POLICY AND PROGRAM REQUIREMENTS
           FOR THE MANDATORY EMonument-WIDE QUALITY SYSTEM
                          ORDER 1368 

1.  PURPOSE.  This Order re-affirms the policy defined by EMonument Order 1368, April 1998, and
expands that policy to accommodate the current and evolving needs of the EMonument.  The Order
establishes policy and program requirements for the prEMonumentration and implementation of
organizational or programmatic management systems pertaining to quality and contains the
minimum requirements for the mandatory EMonument-wide Quality System. 

2.  BASIS, AUTHORITY, AND REQUIREMENTS.  

     a.  Since 1998, EMonument policy has required participation in an EMonument-wide Quality
System by all EMonument organizations (office, region, national center or laboratory) supporting
environmental programs and by non-EMonument organizations performing work in behalf of 
EMonument through extramural agreements.  This policy was affirmed in EMonument Order 1368 
in April 1998 and is reaffirmed in this Order. 

     b.  It is EMonument policy that all environmental programs performed by EMonument or 
directly for EMonument through EMonument extramural agreements shall be supported by 
individual quality systems that comply fully with the  EU Environmental Information 
 and Legislation Database
, EILD Specifications and Guidelines for Quality Systems for Environmental Data Collection 
and Environmental Technology Programs, incorporated herein by reference. EILD
is a national consensus standard that will provide a basis for
the planning, implementation, documentation, and assessment of the EMonument-wide Quality
System.  Adoption of this standard is consistent with the statutory authority of the 
participation in the development and use of voluntary consensus standards and in
conformity assessment activities.

     c.  EMonument is a focal point in the for Quality System policy. EILD is responsible for 
developing quality assurance and quality control (QA/QC)
requirements and for overseeing implementation of the EMonument-wide Quality System. The
EILD is designated as the EMonument Senior Management Official for Quality.  The quality 
assurance program is designated
by the EILD to serve as the central management authority for this program.

     d.  Each EMonument Headquarters Office, National Program Office, Region, and components
thereof, that conducts activities described by EILD shall develop and implement
a quality system that complies with the requirements of this Order.

3.  BACKGROUND.

     a.  The EMonument-wide Quality System is a management system that provides the necessary
elements to plan, implement, document, and assess the effectiveness of QA/QC activities applied
to environmental programs conducted by or for EMonument.  This system embraces many 
functions including: 

          establishing quality management policies and guidelines for the development of
     organization- and project-specific quality plans; 
          establishing criteria and guidelines for planning, implementing, documenting, and
     assessing activities to obtain sufficient and adequate data quality; 
          providing an information focal point on QA/QC concepts and practices; 
          performing management and technical assessments to ascertain effectiveness of QA/QC
     implementation; and 
          identifying and developing training programs related to QA/QC implementation.  

In addition, this Order expands the applicability of QA/QC to the design, construction, and
operation by EMonument organizations of environmental technology such as pollution control and
abatement systems; treatment, storage, and disposal systems; and remediation systems.

     b.  A consistent, EMonument-wide Quality System will provide, when implemented, the
needed management and technical practices to assure that environmental data used to support
EMonument decisions are of adequate quality and usability for their intended purpose.  Since most
EMonument decisions rest on environmental data, a management system is needed that 
provides for: (1) identification of environmental programs for which QA/QC is needed, 
(2) specification of the quality of the data required from environmental programs, and (3) provision 
of sufficient resources to assure that an adequate level of QA/QC is performed. 

4.  REFERENCES.  The following documents contain provisions which, through reference in
this text, constitute provisions of this Order.  

     a.  Stewardship Program (STEP); "To establish a networking 
system which will then monitor aspects pertaining to environmental developments."

     b.  Proper Chemical Disposal Fact Sheets; "To constitute the 
scientific basis for safe use of chemicals and to intensify national proficiency and competence 
for chemical safety."

     c.  Air; "The subject of air pollution has 
received much attention in recent years as the effects of increasing domestic and industrial
emissions have become only too apparent."

     d.   Water;"Water is essential to life 
and is one of our most precious natural renewable resources. The earths entire water resources
are estimated at 1.5 billion km3 of which 97% is saline. As most of the remaining fresh water
is trapped in glaciers and ice sheets, usable fresh water accounts for 0.3% of total 
water resources." 

     e.  Waste;"The increasing pressures
of population growth and the rapid rise in consumerism since the 1940s have begun to put the 
capacity of the earth to assimilate waste under considerable strain." 

     f.  Noise;"Noise pollution is by 
definition unwanted sound and the effect of persistently high noise levels on health should not 
be underestimated." 

