ISO/IEC 17025:2017 Transition Webinar Questions & Answers

Contents
1. Complaints .......................................................................................................................... 1
2. Decision Rules .................................................................................................................... 2
3. General ............................................................................................................................... 3
4. MS Options ......................................................................................................................... 4
5. Risk..................................................................................................................................... 5
6. Sampling ............................................................................................................................. 6
7. Traceability ......................................................................................................................... 7
8. Transition ............................................................................................................................ 8

1. Complaints
Question Answer
Is the Complaints process expected to be A description of the process, yes. This may
available to any interested party on be a brief account rather than a copy of the
request? process.
7.9.2 If a description of the complaint We assess the lab’s compliance with 17025,
handling process has to be available to any not explicitly their compliance with Law. See
interested party. In some UK countries (e.g. other related question on this topic.
Wales) this would have to be bilingual for
public body laboratories. Would we rely on
the lab’s translation or would we have to
use an external translation resource?
Is it in your view acceptable for small labs to The requirement is that it is reviewed before
have the 2nd person for complaint handling giving to client, so probably generally not.
to come in annually to look over de Would need to be accessible on demand.
complaints as part of the internal auditing
process?
7.9.2 says, A description of the handling Yes, a description of the process is easier
process for complaints shall be available to than a copy of the procedure. It could just be
any interested party on request. Not a sentence to complainant?
mandatory to send to complainant.

Page 1 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
2. Decision Rules
Question
Fail is based on 95% Confidence level,
should this be stated in Compliance
statement?
Will it be allowed on a test certificate to
provide the results, together with the
specification, but leave it to the customer to
decide pass/fail, rather than indicating it on
the test certificate?
Can the decision rule be declared as not
taking the uncertainty into account?
If the customer says for example, they do
not require Uncertainty to be taken into
account of a pass/fail criteria what level of
documentation does this require?
It is worth pointing out that M3003 Appendix
M contains specific detail on decision rules
and risk levels (probability) associated with
false acceptance or reject.
Do the decision rules apply to observational
results e.g. positive identification of amosite
asbestos in a sample of lagging?
Answer
The decision rule is to be stated. Fail will be
based on agreed criteria.
Absolutely yes, unless the lab has contracted
with you for a decision, or it is part of the test
spec. Depends on contract review.
It should take it into account (i.e. ensure it is
not ridiculously large for example) Sometimes
the test specs suggest it can be ignored. So,
sometimes it can be accounted for but
dismissed and not included in the calculation.
This would be described in the statement on
test report.
Not a matter of documentation, the contract
review will conclude what is to be done. The
lab must maintain its integrity. It should take it
into account (ie ensure it is not ridiculously
large for example) Sometimes the test specs
suggest it can be ignored. So, sometimes it
can be accounted for but dismissed and not
included in the calculation. This would be
described in the statement on test report. If
the customer has supplied a decision rule, no
further assessment of risk is required, but it
must be sound.
Yes, Thank you. The point here is that now
we appreciate that almost any decision rule is
acceptable rather than relying on the ILAC
model.
If there are pass/fail criteria, Yes.
Page 2 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
3. General
Question
Should external Proficiency Testing be
done annually?
Can opportunities be raised as mandatory
findings?
Can an organisation holding ISO 17025
accreditation legitimately claim ISO9001
certification?
The copy I have of the Final Draft – ISO/EC
FDIS 17025 does not have a Section under
7.8.1.3 as discussed in the first part of this
talk.
5.3 Is it OK for the laboratory to simply say
its scope is defined on the UKAS schedule?
Will we expect the scope to cover all
activities, or just those relevant to ISO
17025?
I read from clause 8.7.1 that the extent
analysis is more clearly required than the
2005 version of the standard requires. Do
you agree?
7.8.8.2 - Does this mean that any change
[to the report] must be explained in the
report? In annex for example but not in a
mail associated with the report?
Answer
No such prescription. It depends on technical
and availability considerations.
Failure to cover opportunities and risks in the
MS would be a finding.
No. It should rely on the equivalence
statements in the Standard and the tripartite
agreement.
All references should have been to the ISO/IEC
17025:2017 and not to the DIS or FDIS. I am
aware of a couple of errors. Thanks.
If that is true, I don’t see why the same
document should not be used, but bear in mind
that they must not depend on us for the
conformity with 17025. That is against 17011.
So, they would need to reproduce it and keep it
up to date, not just link to our website.
I take this to be about technical scoping for
sampling, calibration and testing.
The requirement is, I agree, clearer now. I
believe the intent is the same.
