DISTRIBUTION RESTRICTED

WORKING MATERIAL

QUALITY MANAGEMENT SYSTEMS

FOR TECHNICAL SERVICES IN RADIATION SAFETY

Prepared by the Division of Radiation and Waste Safety Radiation Monitoring and Protection Services Section

International Atomic Energy Agency

Reproduced by the IAEA Vienna, Austria, 2003

NOTE

The material in this document has been supplied by the authors and has not been edited by the IAEA. The views expressed remain the responsibility of the named authors and do not necessarily reflect those of the government(s) of the designating Member State(s). In particular, neither the IAEA nor any other organization or body can be held responsible for any material reproduced in this document.

CONTENTS

1. INTRODUCTION 1 Background 1 Objective 2 Scope 2 Definitions 3 Structure 4 2. IAEA PUBLICATIONS SUPPORTING TECHNICAL SERVICES IN RADIATION SAFETY 5 3. ISO STANDARDS ON QUALITY MANAGEMENT SYSTEMS 7 4. GENERAL GUIDANCE ON ESTABLISHING A QUALITY MANAGEMENT SYSTEM 9 Recommended Approach for the Establishment of a Quality Management System 9 Introduction 9 Requirements of applicable standards 11 Implementation process 11 Decision taking 11 Management commitment 12 Appointing an implementation team 12 Planning the implementation 13 Identifying existing processes 14 Defining document structure 14 Writing procedures 15 Initial training 15 Implementation, first internal audit and management review 15 5. REQUIREMENTS FOR SERVICES NEEDING CERTIFICATION BY ISO9001 18 Management Responsibility 18 Management Commitment 18 Customer Focus 18 Quality Policy 19 Planning 19 Quality objectives 20 Quality planning 20 Documentation requirements 21 General 21 Quality manual 21

Control of documents 22 Control of records 22 Responsibility, Authority and Communication 23 Responsibility and authority 23 Management representative 24 Internal communication 24 Management Review 25 Purpose 25 Frequency 25 Management review input 25 Output and documentation of the management review 26 Follow up 26 6. RESOURCE MANAGEMENT 27 Provision of Resources 27 Human Resources 27 Infrastructure 29 Requirements of the process 29 Requirements of the relevant nuclear or radiation safety regulatory body 29 Requirements established by other regulatory authorities 29 Work Environment 30 7. PRODUCT REALIZATION 31 Planning of Product Realization 31 Customer Related Processes 32 Design and Development 32 Purchasing 33 Production and Service Provision 34 Control of Monitoring and Measuring Devices 35 8. MEASUREMENT, ANALYSIS, AND IMPROVEMENT 36 General 36 Monitoring and Measurement 36 Customer satisfaction 36 Internal audit 37 Purpose 37 Selection and training of internal auditors 37 Audit frequency 38 Audit scope 38

Audit reporting and follow-up 39 Monitoring and Measurement of Processes 39 Monitoring and Measurement of Product 40 Control of Nonconforming Product 40 Analysis of Data 40 Improvement 41 Corrective action 41 Selection and implementation of corrective actions 42 Monitoring of corrective actions 42 Preventive action 43 9. ADDITIONAL REQUIREMENTS FOR SERVICES NEEDING ACCREDITATION BY ISO17025 45 Additional Management Requirements 45 Organization 45 Review of requests, tenders and contracts 46 Subcontracting of tests and calibrations 46 Purchasing services and supplies 46 Service to client 47 Complaints 47 Control of non-conforming testing and/or calibration work 47 Control of records 47 Internal audit 48 Additional Technical Requirements 48 Personnel (human resource planning) 48 Laboratory facilities (accommodation and environmental conditions) 49 Test and calibration methods and method validation 50 Equipment (equipment used for calibration or testing ) 50 Measurement traceability (calibration and testing) 51 Sampling 52 Handling of test and calibration items 53 Assuring quality of test and calibration results 53 Reporting results 54 REFERENCES 55 BIBLIOGRAPHY 58 Annex I Grouped Processes List 61 Annex II Quality Policy 65 Annex III Quality Objectives 66 Annex IV Duties of Quality Manager 67 Annex V Checklist to Evaluate Requests for Contracts 70

Annex VI Example of a Job Description 71 CONTRIBUTORS TO DRAFTING AND REVIEW 73

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1. INTRODUCTION

BACKGROUND

1.1. Quality assurance (QA) was identified as one of the five areas of the Nuclear Safety

Standards Programme (GOPV/1687 and GC (XVIII)/526/Mod.1, 16 September 1974) for the

development of safety standards.

1.2. The Nuclear Safety Convention and the Joint Convention on the Safety of Spent Fuel

Management and on the Safety of Radioactive Waste Management reflect the importance of

quality assurance by including Articles 13 and 23 respectively, emphasizing that ‘Each

Contracting Party shall take the necessary steps to ensure that appropriate quality assurance

programmes are established and implemented’.

1.3. In all three Safety Fundamentals publications issued by the IAEA, there are clear

references to quality assurance as an essential component of radiation safety. The Safety

Fundamentals publication on Radiation Protection and the Safety of Radiation Sources [1]

issued in 1996 states that:

“The source and associated facilities and equipment shall be regularly inspected, tested

and maintained in accordance with approved procedures and quality assurance

programmes to ensure that components, structures and systems continue to be available

and to operate as intended.” (Para. 6.9.)

“In the organization of a registrant or licensee, it is the management’s responsibility to

recognize the significance for protection and safety of its activities, and to promote a

radiation safety culture aimed at developing and maintaining an attitude of rigour and

thoroughness towards safety that permeates the entire organization. …. An important

aspect of this effort is the establishment of programmes of verification and quality

assurance.” (Para. 7.7.)

1.4. The Safety Fundamentals publication on The Safety of Nuclear Installations [2] issued

in 1993 states (para. 406) that:

“Quality assurance practices are an essential part of good management and are to be

applied to all activities affecting the quality of items, processes and services important

to safety.”

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1.5. The Safety Fundamentals publication on The Principles of Radioactive Waste

Management [3] issued in 1995 states in para. 330 that:

“An appropriate level of quality assurance and of adequate personnel training and

qualification shall be maintained throughout the life of radioactive waste management

facilities.”

1.6. The International Basic Safety Standards for Protection against Ionizing Radiation and

for the Safety of Radiation Sources (BSS) [4] issued in 1996 established in § 2.29 as a

management requirement:

“Quality assurance programmes shall be established to provide, as appropriate:

adequate assurance that the specified requirements relating to protection and safety are

satisfied; and quality control mechanisms and procedures for reviewing and assessing

overall effectiveness of protection and safety measures.”

1.7. Since the publication of the International Basic Safety Standards for Protection against

Ionizing Radiation and for the Safety of Radiation Sources (BSS), the IAEA and its Member

States have engaged in an extensive effort to establish and strengthen national radiation

protection infrastructure.

OBJECTIVE

1.8. The purpose of this publication is to provide guidance to individuals and organizations

providing technical services in radiation safety on developing and implementing a quality

management system consistent with the requirements provided in applicable ISO-standards

(ISO9001, ISO9004 and ISO17025) and other relevant IAEA safety standards.

1.9. This document matches the needs of the technical services with the requirements of

applicable ISO-standards and explains how the requirements may be applied in practice. The

document will help technical services to demonstrate competence, to produce technically valid

data and results, to facilitate co-operation, and to assist in the exchange of information and

experience and in the harmonization of procedures.

SCOPE

1.10. The document focuses on technical services in radiation safety that require certification

and/or accreditation.

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1.11. Services requiring certification could include:

a) radiation protection consultancy;

b) shielding calculations;

c) modelling for dose assessment, containment and ventilation;

d) maintenance services covering both in-house operations; and services contracted with an

outside organization.