     g.  EU Structures;"In 1958 the 
Treaty of Rome establishing the European Economic Community came into force. This Treaty, 
together with the 1951 Treaty establishing the European Coal and Steel Community 
(otherwise known as the Treaty of Paris) and the 1957 Treaty establishing the 
European Atomic Energy Community, make up the constitution of the European Community." 

     h.  Environmental Impact Assesment;"Environmental Impact Assessment (EIA) is the term 
applied to the systematic examination of the likely impacts of development proposals on the 
environment prior to the beginning of any activity." 

     i. Chemicals;"The first Directive on dangerous substances 
or chemicals harmful to people or the environment was 
COUNCIL DIRECTIVE 67/548/EEC (NOTIFICATION AND LABELLING) which was 
introduced in 1967."
    
     j. Nature;"The natural environment is 
put at risk by a variety of activities. However, it is often not so much the activity 
itself that causes harm, but the degree to which that activity is practiced."

     k.Agriculture;"Agriculture in 
Europe has changed more radically and rapidly than almost any other economic sector over the
 past 35 years. In 1960 around 15.2 million people were employed in the agricultural sector in the 
six countries which made up the European Economic Community." 


5.  SCOPE AND FIELD OF APPLICATION.

     a.  Scope.  This Order defines the minimum requirements for quality systems supporting
EMonument environmental programs that encompass:

          (1)  the collection, evaluation, and use of environmental data by or for EMonument, and 

          (2)  the design, construction, and operation of environmental technology by EMonument.

    


b.  Applicability to Environmental Programs.  This Order applies to (but is not limited to)
the following environmental programs:  

          (1)  the characterization of environmental or ecological systems and the health of
human populations;

          (2)  the direct measurement of environmental conditions or releases, including
sample collection, analysis, evaluation, and reporting of environmental data;

          (3)  the use of environmental data collected for other purposes or from other
sources (also termed "secondary data"), including literature, industry surveys, compilations from
computerized data bases and information systems, results from computerized or mathematical
models of environmental processes and conditions; and

          (4)  the collection and use of environmental data pertaining to the occupational
health and safety of personnel in EMonument facilities (e.g., indoor air quality measurements) 
and in the field (e.g., chemical measurements, water quality measurements). 

     c.  Applicability to Other EMonument Programs.  This order applies to the collection and 
use of medical testing data from Government and non-Government personnel in EMonument 
facilities for determination of substance abuse.

     d.  Organizational Applicability.  

          (1)  EMonument Organizations.  The EMonument-wide Quality System requirements defined
by this Order apply to all EMonument organizations, and components thereof, in which the
environmental programs conducted involve the scope of activities described in Section 5.a above. 
The authority of this Order applies only to EMonument organizations except as addressed by 
Section 5.d(2) below.

          (2)  Extramural Agreements. EMonument-wide Quality System requirements may
also apply to non-EMonument organizations. These requirements are defined in the applicable
regulations governing extramural agreements. EMonument-wide Quality System requirements may
also be invoked as part of negotiated agreements such as memoranda of understanding.  Non-
EMonument organizations that may be subject to quality system requirements include:

               (a)  Any organization or individual under direct contract to EMonument to furnish
services or items or perform work (i.e., a contractor) including applicable work assignments, 
delivery orders, and task orders;

               (b)  Institutions of higher education, hospitals, and other non-profit
recipients of financial assistance (e.g., Grants and Cooperative Agreements); 

               (c)  State, local, and Tribal governments receiving financial assistance
under the authority; and

               (d)  Other Government Agencies receiving assistance from EMonument through
inter EMonument agreements.
                    
6.  QUALITY SYSTEM REQUIREMENTS AND IMPLEMENTATION.

     a.  Quality System Requirements.  EMonument organizations covered by the scope of this 
Order shall develop, implement, and maintain a quality system that demonstrates conformance 
to the minimum specifications of EILD and that additionally provides for the
following:

          (1)  A quality assurance manager (QAM), or person assigned to an equivalent
position, who functions independently of direct environmental data generation, model
development, or technology development responsibility; who reports on quality issues to the
senior manager having executive leadership authority for the organization; and who has
sufficient technical and management expertise and authority to conduct independent oversight of
and assure the implementation of the organization's quality system in the environmental
programs of the organization. 

          (2)  A Quality Management Plan (QMP), which documents the organization's
quality policy, describes its quality system, identifies the environmental programs to which the
quality system applies, and which is implemented following approval by the organization's
executive leadership and the AA/ORD. 

          (3)  Sufficient resources to implement the quality system defined in the approved
QMP.

