ETV TEST CENTRE AND TEST ORGANIZATION CENTRE QUALITY MANUAL
Document Sample


NORDTEST METHOD NT ENVIR 011 1
Approved 2010-04
NT ENVIR 011
ETV TEST CENTRE AND TEST ORGANIZATION 1(27)
CENTRE QUALITY MANUAL TEMPLATE
NOWATECH
Key words: Environmental technology verification; water monitoring; water treatment
CONTENTS 3.2.2 Expert group ......................................... 9
3.2.3 Verification protocol ............................. 9
PREFACE .................................................................. 2
3.2.4 Test plan ............................................. 10
1 TEST CENTRE QUALITY MANUAL ..................... 2 3.3 Test and verification reporting ....................... 11
1.1 Principles and organization of the manual .... 2 3.3.1 Test report ........................................... 11
1.1.1 Scope ................................................... 2 3.3.2 Verification report ............................... 12
1.1.2 Background .......................................... 3 3.3.3 Verification statement with logo ......... 12
1.1.3 References ........................................... 3 3.4 Additional verification parameters ............... 12
1.1.4 Legal status .......................................... 3 3.4.1 Evaluation of user manuals ............... 12
1.1.5 Terms and definitions ........................... 3 3.4.2 Evaluation of product costs ............... 13
1.2 Organization ................................................... 4 3.4.3 Evaluation of occupational health and
1.2.1 Duties and responsibilites ................... 4 environmental impact ......................... 13
1.2.2 Staff ...................................................... 5 3.4.4 Other additional verification
1.2.3 Information ........................................... 6 parameters ......................................... 13
1.3 Test centre quality management .................... 6
4 REFERENCES .................................................... 13
1.4 Verification operation ..................................... 6
1.5 Document responsibilities .............................. 6 APPENDIX 1. Quick scan report template .............. 14
2 QUALITY MANAGEMENT PROCESSES ............. 7 APPENDIX 2. Verification contract template .......... 15
2.1 Review of plans, protocols and reports ......... 7 APPENDIX 3. Verification protocol template .......... 18
2.2 Document and record control ........................ 7 APPENDIX 4. Test plan template ............................ 19
2.3 Internal audits ................................................. 7 APPENDIX 5. Test report template, parts
2.4 Complaint management ................................. 7 substituted or added in test plan ............................. 20
2.5 Subcontractor management .......................... 7 APPENDIX 6. Template for verification report,
2.6 Staff competence management ..................... 8 parts substituted or added in verification protocol .. 21
2.7 Facility management ...................................... 8
APPENDIX 7. Template for review report ............... 22
2.8 Management review ....................................... 8
APPENDIX 8. Template for verification statement
3 VERIFICATION PROCESSES .............................. 8
with logo ................................................................... 23
3.1 Access assessment ....................................... 8
3.1.1 Information from the vendor ................ 8 APPENDIX 9. Templates for additional parameter
3.1.2 Application definition ............................ 8 evaluations .............................................................. 24
3.1.3 Evaluation of quick scan ...................... 9 APPENDIX 10. Template for report on ammend-
3.1.4 Reporting of quick scan ....................... 9 ment to verification protocol or test plan ................. 25
3.2 Verification and test planning ........................ 9 APPENDIX 11. Template for report on deviation
3.2.1 Verification contract ............................. 9 from verification protocol or test plan ...................... 26
Nordic Innovation Centre Telephone +47 47 61 44 00 ISSN: 1459—2800
Stensberggata 25 Fax +47 22 56 55 65 Project: 06223
NO-0170 OSLO info@nordicinnovation.net
Norway www.nordicinnovation.net
NORDTEST METHOD NT ENVIR 011 2
PREFACE foreseen and accordingly, this principle has been
implemented in the present quality manual template.
This centre quality manual template provides the framework
for organization, operation and quality management of the Also in preparing the manual template, two considerations
NOWATECH test centres established in compliance with the have been of high priority: to avoid duplication of text in
emerging EU ETV system. The template is implemented at different documents and to reuse documents to the widest
each NOWATECH test centre. degree possible.
The quality manual has the form of a conventional quality
manual with the test centre quality manual giving the overall 1 TEST CENTRE QUALITY MANUAL
principles, organization and operation (strategic level,
Chapter 1), the general procedures of centre quality 1.1 Principles and organization of the manual
management and verification operation at the next (tactical This quality manual is the framework for organization,
level, Chapters 2-3) and the specific instructions, documents operation and quality management of the NOWATECH test
etc at the lowest, operational level (Appendices 1 to 11). centre: {insert centre name} established in compliance with
At the tactical and operational levels, the outset has been the emerging EU ETV system. The quality manual has the
the documentation of the working processes, Chapters 2-3 form of a conventional quality manual with three levels:
with appendices. These chapters describe the working quality manual (Chapter 1), processes (Chapters 2 and 3)
processes with reference to the documentation to be and instructions/descriptions (Appendices), and is prepared
provided. Subsequently, further procedures, templates and to comply with the requirements expected from the emerging
checklists may be added, as the centres proceed with EU ETV system, see Appendix Figure 1.
implementation and thus acquire the knowledge required to
prepare these.
The quality manual template is elaborated to be used
directly. By nature, the text can not cover all verification
technology areas and is accordingly kept in terms of
principles and templates, rather than specific methods for
any area. Adaptations by each centre have been required
but in adapting the manual, the overall principles,
requirements and workflows has been maintained.
The approach to implementation has been to open this
quality manual template document and:
• Modify Chapter 1 with respect to test centre specific
details
• Prepare the processes required in Chapter 2 (centre
quality management)
• Insert those as appendices in the quality manual
• Transform the “shall” sentences under the subheadings
of Chapter 2 into “purpose of this process” sentences
and insert references to the processes just inserted as
appendices under the relevant subheadings
• Revise and add to text in Chapter 3 (ETV processes) and
associated appendices
• Delete this preface as it is considered a user guide only
and shall be omitted in centre implementation
Appendix Figure 1. Organization of the NOWATECH test
• Review, approve and publish the final test centre quality centre quality manual.
manual.
In the text, please recall that the word “shall” means The quality manual has 3 main sections: principles (Section
mandatory action, “should” means recommended action, 1.1), organization and quality management (Section 1.2)
and “may” means possible action /1/. and operation (Section 1.4).
Text that is a comment to implementation is shown in
{brackets}. 1.1.1 Scope
All figures can be edited from the supplied PowerPoint file. Verification statements (verificates) are granted to
In the emerging European ETV system, subdivision of the environmental technology products within the technology
ETV process into a verification part and a test part is area {delete as appropriate}:
NORDTEST METHOD NT ENVIR 011 3
• Water monitoring technologies ISO/IEC 17011. Conformity assessment – General re-
• Water treatment technologies/cleaner technologies quirements for accreditation bodies accrediting conformity
assessment bodies /18/.
• Water treatment technologies/advanced chemical water
treatment US EPA. Environmental Technology Verification Program.
Quality Management Plan /10/.
• Water treatment technologies/biological water treatment
technologies. EN ISO 9001. Quality management systems –
Requirements /19/.
The verificates provide independent, third party
documentation for performance for a specified application ANSI/ASQ E4. Quality systems for environmental data and
under defined conditions and adequate quality assurance technology programs – Requirements with guidance for use
and as described in this manual. /20/.
