First Annual Quality Congress, Tehran, 3rd & 4th November 2002

The Design and Implementation of ISO

17025:1999 in the
Civil Engineering Testing Center at Kuwait
University

Dr. Tariq A. Aldowaisan, ASQ

CQA/CQE/CQMgr
Dr. Souhaila Almutawa, ASQ CQA
Eng. Ashraf S. Youssef, M.Sc.
Department of Industrial and Management
Systems Engineering
College of Engineering and Petroleum
Kuwait University
P.O. Box 5969 Safat 13060
Tariq@kuc01.kuniv.edu.kw
almutawa@kuc01.kuniv.edu.kw
gomma@kuc01.kuniv.edu.kw

The application of ISO 17025:1999 is relatively rare world-wide compared

to ISO 9001:2000 or ISO 14001:1986. Despite its limited scope of
application to testing and accreditation laboratories, ISO 17025 is superior to
ISO 9001 because it covers both management and technical requirements.
Moreover, unlike ISO 9001 which is awarded by a registration body, ISO
17025 is awarded by an accreditation body.

We have applied ISO 17025 to the Civil Engineering Testing Center at the
College of Engineering & Petroleum in Kuwait University. In this
presentation we shall describe the main requirements of ISO 17025
underlining its differences from ISO 9001. In addition, we shall highlight the
approach we have undertaken and the challenges we have faced. This
includes preparation steps, documentation, and implementation. Finally we
shall report on our experience with the selected accreditation body; namely
A2LA (American Association for Laboratory Accreditation).

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Why ISO 17025:1999?

Pioneering: One of the roles of the College of Engineering & Petroleum

(CEP) at Kuwait University is to serve industry to help promote economical
and societal growth. Therefore, undertaking pioneering projects is one
approach to fulfilling this role for the following reasons:
1. Pave the way for other laboratories to follow by facing up to obstacles
and finding appropriate solutions to them.
2. Pressure other commercial labs by putting them at a temporary market
disadvantage.
Getting CEP labs accredited to ISO 17025 would immediately make CEP a
pioneer since our investigations have revealed that no labs in Kuwait or in
the Gulf region are accredited to ISO 17025. As a matter of fact our
investigation revealed that labs in only two countries have taken serious
steps to implementing ISO 17025; namely South Africa and “Israel”!

Market advantage: In addition to their educational function, many CEP

labs provide testing and calibration services to outside clients; thus acting as
commercial units. Undoubtedly, getting accredited to ISO 17025 would
provide them advantage for the immediate future.

Improve performance: CEP labs are equipped with state-of-the-art

equipment. Performance and test quality, however, is a function of more
than just equipment; equipment must be integrated within a system of
technical and managerial policies and procedures and a competent
administrative and technical staff. The leadership at CEP (Dean and
Chairpersons) was convinced that accreditation would constitute a point in

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time in the future for pooling resources and motivating personnel to improve
the performance of labs.

Anticipating Client Request: As a result of the widespread application of

ISO 9001:2000 QMS in Kuwait, some clients started to ask to see quality
manuals. In response, CEP had the option of getting its labs certified to ISO
9001 or accredited to ISO 17025. As we shall explain later, the final decision
came to be in favor of ISO 17025.

ISO 17025 versus ISO 9001

We may summarize the differences between ISO 17025 and ISO 9001
through Table 1.
Criteria ISO 17025 ISO 9001
Requirements Management & Technical Management
Industry Laboratories All
Certificate Provider Accreditation body Registrar
Accreditation/ For specific tests or For very broad industry
Registration Scope measurements for a or product categories
particular products and
tests specifications
(standards)
Table 1. ISO 17025 versus ISO 9001

Based on the above table, we can say that ISO 17025 is preferred over ISO
9001 for laboratory organizations, or for laboratories operating within
organizations since it provides assurances to clients that the lab has the
necessary technical and managerial standards. In other words, a laboratory
that has ISO 17025 does not need to have ISO 9001; however, it’s not true
the other way around. ISO 17025 not only requires a quality system and

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manual in the laboratory but also requires the lab to be competent to perform
specific tests or calibrations.

Also, from a recognition/marketing point of view, ISO 17025 is superior to

ISO 9001 because, as we have mentioned earlier, very few laboratories in
the region are accredited by an internationally recognized body to ISO
17025. Moreover, accreditation has a higher recognition status than
registration, as accreditation bodies are responsible for auditing registrars.
We may capture the relationship between the two standards based on the
requirements scope and certification provider in the following two diagrams
(Figure 1).

ISO 9001
ISO 17025

Management
Requirements

Technical
Requirements

Accreditation Body

Registrars

Figure 1. (a) ISO 17025 versus ISO 9001. (b) Accreditation Body is a higher
authority than Registrars.