1.12. Services requiring accreditation could include:

a) laboratories providing monitoring services including individual -, workplace -, and

environmental monitoring;

b) laboratories dealing with calibration and verification services for monitoring devices

and radiation sources.

1.13. Issues relating to quality management systems for transport, waste management,

education, and training are outside the scope of this document.

DEFINITIONS1

1.14.

Accreditation: Procedure by which an authoritative body gives formal recognition that a body

or person is competent to carry out specific tasks.

Body (responsible for standards and regulations): Legal or administrative entity that has

specific tasks and composition, (e.g. organizations, authorities, companies and foundations).

Certification: Procedure by which a third party gives written assurance that a product, process

or service conforms to specified requirements.[cf. ‘authorization’]

Quality: Degree to which a set of inherent characteristics fulfils requirements.

Third party: Person or body that is recognized as being independent of the parties involved,

as concerns the issue in question.

1 According to ISO/IEC Guide 2 [5]

4

STRUCTURE

1.15. This publication is intended to cover recommendations that apply to parties providing

technical services in radiation safety. It might also be used by competent regulatory authorities

to ‘confirm/recognize/approve’ the competence of technical services.

1.16. The ‘Licensee/user/customers’ are encouraged to use the document as a means of

identifying and selecting appropriate services.

1.17. Section 2 discusses IAEA publications supporting technical services in radiation safety.

Section 3 covers ISO Standards on quality management systems. Section 4 gives general

guidance on establishing a quality management system and describes in a chronological

manner the necessary steps for introducing a quality management system when no such

system was in place previously. Section 5 on requirements for services needing certification

details and comments on the requirements of the two main standards in quality management:

ISO9001 [6] and ISO17025 [7]. Section 6 covers additional requirements for services needing

accreditation’ and explains the different and additional requirements that have to be fulfilled

by organizations needing accreditation by ISO17025. Section 7 covers product realization.

Section 8 covers measurement, analysis and improvement. Section 9 is on additional

requirements for services needing accreditation by ISO17025. The annexes give some

examples of key issues in a quality management system.

1.18. This document is advisory in nature. As used in this document, the term ‘shall’ refers to

a specific criterion for accreditation or an action specified as mandatory by one or more

accepted international standards such as ISO-9000:2000, ISO-9004:2000, ISO-17020 and/or

ISO-17025. The term ‘should’ refers to an action or practice that is recommended for

implementation by general practice or by applicable international standards such as ISO-

9000:2000, ISO-9004:2000, ISO-17020 and/or ISO-17025.

1.19. As used in this document, the term ‘customer’ refers to the client or other recipient of

services from a technical services provider. As examples, companies receiving personnel

dosimetry services, clients submitting instruments for calibration are all considered to be

‘customers’.

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2. IAEA PUBLICATIONS SUPPORTING TECHNICAL SERVICES IN RADIATION SAFETY

2.1. To assist Member States in occupational radiation protection, the IAEA has published

three Safety Guides, which are jointly sponsored by the IAEA and the International Labour

Office. These are Occupational Radiation Protection [8], Assessment of Occupational

Exposure Due to Intakes of Radionuclides [9] and Assessment of Occupational Exposure Due

to External Sources of Radiation [10]. The IAEA has also published additional technical

information on particular techniques, some of which are described below.

2.2. The Safety Guide on Occupational Radiation Protection deals with the overall

implementation of the requirements in the Basic Safety Standards (BSS), giving general

advice on the exposure conditions for which monitoring programmes shall be set up to assess

radiation doses arising from external radiation and from intakes of radionuclides by workers.

This Safety Guide addresses the technical and organizational aspects of the control of

occupational exposures, in situations of both normal and potential exposure. The intention is

to provide an integrated approach to the control of normal and potential exposures due to

external and internal irradiation from both artificial and natural sources of radiation.

2.3. The supplementary Safety Guide on Assessment of Occupational Exposure Due to

Intakes of Radionuclides addresses in detail the methods of assessing exposure due to intakes

of radionuclides in the workplace (direct and indirect activity measurements and interpretation

of the results) without going into details on QA methods. The second supplementary Safety

Guide on the Assessment of Occupational Exposure Due to External Sources of Radiation is

of primary interest for this report. This Safety Guide contains guidance on establishing

monitoring programmes for external exposure, the appropriate dosimetry to be used for

individual and workplace monitoring and the interpretation of results. Particular attention is

being paid to the quantities to be measured and the necessary precision and accuracy.

Guidance on the type testing and performance testing of dosimeters is given, together with the

necessary dosimetric data to carry out this work.

2.4. Complementary advice on specific topics in occupational radiation protection is

published in Safety Reports (and previously in Safety Practices). These publications provide

either topic specific or practice specific guidance. The Safety Guide on Occupational

Radiation Protection is supported by two Safety Reports: Health Surveillance of Persons

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Occupationally Exposed to Ionizing Radiation: Guidance for Occupational Physicians [11]

and Optimization of Radiation Protection in the Control of Occupational Exposure [12].

2.5. The Safety Guide on Assessment of Occupational Exposure Due to Intakes of

Radionuclides is to be supported by three Safety Reports: Direct Methods for Measuring

Radionuclides in the Human Body [13] was published in 1996 and the Safety Report on

Indirect Methods for Assessing Intakes of Radionuclides Causing Occupational Exposure [14]

was published in 2000. While these two publications provide advice on measurements of levels

of radionuclides in the whole body or in organs and tissues, a third safety report on Assessment

of Radiation Doses from Intakes of Radionuclides by Workers [15], which is still under

development, presents the main considerations for dose assessment, in both routine and

accidental situations.

2.6. The Safety Guide on Assessment of Occupational Exposure due to External Sources of

Radiation will be supported by at least two Safety Reports. Calibration of Radiation Protection

Monitoring Instruments [16], is provided for those who are establishing or operating

calibration facilities for radiation monitoring instruments

2.7. Among the practice specific Safety Reports, published or under development are [17-19].

1. Radiation and Waste Safety in the Oil and Gas Industry.

2. Radiation Protection against Radon in Workplaces other than Mines.

3. Methods for Reducing Occupational Exposure during Decommissioning of Nuclear

Facilities.

2.8. Safety related material is also published in the IAEA Technical Reports Series. A

selection is presented in [20–22].

1. Neutron Monitoring in Radiation Protection [20].

4. Compendium of Neutron Spectra and Detector Responses for Radiation Protection

Purposes [21,22].

2.9. Practical Radiation Technical Manuals (PRTMs) are designed to provide guidance on

radiological protection for persons who have the responsibility of ensuring the safety of

employees working with ionizing radiation. Two of these deal with personal monitoring [24]

and workplace monitoring for radiation and contamination [25]. One PRTM on personal

protective equipment [26] is under development.

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3. ISO STANDARDS ON QUALITY MANAGEMENT SYSTEMS

3.1. The International Standards Organization (ISO) is a worldwide federation of national

standards bodies, which develops reference standards that are recognized and implemented in

many managerial and technical fields. Before the 1970s, quality was rapidly emerging as a

new concept in commerce and industry. Several national or multinational standards had been

developed for commercial and industrial use, and for the needs of the nuclear power industry.

The first publication of the ISO9000 series in 1987 brought harmonization on an international

scale and supported the growing impact of quality as a factor of international trade. The

ISO9000 series ISO9001:2000 [6] and ISO9004:2000 [27] embodies comprehensive quality

management concepts and guidance, together with several models for external quality

assurance requirements.