1.1.4 Legal status
1.1.2 Background
The legal status of the centres will be established when
The emerging EU ETV system has not yet found it final form. adapted to a final EU ETV normative document. An interim
Therefore, the requirements have been anticipated as legal status as a Nordic Council of Ministers/Nordic
described in /2; 3/ with the emphasis upon the first Innovation Centre system will be established by adaptation
descriptions of the EU ETV system /4; 5/, upon the ETV of this manual as a Nordtest method and by establishing a
system described for water treatment and water monitoring Nordtest ETV scheme, NTETV.
technologies, TESTNET /6/, and supported by the
framework being established in other EU ETV development
projects: PROMOTE /7; 8/ and AIRTV /9/. Furthermore, to 1.1.5 Terms and definitions
the extent possible, the requirements of US EPA system /10/
This handbook is using a set of definitions derived from ISO
and the international standard for product certification /11/
9000, ISO 17000, ISO 45020, ISO VIM, EN 45011 and the
are considered.
emerging EU ETV system as described in /2; 21; 22/, see
Appendix Table 1.
1.1.3 References Appendix Table 1. Terms and definitions used by the
For undated references, the latest edition of the publication NOWATECH test centres.
referred to applies. Word NOWATECH Comments on
This quality manual template is the normative references for NOWATECH
approach
the operation of the NOWATECH test centres. The method
of verification described here is endorsed as a Nordtest Analytical Independent analytical The test centre may use
laboratory laboratory used to an analytical laboratory
Method ENVIR 011 and takes over as normative document.
analyse test samples as subcontractor
New versions will be launched with updates according to
lessons learned by doing verifications. When a final Application The use of a product The application must be
specified with respect to defined with a precision
document describing the EU ETV system is available, this matrix, target and effect, that allows the user of a
will be the normative reference for operation of the centres. clarified by statement of product verification to
any limitations judge whether his needs
Non-normative references include: are comparable to the
ISO 9000: Quality management systems – fundamentals verification conditions
and vocabulary /12/. Effect The way the target is The effect could be
affected concentration reduction,
ISO 17000: Conformity assessment – vocabulary and decrease in treatment
general principles /13/. period, pH increase etc
EN 45020: Standardization and related activities – general Environ- The practical application The term technology is
vocabulary /14/. mental of knowledge in the covering a variety of
technology environmental area in a products, processes,
ISO VIM: International vocabulary of basic and general technology whose use is systems and services.
terms in metrology /15/. less environmentally
harmful than relevant
ISO/IEC Guide 7. Guidelines for drafting standards suitable alternatives
for use for conformity assessment /16/. Evaluation Evaluation of test data None
CEN: Rules for the structure and drafting of CEN/CENELEC for a technology product
for performance and data
publications. ISO/IEC Directives – Part 2 /1/. quality
EN 45011. General requirements for bodies operating Experts Independent persons These experts may be
product certification systems /11/. qualified on a technology technical experts, QA
in verification or on experts, .e.g. for other
ISO/IEC Guide 65:1996. General requirements for bodies verification ETV systems, or
operating product certification systems /17/. regulatory experts
NORDTEST METHOD NT ENVIR 011 4
Word NOWATECH Comments on Word NOWATECH Comments on
NOWATECH NOWATECH
approach approach
Matrix The type of material that Matrices could be soil, Test/testing Determination of the None
the product is intended drinking water, ground performance of a product
for water etc. for parameters defined
for the application
Method Generic document that An in-house method may
provides rules, guidelines be used in the absence Vendor The party delivering the Can be the producer
or characteristics for of a standard, if prepared product to the customer
tests or analysis in compliance with the
format and contents Verification Evaluation of product None
required for standards, performance parameters
see e.g.: /16/ for a specified application
under defined conditions
NOWATECH Nordic Water Technology and adequate quality
Verification Centers assurance
(NOWATECH) Preliminary name for the Name will be changed,
test centre verification bodies in when the final
NOWATECH with a nomenclature in the EU
verification and a test ETV has been set. 1.2 Organization
sub-body
The test centre organization is shown in Appendix Figure 2.
Performance The effects foreseen by None
claim the vendor on the target
(s) in the matrix of
intended use NOWATECH
Performance Parameters that can be The performance Steering
parameters documented parameters must be Committee
quantitatively in tests and established considering
that provide the relevant the application(s) of the
information on the product, the
performance of an requirements of society Organization
environmental (regulations), customers management
technology product (needs) and vendor {name}
claims
Procedure Detailed description of The procedure specifies
the use of a standard or implementing a standard
a method within one or a method in terms of Test centre
body e.g.: equipment used management
Producer The party producing the None {name}
product
(Environmen- Ready to market or The product is the item
tal) product prototype stage product, produced and sold and Test centre, Test centre, test
process, system or thus the item that a verification sub- sub-body
service based upon an vendor submit for
environmental verification body {name} {name}
technology
Standard Generic document None
established by
consensus and approved Technical Analytical
by a recognized experts laboratory(-ies)
standardization body that
provides rules, guidelines
or characteristics for Appendix Figure 2. NOWATECH test centre organization.
tests or analysis
Target The property that is Targets could be e.g..
affected by the product contaminant
concentration 1.2.1 Duties and responsibilites
Test centre, Sub-body of the test May by within same NOWATECH steering committee
test sub-body centre that plans and organization as the
performs test verification sub-body, or The NOWATECH steering committee with representatives
may not from the 4 project participants (DHI, IVL, Aquateam and
Test centre, Sub-body of the test May by within same
VTT) is the overall responsible for the centres, until an EU
verification centre that plans and organization as the test ETV body has been established. The steering committee
sub-body performs the verification sub-body, or may not has the overall responsibility for the centre operation, and
shall handle complaints that have not been settled in the test
centres.
NORDTEST METHOD NT ENVIR 011 5
Organization management results of the test centre verification sub-body and they
The management of the organization hosting the test centre should not have be dependent upon these.
at the adequate management level is overall responsible for
the operation of the test centre according to this manual. Technical experts
The organization management has the overall responsibility The technical experts shall have the overall responsibility
for providing the resources (staff and facilities) required to for:
follow the manual and for handling any complaints over the
• Providing input on relevant applications and
test centre, including an organization quality system
performance parameters of the technology to be verified
compliant with ISO 9001 /19/ for at the least the verification
and test activities. • Elaboration of review reports after quality assurance of
the plan document and report document, including the
Test centre management test report appendix.
The test centre management of the hosting organization is The technical experts shall be independent, qualified and
responsible for practical operation of the test centre without any undue interests in the technologies verified. The
according to this manual. The test centre management has experts may also be regulators or quality assurance experts
the responsibility for: from other ETV systems.
• Maintaining this manual
Analytical laboratories
• Keeping records of staff training and experience
Analytical laboratories providing analysis of any kind as part
• Keeping record of facilities and their maintenance of the verification tests, within or outside the test centre body
• Keeping records of complaints. has the responsibility for:
• Maintaining an ISO 17025 accreditation with the quality
Test centre, verification sub-body management system required herein
The test centre verification sub-body has the overall • Application of accredited analytical methods, where
responsibility for: available
• Preliminary evaluation of applicant technology products • Application of other methods according to both
• Identification of qualified and independent technical international standard methods or in-house methods that
experts for the verifications are validated as required for accredited methods.