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 First Annual Quality Congress, Tehran, 3rd & 4th November 2002

ISO 17025 Requirements

Tables 2 and 3 provide the requirements for ISO 9001:2000 and ISO
17025:1999 respectively. As can be seen, ISO 9001:2000 has only
management requirements that are classified under five categories (4 to 8)
with a total of 23 subcategories; whereas, ISO 17025 has management and
technical requirements that are classified under two categories (4 and 5) with
a total of 24 subcategories.

ISO 9001:2000 Requirements

4 Quality (4.1) General requirements, (4.2) Documentation
Management requirements.
System
5 Management (5.1) Management commitment, (5.2) Customer
Responsibility focus, (5.3) Quality policy, (5.4) Planning, (5.5)
Responsibility, authority and communication, (5.6)
Management review.

6 Resource (6.1) Provision of resources, (6.2) Human

Management resources, (6.3) Infrastructure, (6.4) Work
environment.

7 Product (7.1) Planning of product realization, (7.2)

Realization Customer-related processes, (7.3) Design and
development, (7.4) Purchasing, (7.5) Production
and service provision, (7.6) Control of monitoring
and measuring devices.

8 Measurement, (8.1) General, (8.2) Monitoring and measurement,

analysis and (8.3) Control of nonconforming product, (8.4)
improvement Analysis of data, (8.5) Improvement.

Table 2. ISO 9001 Requirements.

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ISO 17025:1999 Requirements

4 Management (4.1) Organization, (4.2) Quality system, (4.3)
Requirements Document control, (4.4) Review of requests,
tenders and contracts, (4.5) Subcontracting of tests
and calibrations, (4.6) Purchasing services and
supplies, (4.7) Service to the client, (4.8)
Complaints, (4.9) Control of nonconforming
testing and/or calibration work, (4.10) Corrective
action, (4.11) Preventive action, (4.12) Control of
records, (4.13) Internal audits, (4.14) Management
reviews.

5 Technical (5.1) General, (5.2) Personnel, (5.3)

Requirements Accommodation and environmental conditions,
(5.4) Test and calibration methods and method
validation, (5.5) Equipment, (5.6) Measurement
traceability, (5.7) Sampling, (5.8) Handling of test
and calibration items, (5.9) Assuring the quality of
test and calibration results, (5.10) Reporting the
results.

Table 3. ISO 17025 Requirements.

Do-it-yourself or Call on Consultant

The dean contacted the authors for advice on whether to seek external
consultant or do it ourselves; the initial decision is to seek proposals. We
received two proposals; one from Dubai claiming that we should do ISO
9001 instead; and the other is from a British firm. Both offers are expensive.
Therefore, we finally decided to do it ourselves on the following two
premises:
1. Be patient as we shall learn as we implement.
2. Provide resources for training the development team.

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Another main motivator for doing it ourselves is that we may utilize the
experience we gain in future consulting opportunities with laboratory clients.

So the team was formed as follows:

1. Dr. Tariq Aldowaisan, Project Manager
2. Dr. Souhaila Almutawa, Project Member
3. Eng. Ashraf Youssef, Engineer Assistant

Realization Approach

The following Steps summarize our development and implementation

approach:
1. Form team and develop project plan
2. Select accreditation scope & define client team
3. Select accreditation body
4. Develop quality manual and verify
5. Implement system
6. Conduct awareness
7. Conduct internal audit
8. Prepare application package

1. Form team and develop project plan

The team consists of a Project Manager who is an Industrial Engineer and
has extensive background and experience in quality and ISO 9001:2000. The
Project Member is a Mechanical Engineer who has extensive background
and experience in laboratory work and manufacturing processes. The
Engineer Assistant is the Chief Engineer in the Department of Industrial &

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Management Systems Engineering and he has detailed experience in

laboratory work.

The first step was to develop a project plan that involves the following main
tasks:
• survey of all labs in all of the engineering college (about 80),
• self-learning of ISO 17025 and attendance of training programs,
• survey of accreditation bodies to select the appropriate one,
• development of documentation,
• implementation and fine-tuning of documentation, and
• communication with selected accreditation body to set date for
accreditation audit.

2. Select accreditation scope & define client team

From our initial investigation, it became clear to us that it’s going to be very
difficult to approach all 80 labs for the following reasons:
1. very time consuming
2. a failure of one would fail all
3. very expensive
So, we changed our strategy and decided to focus our efforts on few labs and
tests, seek accreditation for these labs, and then expand the scope to other
labs. So, the question became one of deciding the criteria for selection. After
conferring with the Dean, and other parties in the college, we decided to
focus on the labs that provide the highest revenue. This narrowed our scope
quickly to labs in the Civil Engineering Testing Center (CETC).

