ISO 17025 Standard: Evaluating Quality Using Deming’s Principles

This essay analyzes the requirements and clauses of the ISO/IEC 17025 standard in terms of quality improvement and organizing positive changes, assessing the feasibility and potential effectiveness of these clauses against Dr. Edwards Deming’s 14 points of quality management. It discusses the first three principles of Deming's points, highlighting how ISO 17025 adopts and improves upon these principles, particularly in areas like creating constancy of purpose, ceasing dependence on inspection, and adopting new philosophies for overall quality improvement. The analysis reveals that while ISO/IEC 17025 aligns well with Deming's principles, there are gaps in workforce development and policy adaptation that could be addressed in future revisions of the standard. The document references several academic papers to support its claims and provide context.

Running head: LABORATORY QUALITY SYSTEM
Laboratory Quality System
Name of the Student
Name of the University
Author note

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Introduction
The purpose of this paper is to analyse the requirements and clauses of the ISO/IEC
17025 in terms of quality improvement and organising positive changes. To assess the
feasibility and potential effectiveness of these clauses are assessed by the first principles of
the Dr. Edwards Deming’s 14 points of quality management for any organisation. In this
paper the first three principles of these 14 points will be analysed in the following section.
The aim is to analyse and discuss of the clauses of the ISO 17025 and present the verdict
regarding how this international standardisation improve or adopt the initial work of Dr
Deming.
Requirements of ISO/IEC 17025 for quality management
ISO/IEC 17025 is the international standardisation for calibration and testing the
operations and output of the laboratories. In 2017, the last ISO 17025 standards have been
revised (Leonard, 2018). Currently the standardisation procedure consists of five clauses
namely Scope, Normative reference, Terms and definitions, Management requirements and
Technical requirements. The scope refers the clear statement of current procedure and the
assessment of potential improvement. The Normative references are necessary for every
documented standardisation system which can only use the terms permitted by the ISO
standardisation (Grochau & ten Caten, 2012). Management requirements consist of clause of
all service measurement, integration policies, corrective and preventive action, audits and
others. The technical requirements cover all the technical issues and possible measurement
that should be undertaken by the respective organisation.
Dr. Edwards Deming’s 14 points of quality management has all the consideration and
recommendations that a laboratory should have to comply with in order to preserve their
quality of service, product and procedure or execution. The major coverage of this clause are

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the management system, document control, reviewing, complaints, auditing, controlling and
testing. The purpose of these clauses is documentation, management reviews and taking
initiatives for changes.
Discussion of Principle 1 and analysis of quality standards
The principle 1 defines the clause of creating constancy of purpose toward
improvement of product and service. The aim of this principle is to become competitive and
make the process of the organisation aligned with the business and to provide jobs. Any
organisation, the two usual types of problems always exist that are the existing problems and
the potential future problems. Existing problems can be solved easily; however the problems
of the future demand, constancy of purpose and dedication make the management worried.
As per this principle, the decisions need to be made through cultivate innovation,
collaborative research and education while improving the product design and service (Rivera
& Rodríguez, 2014).
Throughout the process of development and improvement, prioritising the customer’s
needs is the most important part of the production line. This perception is completely
followed under the scope section of the ISO 17025 standardisation statement. The
standardisation procedure of ISO 17025 does not imply any specific components or
parameter to create a purpose toward improvement of product and service of an organisation.
At the same time, in any section of this standardisation procedure the alignment of creating
the platform for new jobs was not mentioned.
Discussion of Principle 2 and analysis of quality standards
The principle 2 is completely emphasised on ceasing dependence on inspection to
achieve quality. Along with that eliminating the requirement for regular in depth inspection

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can enhance the quality of the product in the first place. These responsibilities can be fulfilled
through the approach of appropriate leadership and the investigation procedure while
replacing the disputed part of the operation with a more comprehensive substitute (Sadikoglu
& Temur, 2012). Similarly, in ISO 17025 the compliance of Government regulations and
antitrust activities are clearly mentioned.
The scope clauses of the ISO 17025 ensure that the quality of any product and service
do not comes from inspection rather from the upgrading the production process. Therefore
the crucial actions do not include the inspection, scrap, downgrading, and rework the process.
In management clauses section the ISO standardisation clearly emphasise on the Policy and
procedure for conducting internal audits and implementing findings. The clauses also
mention the procedure for management that includes the reviews of policies and procedures,
audit findings, corrective and preventive action, customer feedback and other essential
process.
Discussion of Principle 3 and analysis of quality standards
The principle 3 refers the process of adopting new philosophies in order to improve
the overall quality of the organisational procedures. In this age of globalised economy, the
libratory management system should identify the challenges while learning their
responsibilities. Still the responsible organisation can take all the responsibilities to ensure
the quality of a product after dispatching the product from the production premises (Weitzel
& Johnson, 2013). The Technical Clauses of the ISO 17025 are completely made to secure
the quality of the products and procedure

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This principle also indicates that commonly accepted levels of mistakes and defects
should not be tolerated. Therefore, complying this principle the managerial clauses the ISO
17025 standardisation enhancing the workforce capabilities are mentioned. However, there is
no direct indication that can convey the core purpose of the principle that implies that the
workforce of the organisation should receive effective training in order to understand their
duty, roles and responsibilities without having any ambiguity and fear for asking assistance
(Silva, Faria & Nogueira, 2014). However, ISO 17025 states that supervision is a necessity of
any workforce maintenance aimed towards the adequacy and effectiveness. However, there is
a clear gap between the core value of this third principle and the Management Clauses of ISO
17025. In the procedural standardisation the clause states that by providing Policy and
procedure for taking corrective action after identifying the disputes in the QMS or any
technical procedures.
Conclusion
Form the above discussion it is clearly visible that ISO/IEC 17025 tries to adopt and
even improve the implication of all the core components of the Deming’s principles in terms
of quality improvement and organising positive changes. However, there are some gapes in
workforce development and policy adaptation process that could be improved more in the
further revision of ISO/IEC 17025 standard.

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References:
Grochau, I. H., & ten Caten, C. S. (2012). A process approach to ISO/IEC 17025 in the
implementation of a quality management system in testing laboratories. Accreditation
and Quality Assurance, 17(5), 519-527.
Leonard, R. (2018). Implementasi ISO/IEC 17025 Pada Dunia Penerbangan. Jurnal Industri
Elektro dan Penerbangan, 1(3).
Rivera, C., & Rodríguez, R. (2014). Horwitz equation as quality benchmark in ISO/IEC
17025 testing laboratory. Private communication, 7(5), 51-57.
Sadikoglu, E., & Temur, T. (2012). The relationship between ISO 17025 quality management
system accreditation and laboratory performance. In Quality Management and
Practices. InTech. 5(2), 127-135.
Silva, G. M., Faria, A. C. O., & Nogueira, R. (2014). The lead assessor role in the ISO/IEC
17025: 2005 accreditation of Brazilian calibration and testing laboratories by the
General Coordination of Accreditation (Cgcre). Accreditation and Quality
Assurance, 19(2), 127-132.
Weitzel, M. J., & Johnson, W. M. (2013). Application of ISO/IEC 17025 Technical
Requirements in Industrial Laboratories. Friesenpress., 12-66.