• Identification of suitable verification methods and test The selected analytical laboratory subcontractors shall be
design listed by the test centre, test sub-body.
• Elaboration of verification protocol (see Section 1.4 for
explanation) in cooperation with the technical experts 1.2.2 Staff
• Elaboration of verification report
The test centre has, develops and maintains staff that is
• Revision of verification report after quality assurance by qualified for the technology verifications and tests within the
the technical experts scope of the centre with the executive staff responsible for
• Elaboration of verification statement with logo. the units shown in Appendix Table 2.
The staff of the test centre verification sub-body shall not be {insert test centre responsible, verification sub-body and test
the same as those responsible for the test of the test centre sub-body responsible name and function in organization,
test sub-body and they should not be dependent upon example in Appendix Table 2}.
these.
Appendix Table 2. Responsible staff summary, example.
Test centre, test sub-body Organization element Name Function/title
The test centre test sub-body has the overall responsibility NOWATECH steering
for: committee member
Organization management
• Identification of and subcontracting with one or more responsible
independent analytical laboratories for analyses of test Test Centre manager
samples, if required Verification sub-body
responsible
• Elaboration of test plan within the requirements set in the
Test sub-body responsible
verification protocol with test design requirements
Verification staff
• Performance of the test according to the test plan Test staff
• Elaboration of the test report.
The staff of the test centre testsub-body shall not be the Staff competence management procedures are found in
same as those responsible for the evaluation of the test Section 2.6.
NORDTEST METHOD NT ENVIR 011 6
1.2.3 Information In order to facilitate the preparation of the documents,
The test centre provides information on the verification templates have been prepared and are available in
operation and reports on the web site www.etvnord.org in appendices. The use of the templates is outlined in
English. Appendix Figure 4. Reports are in principle protocols and
plans with data and evaluations inserted.
All protocols and plans (on-going verifications) and reports
and verification statements (completed verifications) are The verification processes are further detailed in Chapter 3
published on the web site. in a form structured to respond to the documentation
required.
1.3 Test centre quality management Appendix Figure 4. Templates for verification and tests with
The quality management of the test centre has the following the use at product, product group or test centre levels
main points: indicated, product groups may include one product only.
• Review of plans, protocols and reports Product level
Product Test centre
Template group level level
• Document and record control document
document document
• Internal audits with corrective and preventive actions Test centre
Test centre
quality
• Complaint management quality manual
manual
• Subcontractor management Quick scan Quick scan
report report
• Staff competence management
• Facility management Contract Contract
• Annual management reviews.
Verification Verification
The quality management processes are further described in protocol protocol
Chapter 2. Test plan Test plan
Test report Test report
Verification Verification
1.4 Verification operation report report
The principles of operation with the role of the verification Verification Verification
and test documents and the different sub-bodies statement with statement with
responsible are given in Appendix Figure 3. logo logo
Verification
sub-body Quick scan
Verification
protocol Verification
Verification Verification 1.5 Document responsibilities
report statement
The responsibilities for preparing, reviewing and approving
Test
sub-body est
T plan Test est
T report documents in the verification are summarized in Appendix
Access Plan document est
T and Report Verificate Table 3.
assessment verification document
Technical Internal Technical
expert QA audit expert QA Appendix Table 3. Verification document responsible
summary.
Appendix Figure 3. Principles of operation of the
NOWATECH verification scheme. Document Preparation Review Approval
Quick scan Verification staff Verification Verification
The verification protocol and report may be prepared for one report sub-body sub-body
product or for a group of products aiming at the same responsible responsible
application. Once elaborated, a verification protocol shall be Contract Verification staff Test centre Test centre
used for future verifications of products aiming at the same manager manager
application, just substituting product specific information. Verification Verification staff Technical Test centre
The remaining documents are each prepared for one protocol and experts manager
product. report
Test plan and Test staff Technical Verification
A contract between the vendor and the test centre must be report experts staff
entered before initiating the verification. Definition of the
Review reports Technical None None
application and of the relevant performance parameters, as
experts
well as detailed assessment of any existing test data and of
the need for additional test data is done in the first phase of Verification Verification staff Technical Test centre
statement experts manager
protocol development.
NORDTEST METHOD NT ENVIR 011 7
2 QUALITY MANAGEMENT PROCESSES A list of documents in the test centre quality manual shall be
maintained with indication of the persons authorized to draft,
The test centre shall work according to the principles of ISO
revise and approve the documents.
9001 /19/ or ANSI/ASQ E4 /20/. This can be done by
working according to a quality management system certified It shall further be described how records of verification and
according to one of these standards, by working according testing are stored, transferred, maintained and controlled in
to a quality management system with third party order to ensure data integrity for a period defined in the
documented compliance with one of these standards or by procedure, but not shorter than 5 years from completion of
working according to documented procedures prepared for the verification.
the processes listed in this chapter. This point can be fulfilled by reference to the relevant part(s)
Management, organization and responsibilities are defined of a certified or compliant quality management system as
by adopting Chapter 1 of this quality manual template, with defined in Chapter 2.
additions as required by the test centre in question. An example of a record description is given in Appendix
Table 6.
2.1 Review of plans, protocols and reports
This procedure shall describe how the test centre plans the 2.3 Internal audits
reviews required in this template: This procedure shall describe the process of periodic
• external expert review of internal auditing of the verification and test activities in the
test centre including audit responsibilities and planning,
o verification protocol and test plan, plan document
auditor training and competences and audit reporting.
o test and verification report, report document
Internal audits may be implemented as an integral part of
• internal review of the verification and test procedures, but may also be
o verification protocol and report implemented as a regular and planned internal audit
process.
o test plan and report
It shall be described how deviations identified during
including recruitment of external experts, competence and
auditing are corrected (corrective actions) and how future
independence requirements for external experts and internal
occurrence of the same deviations is prevented by
reviewers, payment and scheduling.
improving the quality manual including the process
The procedure should include the information given in the descriptions and working methods (preventive actions).
example in Appendix Table 4.
This point can be fulfilled by reference to the relevant part(s)
of a certified or compliant quality management system as
defined in Chapter 2.
Appendix Table 4. Summary of review and audit tasks,
example.
Centre internal Technical 2.4 Complaint management
experts,
external
This procedure shall describe how vendor complaints are
recorded, resolved, reported and if not resolved, referred to
Function Technical Trained Technical the NOWATECH Steering Committee for resolving.
expert auditor expert
This point can be fulfilled by reference to the relevant part(s)
of a certified or compliant quality management system as
Tasks
defined in Chapter 2.