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The next step was to select the tests to include for accreditation; we started
with over 30 tests but the list quickly shrunk to only 9 tests as shown in
Table 4.

Concrete ASTM-C138
ASTM-C143
ASTM-C173
Aggregates ASTM-88
ASTM-C117
ASTM-C127
ASTM-C128
ASTM-C131
ASTM-C139
Table 4. The Selected Tests.

We purposely decided to focus on the tests that are most ready in order to
focus our effort on the development of the system with the understanding
that we shall widen the scope of tests after we obtain accreditation. This
increase of tests shall include customized tests as well.

Another important task is to determine the client team. That wasn’t a

difficult task since it was clear that the Manager of CETC is the most
knowledgeable technically and administratively of CETC activities. So, the
CETC Manager was designated as the Quality Representative. Another
important person is the Laboratories Coordinator in the Civil Engineering
Department who happens to be a faculty that overlooks the well-being of
laboratories. Therefore, our counterpart in CETC consisted of the CETC
Manager and the Laboratories Coordinator.

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3. Select accreditation body

This activity is one of the most challenging because there are very few
international accreditation bodies world-wide. From the beginning, we were
committed to select an international accreditation body that is world-wide
recognized. Our investigation revealed that our selection should be limited to
accreditation bodies that enjoy a mutual recognition agreement (MRA) with
well-known accreditation bodies in order to make the accreditation of the
selected body recognizable by other well-known bodies. Moreover, the
selected recognition body should be accredited to Guide 58 which is a
standard that governs the systems of accreditation bodies. The following is a
list of accreditation bodies that we have considered:
• American Association for Laboratory Accreditation, USA (A2LA).
• National Voluntary Laboratory Accreditation Program, USA
(NVLAP).
• United Kingdom Accreditation Service, UK (UKAS).
• National Association of Testing Authorities, Australia (NATA).
• Raad Voor Accreditatie, Netherlands (RvA).

For quick access and information on the accreditation bodies world-wide,

visit the web site of International Laboratory Accreditation Cooperation
(www.ilac.org).

After a lengthy correspondence process that involved inquiries on services,

and cost, we selected A2LA (www.a2la.org). It is interesting to note that
UKAS was one of our considerations but its operations are limited to the
United Kingdom.

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To better know the selected accreditation body and to establish personal

contact, one of the team members, Dr. Souhaila Al-Mutawa, attended two
training programs with A2LA; they are:
• ISO 17025 and accreditation.
• Introduction to measurement uncertainty in testing laboratories.

She also visited A2LA headquarter to establish contact and to obtain

answers to some questions.

4. Develop the quality manual and verify

The quality manual has two parts; the policy part and the procedure part.
The policy part was prepared relatively quickly based on two sample
policies available to us. We basically stated CETC policy with regard to
each requirement in the ISO 17025.

It is important to note that in addition to ISO 17025 requirements; there are

accreditation body requirements which we had to address. These additional
requirements are specific to the fields of testing; e.g. Acoustics & Vibration,
Biological, Chemical, Construction Materials, Environmental, Geotechnical,
Mechanical, and Nondestructive.

The development of the procedures took a lot of time; as the team has no
prior experience in developing ISO 17025 procedures, especially the
technical ones. The development team has established a weekly meeting
with the client team to solicit feedback and to verify each procedure after it
gets developed. Finally a first draft quality manual was prepared.

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5. Implement system
The system implementation phase consumed a lot of time; about 9 months as
implementation revealed many issues that require modifications to the
quality manual; so the Project Member and the Engineering Assistant held
weekly meetings with the CETC Manager and Laboratory Coordinator again
over every procedure with focus on modification and simplification. Also,
implementation revealed situations that require immediate attention; e.g.
proper documentation, and calibration records.

6. Conduct awareness
A two-hour awareness program was conducted for two groups; the first
group consists of about 30 faculties who play the role of test consultants, and
the second group consists of about 30 engineers. The seminar focused on
providing general understanding of ISO by organizing it around the 5W+H
approach. We didn’t see a need for providing formal training to the client
team as they were getting informal continuous training through the very
frequent meetings we were having with them.

7. Conduct internal audit

A two-man internal audit was conducted by the Project Manager and the
Engineering Assistant. Attached at the end of this paper is a copy of the
Audit Plan. The main finding of the audit was the need to conduct more
training on the new system to testing staff.

8. Prepare application package

This is a rather lengthy but important step; we had to prepare the application
package as per A2LA instructions, which consist of (see www.a2la.org):
• Completing the application form. (8 pages)

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• Completing an Assessor Checklist: General Criteria. (29 pages)

The application has been forwarded to A2LA and we anticipate the
accreditation process to follow the flow shown in Figure (2).