Reporting may be in various forms as agreed
with client, but normally, I would say yes so
that any reader may see this in the context of
the report.
Page 3 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
4. MS Options
Question
There has been no reference made to the
context of the organisation which is a key
ISO 9001 requirement; is this applicable to
ISO 17025?
If a laboratory has opted for an option B
quality system, should the 17025 assessor
assess that the laboratory meet the
requirements of section 4 to 7?
If the lab take Option B can you confirm that
we still have to assess the management
system. I am already getting labs asking me
if the assessment effort can go down as we
don’t need to assess this area anymore.
For option B Do we allow non-accredited
certification?
Having assessed labs which were part of
an ISO 9001 certified manufacturer I have a
certain amount of scepticism about the
quality of some ISO 9001 audits. With
Option B are [we] going to be able to raise
NCs against the management system as
accepted under ISO9001 e.g. in the quality
and effectiveness of their audits, document
control process etc?
Could a lab easily apply for ISO 9001 and
not have to change anything in their
management system if they hold ISO
17025:2017?
Answer
If taking Option B then the lab will be
expected to ensure it adequately covers
17025 requirements. That’s all, so I suppose
not. However, although the word context is
not used, the intention is much the same.
Yes sections 4 to 7 in all cases to be covered
by the MS, but issues are raised against 8.1.3
for MS issues, not 8.2.
We assess that the lab’s MS adequately
covers 17025 cl 4 to 7. This may be more or
less than if taking option A. It depends on the
complexity of the MS. Initially I would expect
no change but later effort may go up or down.
At present there is no policy on this. It is not
for us to allow or not, Accredited certification
is likely to need less assessment by us to see
that it is adequate.
Yes, we assess the suitability of the MS to
cover 17025 requirements. Deficiencies in
the MS would be 8.1.1 or 8.1.3. Technical
deficiencies would be in Cl 4 to 7.
It is not a matter of “accepted”. The MS may
not be certificated anyway, or may have used
a non-accredited registrar. There is presently
no policy on this.
Probably not. Some things in 9001 like
development, research etc don’t appear in
17025. Anyway, if it is only a lab there is no
point. See the tripartite agreement and joint
communique.
Page 4 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
5. Risk
Question
A labs own perception of risk may be very
different to ours. How do you deal with this?
7.8.6 - How will the laboratory be in a
position to quantify the risk to the client?
The laboratory may not be aware of the
clients’ requirements, and their risk
strategy.
Should the process of evaluation of a
specific risk be documented?
In order to assess the suitability of the labs
determination of risk, does this mean that
the AM or Lead Assessor must have
knowledge of the industry sector the
laboratory is involved in?
So, the risk based approach will require
assessors to make judgement calls on the
laboratory's own judgement calls. Won't that
lead to greater 'disagreement' about
whether requirements of the Standard are
met or not?
Do you see any changes from a monitoring
perspective as to what is being accepted as
an acceptable risk management process?
Are UKAS going to look at the risks
associated with us assessing risk and
opportunity in the new standard? It’s not
about impartiality but about consistency of
assessment.
Answer
By persuasion and being a great assessor. The
decision is the lab’s but whether the handling of
risk and opportunity is adequate is ours.
By contract review, especially when
considering decision rules.
It depends on the complexity of the lab. In
order to achieve this, they will need to know
what the process is and it may therefore need
documentation.
It certainly would help but ultimately the
decision is that of the lab anyway.
Yes, but it is clear that the lab decides which
risks to attack. We comment on degrees of
compliance with 17025 and these judgement
calls comprise the difference between
assessing and auditing.
No, but I expect the necessary measures to
vary greatly, but it is very clear that this should
be ongoing.
Interesting point. I would say that the
assessment is now more skilled and about
competence rather than conformity so findings
will vary between labs for good reason. This is
essentially the difference between skilled
assessing and simple auditing.
Page 5 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
6. Sampling
Question
In sampling e.g. for deposition of pollutants,
a soil sampling grid can have a very large
uncertainty due to patchy deposition. Does
this large uncertainty need to be (a) defined
and (b) combined into the overall
uncertainty of the result of the pollutant in
'concentration units per square metre'?
Must the subsequent calibration/testing be
accredited?
Does sampling include the taking of sub
samples in the lab?
Reporting sampling – of [sic] [if] a lab
declares that it has sampled in accordance
to a known standard/standard requirement,
would that negate the need to evaluate
measurement uncertainty?
Can an organisation be accredited
according to ISO 17025 for sampling
alone?
