Exercise (2)

Writing Findings Against ISO/IEC 17011: 2017

Finding
# Scenario Clause # Description of the Finding
(NCR, OBS)

The evaluator asked for the list of individuals

deemed qualified by the AB to serve on their
committee as the decision makers on
accreditation decisions. The evaluator noted
that all of the individuals deemed qualified had
technical expertise limited to life sciences
(biology, chemistry and
1 pharmaceutical). However, the AB has a very
large number of accredited CABs, including
many in the automotive, electrical and
construction materials testing areas and
calibration area.

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 The evaluator was reviewing a new medical
accreditation program scheme based on ISO
15189 with the supervisor of the medical
accreditation program. The evaluator noted
that this new scheme did not include the
requirements for method validation or
2
measurement uncertainty for test
methods. When asked about this the Medical
Accreditation Supervisor agreed but said that
these requirements were too onerous for the
medical laboratories to meet so the AB decided
not to include them in this new scheme.
During the evaluation team member’s
witnessing of the closing meeting as part of the
assessment of an automotive testing CAB, the
assessment team leader orally delivered the
3 findings, including the nonconformities. The
assessment team leader then indicated that the
AB would provide the written nonconformities
to the CAB in about a week’s time.

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 The evaluator noticed in the competency
records of one of the accreditation officers that
this officer was written up during three different
competency reviews over two years for
4 incorrectly entering assessment dates into the
AB’s database. When the evaluator watched
this accreditation officer enter data into the
database, this mistake in entering assessment
dates occurred again.
The evaluation team member for the ISO 15189
medical accreditation program noticed that the
AB’s assessment program for medical testing
laboratories was a four years accreditation cycle
with an initial onsite assessment at year 0;
remote assessments at years 1 and 2 and 3, and
5 a full renewal assessment at year 4. When asked
why remote assessments were being done
between full assessments, the Medical
Accreditation Supervisor indicated that the AB
made this decision because the medical labs did
not want to pay to have assessment teams visit
their labs.

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 The evaluation team leader was reviewing the
AB’s internal audit records for the past three
years. She noticed that for every internal audit,
6
an ISO/IEC 17011 checklist was used and only
conformance with the ISO/IEC 17011
requirements was verified.
The team leader had the good fortune to be able
to witness a training course offered by the AB
under evaluation. The instructor for this
training course was also an assessor for the
AB. At a break in the training course schedule,
7
one of the attendees showed the instructor a
copy of his quality manual and the instructor sat
together with the attendee to make
improvements to the attendee’s quality manual
before the training course resumed.

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 When the team leader was reviewing the AB’s
in-house procedure for accrediting calibration
laboratories, there was a very clear requirement
in this procedure that all first-time applicants
for calibration accreditation must first undergo
8
a preliminary visit (pre-assessment) prior to the
full-on site assessment.
There was nothing in the corresponding
calibration labs records to indicate that the
calibration labs had agreed to a preliminary visit.

The team leader was reviewing the AB’s website

and noticed that one link led to a list of 17
suspended CABs.
9
This list only contained the names and
addresses of these CABs.

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 The evaluator was reviewing the risk
management program with the AB’s risk
management director. The evaluator
commented that it was a good program but also
noted that every risk situation was completely
eliminated, with no residual risk, which did not
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seem feasible for some of the risk activities
described. The risk management director said
that all risks were recorded as completely
eliminated so that top management would not
have to spend a lot time looking at risk data
during the management review.
.

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