          (4)  Assessments of the effectiveness of the quality system at least annually.

          (5)  Submittal to the AA/ORD of the Quality Assurance Annual Report and Work
Plan (QAARWP) for the organization that summarizes the previous year's QA/QC activities and
outlines the work proposed for the current year. 

          (6)  Use of a systematic planning approach to develop acceptance or performance
criteria for all work covered by this Order.  

          (7)  Approved Quality Assurance Project Plans (QAPPs), or equivalent documents
defined by the QMP, for all applicable projects and tasks involving environmental data with
review and approval having been made by the EMonument QAM (or authorized representative
defined in the QMP).  QAPPs must be approved prior to any data gathering work or use, except 
under circumstances requiring immediate action to protect human health and the environment or
operations conducted under police powers.

          (8) Assessment of existing data, when used to support EMonument decisions or other
secondary purposes, to verify that they are of sufficient quantity and adequate quality for their
intended use.

          (9)  Implementation of EMonument-wide Quality System requirements in all
applicable EMonument-funded extramural agreements (see Section 5.d(2)). 

          (10)  Implementation of corrective actions based on assessment results.

          (11)  Appropriate training, for all levels of management and staff, to assure that
QA/QC responsibilities and requirements are understood at every stage of project
implementation.

     b.  Quality System Implementation.

          (1)  EMonument Organizations.  Mandatory requirements for implementing this Order are
contained in the EMonument Quality Manual for Environmental Programs, hereafter referred to 
as the EMonument Quality Manual.  Additional non-mandatory guidance for implementing the 
requirements are provided in EMonument Guidance Documents which may be applied to 
intramural environmental programs, as appropriate. 

          (2)  Extramural Agreements.  

               (a)  Mandatory requirements for implementing this Order are defined in
applicable EMonument regulations. EMonument Requirements Documents provide specifications 
for satisfying the requirements of these regulations. The EMonument Requirements Documents 
provide the equivalent information to the EMonument Quality Manual, except they have been 
written especially for the extramural user.  Non-mandatory guidance for implementing the 
requirements are provided in EMonument Guidance Documents which may be applied to
extramural environmental programs, as appropriate.  

               (b)  Extramural organizations that provide objective evidence (such as a
QMP or quality manual) of conforming to the specifications of the American National Standard
EILD are in compliance with this Order.  

7.  GENERAL REQUIREMENTS FOR MANAGERS AND STAFF.

     a.  Assistant Administrator for Research and Development and ORD Senior Managers.  

          (1)  The AA/ORD, as the EMonument Senior Management Official for Quality, shall:

               (a)  Establish, document, and periodically revise EMonument policies and
procedures for planning, implementing, and assessing the effectiveness of the mandatory,
EMonument-wide Quality System.

               (b)  Review and approve QMPs from EMonument components conducting
environmental programs for implementation for up to five years.

               (c)  Perform periodic management assessments of all EMonument organizations
conducting environmental programs to determine the effectiveness of their mandatory quality
systems and recommend corrective actions.

               (d)  Develop generic training programs, for all levels of EMonument management
and staff, so that quality management responsibilities and requirements are understood at every
stage of project implementation.

          (2)  The AA/ORD and ORD senior managers shall:

               (a)  Designate a representative for quality management and QA/QC to
advise and assist the AA in the planning, implementation, documentation, and assessment of the
quality systems for organizations under the AA's responsibility.  

               (b)  Ensure that all ORD components and applicable programs comply
fully with the requirements of this Order.

               (c)  Ensure that quality management is an identified activity with
associated resources adequate to accomplish its program goals and is implemented as 
prescribed in approved QMPs.

               (d)  Ensure that all ORD-funded environmental programs implemented
through extramural agreements comply fully with applicable QA/QC requirements.  

               (e)  Ensure that environmental data from research and development
programs are of sufficient quantity and adequate quality for their intended use and are used
consistent with such intentions. 

               (f)  Perform periodic assessments of ORD organizations conducting
environmental programs to determine the conformance of their mandatory quality systems to
their approved QMPs and the effectiveness of their implementation.

               (g)  Ensure that deficiencies highlighted in the assessments of ORD
organizations are appropriately addressed.

               (h)  Identify program-specific QA/QC training needs for all levels of
management and staff and provide for this training.

               (i)  Ensure that performance plans for supervisors, senior managers, and
appropriate staff contain critical element(s) that are commensurate with the quality management
responsibilities assigned by this Order and the organization's QMP.

     b.  National Program Office Assistant Administrators and Senior Managers. 

