IJCA - Volume 2 - Flipbook - Page 57
2023 | Volume 2, Issue 1
57
DOI: doi.org/10.55459/IJCA/v2i1/SCSR
Risks and Opportunities: An Assessor’s Perspective
of ISO/IEC 17025 Expectations
By Dr. S.C. Soundar Rajan, Advisor, Dr. Amin Controllers Pvt. Ltd.
-ABSTRACTFor many laboratories as well as the assessors
of testing and calibration laboratories, there has
been a lack of clarity about the specific intentions
of ISO/IEC 17025:2017 under the topic “Risks and
Opportunities” in clause 8.5. This paper presents
the author’s understanding and perception of the
standard.
Keywords: ISO/IEC 17025:2017, risks and opportunities, testing and
calibration laboratories, accreditation body, National Accreditation
Board for Testing and Calibration Laboratories
The author has dealt extensively with the standard
ISO/IEC 17025, both as a member of the laboratories
for which he has worked and also as an assessor
evaluating several other laboratories on behalf
of the National Board for Testing and Calibration
Laboratories, India. The author admits that when
he first read the 2017 version of the standard, he
was at a loss to understand why ISO/IEC 17025
felt it necessary to include the topic “Risks and
Opportunities” in clause 8.5 and what exactly the
standard expects from laboratories. He wondered
what risks a laboratory could undertake that
might result in producing unreliable, unsure or
unacceptable results.
Unsure of how to interpret clause 8.5, the author
used to avoid analyzing it extensively in his
assessment undertakings. In the laboratories he
worked or guided, he allowed the laboratories to
merely copy from other laboratories simply to satisfy
the assessment process. He found it amusing that
several laboratories produced documents containing
a big list of risks associated with laboratory activities
and how they are mitigated and even accorded
grading to the potential risks. The identified risks
included factors such as inadequate/improper
training to personnel, lacking or expired calibration of
measuring equipment, unavailability or inappropriate
CRM, nonparticipation in interlaboratory and
proficiency testing programs, and similar. He noted
that some laboratories even included risks to
impartiality, though this topic is covered under a
different clause in the standard, and he was further
intrigued that even a grade was accorded for the risk
to impartiality.
Laboratories Are Missing the Point of
ISO/IEC 17025
The author feels these so-called risks are not risks,
rather they are clearly nonconforming acts, which are
not allowed to happen and several laboratories failed
to understand the same. Such nonconformities can
generate unreliable and questionable results. These
so-called risks are potential threats for laboratories
and can cause them to lose their credibility. The
author thinks that these laboratories did not seem to
be able to differentiate between risk assessment and
risk mitigation as dealt with in other situations and
“Risks and Opportunities” as dealt with in ISO/IEC
17025.
It took quite a long time for the author to understand
the essence of this clause. Clarity finally dawned
on him when he revisited the 2005 version of the
standard for some other purpose and chanced to
read Note 3 under clause 5.4.5.3. And then when
he again read the 2017 version of the standard,
Clause 8.5, Note 2 under 8.5.3, it dawned on him
that that ISO/IEC 17025 talks about risks that open
doors for increased, improved, or new business
opportunities for laboratories, out of the risks
the laboratories are prepared to undertake. He
feels that several laboratories missed this point.
The standard allows or even probably seemed
to encourage laboratories to be innovative and
undertake conscious, calculated, measurable risks
whenever certain situations demand the same and
to cater to the needs of the customer and effectively
serve the intended purpose for which such risks are
undertaken.
The author recalls several situations in his career
when laboratories were compelled or obligated to
undertake testing for which there may not have been
any existing standard or published material and
public domain information was not readily available.
Such problems manifest in different ways. In a
production plant, the process could be impacted
by unexpected behavior, maybe due to variations
in the input materials or the loss of valuables into