Plan document with Review – Review
verification protocol
and test plan
2.5 Subcontractor management
Test system – Audit –
This procedure shall describe how the test centre ensures
Report document Review – Review
with test report and that subcontracting of tasks such as tests, sampling,
verification report measurement or analysis to other independent bodies is
done while ensuring that the subcontractor follows the
quality requirements, the verification protocol and the test
plan for the task, see also Section 1.2.1 for the
2.2 Document and record control responsibilities of an analytical laboratory working for a test
This procedure shall describe the process of drafting, centre.
revising and approving the documentation of the test centre The procedure shall furthermore describe how it is ensured
manual with the aim of ensuring that all involved in the that purchased items for verification and testing resemble
verification processes have access to and uses the latest requirements, such as those that may be specified in a
approved version of the manual with process descriptions. verification protocol, a test plan or a working method. In
NORDTEST METHOD NT ENVIR 011 8
particular, the procedure shall describe how the purchased The purpose of the quick scan procedure is to ensure, that
items are controlled, accepted and calibrated. the vendor knows the probability of acquiring a verification
This point can be fulfilled by reference to the relevant part(s) certificate after completed test.
of a certified or compliant quality management system as The quick scan is done by the test centre free of charge
defined in Chapter 2. initially, but the costs are included in a subsequent
verification contract, if decided for.
2.6 Staff competence management
This procedure shall describe how the test centre will ensure 3.1.1 Information from the vendor
that verifications and tests are done by staff with confirmed
The vendor supplies the required information by partially
and documented adequate competences and knowledge of
filling in the quick scan form, see Appendix 1. The
their responsibilities. In particular, all staff working with test
information shall be as quantitative as possible.
and verification shall have documented training in ETV
procedures and requirements, as used in the test centre.
This may be done by maintaining a list of functions in the
verification and test process with competence requirements 3.1.2 Application definition
and responsibilities, staff approved for the function. The list The quick scan procedure should include a first definition of
may be supported by reference to staff files with contracts and agreement with the vendor upon the application in
and training documentation. terms of the matrix, effect and target of the technology
This point can be fulfilled by reference to the relevant part(s) product, see Appendix Table 5.
of a certified or compliant quality management system as
defined in Chapter 2.
Appendix Table 5. Definition of application.
2.7 Facility management Matrix Effect Targets Technologies
The type of The way the The measurable The practical
This procedure shall describe how the test centre ensures material target is property that is application of
that the facilities and the equipment for verification and test that the affected affected by the knowledge in
of products belonging to the technology area covered by the product is product the
intended for The effect could environmental
centre are available and fit for the purposes. be The target could area
Matrices concentration be nitrate
This point can be fulfilled by reference to the relevant part(s)
could be reduction, concentration, The term
of a certified or compliant quality management system as soil, decrease in MW/kg, etc. technology is
defined in Chapter 2. drinking treatment covering a
water, period, pH Operational variety of
ground increase, etc. parameters: products,
water, etc. Measurable processes,
2.8 Management review Additional parameters that systems and
parameters: define the services. The
This procedure shall describe how the management of the Other effects application and technologies
organization hosting the centre is ensuring that the test that will be the could be air
centre is working according to this quality manual through described but verification/test scrubbers, GAC
mechanisms such as e.g. an annual management review are considered conditions filtering, etc.
secondary
process. Operational
The additional parameters
This point can be fulfilled by reference to the relevant part(s) parameters could be
of a certified or compliant quality management system as could be production
defined in Chapter 2. product costs capacity,
(including also concentrations
energy of non-target
consumption compounds in
3 VERIFICATION PROCESSES and chemical matrix, etc.
consumption),
Verification is done by the test centre verification sub-body environmental
and testing by the test centre test sub-body. health and
safety and user
The verification and documentation follow the flow shown in
manual quality,
Appendix Figure 3. etc.
3.1 Access assessment
The application definition should be refined during the
Access to the verification process is given after a quick scan application and performance parameter definition done as
of the properties of the technology product in question. part of protocol preparation.
NORDTEST METHOD NT ENVIR 011 9
3.1.3 Evaluation of quick scan 3.2.3 Verification protocol
In the evaluation of the information supplied by the vendor, The verification protocol shall describe the framework for the
the emphasis is upon: verification of the technology product and provide the
• Description of product function information required for the test plan. The template for the
verification protocol given in Appendix 3 shall be used.
• Relevance of performance claims
When a verification protocol has been accepted for one
• Data supporting performance claims. product aiming at one application (matrix/target
The evaluation is based upon the information supplied be combination), all subsequent verifications within this
the vendor and the general information on relevance of combination shall include the first accepted verification
product performance available with the centre. protocol.
The verification protocol shall be approved by the
verification responsible and the internal reviewer.
3.1.4 Reporting of quick scan
The quick scan shall be reported by completing the quick Technology and product description
scan form, Appendix 1. The technology behind the product in verification shall be
Recommendation not to proceed with the verification described in principle with respect to the mechanisms of
procedure can be because: operation and the construction.
• The technology is not ready for market The product in verification shall be described in detail with
respect to the mechanism of the operation and the
• The technology falls under an established product
construction. The description shall allow understanding of
certification or type approval scheme
the mode of operation within an accepted scientific and
• The application can not be defined as required for the technical context.
process (matrix, effect and/or target not clear)
References to any patents on the product shall be given with
• The technology is not an environmental technology as information on the owner of the patents and on licensing to
defined here (Section 1.1.5). the vendor, when the vendor is not the patent owner.
The vendor shall be informed on the results of the quick This part of the verification protocol will be changed, when
scan, and the vendor can decide to proceed with the a protocol is used in subsequent verifications.
verification procedure irrespective of the conclusion of the
quick scan.
Application and performance parameter definitions
The application that the product shall be verified for shall be
further defined with respect to the matrices, targets and
3.2 Verification and test planning effects for the product.
3.2.1 Verification contract The performance parameters shall be set to ensure that the
If the vendor decides to proceed with verification, the centre product is tested for parameters and in ranges that are
shall provide a cost estimate for the verification. Based upon relevant for the buyers of the technology considering
the cost estimate, a verification contract is drawn and signed regulatory requirements, application based needs and state
by the vendor and the centre and subsequently, the of the art performance of similar products.
verification planning can start. The definition of the application and the performance
The verification contract shall be done applying the template parameters should be done using the template given in
found in Appendix 2. It is recognised, that parts of the Appendix 3 of the verification protocol template. As a
verification budget may in some cases need to be revised minimum, it shall be documented that systematic evaluation
after elaborating the first parts of the verification protocol of the issues listed in the template is behind the precise
(application and performance parameter definition, detailed definitions of application (matrix, target and effects) and
evaluation of existing data, test plan design). In such cases, performance parameters.
a contract is entered with a preliminary maximum budget for If a standard giving relevant performance parameters for the
these first parts, opening for a later revision and negotiation. applications verified is available, reference to this standard
can substitute the derivation of the performance parameter
definitions.
3.2.2 Technical experts Selection of the parameters to be verified shall be done
For each verification, not less than two technical experts separately for each application for verification in order to
shall be appointed. At the least one of the experts must be reflect the different requirements for different applications.
independent of the test centre (external). When a set of application and performance parameter
definitions have been derived, for one product aiming at one
NORDTEST METHOD NT ENVIR 011 10
application (matrix/effect combination), all subsequent If available and relevant, test standards or methods shall be
verifications within this combination shall comply with this given. If specific requirements for analytical methods or their
set. performance have been identified during planning, these
In the protocol text, the application and parameters are shall be given.
presented in summary, as e.g. in Appendix Table 5 for the The requirements for test data management with respect to
application, whereas their derivation is described in more the format of data storage shall be defined. If needed, the
detail in the appendix to the protocol. methods to be used for processing of raw data into
measurement results shall be given.