3.2. The current ISO Standards Series ISO9000-ISO9004 on the topic of ‘Quality

Management and Quality Assurance Standards’ are used worldwide. ISO17025 ‘General

requirements for the competence of testing and calibration laboratories’ was published in

1999. It contains all of the requirements that testing and calibration laboratories have to meet

if they wish to demonstrate that they operate a quality system, are technically competent, and

are capable of generating technically valid results. It has been produced as the result of

extensive experience in the implementation of ISO/IEC Guide 25.

3.3. The increasing use of quality systems has generally emphasized the need to ensure that

laboratories, which are part of larger organizations or offer other services, can operate a

quality system that complies with applicable international standards. Care has been taken to

incorporate all those requirements of ISO9001 that are relevant to testing and calibration

services covered by a laboratory’s quality management system (QMS). Testing and calibration

laboratories that comply with these standards will therefore also operate in accordance with

ISO9001.

3.4. ISO17025 specifies the general requirements necessary for competence to carry out tests

and/or calibrations, including sampling. It covers testing and calibration using standard

methods, non-standard methods, and laboratory-developed methods.

3.5. The acceptance of testing and calibration results between countries would be facilitated

if laboratories complied with this international standard, and if they obtain accreditation from

bodies which have entered into mutual recognition agreements with similar bodies in other

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countries. The use of this standard will facilitate co-operation between laboratories and other

bodies, and assist in the exchange of information and experience, and in the harmonization of

standards, standard methods and procedures. There is nothing to preclude a country from

establishing a unilateral accreditation system and electing not to participate in mutual

recognition agreements.

3.6. Implementation of a quality management system based on the ISO9000 series,

ISO17025 and other generally accepted standards brings several benefits to organizations

using them, enabling them:

a) to convert skills and experiences into recorded knowledge;

b) to force staff to think it through;

c) to make responsibilities clear and to create conditions of self-control;

d) to provide legitimacy and authority for the staff needed to execute plans;

e) to improve communication and to provide consistency in carrying out tasks;

f) to provide training and reference material to newcomers;

g) to identify training needs for the staff involved in the tasks;

h) to provide a respected reference in the event of conflicts or nonconformity;

i) to provide criteria for audit and reviews;

j) to establish means for clear goals for improvements.

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4. GENERAL GUIDANCE ON ESTABLISHING A QUALITY MANAGEMENT SYSTEM

RECOMMENDED APPROACH FOR THE ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM

Introduction

4.1. A quality management system consists of a set of interrelated or interacting elements. It

is designed to establish the overall intentions and direction of an organization as related to the

ability of a product, system, or to fulfil the requirements of customers and other interested

parties.

4.2. The ISO Standards series encourages the adoption of a process approach to quality

management. In this context, any activity that receives inputs and converts them to outputs

can be considered a process. For organizations to function effectively, organizations have to

identify and manage numerous linked processes. Often the output from one process will be the

direct input into the next process. The systematic identification and management of the

processes applied within an organization and the interactions between such processes may be

referred to as the process approach.

4.3. Figure 1 is a conceptual illustration of one model of the process approach described in

the ISO Standards. The model recognizes that customers play a significant role in defining

requirements as inputs. Monitoring customer satisfaction is necessary to evaluate and validate

whether customer requirements have been met. This model does not reflect processes at a

detailed level, but covers all the requirements of the international standards.

4.4. More detailed information on the applicability of this approach will be presented later in

the text.

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Fig. 1. Model of the process approach.

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Requirements of applicable standards

4.5. International standards specify requirements for a QMS which urge an organization

a) to demonstrate its ability to deliver a product that consistently meets customer and

applicable regulatory requirements; and

b) to address customer satisfaction through the effective application of the system,

including processes for continual improvement and the prevention of non-conformity.

4.6. The organization shall establish, document, implement, maintain and continually

improve a QMS in accordance with the requirements of applicable international standards and

this document.

4.7. The steps that shall be taken by an organization in order to implement a quality

management system include:

a) identifying the processes needed for the QMS;

b) determining the sequence and interaction of these processes;

c) determining criteria and methods required to ensure the effective operation and control

of these processes;

d) ensuring the availability of information necessary to support the operation and

monitoring of these processes; and

e) measuring, monitoring and analysing these processes, and implementing action

necessary to achieve planned results and continual improvement.

Implementation process

Decision taking

4.8. The implementation of a QMS into an operating organization starts with the decision to

do so by the top management. There may be different external and internal factors that could

convince the top management of the need for such a system.

4.9. Examples are:

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External factors like demand by customers or State or regulatory authorities, or new

information during a peer meeting or conference.

Internal factors like demand by internal customers, cost-effectiveness analysis, need to

restructure the organization due to mayor changes in work focus or workforce.

Management commitment

4.10. After arriving at the decision to implement a QMS, top management has to demonstrate

its commitment to implementation of the project by:

a) appointing one of its members as the responsible person for the task;

b) supplying adequate funds; and

c) establishing an information policy to make the implementation decisions and actions

transparent to both the top management and the staff.

4.11. This commitment shall be communicated to the entire organization (by issuing a quality

policy statement and preliminary quality objectives/goals) and demonstrated throughout the

whole process of implementing the QMS (by active participation in review meetings).

Appointing an implementation team

4.12. The next step is to appoint a task force (implementation team) under the supervision of

the above appointed member of the top management to do the job. Here, the assistance of

external experts might be requested either as leaders of the task force or as advisory members.

The members of the task force will need good knowledge and experience or receive training,

as appropriate, in at least one of the following fields:

a) Structure and workload of the organization;

b) Applicable standards, laws and regulations;

c) Internal processes and procedures of the organization;

d) Installed methods to communicate effectively within the company;

e) Team organization and teamwork.

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4.13. The team shall have an appointed leader, who in the course of the implementation of the

QMS may become the quality manager of the organization.

Planning the implementation

4.14. The first task of the implementation team is to evaluate the workload that will be

necessary to reach the goal of an implemented QMS. This information may already be easily

available within organization or may be gathered by a newly organized initiative of the

implementation team.

4.15. Some ways of gathering this information may include:

a) conducting a survey of laws, regulations and standards (besides the Quality

Management standards) applicable to the product portfolio of the organization;

b) collecting customer needs expressed to representatives of the organization;

c) reviewing the day-to-day work schedule of the organization by going out to the staff;

and

d) doing a survey and count of all processes already in operation within the organization.

4.16. This may be the first opportunity to motivate all the personnel of an organization to

participate actively in the implementation of the system.

4.17. A preliminary timetable shall be established for tracking progress in developing the

QMS. Depending on the size of the organization and the complexity of the task, this timetable

could be relatively short or extend over a period that could range from several months to a

year or more.

4.18. Using the information gathered by the above mentioned or otherwise organized

methods, the implementation team will need to devise a quality plan2 for the implementation

of the system. This plan shall include:

a) a representation of the workload, divided into work packages;

b) a timetable for completion of the different work packages;

2 A Quality Plan sets up a Quality Objective (here to implement a Quality Management System) and

specifies necessary operational procedures and resources to fulfil this objective (see ISO-9000 2.2.9).

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c) a responsible person for each of the different work packages;

d) a reporting schedule for providing information to the responsible manager;

e) a system of quality reviews to ensure the smooth performance of the plan.

Identifying existing processes

4.19. In order to have a complete overview of all existing processes it will be helpful to group

them, according to the action they are describing into four categories:

a) Management processes;

b) Resource management processes;

c) Product realization processes;

d) Measurement, analysis and improvement processes.

4.20. During identification of the processes, it would be helpful to also identify their

interconnections in order to arrive at a process correlation diagram. This diagram will show in

graphical form how a change of one process may influence others and where there may be

some gaps in the flow. These gaps will have to be filled by designing new processes.

