Exercise - I

NATIONAL INSTITUTE OF TRAINING FOR STANDARDIZATION, NOIDA

IS/ISO/IEC 17025:2017

The 20 brief scenarios represent requirements given in ISO/IEC 17025:2017. Everybody should attempt
to relate each one of the listed scenarios to a clause in Clause 4, Clause 5 & Clause 6 of ISO 17025:2017.
Berar in mind that:

1. We only want you to identify the clause including sub-clause in ISO/IEC 17025: 2017 which apply
to the situations.
2. Try to identify the most appropriate clause including sub-clause without going to extremes.

S. No. Scenarios/ Requirements Clause No.

of ISO/IEC
17025:2017
1. The laboratory has retained records for documentation of reference 6.4.13f
materials, results, acceptance criteria, relevant dates and the period of
validity.
2. ABC laboratory has only claimed conformity for facilities it possesses i.e 5.3
the range of laboratory activities documented, and excludes
subcontracting activity with “xyz” on as ongoing basis.
3. The test laboratory receives information, about ‘Raj enterprises’ from 4.2.3
FSSAI, was carefully used and not revealed to anyone.
4. XYZ laboratory uses the manual and has not developed a separate 6.4.3
procedure for handling, transport, storage, use and planned maintenance
of reference materials & measurement standards in order to ensure
proper functioning.
5. The laboratory has not retained records for taking any actions arising 5.3
from evaluations, monitoring of performance and re-evaluations of the
external providers.
6. The laboratory doesn’t have all the facilities necessary to manage and 6.6.1
perform all the activities documented. They seek the help of external
experts/services, whenever required.
7. The assessor ahs observed a risk similar to the one identified in his lab 4.1.5/4.1.4
was suggesting the lab audited to implement it in their lab also. However,
the laboratory was not able to understand/demonstrate how it
eliminates the risk of impartiality in their lab. The assessor went ahead
raising a minor non-conformity.
8. The laboratory has verified all the equipment conforms top specified 6.4.4
requirements before being placed into service. It was unclear to them for
why to get all calibrated.
9. The laboratory has documented minimum procedures needed to the 5.5
extent necessary to ensure the consistent application of their activities
and the validity of the results.
10. The laboratory has ensured the reference values and correction factors
are updated and implemented, as appropriate, to meet specified 6.4.11
requirement.
11. While going through the lab documented system as well as website, it 4.2.1
was observed in internal audit that the laboratory has not informed the
customer in advance, of the information it intends to place in the public
domain.
12. The laboratory has not authorized specific personnel for reporting, 6.2.4
reviewing and authorization of results instead say that the head of the lab
does all the work.
13. The lab analyst carries out their work even after the validity of calibration 6.4.8/6.2.9
is over without examining the effect from specified requirements and
when the assessor enquired, the lab mentions it missed managing the
situation.
14. PQR laboratory is having personnel for identification of deviations from 5.6b
the management system or from the procedures for performing
laboratory activities and appreciated their fine work/services.
15. When calibration of the equipment is required to establish the 6.4.6
metrological traceability of the reported results, the lab doesn’t plan it to
get it calibrated.
16. The laboratory management is providing incentives to their personnel 4.1.3
based on the number of samples tested in a day.
17. The laboratory always ensures to employ personnel having the requisite 6.2.3
competence to perform particular laboratory activities.
18. ABC chemical testing laboratory does not ensure the integrity of the 5.7
management system are planned and implemented.
19. ABC laboratory has established the measures taken to control the 6.3.4
facilities are implemented, monitored and periodically reviewed.
20. PQR chemical testing laboratory has demonstrated metrological 6.5.3a
traceability to certified values of certified reference materials provided by
a competent producer.