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We hope these questions and answers will be of help to you. Should you
have further questions please do not hesitate to contact us.
Questions regarding proficiency tests, accreditation, quality assurance or auditing should be addressed to Martina Rösch, Head of the ISTA Accreditation Department. |
1. What are the required qualifications of personnel and the laboratory staff of the ISTA accredited lab?
It is the responsibility of the laboratory to hire qualified personnel
or train them at the lab. ISTA does not request any specific
qualification. The lab has to test according to the ISTA Rules and
execute accurate, reliable and reproducible tests. ISTA offers from
time to time workshops, where seed people can update their knowledge.
(Aug-06)
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2. Are the conditions for accreditation the same with a government institution, a private independent or a company lab?
The conditions and requirements for laboratory accreditation are the
same for all categories of ownership. In essence, a laboratory has to
adhere to the ISTA Rules for Seed Testing, have competent staff and
appropriate equipment and demonstrate its independence of judgement and
integrity in relation to sampling and testing. In practice, a
laboratory that is not part of the public sector is bound to have more
potentially critical interactions and connections to entities that
might have an interest in exerting undue influence on the reported
results of analysis. This is generally assumed on the basis of the
strong link between the services rendered by the laboratory and its
economic success. Consequently, the examination of its independence of
judgment may seem more elaborate. Still it serves the same purpose in
all laboratories, irrespective of their organisational structure.
The procedure for becoming an ISTA accredited laboratory is outlined in
the relevant document that can be downloaded from this site under
"Accreditation". In short, it entails becoming member, participating in
a number of proficiency test rounds and undergoing the on-site
assessment. Depending on the experience of the applicant and its
preparedness to fulfil all requirements, this process may take from
less than a year to several years. (Aug-06)
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3. Can Seed Health be excluded from ISTA accreditation of
laboratories? Isn't Seed Health necessary condition for ISTA
accreditation?
The scope of accreditation (SOA), the
analysis methods and the species they are applied to, can be determined
by the laboratory. In principle, the Association leaves the choice to
the laboratory. There are of course some restrictions:
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only the methods and species covered by the ISTA Rules for Seed Testing
can be part of the SOA
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a laboratory with the intention to issue Orange International Seed Lot
Certificates needs to be accredited for sampling, although this is not
a testing method strictly spoken
Similarly, a laboratory can seek
accreditation for a limited number of species within a given method and
alter its scope of accreditation with approval by the Association.
(Aug-06)
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4. How can results of Seed Health Tests be reported, as the
ISTA Certificates do not have a column for this kind of results?
Results of seed health analysis may be placed in the section titled
'OTHER DETERMINATIONS' on the ISTA International Certificate. Results
from other tests not currently in the ISTA Rules may be included in the
same section 'OTHER DETERMINATIONS', including a statement on the
method used and followed by: ("This method is not covered by the International Rules for Seed Testing"). (Aug-06) |
5. What does the Blue ISTA Certificate cover?
The
Blue International Seed Sample Certificate refers to the sample at the
time of testing as opposed to the Seed Lot Certificates, that refer to
the lot as a whole at the time of sampling. Its design follows the
Green and Orange Certificates, except that information related to
sampling is not under the responsibility of the testing laboratory.
Handling of the sample upon receipt by the laboratory and the technical
protocols are identical to tests performed for the issuance of Seed Lot
Certificates. The laboratory is not accountable to what extent the test
results may be used to infer characteristics of the lot as a whole.