4.21. The proper design of a QMS requires knowledge of all existing processes and the

development of a number of new ones. The best way to organize the system depends on the

organization of the laboratory providing the services.

Defining document structure

4.22. The implementation team has to define the structure of the ensuing documents to help

the authors develop their documentation. The quality manual, which contains the total

documentation of the quality management system, may be organized in different ways.

4.23. It may be one large manual containing all necessary statements, procedures and working

instructions.

4.24. Another possibility is to create a centralized quality management document, which

contains the basic information about the organization and the principal commitment

statements by top management, and to supplement this with annexes containing the technical

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information to perform the described tasks, which may be tailored to different branches of the

organization.

Writing procedures

4.25. A protocol shall be written defining the process to be followed for writing, reviewing,

approving, and revising procedures and establishing their general format.

4.26. With this procedure in place, the search for authors shall begin. It is of great importance

to the later acceptance of the QMS by all members of the staff that as many of them as

possible are included into the authoring process. It will be the task of the implementation team

to devise the procedures about such central themes as the QMS itself, document control and

the assessment process. The assistance and authorship of the people currently doing specific

jobs shall be solicited throughout the process of developing the QMS, particularly for the

technical procedures. Wherever it is needed, the members of the implementation team, due to

their better training in the contents of standards and regulations, shall provide assistance in

editing the process descriptions (procedures).

4.27. All drafted procedures will have to be reviewed and compared by the implementation

team, i.e. checked against each other, against the management directives and against the

applicable international standards in order to ensure conformity and integrity of the quality

documentation. This process shall include all necessary new procedures, changes to existing

procedures, their authorization and their inclusion in the quality manual.

Initial training

4.28. In this way, the organization will arrive at a first version of the quality manual which

does not need to contain all the planned procedures, but may be used to train the personnel in

the application of the newly developed or changed procedures.

4.29. Members of the implementation team, in conjunction with members of the management

of the organization, shall supervise this training in the application of the QMS to show the

permanent commitment of management to the ideas of quality management.

Implementation, first internal audit and management review

4.30. After the training period, which in itself may show additional need to correct the

documentation, the QMS may be implemented for an initial testing period, typically a pilot

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project lasting three to six months. At the end of this period, the first assessment of the QMS,

the first internal audit3 followed by the first management review shall be scheduled.

4.31. The outcome of these two evaluation processes will show whether additional adaptation

of the documentation is still necessary. When these changes have been made, the QMS will be

ready for final implementation and may start its life cycle of improvement.

4.32. Top management, with the assistance of the implementation team, shall revise the

quality policy and the quality objectives, which shall be based on this policy and be

quantitative at least at operational levels. These quality objectives may change over time

reflecting changes in the needs and priorities of the organization.

4.33. Finally, top management shall establish ways of assessing the performance of the

organization by defining performance indicators (and the way these indicators shall be derived

from existing data) for quality related processes and the way of conducting the overall

assessment of the QMS through a management review.

3 Systematic and documented process for obtaining evidence and evaluating it objectively to determine the

extent to which the policies, procedures and requirements are fulfilled.

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Fig. 2. Establishment of a Quality Management System

Qualitymanagement

system needed

Managementcommits to

QMS

Collect Input

Customer needs,regulations, laws &

standardsDay-to-day workplace

experiance

Implementationteam for QMS

installed

Design quality

TimetableResponsibilities

Objectives

Process Identification

Managerial processesworkforce

Product realizationResource management

Measurement andimprovement

Designing the QualityManagement System

Quality manual (Handbook)Managerial procedures

Administrative proceduresTechnical procedures

Document control

Develop System forDocumentation

Prepare draftsTraining & evaluation

ImplementQMS

Feedback to Management

Measurement,analysis andimprovement

Implementsystem

improvement

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5. REQUIREMENTS FOR SERVICES NEEDING CERTIFICATION BY ISO9001

MANAGEMENT RESPONSIBILITY

5.1. This Section describes the various detailed tasks involved in developing and

implementing a Quality Management System (QMS) that are collectively referred to as

‘Management Processes’. Accomplishing these tasks is a responsibility of top management of

the organization.

MANAGEMENT COMMITMENT

5.2. ‘Management commitment’ is a declaration signed by the top management committing

the organization to quality. This commitment acknowledges management’s responsibility to

establish a QMS, to provide the necessary resources, guarantee review and revision of the

system as needed and define a quality policy and quality objectives that will govern the

system. After it is issued, the document is included in the quality manual and brought to the

awareness of the staff. In this context, ‘necessary resources’ might include the people,

infrastructure, work environment, information, supplies and partnerships, natural resources,

and financial resources needed to accomplish the quality objectives.

CUSTOMER FOCUS

5.3. Customer focus means that there is a responsibility to ensure that customer needs and

expectations are determined, converted into processes and fulfilled with the aim of achieving

customer satisfaction consistent with regulatory and legal obligations. Top management shall

ensure that customers’ requirements are well known and that the organization is structured in

a manner appropriate to meet their needs so that customer satisfaction is maximized.

5.4. In order to accomplish this, customers’ requirements shall be determined. This can be

done by asking customers about their needs, by providing information about available

services, or other means such as market surveys or polls. The organization then applies its

technical, legal, regulatory, and other relevant knowledge to develop a recommendation as to

the most appropriate service to be provided in order to meet the requirements.

5.5. The organization shall ensure that customer reactions are considered. Both positive and

negative customer feedback shall be collected and evaluated. Therefore the QMS shall

establish a monitoring process designed to assess and analyze all customer reactions so as to

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ensure that the organization takes action designed to result in continuous improvement of

quality.

QUALITY POLICY

5.6. The quality policy shall be issued by top management and shall be appropriate to the

purpose of the organization. It shall be simple (concise) and easily understandable for all

members of the organization (staff).

5.7. It shall include brief descriptions of actions designed to address issues such as:

a) defining and maintaining the expected level of customer satisfaction;

b) needs of other interested parties (regulatory agencies, other parts of the organization,

public, etc.);

c) opportunities and needs for continual improvement;

d) commitment to provide resources needed to accomplish the task;

e) contributions of suppliers and partners (ensuring that suppliers and partners are capable

of providing support goods and services that meet the established quality standards);

f) commitment to follow good professional practices when providing services;

g) commitment to the competence (qualification) of the personnel involved in the

execution of the services;

h) commitment to adhere to the requirements of the applicable standards.

5.8. Once established, the quality policy shall be translated into measurable quality

objectives that are continually evaluated through performance indicators to ensure their

adequacy.

PLANNING

5.9. In order for a QMS to be effective, it is important that a plan be developed to provide

management and the implementation team with a series of clearly defined objectives. These

objectives apply both before and after the QMS has been implemented.

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Quality objectives

5.10. This means a series of goals or targets established at different levels of the organization,

which describe the desired outcome of the QMS. These objectives shall be established during

the planning process and shall be consistent with the stated Quality Policy. Particularly at the

technical level, quality objectives shall be quantifiable.

5.11. Information sources such as internal audit reports, process reviews, and feedback from

customers can all help in identifying appropriate quality objectives. As an example, an initial

quality objective for a testing laboratory might be to provide a result to the customer that

meets certain performance testing criteria. Over time, if the organization consistently

demonstrates its ability to meet those criteria, other factors such as improving customer

satisfaction through shorter turn-around time for tests might become additional quality

objectives. In other words, quality objectives are established after considering many factors,

including the current and future needs of the organization, the needs of the market served, and

regulatory requirements. It is very important that quality objectives be continually reviewed

and revised in order that the QMS continues to meet the needs of the organization.