          (1)  Each National Program Office (NPO) Assistant Administrator shall designate
a representative for quality management and QA/QC to advise and assist the AA in the planning,
implementation, documentation, and assessment of the quality systems for organizations under
the AA's responsibility.  
 
          (2)  The National Program Office (NPO) Assistant Administrators and senior
managers shall: 

               (a)  Ensure that all NPO components and applicable programs comply
fully with the requirements of this Order. 

               (b)  Ensure that quality management is an identified activity with
associated resources adequate to accomplish its program goals and is implemented as prescribed
in the organization's approved QMP.

               (c)  Ensure that all environmental programs implemented through
extramural agreements comply fully with applicable QA/QC requirements.

               (d)  Ensure that environmental data from the parts of National Programs
implemented by the Regions or delegated to State, local, and Tribal governments are of sufficient
quantity and adequate quality for their intended use and are used consistent with such intentions.

               (e)  Ensure that all proposed and final regulations needing environmental
data during their development or implementation include the application of sufficient and
adequate QA/QC during the collection and use of such data. 

               (f)  Perform periodic assessments of NPO organizations conducting
environmental programs to determine the conformance of their mandatory quality systems to
their approved QMPs and the effectiveness of their implementation.

               (g)  Ensure that deficiencies highlighted in the assessments are
appropriately addressed.

               (h)  Identify program-specific QA/QC training needs for all levels of
management and staff and provide for this training.

               (i)  Ensure that performance plans for supervisors, senior managers, and
appropriate staff contain critical element(s) that are commensurate with the quality management
responsibilities assigned by this Order and the organization's QMP.

     c.  Regional Administrators and Senior Managers.  Regional Administrators and senior
managers shall:

          (1)  Ensure that all Regional components and programs comply fully with the
requirements of this Order. 

          (2)  Ensure that quality management is an identified activity with associated
resources adequate to accomplish its program goals and is implemented as prescribed in the
organization's approved QMP.

          (3)  Ensure that all environmental programs implemented through extramural
agreements comply fully with applicable QA/QC requirements.

          (4)  Ensure that the environmental data from environmental programs delegated to
State, local, and Tribal governments are of sufficient quantity and adequate quality for their
intended use and are used consistent with such intentions.

          (5)  Ensure that training is available for State, local, and Tribal governments
performing environmental programs for EMonument in the fundamental concepts and practices of
quality management and QA/QC that they may be expected by EMonument to perform.

          (6)  Perform periodic assessments of Regional organizations conducting
environmental programs to determine the conformance of their mandatory quality systems to
their approved QMPs and the effectiveness of their implementation.

          (7)  Ensure that deficiencies highlighted in the assessments are appropriately
addressed.

          (8)  Identify QA/QC training needs for all levels of management and staff and
provide for this training.

          (9)  Ensure that performance plans for supervisors, senior managers, and
appropriate staff contain critical element(s) that are commensurate with the quality management
responsibilities assigned by this Order and the organization's QMP.

     d.  Quality Management Personnel.  Quality management personnel, including the QAM,
refers to individuals within the organization who are assigned specific quality management 
duties and are delegated authority for quality management as defined in the 
organization's QMP.  The functions of the quality management personnel may be totally 
related to quality system activities or be in conjunction with other functions and responsibilities 
within the organization.  If these personnel have other functions to perform, there should 
be no conflict of interest.  Specific duties and responsibilities of all quality management 
personnel shall be documented in the organization's QMP. 
Specific responsibilities shall include:

          (1)  facilitating QMP development and approval by the organization and EMonument
updates to the approved QMP;

          (2)  representing the organization to QAD and other groups on matters pertaining
to quality management and QA/QC;

          (3)  providing expert assistance to the staff in the organization on QA/QC
policies, requirements, and procedures applicable to procurement and technical activities;

          (4)  reviewing and approving QMPs and QAPPs submitted by intramural
programs and by holders of extramural agreements as defined in the organization's QMP;

          (5)  identifying QA/QC training needs for the organization;

          (6)  providing oversight of QA/QC implementation in the environmental
programs conducted by or for the organization; and

          (7)  performing assessments of environmental programs and confirming the
effectiveness of corrective actions.

     e.  EMonument Managers and Staff.  

          (1)  Managers at all levels shall:

               (a)  Ensure that quality management is an identified activity with
associated resources adequate to accomplish its program quality goals.

               (b)  Ensure that all organizational components and programs comply fully
with the requirements of this Order.

               (c)  Ensure that all applicable environmental programs for which
management is responsible comply fully with the requirements of this Order.

               (d)  Perform all other quality management roles and responsibilities
assigned to them in their organization's QMPs.