Additional parameters The quality assurance requirements described for the test
Further aspects may be included when relevant and shall plan shall include requirements for reference analysis
then be described: user manual (Chapter 3.5.1), product quality control, test system control, data integrity control,
costs (Chapter 3.5.2) and occupational health and review of plans and reports and audit of test system.
environment (Chapter 3.5.3).
Evaluation method
Existing data The methods of processing of measurements into
Existing data, i.e. produced before approval of the performance parameters including statistical methods and
verification protocol and the test plan for the product, any required statistical levels of confidence shall be defined
supplied by the vendor are summarized with the name, full or referenced.
address and status (independent/dependent, certifications The methods of evaluation of the test quality assurance data
and accreditations) of the data supplier. shall be outlined.
The data quality of the existing data is evaluated by
inspection done by the verification sub-body checking Verification quality assurance
documentation, raw data and quality control data from the The member of the verification sub-body that will review the
data production. The same data quality requirements as set draft verification protocol and report before submission to
for the test during verification must be fulfilled by existing the external review is named. The verification protocol and
data. Existing data must be produced under a quality report reviewer can not be responsible for verification
management system comparable to that of EN ISO 9001 / planning or operation.
19/ or ANSI/ASQ E4 /20/, and analytical data under quality
assurance equivalent to that of ISO 17025 /23/ or GLP /24/ The external expert(s) that will perform review of the
. Existing data produced by the vendor or by bodies verification protocol and report shall be named. A template
dependent upon the vendor can be used for planning of the for review reports as given in Appendix 7 may be used but
verification but not as verification data. in all cases, the review results and their implementation in
the protocol and report shall be documented.
The accepted existing data are summarized in the format to
be used reporting test data. If the verification is done within the framework of another
ETV scheme, the involvement of this scheme in quality
assurance of the verification shall be given.
Test plan requirements
The verification protocol describes the requirements for the
Verification schedule
test design for the product, as it shall be implemented in the
test plan. The schedule for the verification shall be given.
The test plan requirements must reflect the application and
the performance parameters defined for the verification, but 3.2.4 Test plan
specific requirements for the test design shall be given in
order to ensure that the tests will provide data reflecting the The test plan is the implementation of the verification
application and the performance parameters required for the protocol test design requirements in detailed tests producing
evaluation. The test plan requirements shall be specified the required measurements and data. A template for the test
with respect to: plan is given as Appendix 4 and shall be followed.
Reference to the verification protocol used shall be given.
• Overall test design
The test plan is unique for each test occasion giving the
o Scale (laboratory, pilot and/or field)
exact information required by the test staff to conduct the
o Performance parameters to be measured tests.
• Methods of reference analysis
The test plan shall be approved by the test responsible and
• Data management the internal reviewer.
• Quality assurance
• Test report. Test design
If relevant, operational conditions for the tests shall be The types of test sites shall be described responding to the
described, see operational parameters in Appendix Table 5. requirements set in the verification protocol. The description
NORDTEST METHOD NT ENVIR 011 11
shall allow for an understanding of the site in relation to the Data management should describe filing and archiving of: e-
matrix/matrices, targets, effects and operational parameters mail communication, paper communication, recordings in
defined for the verification. the laboratory and in field (if relevant), data, calculations and
The information required for the test staff to access the site other files.
shall be included.
A field site shall not be dependent upon the vendor. If the Quality assurance
product in verification is installed and used at the field site, The measures taken to ensure and quantify the test
it shall be ensured that no commercial or other interests are traceability and reproducibility are described. Measures
associated with using the site as test site for the product, such as replicate samples, replicate tests, replicate analysis,
besides the vendor’s interest in obtaining the verification field blanks and field controls may be selected. The way
statement. reproducibility of the tests will be quantified shall be
The test method(s) used shall be given by reference, if described. Reference analysis, performance requirements
standard or equivalent. If in-house methods are used, the and quality control shall be detailed.
method shall be referenced and outlined, or included in an The procedures to be applied in control of data integrity
appendix to the test plan. during transfer from one format to another shall be
The test schedule shall be given. described, if such transfers take place.
The descriptions of test operation shall allow the test staff to The member of the test sub-body that reviewed the draft test
perform the tests as required in the verification protocol and plan and report before submission to the verification sub-
to replicate operations with the least possible variation body is named. The test plan and report reviewer can not be
during the test. The description shall allow tracing of any responsible for test planning or operation. Plans for
errors back to sources with equipment, methods, operations additional review and/or audits shall be given, if relevant.
or staff.
Test report formats
Reference analysis
The format of the test report shall be set, such as e.g. by
The analytical programme shall be described including reference to the template used in this manual (Appendix 5).
agreed analytical methods and required analytical The format and location for archiving of raw data shall be
performance (detection limit, uncertainty). Contact defined.
information, requisitions and logistics should be given. The
format of reporting from the laboratory (data files, accredited
reports etc.) should be described.
3.3 Test and verification reporting
Data management Testing shall be done according to the test plan and
verification according to the verification protocol. If changes
The methods of calculation of test measurements from raw
to either need to be done before doing the testing and/or
data shall be described, if not given in the analytical and test
verification, an amendment form is filed in and approved by
methods used. Formats of data storage (data files,
the same persons that are responsible for preparation and
instrument prints, report forms) shall be laid down. Software
approval of testing and/verification, respectively, see
other than standard spread sheets used for data collection,
Appendix Table 3. Similarly, if changes are recorded during
storage and calculations shall be indicated.
testing and/or verification, these are recorded in a deviation
A data compilation and storage table, Appendix Table 6, form and approved as for the amendment forms. Examples
should be used to summarize the requirements. of amendment and deviation forms are given in Appendices
10 and 11. The amendment and deviation forms shall be
Appendix Table 6. Data compilation and storage summary, retained as documentation as part of the records of testing
example. and verification.
Data type Data Data Data Data
media recorder recording storage
timing 3.3.1 Test report
Test plan Protected Test When Location The test report uses all chapters from the test plan, see
and report PDF files responsible approved
Appendix 4, except for the last chapter describing the
Test details Log book Technician During Location planned report being replaced by a data report chapter such
in laboratory and pre- collection
and field prepared as that shown in Appendix 5.
forms A summary of any amendments to and deviations from the
Calculations Excel files Test During Location test plan recorded during tests from the plans shall be
responsible calculations included.
Analytical Paper Test When Location The appendix from the test plan with data reporting forms
reports responsible received
shall be replaced by a test data report listing any and all
NORDTEST METHOD NT ENVIR 011 12
deviations from the test plan with description, justification Statement and logo use
and effect evaluation, as well as all required measurements. The verification statement with logo may be used by the
The test data report shall include all analytical and vendor for marketing and approval. The vendor shall make
calculated data. the statement available in full and shall not use parts of the
The test report shall be approved by the test responsible statement for any purpose.
and the internal reviewer. The vendor may quote the verification statement as follows:
the XX product has been verified for ZZ effect on WW target
in YY matrix by QQ test centre on DD.MM.YYYY, while
3.3.2 Verification report giving the reference for access to the full verification
The verification report uses all chapters of the verification statement.
protocol, Appendix 3, with a Chapter describing the The vendor shall not use the logo alone neither on products
evaluation of obtained data inserted as an additional nor on published (printed, web or other) matter other than
chapter, see Appendix 6 for a template that shall be used. the verification statement.