Answer
Remember that they are to report components
relevant to later establishing the uncertainty of
measurement in the subsequent testing. This
is not an uncertainty of sampling which is
covered by the very nature of the sampling,
sampling plan design, agreement and
understanding of the client etc. The laboratory
is required to report items affecting the
uncertainty of measurement and anything else
that could affect the validity of the test
results. Comments perhaps on the adequacy
of the sampling plan if supplied by the client,
comments on the need or not to homogenise or
sub sample, features of the sampling site in
practice, observation of adjacent features,
weather conditions, etc. The important thing is
that the contract review establishes the
needs. This will vary; sometimes the sampling
lab is the main contractor, sometimes the test
lab or the client. Discussions and agreement
are vital. Lessened, of course, if this is covered
in a comprehensive specification containing it
all.
The standard is not about accreditation, so
fundamentally no, but EA policy and our
ACC1000 requires the subsequent testing to
be accredited, as far as the sampling lab can
ensure. So, it depends on the contractual
setup.
Effectively yes, but that may be included in the
test regime sometimes. Either way, any
sampling undertaken shall comply.
The lab is expected to pass on all information
on things that could affect uncertainty of
measurement, not to evaluate measurement
uncertainty because it is not making
measurements. The use of a known standard
handling such matters certainly helps.
Yes, provided it is intended for subsequent
testing or calibration, not necessarily by the
same entity.
Page 6 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
7. Traceability
Question
Is there guidance for accredited
laboratories on what sections of the new
standard are to be covered when
determining the technical competence for
traceability requirements?
Traceability of test results are still the key
added value of a third party lab to me. If
customer is taken to court, the lab shall be
able to provide traceable and reliable
results.
6.5.2 - Does a lab supplying traceability
need to be accredited? If not, how to
ensure it complies with ISO 17025?
Answer
No, Labs shall comply with all the clauses if
they are claiming conformity with 17025. A
supplier of calibrations shall be competent;
ILAC MRA accredited, CIPM NMI listed or
“the third way”. If the third way then they
would need to be assessed as competent.
Conformity with 17025 is an indicator of such
competence.
Traceability is provided by features that do
not require independence. See Annex A and
JCGM, VIM etc. It is for the customer to be
happy with lack of independence. Some 1st
party manufacturer’s labs are the very best as
they are the experts in their kit and have a
direct interest in getting the right answer.
It does not need to be accredited, nor CIPM
MRA listed but if not, establishing
competence would be difficult. See Appendix
to 17025, and the help in ILAC G8 Appendix
continues to apply.
Page 7 of 8
 ISO/IEC 17025:2017 Transition Webinar Questions & Answers
8. Transition
Question
How will the transition plan be managed for
Enterprise labs where they do not have an
AM?
Can new customers be accredited against
the new standard i.e. for an initial
assessment in May 2018?
After March 2018, will all applications have
to be for the new standard?
Will the IAR form have two dropdowns, one
for each version, so that IAs and
Observations can be documented?
Will the charges be relevant to the changes
made by the lab rather than the size?
I have been asked - will there be specific
guidance provided for lab customers?
When assessing to the new version of the
standard, should this be an Initial
assessment approach, i.e. longer time on
site, more depth covered. This could be
during the labs SU cycle.
If the assessment against the new standard
is a surveillance visit and recommendation
is not positive and only includes one
assessor could this not be an issue and
how will we handle this?
Answer
The Case Manager acts as AM, and will call for
help as required.
See transition plan. Possibly, if our resources
are available and signed off.
No, but this is advised as assessments after 1
Jan 2019 are only to new standard.
The Accreditation standard column auto
populates with the standard only, not the year,
so the next column, Additional accreditation
standards, will also need to be used where
assessment is against both 2005 and 2017
versions (free text fields).
I would say, complexity, rather than changes or
size. It is determined initially by simple UKAS
man day size rule but you may represent to
your manager if you disagree in a case.
Complex cases should be charged more.
There is help from ISO/CASCO and we are
putting some information on our website. We
are also offering awareness seminars.
We expect the site time to be as normal for that
visit in the cycle. WE would adjust the other
topics covered to suit. The extra work is in the
transition template analysis etc. as desktop.
I would say that we handle it as we would any
findings and it should not be a problem. If we
have messed up then the corrective activity
would be at our expense so maybe best to
have an experienced assessor or AM attend
that visit. I think it unlikely that we would need
all the technical assessors present to conclude
if the transition had been made, but the use of
decision rules in different areas needs to be
watched.
Page 8 of 8