The Design and Implementation of ISO 17025 in the Civil Engineering Testing Cneter

First Annual Quality Congress, Tehran, 3rd & 4

th November 2002

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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

[email protected]

[email protected]

[email protected]

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/

Registration Scope

For specific tests or

measurements for a

particular products and

tests specifications

(standards)

For very broad industry

or product categories

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).

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

authority than Registrars.

Management

Requirements

Technical

Requirements

ISO 9001

ISO 17025

Accreditation Body

Registrars


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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

Management

System

(4.1) General requirements, (4.2) Documentation

requirements.

5 Management

Responsibility

(5.1) Management commitment, (5.2) Customer

focus, (5.3) Quality policy, (5.4) Planning, (5.5)

Responsibility, authority and communication, (5.6)

Management review.

6 Resource

Management

(6.1) Provision of resources, (6.2) Human

resources, (6.3) Infrastructure, (6.4) Work

environment.

7 Product

Realization

(7.1) Planning of product realization, (7.2)

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,

analysis and

improvement

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

(8.3) Control of nonconforming product, (8.4)

Analysis of data, (8.5) Improvement.

Table 2. ISO 9001 Requirements.


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ISO 17025:1999 Requirements 4 Management

Requirements

(4.1) Organization, (4.2) Quality system, (4.3)

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

Requirements

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

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).

Figure 2. A2LA Accreditation Process.

Complete

Application

Review

Application

Review

QM

Assess

On-Site

Respond

To NC

Assess

CA

Grant

Accreditation

Lab

A2LA

Assessor

Assessor

Lab

Assessor/A2LA

A2LA


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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

Lab Committee Chair

Chief Engineer

CETC Manager

All 8:00 – 8:15

Top Mgt. CE Dept. Chairperson

Lab Committee Chair

Dr. Tariq 8:15 – 9:15

Center CETC Manager

CETC Staff

Dr. Tariq 9:15 – 11:15

All Tests Test Consultant

Test Engineer

Test Technician

Test Worker

Eng. Ashraf 8:15 – 11:30

Labs. Chief Engineer

Lab Engineers

Eng. Ashraf 11:30 – 12:30

Prepare draft report None All Thursday 30/5

Closing meeting CE Dept. Chairperson

Lab Committee Chair

Chief Engineer

CETC Manager

All Saturday 1/6

9:00 – 10:00

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

Documents

The Design and Implementation of ISO 17025 in the Civil Engineering Testing Cneter