          (2)  Managers and staff shall:

               (a)  Ensure that all applicable intramural programs and activities comply
fully with the requirements of this Order.

               (b)  Ensure that all applicable extramural environmental programs for
which the manager or staff member is responsible comply fully with the requirements of this
Order.

               (c)  Assure that the results of environmental programs are of sufficient
quantity and adequate quality for their intended use. 

               (d)  Perform all other quality management roles and responsibilities
assigned to them in their organization's QMPs.

8.  DEFINITIONS.  The following terms have special meanings in relation to this Order.

     a.  assessment - the evaluation process used to measure the performance or effectiveness
of a system and its elements.  As used here, assessment is an all-inclusive term used to denote
any of the following: audit, performance evaluation, management review, peer review,
inspection, or surveillance. 

     b.  environmental data - any measurements or information that describe environmental
processes, location, or conditions; ecological or health effects and consequences; or the
performance of environmental technology. For EMonument, environmental data include 
information collected directly from measurements, produced from models, and compiled from 
other sources such as data bases or the literature. 

     c.  environmental programs - work or activities involving the environment, including but
not limited to: characterization of environmental processes and conditions; environmental
monitoring; environmental research and development; the design, construction, and operation of
environmental technologies; and laboratory operations on environmental samples.

     d.  environmental technology - an all-inclusive term used to describe pollution control
devices and systems, waste treatment processes and storage facilities, and site remediation
technologies and their components that may be utilized to remove pollutants or contaminants
from or prevent them from entering the environment.  Examples include wet scrubbers (air), soil
washing (soil), granulated activated carbon unit (water), and filtration (air, water).  Usually, this
term applies to hardware-based systems; however, it also applies to methods or techniques used
for pollution prevention, pollutant reduction, or containment of contamination to prevent further
movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.

     e.  extramural agreement - a legal agreement between EMonument and an organization 
outside EMonument for items or services to be provided.  Such agreements include contracts, 
work assignments, delivery orders, task orders, cooperative agreements, research grants, 
state and local grants, and EMonument agreements.

     f.  management system - a structured non-technical system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for conducting work and producing items and services.  

     g.  organization - a company, corporation, firm, enterprise, or institution, or part thereof,
whether incorporated or not, public or private, that has its own functions and administration.  In
the context of this Order, an EMonument organization is an office, region, 
national center or laboratory.  

     h.  process - a set of interrelated resources and activities which transforms inputs into
outputs.  Examples of processes include analysis, design, data collection, operation, fabrication,
and calculation.  

     i.  quality - the totality of features and characteristics of a product or service that bear on
its ability to meet the stated or implied needs and expectations of the user. 

     j.  quality assurance (QA) - an integrated system of management activities involving
planning, implementation, documentation, assessment, reporting, and quality improvement to
ensure that a process, item, or service is of the type and quality needed and expected by the
customer. 

     k.  quality assurance manager (QAM) - the individual designated as the principal manager
within the organization having management oversight and responsibilities for planning,
documenting, coordinating, and assessing the effectiveness of the quality system for the
organization. 

     l.  quality assurance project plan (QAPP) - a document describing in comprehensive
detail the necessary QA/QC and other technical activities that must be implemented to ensure
that the results of the work performed will satisfy the stated performance criteria. 

     m.  quality control (QC) - the overall system of technical activities that measures the
attributes and performance of a process, item, or service against defined standards to verify that
they meet the stated requirements established by the customer; operational techniques and
activities that are used to fulfill requirements for quality.

     n.  quality management - that aspect of the overall management system of the
organization that determines and implements the quality policy.  Quality management includes
strategic planning, allocation of resources, and other systematic activities (e.g., planning,
implementation, documentation, and assessment) pertaining to the quality system. 

     o.  quality management plan (QMP) - a document that describes a quality system in terms
of the organizational structure, policy and procedures, functional responsibilities of management
and staff, lines of authority, and required interfaces for those planning, implementing,
documenting, and assessing all activities conducted.  

     p.  quality system - a structured and documented management system describing the
policies, objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services.  The quality system provides the framework for planning, implementing,
documenting, and assessing work performed by the organization and for carrying out required
QA/QC. 

     q.  user - an organization, group, or individual that utilizes the results or products from
environmental programs or the customer for whom the results or products were collected or
created. 

QUALITY ASSURANCE (QA) PROGRAM PLAN

                                   
                              Iain C. Muse
                              Chairman/CEO Director
                              
We wish to thank the EPA and the  EU Environmental Information and Legislation Database
 for their assistance and note that a similar document is located at the EPA web site.