The evaluation shall give a summary of the test results,
amendments to and deviations from protocol and test plan, Surveillance
and performance of the product in the verification is
The vendor shall be obliged to report any information on
summarized. The impact of any and all amendments and
changes in the product to the test centre with the data
deviations from the verification protocol and test plan shall
needed to evaluate whether the conditions for verification
be evaluated and summarized.
have changed. The test centre shall perform this evaluation
The evaluation includes calculation of the performance at the cost of the vendor. Substitution of one part with
parameters, evaluation of the data quality based upon the another with the same documented specifications is not
test quality assurance and compilation of the additional considered a change.
parameters.
Evaluation of required additional parameters shall be Statement validity
summarized.
The verification is valid as long as the product has not been
The test report shall be publically available either as an changed in such way that the conditions for verification have
appendix to the verification report or as a separate report. changed, see previous section.
The verification report shall be approved by the verification
responsible and the internal reviewer. Withdrawal
Documentation for the verification report document review The verification statement shall be withdrawn by the test
by the external expert(s) identified in the verification protocol centre if misused by the vendor. Misuse is defined as
shall be included as an appendix. Appendix 7 gives a violation of the conditions stated in this section. In case of
template for review report that may be used but in all cases, withdrawal, this is announced on the ETV web, and reports
the review results and their implementation in the report are removed from the web.
shall be documented.
3.4 Additional verification parameters
3.3.3 Verification statement with logo
Additional parameters selected for evaluation in the
The verification statement is a maximum 4 page summary of verification protocol, see Section 3.2.3, shall be evaluated
the verification including applications, performance using documented procedures.
parameters, test design, operation conditions, test results
and evaluation of additional parameters.
3.4.1 Evaluation of user manuals
Statement format The verification parameter for the user manual is the
The format of the statement shall be as given in Appendix 8. completeness of the description of the use of the product as
The overall format shall be implemented in the same form adequate and understandable for the typical user. This
for all products, and an identical format shall be applied for parameter is evaluated through evaluation of a number of
all products aiming at the same application. specific points of importance. An example of a matrix that
may be used for the purpose is given in Appendix 9.
Statement issue A description is complete, if all essential steps are
The verification statement with logo is prepared after described, if they are illustrated with a figure or a photo,
verification and is signed by an issuing body representative where relevant, and if the descriptions are understandable
(the verification sub-body of the test centre). without reference to other guidance.
NORDTEST METHOD NT ENVIR 011 13
3.4.2 Evaluation of product costs 8. CEN/WS 32. Environmental Technology Verification –
Soil and Groundwater Remediation and Monitoring
The capital investment costs and the operation and
Technologies. CEN workshop agreement. 2008.
maintenance cost should be itemized based upon a
determined design basis /25/. An example of a matrix that 9. AIRTV. Testing network for verification of air emissions
may be used for the purpose is given in Appendix 9. abatement technologies. AIRTV project flyer. 2007.
The design basis should be described and the cost items 10. US EPA. Environmental Technology Verification
relevant for the use of the product listed. Program. Quality Management Plan. 2008.
Actual costs for each cost item may be compiled and 11. European Standard. EN 45011. General requirements
reported if found relevant for the technology area and for bodies operating product certification systems. 17-6-
industry praxis in question. 1998.
12. International Standardization Organisation. ISO 9000.
Quality management systems – Fundamentals and
3.4.3 Evaluation of occupational health and
vocabulary. 15-9-2005.
environmental impact
13. International Standardization Organisation. EN ISO/IEC
The risks for occupational health and safety and for the
17000. Conformity assessment – Vocabulary and
environment associated with the use of the product should
general principles. 11-1-2004.
be compiled including a list of chemicals used during
product operation and classified as toxic, T, or very toxic, Tx, 14. European Standard. EN 45020. Standardization and
for human health and/or very environmentally hazardous (N) related activities – General vocabulary. 2006.
according to /26/. The information should be given as 15. International Standardization Organisation. ISO VIM.
amount used per product unit (sample). An example of a International vocabulary of metrology – Basic and
matrix that may be used for the purpose is given in general concepts and associated terms (VIM). 2008.
Appendix 9.
16. International Standardization Organisation. ISO/IEC
Additional risks from installing, operating and maintaining
Guide 7:1994. Guidelines for drafting standards suitable
the product should be eva-luated, compiled and reported, if
for use for conformity assessment. 1994.
relevant. In particular, risks for human health associated
with power supply and danger of infections will be 17. ISO and IEC. ISO/IEC Guide 65:1996. General
considered. requirements for bodies operating product certification
systems. 1996.
If relevant, production of hazardous waste or emissions may
be recorded. 18. International Standardization Organisation. ISO/IEC
17011. Conformity assessment – General requirements
for accreditation bodies accrediting conformity
3.4.4 Other additional verification parameters assessment bodies. 2007.
If relevant, other additional verification parameters may be 19. International Standardization Organisation. EN ISO
defined and verified using documented procedures. 9001. Quality management systems – Requirements.
15-11-2008.
20. American Society for Quality. ANSI/ASQ E4-2004.
4 REFERENCES Quality systems for environmental data and technology
1. CEN. Rules for the structure and drafting of CEN/ programs – Requirements with guidance for use. 4-2-
CENELEC publications. ISO/IEC Directives – Part 2. 2004.
2003. 21. EURODEMO, PROMOTE, and TESTNET. Common
2. Grøn, C. ETV Test Centre and Test Organization. Basic Glossary of Terms. 12-7-2006.
requirements. 13-7-2007. 22. EURODEMO, PROMOTE, and TESTNET. Verification
3. Merkourakis, S., Calleja, I., Delgado, L., Oçafrain, A. and scheme definitions. 2007.
Laurent, S. Environmental Technologies Verification 23. ISO. General requirements for the competence of testing
Systems. 2007. Joint Research Centre, Institute for and calibration laboratories. ISO 17025. 2005.
Prospective Technological Studies.
24. OECD. OECD Principles of Good Laboratory Practice.
4. Draft Scheme of the Verification Procedure. Submitted to OECD GLP Document No. 1. 21-1-1998.
the Commission. 2007.
25. Gavaskar, A. and Cumming, L. Cost Evaluation
5. European Commission. Consultation paper on an EU Strategies for Technologies Tested under the
system for environmental technology verification. 2007. Environmental Technology Verification Program. 2001.
6. KIWA. EU ETV – the SYSTEM. TESTNET. Draft. 2006. Battelle.
7. PROMOTE. Draft of European Environmental 26. European Commission. Commission Directive on
Technology Verification System for Monitoring and classification, packaging and labelling of dangerous
Remediation Technologies. 30-6-2006. substances. 2001/59/EC. 2001.
