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Laboratory System and Internal Audit program as per ISO/IEC 17025:2017

Exercise-1

Below is a list of scenarios from Clause 4 and 5 of ISO/IEC17025:2017. Relate listed scenarios to
relevant clause that is most appropriate to the given situation including sub clause without going to
extremes.

DO NOT FIND NON-CONFORMANCES. WRITE ONE CLAUSE ONLY.

S. Scenarios / Situation Clause

No.
1. The Food testing laboratory is being operated by Food and Drug
Administration which is under control of State Government Health
Department.
2. The laboratory has documented it procedures to the extent necessary to 5.5
ensure the consistent application of its activities and the validity of the results.
3. The laboratory shall be responsible for the impartiality of its laboratory 4.1.3
activities and shall not allow any pressure to compromise impartiality
4. The laboratory has documented its range of activities as Scope of testing 5.3
which conforms the requirement of ISO/IEC 17025: 2017. The laboratory is
claiming the conformity only with the scope /range as defined in the document
and laboratory does not claim for externally provided activities on ongoing
basis.
5. The laboratory is carrying out its activities in such a way that’s meeting the 5.4
requirement of ISO/IEC 17025:2017, its customers, and all applicable
regulatory authorities.
6. The laboratory is informing the customers in advance of the information being 4.2.3
placed in public domain through its website. The same has been agreed
between customer and laboratory
7. The laboratory is paying the financial incentives to those employees of the 4.1.3
laboratory, who are doing more number of testing, which is putting the
financial pressure to the testing personnel.
8. The Five persons of the laboratory are planning to leave the laboratory and 5.6
served the notice in advance. The 3 of them are the only authorized personnel
to perform the biological testing and 2 of them are responsible for
maintenance of laboratory management system, to maintain the integrity of
management system the laboratory is not planning in advance.
9. The laboratory is hiring the personnel from external bodies for the calibration 4.2.4
and maintenance services of its equipment and they are acting on behalf of
the laboratory and bound to keep all information as confidential.
10. The Sr. Analyst irrespective of his routine responsibilities has been 5.7
designated as Management system Coordinator and has been authorized for
reporting to laboratory management on performance of management system
and need for improvement.
11. In an organization, two brothers are working at management decision taking 4.1.4
positions, one is responsible for the production who is drawing the samples
and submitting for testing in In-house laboratory, the testing is being carried
out by his brother, however the laboratory has identified it as risk to
impartiality which arise from the relationships of its personnel
12. A laboratory is an in-house calibration laboratory, which is part of 5.5a
manufacturing organization, the organization and management structure of
the laboratory has shown its place with its parent organization.

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 Virtual Training on
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017
13. The laboratory management has the practice to hold meeting of all its 5.7a
employees daily in morning before start of the work, so that importance of
meeting customers’ requirements and other issues which are essential for
effectiveness of management system, can be communicated.
14. The pharmaceutical products of M/S YYYY are being tested by M/s Drug 4.2.3
Testing laboratory, The CDSO a Drug Controlling authority asked the
laboratory to submit test data /reports of Drug samples submitted by M/s
YYYY as drugs supplied by this organization to market are fake. The
Laboratory did not share the provider (source CDSO) of this information to
Customer (M/s YYYY) and it was kept confidential by the laboratory
15. Mr. ABC has been designated as Head of the laboratory, who is overall 5.2
responsible for the laboratory activities

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