Quality planning

5.12. In order to ensure that the planning process remains focused on the defined objectives, it

is important that planning activities be systematic and documented. Top management has a

responsibility to make sure adequate resources are provided to make it possible to meet the

defined quality objectives.

5.13. The quality planning process results in a description of the processes of the QMS, an

indication of the resources needed to meet stated objectives, and the continual improvement of

the QMS. It is very important that changes identified through the planning and evaluation

process be implemented in a controlled manner to maintain the integrity of the system.

5.14. To summarize, the quality planning process is a formal, dynamic activity conducted

during all phases of the development and implementation of a QMS. It is a management tool

designed to help keep all involved in the system focused on defined objectives so that, in a

measurable way, the overall quality of the product or service is maintained and continuously

improved.

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Documentation requirements

General

5.15. A formal system shall be developed to establish, maintain and control the quality

documentation. Quality documentation includes the quality manual, documents, and records

associated with the QMS.

Quality manual

5.16. The quality manual describes the structure of the QMS and the interaction of all the

elements of the system. It incorporates the policies and objectives of the quality system,

together with supporting procedures. Topics covered in the quality manual include:

a) organization structure;

b) roles and responsibilities of key personnel (job descriptions);

c) quality policy;

d) quality objectives;

e) quality plans;

f) structure of documentation used in the quality system;

g) structure and interaction of the processes that collectively form the system;

h) reference to applicable external standards and regulations;

i) instrument certifications, data tables, forms.

5.17. The quality manual may be used to demonstrate compliance with applicable standards,

as an aid to in-service education and training, and as a concise description of the QMS for

interested individuals outside the organization.

5.18. It may make a clear reference to where more details may be found regarding specific

topics rather than including extensive details within the manual itself and may be organized

on any relevant media used as a means of communication within the organization.

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Control of documents

5.19. A document is defined as ‘information and its support media’. Documents may be

organized on any relevant media used within the organization so long as an appropriate

system of control is implemented.

5.20. There has to be a procedure in place that describes how documents are to be controlled

within the organization. This control includes:

a) creating a new document (who may do it, according to which procedure);

b) approving a new document before it is implemented;

c) implementing a new document;

d) distributing of documents and marking or removing of obsolete documents ;

e) reviewing implemented documents to determine whether an update (revision) may be

necessary;

f) discerning the current revision status of a document and identifying who is responsible

for tracking the status of all documents ;

g) archiving documents to maintain a history of their development and revision;

h) incorporating external documents into the quality management system;

i) tracking and incorporating revisions of external documents (laws, regulations,

standards).

Control of records

5.21. A record is defined as a ‘document that states results achieved or provides evidence of

activities performed’. A record is a special kind of document that, while not undergoing all the

periodic review and update activities described above, is subject to additional special

requirements to ensure correctness. Normally records may not be changed. If a record is found

to be inaccurate, a clearly identified corrected record is issued, while retaining the old one

marked as incorrect.

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5.22. There has to be a procedure in place that defines how records are identified, collected,

and stored, while being kept retrievable and readable; how long records have to be kept, and

what has to be done with records after this time period expires.

5.23. In this context, records may typically be:

a) results of measurements, calculations, calibrations and the data used to derive those

results;

b) reports of client feedback;

c) descriptions of identified nonconformities and preventive/corrective actions;

d) reports of internal or external audits and management reviews;

e) minutes of quality related meetings, etc.

5.24. Records may be in any media, such as hard copy or electronic media.

5.25. All records shall be held secure and in confidence. The laboratory shall have procedures

to protect and backup records stored electronically and to prevent unauthorized access to or

amendment of these records.

RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.26. This subsection describes how the top management has to organize and communicate

the interrelationships and communication within the QMS so as to guarantee its ongoing

functionality.

Responsibility and authority

5.27. To have a clear understanding of all staff members about their position within the

organization, there shall be a function based job description for each staff member. This

description shall mention:

a) the name of the job/working place/function;

b) job responsibilities;

c) the authority which can be executed;

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d) the necessary technical and managerial skills;

e) additional training needed;

f) identification of supervisor (to whom does this staff member report) and

g) who has to be supervised.

Management representative

5.28. Besides all the other functions, there has to be one person appointed as quality manager

(regardless of other duties). Top management delegates to the quality manager the authority

to:

a) manage the QMS, which includes activities designed to ensure compliance with

applicable standards, harmonize procedures and documents, review operations, identify

and report any nonconformity to the management and or perform quality awareness

training for the staff;

b) communicate with authorities on issues related to quality as may be required by

regulatory and/or accreditation bodies;

c) communicate directly with top management at all times on issues related to the QMS;

d) be the focal point for problem reports regarding quality and suggestions for

improvement;

e) stop all work that is not performed according to established procedures.

Internal communication

5.29. To assist the quality manager, top management has to encourage open communication

within the QMS. This can be done by organizing regular meetings of key quality management

personnel, creating a QMS related communication system (electronic billboard, intranet, QMS

databases, etc.) and similar methods of internal communication. When deemed appropriate by

the quality manager, records of internal communication shall be retained and controlled in the

same manner as other QMS documentation.

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MANAGEMENT REVIEW

Purpose

5.30. Management reviews of the QMS are conducted to ensure its continuing suitability and

effectiveness and to introduce any necessary changes or improvements. ISO17025 and

ISO9001 require that these reviews be performed by ‘top management’.

5.31. One important objective of this process is to verify that the quality policy and objectives

are appropriate to the goals of the organization. In addition, the management review process

identifies opportunities for improvement.

Frequency

5.32. A specific procedure shall be established for the conduct of these reviews on a planned

schedule (usually at least annually), to require that documentation of findings is completed

and to ensure that the corrective action decided upon as part of the review is subject to

appropriate follow-up.

5.33. Management review is an activity that is separate from an internal audit.

Management review input

5.34. Management reviews shall take account of:

a) changes in the policies and goals of the organization;

b) customer feedback or complaints;

c) recommendations of recent internal or external audits;

d) current status of any corrective and preventive actions (possible results of previous

management reviews);

e) results of interlaboratory comparisons or proficiency tests;

f) changes in the volume and type of the work;

g) other relevant factors, such as quality control activities, resources and staff training.

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Output and documentation of the management review

5.35. Decisions made during the management review and any actions arising from them shall

be recorded.

5.36. The output report shall consider:

a) who was involved in the review;

b) what factors were considered;

c) what decisions were reached;

d) what action was planned, the persons responsible for the action and the developed time

schedule

e) provision for review and approval of report.

Follow up

5.37. Results shall be fed into the laboratory planning system and shall include the goals,

objectives and action plans for the coming year. Management shall ensure that planned actions

are carried out within the agreed time scale and that completion is documented.

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6. RESOURCE MANAGEMENT

PROVISION OF RESOURCES

6.1. Resources are essential items needed for conducting the process. They include staff,

equipment and supplies, information, physical facilities, infrastructure services, workplace

conditions and monetary funds.

HUMAN RESOURCES

6.2. Human resources are an essential component of a successful QMS. They include all the

people in the organization who are involved in achieving the quality objectives. Issues such as

staffing levels, education, training, experience, qualifications, and periodic performance

reviews are important when considering human resources.

6.3. First, the implementation team has to define the number of people and the necessary

skills and competences that will be required to achieve the defined quality objectives taking

into account all activities, including the necessary infrastructure and support services. It may

be helpful to create a table including all processes, which identifies the process, and lists the

activity required to complete the process, necessary participants, required qualifications and

individuals responsible for accomplishing the process.

TABLE I. EXAMPLE OF PROCESS LIST

Process Activity Who does this task now?