NORDTEST METHOD NT ENVIR 011 14
APPENDIX 1
APPENDIX 1. QUICK SCAN REPORT TEMPLATE
QUICK SCAN REPORT Product name:
Test centre Vendor
Name: Name:
Contact: Contact:
Address: Address:
Telephone: Telephone:
E-mail E-mail
Quick scan Previous quick scan
Date: Yes Date: No
Product description
Product ready to market Product in last development phase
Yes No Yes No
Performance claims
Matrices:
Targets:
Effects:
Product description clear Performance claims clear
Yes No Yes No
Existing test data
Tests performed Test body qualified
Yes No Yes No
Test report available Test report qualified
Yes No Yes No
Test methods available Test methods adequate
Yes No Yes No
Raw data available QA of raw data adequate
Yes No Yes No
Performance claims sustained Performance claims relevant
Yes No Yes No
Conclusions quick scan
Date Name Signature
NORDTEST METHOD NT ENVIR 011 15
APPENDIX 2
APPENDIX 2. VERIFICATION CONTRACT TEMPLATE
Verification contract
Product name:
Test centre Vendor
Name: Name:
Contact: Contact:
Address: Address:
Telephone: Telephone:
E-mail E-mail
{Test centre name} agrees to verify the above mentioned product for the below tentatively defined application in
accordance with the NOWATECH environmental technology verification method.
Application
Matrices:
Targets:
Effects:
Costs and payments
The steps and the costs in the verification includes {indicate costs as appropriate}:
Verification steps Costs
{currency}
Quick scan report
Verification protocol
Application and performance parameter definition
Assessment of existing data
Test plan design
Verification protocol
Test plan, test and test report
Verification and verification report
Verification statement
Total costs
Costs are all inclusive, VAT exclusive.
The budget for the test is tentative and an exact budget is made during preparation of the verification protocol. If the
final budget for test exceeds the tentative budget, this is subject to negotiation between the {Test centre name} and
{vendor}.
The payment scheme is as follows:
Payment Time of payment
10% advance payment With signed contract
50% payment After approval of verification protocol and test plan, before initiating testing
40% final payment After delivery of verification report and statement
NORDTEST METHOD NT ENVIR 011 16
APPENDIX 2
{Optional text}
{If another product is verified for the same application according to the same protocol by {Test centre}, the vendor of
that product will be charged with an evenly amount of the total costs paid by {vendor} that will receive a back payment
for this amount.}
Deliverables
{Vendor} agrees to provide without costs and delay for {test centre}:
o Contact person for the verification
o Existing performance data for the project
o Technology product(s) for verification as indicated in the test plan
o Installation of product(s) at test sites as indicated in the test plan
o User instructions, training and support as needed during testing
o Information on technology and product details and mode of action as required for a full understanding of the
product
o Comments on documents submitted for commenting.
{Test centre} agrees to provide within the contract:
o Verification of the product as indicated in this contract
o One original verification report and verification statement with logo.
Information
{Test centre} and {vendor} shall both inform the other part, if changes in the conditions for the verification changes.
Intellectual property rights
{Vendor} warrants that the product submitted for verification is owned or controlled fully by {vendor}.
{Vendor} will retain all rights to the product and all technical data produced during the verification.
{Test centre} will retain all rights to the verification process, protocols, plans, methods and procedures developed by
{Test centre}.
Schedule
A detailed schedule will be part of the verification protocol and test plan. These will be available for commenting within
6 weeks from the date of contract signing and first payment, whatever comes latest.
Limitations
{Test centre} performs the verification as described for the application of the product as defined in this contract. This
verification can not be considered an endorsement, approval, authorization or warranty of any kind, and the performance
parameters provided can not be extended to other applications or to other products.
{Vendor} agrees not to use or refer the verification for any other product or application, not to use extracts of the
verification statement for any purpose, and not to use the logo of {Test centre} or the verification scheme except as part
of the verification report or the verification statement.
Confidentiality
All final versions of reports, protocols, plans and statements can be made available for public access by {Test centre}
through media it finds relevant such as the NOWATECH web.
All other information obtained or produced during the verification is considered confidential for the part not owning the
intellectual property rights.
NORDTEST METHOD NT ENVIR 011 17
APPENDIX 2
During verification, {vendors} allows {Test centre} to give external auditors access to all information obtained or produced
during the verification, as specified in the verification protocol and/or the test plan.
Liability
{Test centre} assumes no liability for any damages associated with the use of verification results, and {vendor} agrees
to cover any costs that may be imposed upon {Test centre} in connection with claims raised with this respect.
{Test centre} assumes no liability for delays or for verification results that damage the sales of the product or the vendor.
Force majeure
The parties of this contract shall not be liable for failures beyond their control.
Termination
Either party may terminate this contract with a 15 days written notice. In case of termination, any costs endured by {Test
centre} as part of the verification that can not be averted shall be paid in full by the terminating part. If termination is
done by {Test centre} due to {Vendor}s non-fulfilment of the obligations in this contract and documents referenced herein,
then the costs shall be paid in full by {Vendor}. Termination by {Vendor} does not prevent preparation and publication
of the verification report based upon the data available at the time of termination, and the costs for reporting and
publication will be payable by {Vendor} irrespective of the termination.
Disputes
Disputes shall be governed by {Test centre home country} law.
Signatures
Test centre Vendor
Name: Name:
Signature: Signature:
Title: Title:
Date: Date:
NORDTEST METHOD NT ENVIR 011 18
APPENDIX 3
APPENDIX 3. VERIFICATION PROTOCOL TEMPLATE
Title page 8. Evaluation
1. Table of contents 8.1. Calculation of performance parameters
8.2. Evaluation of test data quality
2. Introduction
8.3. Compilation of additional parameters
2.1. Name of product
8.3.1. User manual
2.2. Name and contact of vendor
8.3.2. Product costs
2.3. Name of centre/verification responsible
8.3.3. Occupational health and environment
2.4. Verification and test organization
2.5. Expert group 9. Verification schedule
2.6. Verification process 10. Quality assurance
3. Description of the technology Appendix 1. Terms and definitions used in the
4. Description of the product verification protocol
5. Application and performance parameter definitions Appendix 2. References (verification protocols,
5.1. Matrix/matrices requirement documents, standards, methods)
5.2. Target(s) Appendix 3. Application and performance parameter
5.3. Effects definitions
5.4. Performance parameters for verification A3.1 Applications
5.5. Additional parameters A3.1.1 Matrix/matrices
6. Existing data A3.1.2 Target(s)
