ETV TEST CENTRE AND TEST ORGANIZATION CENTRE QUALITY MANUAL

W
Document Sample
scope of work template
							 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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