(Aug-06) |
6. What exactly means accreditation and how does it differ from certification?
Both accreditation and certification are a form of recognition based on
an assessment of compliance with stated requirements. ISTA
Accreditation pertains to the technical and managerial competence in a
seed testing laboratory. As a consequence, accreditation is granted to
the laboratory, not to individuals. Whereas accreditation is a
procedure by which an authoritative body gives formal recognition that
a body or person is competent to carry out specific tasks;
certification by a third party gives written assurance that a product,
process or service conforms to specified requirements. More
specifically, by granting accreditation to a seed testing laboratory,
the International Seed Testing Association recognizes the laboratory's
competence for seed testing and the validity of its analysis results as
for the relevant scope of accreditation. In contrast, certification has
a much broader meaning; for instance, certification against ISO 9001 is
applicable to any kind of organisation and merely means that the
management principles laid down in this standard are applied. Whether
the products, services or other output are positively affected is not
under consideration (although it may be assumed). Product
certification, like certification of seed lots under the provisions of
OECD, is intended to facilitate international trade of seed and
represents a tool to demonstrate conformity of a seed lot with minimum
requirements as to circumstances of production and specific properties.
(Jan-03)
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7. What do you understand by Scope of Accreditation?
The Scope of Accreditation (SOA) refers to the analysis methods and
species a laboratory is accredited for and stands for a number of
species/method combinations. Only methods and species that are listed
in the current ISTA International Rules for Seed testing ore that are
performance approved methods for the testing for the presence of
specified traits can be part of a laboratory's SOA. The SOA may differ
from a laboratory's scope of testing, as other seed testing methods may
be used. In that case a clear differentiation between testing work
within the SOA and other tests with regard to reporting and marketing
of services has to be made. The on-site assessment and other elements
of the verification of the laboratory's competence will only take into
account those method/species combinations accreditation is sought for
and, upon request and subject to the Association's approval, the SOA
may be altered in between two audits. (Aug-06) |
8. Could a lab be accredited for only one activity, for example: can it be accredited for germination and not for moisture?
Yes, this is possible. Accreditation may only cover one activity such
as germination of maize and sugar beet, or whatever the laboratory's
choice will be. This does still imply that the lab meets all
requirements of the Accreditation Standard. (Aug 06) |
9. Concerning the internal audits, do they have to be made by one
designated person (by me for example or by anybody else…) or by a
person which is designated by you or accredited by you?
Internal audits may be done by anybody having the necessary competence.
Competence refers more to the technical knowledge in the field that is
audited than to quality-management related qualifications. ISTA
generally does not accept internal audits performed by the same people
that carry out the activities that are audited; people from other
departments or with different responsibilities than those being
assessed are acceptable. External auditors (not from the same
organisation than the lab) are not necessarily required. On the other
hand, external audits my replace or partly serve as internal audits as
long as they adequately cover the requirements of the Accreditation
Standard. It is the laboratory's responsibility to appoint suitable
auditors for their internal audits. (Aug 06) |
10. Do we need a very consistent collection of seeds, or "just" these we use to find in our samples?
A reference seed collection of species you usually test and you find as
'other seeds' in theses samples is a good start. It may be complemented
by other means of helping to identify seeds, such as literature and
internet resources. In the next future, there will be a list of common
weed species that will represent pretty much what is considered a
minimum collection for most labs. For highly specialised labs and labs
with a very limited scope of accreditation it is difficult to specify
this in general terms. Having provisions for adding species to the
collection (for example those retrieved from ISTA proficiency test
samples) certainly is a good arrangement that compensates for one or
another species missing for the time being. (Aug 06) |
11. We have in our company two locations, 110 km between them. My
questions are: Can I make only one Quality manual with only the
specifications of each lab?
One quality manual may be
enough, as long as the particularities of the two (or more) different
locations are adequately taken into account. In similar cases we have
seen central manuals addressing all those things that are handled the
same way in all locations. This central manual is complemented by
specific documents or chapters for all those elements that are specific
to a given location. The quality documentation for each location is
then composed of a range of individual and general documents, document
control is generally under responsibility of one central office. Two
locations with a distance of 110 km would make it impossible to include
them in a single laboratory accreditation. Please see the multi-lab
accreditation document under the following link: http://www.seedtest.org/upload/cms/user/Acc-D-06-Multiple-sitelaboratoryaccreditation.pdf. (Aug-06) |
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