6.1. Summary of existing data A3.1.3 Effects
6.2. Quality of existing data A3.1.4 Exclusions
6.3. Accepted existing data A3.2 General performance requirements
A3.2.1 Regulatory requirements
7. Test plan requirements
A3.2.2 Application based needs
7.1. Test design
A3.3 State of the art performance
7.2. Reference analysis
A3.4 Performance parameter definitions
7.3. Data management
7.4. Quality assurance
7.5. Test report
NORDTEST METHOD NT ENVIR 011 19
APPENDIX 4
APPENDIX 4. TEST PLAN TEMPLATE
Title page 4.2. Analytical parameters
1. Table of contents 4.3. Analytical methods
4.4. Analytical performance requirements
2. Introduction
4.5. Preservation and storage of samples
2.1. Verification protocol reference
2.2. Name and contact of vendor 5. Data management
2.3. Name of centre/test responsible 5.1. Data storage, transfer and control
2.4. Expert group 6. Quality assurance
3. Test design 6.1. Test plan review
3.1. Test site 6.2. Performance control – reference analysis
3.1.1. Types 6.3. Test system control
3.1.2. Addresses 6.4. Data integrity check procedures
3.1.3. Descriptions 6.5. Test system audits
3.2. Tests 6.6. Test report review
3.2.1. Test methods 7. Test report
3.2.2. Test staff 7.1. Test site report
3.2.3. Test schedule 7.2. Test data report
3.2.4. Test equipment 7.3. Amendment report
3.2.5. Type and number of samples 7.4. Deviation report
3.2.6. Operation conditions Appendix 1Terms and definitions used in the test plan
3.2.7. Operation measurements
Appendix 2. References
3.2.8. Product maintenance
3.2.9. Health, safety and wastes Appendix 3. References methods
4. Reference analysis Appendix 4. In-house test methods
4.1. Analytical laboratory Appendix 5. In-house analytical methods
Appendix 6. Data reporting forms
NORDTEST METHOD NT ENVIR 011 20
APPENDIX 5
APPENDIX 5 TEST REPORT TEMPLATE, PARTS SUBSTITUTED OR ADDED IN TEST PLAN
7. Test results
7.1. Test data summary
7.2. Test quality assurance summary
7.3. Test performance summary
7.4. Amendments to and deviations from test plan
Appendix 6. Test data report
Appendix 7. Amendment and deviation reports for test
NORDTEST METHOD NT ENVIR 011 21
APPENDIX 6
APPENDIX 6. TEMPLATE FOR VERIFICATION REPORT, PARTS SUBSTITUTED OR ADDED
IN VERIFICATION PROTOCOL
8. Evaluation Appendix 4. Test report
8.1. Calculation of performance parameters (from the Appendix 5. Review reports
verification protocol) A5.1 Plan document
8.2. Performance parameter summary A5.2 Report document
8.3. Evaluation of test quality
Appendix 6. Amendment and deviation reports for
8.3.1. Control data
verification
8.3.2. Audits
8.3.3. Amendments to and deviations from the
protocol and test plan
8.4. Additional parameter summary
8.4.1. User manual
8.4.2. Product costs
8.4.3. Occupational health and environment
8.5. Operational parameters
8.6. Recommendations for verification statement
NORDTEST METHOD NT ENVIR 011 22
APPENDIX 7
APPENDIX 7. TEMPLATE FOR REVIEW REPORT
Review report
Document title: Document date:
Reviewer name: Review date:
Name:
Organization:
Address:
Telephone:
E-mail
Review results
Rate items Satisfactory Unsatisfactory Overall recommendation
Contents
Scope Acceptable as is
Organization Minor revisions
Data quality Major revisions
Method validity Not acceptable
Conclusions
Other (specify) Reason
Revision details
Topic Report chapter, Revision Reason Revision action (to be filled in by document
section, page required owner during revision after review)
Add additional rows, if pertinent.
NORDTEST METHOD NT ENVIR 011 23
APPENDIX 8
APPENDIX 8. TEMPLATE FOR VERIFICATION STATEMENT WITH LOGO
Title page/page 1
Test centre logo
Technology: Product:
Test centre Vendor
Name: Name:
Contact: Contact:
Address: Address:
Telephone: Telephone:
E-mail E-mail
Web Web
Applications and performances
Matrices:
Targets:
Effects:
Page 2
1. Technology and product description
2. Application(s)
2.1. Matrices
2.2. Targets
2.3. Effects
2.4. Exclusions
Page 3
3. Test design
3.1. Laboratory/field conditions
3.2. Matrix compositions
3.3. Target concentrations
3.4. Operation parameters
3.5. Parameters measured
Page 4
4. Verification results
4.1. Performance parameters
4.2. Users manual
4.3. Product costs
4.4. Occupational health and environment
5. Quality assurance and deviations
6. Names, organizations, dates and signatures
NORDTEST METHOD NT ENVIR 011 24
APPENDIX 9
APPENDIX 9. TEMPLATES FOR ADDITIONAL PARAMETER EVALUATION
Parameters for user manual evaluation
Parameter Complete Summary No description Not relevant
description description
Product
Principle of operation
Intended use
Performance expected
Limitations
Preparations
Unpacking
Transport
Assembly
Installation
Function test
Operation
Steps of operation
Points of caution
Accessories
Maintenance
Trouble shooting
Safety
Chemicals
Power
List of capital cost items and operation and maintenance cost items per product unit
Item type Item Number None
Capital
Site preparation
Buildings and land
Equipment
Utility connections
Installation
Start up/training
Permits
Operation and maintenance
Materials, including chemicals
Utilities, including water and energy
Labor
Waste management
Permit compliance
Compilation of classified chemicals used during product operation
Compound CAS number Classification Amount used per product unit
NORDTEST METHOD NT ENVIR 011 25
APPENDIX 10
APPENDIX 10. TEMPLATE FOR REPORT ON AMENDMENT TO VERIFICATION PROTOCOL
OR TEST PLAN
AMENDMENT
PROTOCOL/PLAN DOCUMENT TITLE AND DATE:
AMENDMENT NUMBER: __________
DATE OF AMENDMENT: __________ AMENDED:
AMENDMENT CONTENTS:
REASON FOR AMENDMENT:
IMPACT OF AMMENDMENT:
PREVENTATIVE ACTION:
If relevant, action to prevent that the same cause of amendment will reoccur in the future.
ORIGINATED BY:
__________
Centre verification or test responsible
__________
DATE
APPROVED BY:
__________
Centre verification or test organization quality responsible
__________
DATE
NORDTEST METHOD NT ENVIR 011 26
APPENDIX 11
APPENDIX 11. TEMPLATE FOR REPORT ON DEVIATIONS FROM VERIFICATION
PROTOCOL OR TEST PLAN
DEVIATION
PROTOCOL/PLAN DOCUMENT TITLE AND DATE:
DEVIATION NUMBER: __________
DATE OF DEVIATION: __________
DESCRIPTION OF DEVIATION:
REASON FOR DEVIATION:
IMPACT OF DEVIATION:
After suggested corrective action
CORRECTIVE ACTION:
If required, actions to be taken to prevent consequences of deviation
PREVENTATIVE ACTION:
If relevant, action to prevent that the same cause of amendment will reoccur in the future.
ORIGINATED BY:
__________
Centre verification or test responsible
__________
DATE
APPROVED BY:
__________
Centre verification or test organization quality responsible
__________
DATE
Return address:
Nordic Innovation Centre,
Stensberggata 25
NO-0170 Oslo, Norway
NORDTEST
NORDTEST is a Nordic Innovation Centre
brand offering competence and expertice
in the field of harmonizing of norms and
methods,a large Nordic net-work of experts,
more than 650 recommended Nordic testing
methods and 550 published technical reports.
Nordic Innovation Centre
www.nordicinnovation.net
The Nordic Innovation Centre initiates and finances
activities that enhance innovation collaboration and
develop and maintain a smoothly functioning market in
the Nordic region.
The Centre works primarily with small and medium-
sized companies (SMEs) in the Nordic countries. Other
important partners are those most closely involved with
innovation and market surveillance, such as industrial
organisations and interest groups, research institutions
and public authorities.
The Nordic Innovation Centre is an institution under the
Nordic Council of Ministers. Its secretariat is in Oslo.
For more information: www.nordicinnovation.net
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