits for Data Users

Consumer Protection Assurance that the laboratory has

been evaluated and has met established standards

Reduces risks associated with unreliable data Expensive re-testing Legal or financial liability

Regulatory acceptance of data

Benefits for the Profession

Advances the Field Uniform standards of practice A venue to share knowledge

Professional interaction in consensus Forum for improvement

Benefits for AgenciesAssurance that data is adequate

for use Dependable environmental decisions

based on data that is: Accurate Traceable Reproducible

Reduced uncertainty Increased public confidence in

governmental management of the environment

Benefits for AgenciesEfficient allocation of

resources A single set of standards to manage Cost effective

Data can be used by multiple stakeholders

Redundant assessments by QA oversight bodies can be reduced

Benefits for AgenciesEfficient allocation of

resources Reduced direct costs due to “problems”

Less re-testing Less re-sampling Less lost time Fewer false positives and negatives

Reduced effort needed to define project expectations and requirements More constant baseline expectations for

environmental projects More efficient communications regarding Data

Quality Objectives and project deliverables

Benefits for the OrganizationSelf-evaluation

Improved training program and communication

Improved processes and procedures Improved internal consistency Reduction in QC incidents, rejections

and complaints

Benefits for the OrganizationSelf-evaluation

Promotes continuous improvement attitude Effective system for accountability Reputation benchmark for maintaining

competence Improved employee quality awareness

A Better Quality System!

Benefits for the Organization and for Accreditation BodiesA Nationally Consistent

Standard An industry hindered by political boundaries

Opportunities for reciprocity and recognition

Removal of barriers Reduced time and expense caused

by redundancy

The Florida Experience

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 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!