Complete
Application Lab

Review
A2LA
Application

Review
QM Assessor

Assess
On-Site Assessor

Respond
To NC Lab

Assess
CA Assessor/A2LA

Grant
Accreditation A2LA

Figure 2. A2LA Accreditation Process.

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Lessons Learned & Recommendations

The following are the main lessons learned from our experience:
1. Start with smallest set of tests and focus on system then expand. We
wasted a lot of time surveying all 80 laboratories and hundreds of tests
and equipment. We recommend to initially focusing on a small set of
tests in one or two labs. This saves time and allows effort to be
concentrated on the development of a good quality system.

2. Design procedures with higher involvement from the Management

Representative from the beginning. We had to perform major
modifications to the procedures. We believe this is due to two factors:
(a) limiting the role of the CETC Manager to verifying the procedures
that were developed by our team rather than being involved in the
development process, and (b) the CETC Manager was not giving
adequate time to the project because of his other responsibilities. To
remedy this situation, we should have insisted to have a higher
participation level from the CETC Manager or his deputy.

The following are recommendation based on our experience:

1. Early affiliation with accreditation body. Unlike ISO 9001 or ISO

14001 where the decision on which registrar to choose can be deferred
to after the implementation phase; in ISO 17025, it is critical to make
the decision on the accreditation body at an early stage of the project.
There are three reasons for that: (a) Get our questions answered, (b) be
aware of the accreditation body requirements on top of the ISO 17025

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requirements, and (c) take advantage of the resources provided by the

accreditation body.

2. Early review of relevant laboratory equipment. This activity should be

started right away as it involves primarily making sure that all
equipment are calibrated and have a well-defined maintenance
program.

3. Need for credible organization to handle proficiency testing &

calibration. This activity should be started as soon as the tests to be
considered are determined; as it takes a good amount of time to find
organization that do proficiency testing; i.e. verifying that the results
of our tests are positively comparable with theirs. Since no labs in the
region are internationally recognized, we had to obtain samples from
Proficiency Testing (PT) providers that are accredited by A2LA (the
selected accreditation body), to perform our tests as per the test
methods within the scope of accreditation, and to send the results back
to A2LA for verification. This task is very important to assure the
quality of our results but it is costly and time consuming. Note that
A2LA recommends that, whenever possible, A2LA-accredited testing
and calibration laboratories use accredited PT providers to meet the
A2LA requirements for participation in proficiency testing.

4. Need for internationally recognized local or regional accreditation

body. Laboratories seeking ISO 17025 accreditation will face the
problem of finding a local or regional accreditation body that is a
signatory of the international MRA in the Middle East. Another
related problem, is that some of the accreditation bodies limit their

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operation to their local geographical areas; e.g. UKAS. This of course

increases the cost of accreditation a lot; as the traveling cost would be
high. Therefore, we highly recommend that countries in the region
pool their resources to establish such a body in order to serve
laboratories in the region at a reasonable price.

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Internal Audit Plan

Audited organization:
Civil Engineering Testing Center (CETC)
Purpose:
To verify conformance (compliance) and effectiveness of the quality system using
ISO 17025:1999 standards and A2LA requirements, and to report any
nonconformance(s) to CETC management.
Scope of the audit:
The CETC management and provisions related to the performance of Concrete Tests
(ASTM-C138, ASTM-C143, ASTM-C173), and Aggregate Tests (ASTM-C88,
ASTM-C117, ASTM-C127, ASTM-C128, ASTM-C131, ASTM-C136) as per ISO
17025:1999 standards and A2LA requirements. This includes Civil Engineering
management, relevant laboratories, and lab engineers.
Applicable documents:
CETC Quality Manual; ISO 17025:1999 standards; and Related A2LA requirements
Interview schedule:
Item/Area/Test Contact Auditor Wed 29/5
Opening meeting CE Dept. Chairperson All 8:00 – 8:15
Lab Committee Chair
Chief Engineer
CETC Manager
Top Mgt. CE Dept. Chairperson Dr. Tariq 8:15 – 9:15
Lab Committee Chair
Center CETC Manager Dr. Tariq 9:15 – 11:15
CETC Staff
All Tests Test Consultant Eng. Ashraf 8:15 – 11:30
Test Engineer
Test Technician
Test Worker
Labs. Chief Engineer Eng. Ashraf 11:30 – 12:30
Lab Engineers
Prepare draft report None All Thursday 30/5
Closing meeting CE Dept. Chairperson All Saturday 1/6
Lab Committee Chair 9:00 – 10:00
Chief Engineer
CETC Manager
Audit Team members:
Dr. Tariq A. Aldowaisan, Lead Auditor, ASQ CQA/CQE/CQM
Eng. Ashraf S. Youssef, Trained ISO 9001:2000 Auditor, and Lab. Ctrl. & Ass.
Approved: _________________________ Approved: ________________________
Lead Auditor CETC Manager

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