Number of people required

Required qualifications

Make measurement

Operate equipment

Technologist 3 Know how to operate equipment

Approve measurement

Review measurement log

Supervisor 1 Understand process and recognize variation

Sign report to client

Review report Manager 1 Train, observe and trust Supervisor

6.4. Upon completion of this table, a second table shall be prepared using the same data, but

sorted by individual rather than by process. This is to assist in identifying training needs and

to enable an evaluation of workload distribution.

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6.5. For each individual, a training plan is developed based on consideration of factors such

as:

a) requirements of the processes as revealed by the two tables described above;

b) existing documented skills and qualifications of the individual;

c) internal and external legislation, regulation, standards and directives affecting the

organization, its activities, and its resources. Many of these may be defined by the

regulatory body.

6.6. For each individual, a record shall be maintained including data relevant to the tasks the

individual performs. This might include items such as:

a) skills qualification records;

b) evidence of qualifications, such as Certificates of course completion;

c) records of training;

d) functional job description developed as described in ‘Responsibility, Authority and

Communication’ (above);

e) workload description detailing the processes the individual is expected to accomplish

together with the source and type of direction received.

6.7. This type of information needs to be readily available within the QMS.

6.8. For the whole organization, it is necessary to develop and document a comprehensive

programme for continuous training for all staff members. This programme is frequently

prepared yearly in advance and considers as a minimum:

a) social skills, (language skills, communication skills, time management, coaching and

counselling, interview skills, management development, and similar individual

development topics);

b) technical skills as derived from the description of required processes;

c) computer skills;

d) knowledge of markets and of customer needs and expectations ;

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e) future demands related to strategic and operational plans and objectives of the

organization.

6.9. The organization needs to establish a method for evaluating the effectiveness of the

training programme and its impact on achieving the organizations goals and objectives.

6.10. The continued competence of individuals to perform assigned tasks shall be periodically

reviewed and documented. This may be accomplished through a variety of methods, including

performance reviews, training records, examinations and observation of task performance,

depending on the nature of the process. This process is also useful for identifying the need for

additional training of individuals.

INFRASTRUCTURE

6.11. Infrastructure includes work place, associated facilities, equipment, hardware, software,

and supporting services. The implementation team shall review the following requirements.

Requirements of the processes

6.12. It is necessary to review the infrastructure requirements of each process in order to

identify the resources that will be required for successful accomplishment of stated quality

objectives. Development of a table similar to that described above for human resources may

be very helpful in accomplishing this review.

Requirements of the relevant nuclear or radiation safety regulatory body

6.13. For services of radiation protection such as consultancy or performance of shielding

calculations, requirements are commonly focused on confirming validation of software used

to provide these services. For services that use equipment, such as evaluating containment and

ventilation, the regulatory body may impose additional requirements such as special

calibration service authorities to be used to ensure the correct certification and calibration of

equipment.

Requirements established by other regulatory authorities

6.14 These requirements may be focused on issues such as safety in the workplace and

associated facilities, protection of personal privacy and confidentiality of data, and backup of

electronic media.

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6.15 Once infrastructure requirements have been identified, the implementation team needs

to evaluate how the existing facilities fulfil these requirements. Actions need to be planned

and implemented to resolve any identified deficiencies.

WORK ENVIRONMENT

6.16. Attention to work environment means consideration of how best to combine human and

physical factors with the goal of enhancing the performance of the organization. Attention to

workload, stress factors, social structure within the organization, internal communication,

workplace safety, ergonomics, lighting, ventilation, and many other factors can all be

combined to enhance the overall effectiveness of the organization in achieving its quality

objectives. The organization shall develop descriptions of minimum criteria for workplace

conditions needed to achieve the various objectives.

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7. PRODUCT REALIZATION

7.1. Within the context of this document, the term ‘product’ refers to a consultative service,

a certificate of calibration or a report of measurements.

7.2. In general, provision of services involving calibration, measurement or testing may

require that the provider be accredited using the requirements of ISO17025. Providing

consultative services generally does not require ISO17025 accreditation, but will likely require

certification of the associated QMS according to ISO9001.

PLANNING OF PRODUCT REALIZATION

7.3. Customer service has to be rendered under controlled conditions. The individual

responsible for accomplishing these actions shall have enough authority to solicit all the

necessary human, technical and financial resources to ensure that the service meets the desired

quality objectives.

7.4. Before starting the service this person shall ascertain that:

a) documented, verified and authorized procedure, including necessary working

instructions, covering the service is in place;

b) information (external and internal to the organization) needed to render the service is

available;

c) all equipment mentioned in the procedure is available, operational and calibrated

according to applicable procedures;

d) the necessary controls to the working environment, as mentioned in the procedure, are

applied;

e) the need for and the way of documenting the completion of different steps of the service

process into applicable records is known and understood by the operators within the

process;

f) person designated to approve the final product for delivery to the customer will be

available.

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CUSTOMER RELATED PROCESSES

7.5. There is a need to establish a process to identify and document the requirements for

fulfilling a contract for service. This includes identification of:

a) customer requirements;

b) related statutory and regulatory requirements;

c) organizational resources needed;

d) communication requirements to customer.

7.6. Establish a process to identify and document changes in previously specified activities,

including:

a) statutory and regulatory requirements changed before and during contract fulfilment;

b) resolution of requirement changes from previously expressed customer wishes;

c) ability to fulfil changed objectives.

DESIGN AND DEVELOPMENT

7.7. Introducing a new service requires careful planning. This includes the definition of the

requirements that the planned new service needs to fulfil; developing a way in which the

activities of the process are carried out and naming the resources that have to be available.

7.8. The management of the organization shall nominate a technical project leader to be in

charge of the planning. It will be the task of the project leader, by applying his/her knowledge

and experience together with the knowledge of the quality requirements that apply to the

service, to develop a planning schedule.

7.8. This definition of the flow of activities during the planning process shall identify:

a) the best conceivable way to arrive at the planning goal;

b) required human and material resources for the planning process;

c) layout of the different planning stages together with their time schedule;

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d) times or trigger actions for reviews of the planning status (preferably also mentioning

who shall attend the review meetings);

e) ways and means of verifying of the planned new service to show that the quality

requirements have been reached;

f) ways and means of validating the planning outcome to show that the new service will be

reaching the stated quality requirements at the customer’s application situation;

g) all records necessary to for the correct documentation of the planning process.

7.9. During development of the service, this plan should be adapted, especially after review

meetings, to the findings and agreements of the meeting. All adaptations will have to be

recorded and the new plan and schedule should be transmitted to all participants of the

planning process.

7.10. The final approved, verified and validated service shall be documented.

PURCHASING

7.11. The organization shall have a procedure in place that governs the whole purchasing

process from the definition of goods that may influence the quality of the service to the

customer, selection of a capable supplier, and verification that the purchased product meets

specified quality standards.

7.12. The procedure shall state:

a) who is authorized to start a purchasing process

b) how the specifications of the purchased goods or services have to be described

c) who checks the adequacy of the description before it is presented to the supplier

d) how to select a capable supplier based on:

— ability to deliver the good or service;

— ability to deliver within required time schedule;

— ability to demonstrate that goods and services meet specified quality standards;

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— ability to deliver at an acceptable price;

— how the delivered good or service is checked against the specification of quality

standards before acceptance of the purchased item.

7.13. This procedure shall also provide a method to inform the purchasing office and the

vendor if the delivered goods do not meet agreed specifications.

PRODUCTION AND SERVICE PROVISION

7.14. The production and provision of a service shall be planned and carried out through

controlled and validated processes. This implies the need to establish a procedure covering all

the processes, which has to be followed to provide the service, or more commonly a procedure

for each process to be followed during processing, storage and delivery of the product. For

each process, the inputs and outputs shall be clearly defined and interconnection among all

processes established. Flowcharts are usually the advisable tool for this purpose. For each

process, detailed work instructions shall be issued and available at the workplace in order to

assure reproducibility of the process.

7.15. The conformity of the product, or of parts of it, shall be assured by defining the

identification, storage, handling, protection and delivery conditions.

7.16. Moreover, when a product can only be fully verified after delivery, each process that

contributes to its production has to be verified according to a procedure specifying acceptable

and suitable criteria for the equipment/methods used and the qualification of the personnel

involved. Therefore, a list of parameters linked to the proper completion of each step is

generally useful to keep the process exact and consistent. The verification procedure usually

requires the production of records, such as checklists, to be filled in and evaluated in order to

assign the final value. In practice, the checklist can have the form of a record in a database file

and the verification process can be established with a software routine.

7.17. A product shall be clearly identified and, if creation of the product requires several

steps, tracking of the product status shall be possible, if required by regulation, identifying

each step’s output. Generating a record such as a checklist confirming the completion of all

necessary steps can be helpful.

7.18. Customer property, including intellectual property, shall be safeguarded throughout all

the production processes. Therefore, the identification of customer property and methods to

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protect it shall be established in advance. For example, access to data provided by the

customer shall only be allowed to a limited number of persons. In the case of a consultancy for

radiation protection, the customer property could be detailed information of the customer’s

facilities, exposure or source data or any method developed by the customer related to the

requested service. Moreover, the service provided in relation to radiation protection becomes

the property of the customer and shall be treated as confidential information (i.e. dose or

calibration reports).

CONTROL OF MONITORING AND MEASURING DEVICES

7.19. The objective of the control of monitoring and measuring devices is to establish an

effective means for ensuring, with a high degree of confidence, that data generated by these

devices used as the basis for reported results, conclusions and interpretations is of suitable

quality. Devices include instruments, custom software and computer simulations used to

perform measurements and surveys.

7.20. To accomplish this, the organization needs to establish processes to confirm that these

devices are suitable for the intended use, tested, calibrated, and verified to be functioning

within specified performance limits. Physical protection to the devices also needs to be

established with the goal of eliminating potential process errors.

7.21. Finally, software used to collect data and to perform calculations on collected data needs

to be validated before being put into use. It shall be protected against unauthorized

modification. Its functionality shall be re-verified following any change to the computer’s

basic operating system, network control parameters, or other activity that could have an

impact on the functionality of the application software. Furthermore the different software

versions might need to be kept (archived) to be able to access older records generated by

specific versions.

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8. MEASUREMENT, ANALYSIS, AND IMPROVEMENT

GENERAL

8.1. At all phases in the development and operation, the technical service provider shall

define, plan and implement measurement and monitoring activities related to the QMS needed

to assure conformity with applicable standards, laws, and regulations and to achieve

improvement. These activities shall include determining the need for, and use of, applicable

methodologies including statistical techniques.

8.2. The general process of measurement, analysis, and improvement includes:

a) actions taken on an ongoing basis to monitor the overall quality of the system,

identifying areas, through appropriate metrics, where improvement may be appropriate;

b) application of basic statistic methods (histogram, distribution analysis, mean value, etc.)

to monitored data of customer satisfaction, equipment performance data, measurement

throughput and similar indicators of the quality of service provided to the customer;

c) actions taken on a proactive basis to ensure system quality by preventing non-

conformance, improving the system, and optimizing service to the client. The internal

audit process, together with quality improvement programmes and similar activities, is

part of these actions;

d) actions taken on a reactive basis to re-achieve system quality by correcting non-

conformances identified by any means – self-identification, client complaints or

recommendations of an internal or external audit.

MONITORING AND MEASUREMENT

Customer satisfaction

8.3. Monitoring customer satisfaction provides a valuable source of information to assess

product quality. The monitoring can be done continuously or on special occasions. It may be

helpful to use any personal contact with the customer (acquiring new contracts, customer

visits at the location of the laboratory, congresses or other general meetings, etc.) for inquiries

into customer satisfaction with the rendered services.

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8.4. Additionally, it may be necessary to organize customer polls at least once every two

years, where the customers are asked to express their opinions about the service in writing.

Internal audit

8.5. The procedures for internal audit shall be documented and shall be included in the

quality manual or related documentation.

8.6. The figure at the end of this section summarizes the general process that shall be

followed for planning an internal audit.

Purpose

8.7. The purpose of internal audit is to verify that the organizations activities comply with

the requirements of its QMS as detailed in the applicable documentation, based on standards

such as ISO9001 and/or ISO17025.

8.8. Initially, an appropriate audit strategy shall be developed by the organization

(ISO17025— §4.13.1 states that it is the responsibility of the laboratory quality manager to

plan and organize audits) considering:

a) who will conduct audits;

b) how auditors will be trained;

c) how frequent and extensive audits will be;

d) what the cost-benefit of the audit will be.

8.9. It is acceptable to contract outside experts to evaluate a QMS in an internal audit.

Selection and training of internal auditors

8.10. Audits shall be carried out by trained and qualified personnel who are, whenever

possible, independent of the activity to be audited.

8.11. Training can be done in house or through external agencies. It shall include:

a) use and interpretation of checklists for audit questions (if used);

b) interview techniques and partner analysis;

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c) assessment and evaluation of non-conformities;

d) documentation and recording of audit findings;

e) teamwork and personality improvement.

8.12. Rotation of internal auditors through different aspects of technical applications within

an organization can promote increased job satisfaction by allowing employees to play an

important role in maintaining the organization’s management system.

Audit frequency

8.13. Audit frequency shall be determined according to the stability of the Quality

Management System and the frequency of changes within an organization. Generally, once a

year, as with other mayor assessments of an organization, is regarded as adequate.

8.14. Audits may be spread over the year or done all at once. Conducting internal audits on a

progressive schedule has several advantages:

a) It helps emphasize that the internal audit/self-assessment process is a continuous activity

designed to improve the overall quality of the system.

b) It helps to reduce the additional workload for individuals selected to conduct the audit.

c) It is very useful in promptly identifying items of potential non-conformance and areas

where improvement may be appropriate.

d) It helps to monitor progress in accomplishing corrective actions that may have been

recommended by previous audits.

Audit scope

8.15. The scope of audits shall include both general criteria and compliance with specific

technical standards or regulations. Checklists can be valuable tools, particularly for internal

audits because they define the ‘ground rules’, i.e. the standard against which the programme is

to be evaluated.

8.16. An audit is a sampling investigation into the QMS of an organization and, therefore

need not encompass all elements of the system in all parts of the organization. The extent of

the probe and the parts of an organization to be audited shall be planned with regard to

39

changes in staff or methods, customer complaints, previous audit findings and ongoing

correction or prevention programmes.

Audit reporting and follow-up

8.17. All audit findings and any planned corrective actions arising from them shall be

documented. Customers whose work may have been affected by problems identified during

the audit process shall be notified in writing. Some findings may require the use of a formal

corrective action system; others may have simpler remedies.

8.18. An audit report comprising:

a) date

b) location

c) names of audit partners

d) scope

e) listing of audit findings (possibly non-conformances) and

f) a statement describing the status of the QMS and regarding the possibility of achieving

the quality objectives shall be prepared and distributed within the organization

according to the requirements in the corresponding procedure (audit partners, quality

manager, management, etc.).

8.19. If it is necessary to quickly check the efficiency of corrective actions, it may be adequate

to schedule an additional follow-up audit out of the usual schedule. Results of internal audits

and any necessary follow-up actions shall be included in management reviews.

MONITORING AND MEASUREMENT OF PROCESSES

8.20. The organization shall have a procedure in place describing a routine of ongoing process

control for quality management processes. The aim is to derive possibilities for further

improvement of the processes. Interesting aspects described in such a procedure could be

monitoring time for reaction to the customer as influenced by the process structure,

throughput volume of the process routine, and resources allocated to the process and their

reduction possibilities, for example.

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MONITORING AND MEASUREMENT OF PRODUCT

8.21. The organization shall have procedures in place that describe necessary measurements

during the production process that will make certain that the delivered product fulfils the

expectations of the customer. For consultancy services, these measurements could be

additional calculations using other algorithms, checks on data entry, on comparison of the

result with previous experience. For measurement and calibration services these checks could

be repeated tests (eventually using different analysis instruments), checks on introduced blank

or test samples, plausibility tests on the results applying expert knowledge, etc.

8.22. Results of these measurements shall be recorded as proof of production in compliance

with the QMS.

CONTROL OF NONCONFORMING PRODUCT

8.23. Non-conformities are mainly deviations from the actions as they are described in

applicable procedures. The organization shall have a procedure in place that encourages all

staff members to report non-conformities as soon as they are observed. The procedure shall

mention some staff members that are trained and authorized to act on non-conformities.

8.24. The procedure shall state methods of segregating, possible ways of improving the non-

conforming products and test methods for acceptance of reworked and improved products.

8.25. For radiation protection services this could include marking and segregating incorrectly

entered raw data; data results arrived at by applying wrong algorithms; incorrect calibration

data or factors; measurement results produced by using instruments out of their application

range; calibration data arrived at by using wrong irradiation conditions; etc.

ANALYSIS OF DATA

8.26. Each organization has many data at hand that are derived from different types of

monitoring during the operation of all ongoing processes. There shall be a procedure in place

describing how these data, through adequate analysis, can be put to use as a basis for decisions

within the organization.

8.27. One of the most common data reduction methods will be the application of statistical

methods to these raw data. This may be especially useful for finding out trends in performance

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of persons and instruments, describing improvement or deterioration. This may give chance

for early action to prevent non-conformities.

8.28. Equally useful may be the application of similar statistical techniques inter alia to the

monitoring of customer satisfaction, resource economics and supplier performance.

IMPROVEMENT

8.29. The organization shall always try to improve the services to the customer and the

internal processes needed to arrive at the product. Error correction and loss prevention are two

ways to improve the quality within an organization.

Corrective action

8.30. A corrective action procedure is started after a complaint or feedback by a customer, or

upon discovery of non-conformity by staff or during a quality audit. Corrective actions need to

be appropriate to the magnitude and the risk of the problem. Any changes resulting from

corrective action investigations shall be documented.

8.31. A preventive action may have to follow a corrective action, or may be processed alone

during the development of new testing or managerial procedures, or because of a decision

taken during a management review. Both follow the same routes, with the one looking back,

the other forward.

8.32. The organization shall have procedures in place that define:

a) who will act during these procedures and to which extend

b) how the action will be structured

c) how decisions are to be arrived at and taken

d) who will be responsible for follow-up action on these decisions

e) how the effectiveness of the action will be measured

f) what is to be done if the actions taken prove ineffective

g) who will keep and archive the documentation of all action.

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8.33. Corrective action begins with an investigation to determine the root cause(s) of the

problem. Depending on the nature of the problem, this investigation may be informal or

formal and very extensive. In any case, the results of the root cause analysis need to be

documented. Root cause analysis is the key to developing effective corrective action (see

Flowchart of Improvement by Internal Audit Process, Fig. 3).

8.34. Some questions that may be considered when determining the root cause of a problem

include:

a) Has the issue been validated as a problem?

b) Have client requirements changed?

c) Have the characteristics of the sample changed?

d) Are the methods and procedures for performing the task adequate?

e) Is there a need for additional staff training or skills development?

f) Does the equipment function properly?

g) Has equipment calibration been verified?

h) Have the specifications of consumable supplies used in support of the operation in

question been changed?

Selection and implementation of corrective actions

8.35. Once an issue has been validated as a problem in need of correction and the root cause

of the problem has been determined, the search for appropriate corrective actions begins. The

individual responsible for approving corrective action selects and directs implementation of

the action(s) most likely to eliminate the problem and to prevent recurrence. As soon as

practical an estimate shall be made of the time and resources that will be needed to implement

the corrective action.

Monitoring of corrective actions

8.36. The QMS needs to monitor the results of corrective actions to ensure that their

implementation has been successful.

43

Preventive action

8.37. Preventive action is a proactive process to identify opportunities for improvement rather

than a reaction to the identification of problems or complaints. Apart from the review of the

operational procedures, the preventive action might involve analysis of data, including trend

and risk analyses and proficiency testing results. Planning, development, implementation, and

monitoring of preventive action will likely involve a similar pattern of activities as is followed

for corrective action except that they are proactive in nature.

44

Fig. 3. Flowchart of Improvement by Internal Audit Process

Measurement, Analysis and Improvement of the

Quality Management System

CustomerComplaint

NonconformityReport

QualityManager

plansInternal Audit

SelectAuditors

Auditorstrained ?

TrainAuditors

DetermineAudit Partners,

Scope andTime-Schedule

ConductInternalAudit

Problemsidentified,

recognized andaccepted

Audit Report

Management Review

RootCause

Analysis

RecommendCorrective

Action

System Improvement

No

Yes

45

9. ADDITIONAL REQUIREMENTS FOR SERVICES NEEDING ACCREDITATION BY ISO17025

9.1. All elements of the quality management system (QMS) discussed so far are applicable;

nevertheless, certification against ISO9001 does not of itself demonstrate the competence of a

laboratory to produce technically valid data and results. ISO17025 establishes additional

requirements, which, on fulfilment are intended to enable a laboratory to demonstrate that it

operates a QMS, is technically competent and able to generate technically valid results.

Testing and calibration laboratories that are accredited as complying with ISO17025 will also

operate in accordance with ISO9001. Section 9 applies only to activities requiring

accreditation – typically calibration and testing laboratories.

ADDITIONAL MANAGEMENT REQUIREMENTS (Chapter 4, ISO17025)

Organization (§4.1, ISO17025)

9.2. Special organizational requirements of ISO17025 for calibration and testing laboratories

emphasize the importance that the laboratory can be held legally responsible for the services

provided and that integrity of services is maintained throughout the calibration and testing

operations.

9.3. The organization needs to have a formal declaration as part of its QMS affirming that

management and personnel are free from any undue internal and external commercial,

financial and other pressures and influences that may adversely affect the quality of their

work. In addition to being stated in the quality manual, this might also be included in

documents such as a separate policy statement, a clause in a labour contract, or an employee

handbook.

9.4. In order to be sure that tests and calibrations are performed according to established

quality standards, laboratories need to provide adequate supervision of testing and calibration

staff, including trainees, by persons familiar with methods and procedures, with the purpose of

each test or calibration, and with the assessment of the test or calibration results.

9.5. Laboratories to be accredited under ISO17025 shall appoint deputies for key personnel

including technical director and quality manager in order to provide continuity of qualified

management even when primary individuals may be absent.

46

Review of requests, tenders and contracts (§4.4, ISO17025)

9.6. When reviewing requests, tenders and contracts, in addition to the requirements of

ISO9001 the laboratory shall make sure that the appropriate test or calibration method is

selected and capable of meeting the clients’ requirements. Contract review also extends to any

work that is to be subcontracted by the laboratory.

Subcontracting of tests and calibrations (§4.5, ISO17025)

9.7. For calibration and testing laboratories, subcontracting means placing work covered by

the scope of accreditation with a third party outside the immediate control of the primary

contracting laboratory. It does not include, for example, contracting with a reference

laboratory to provide intercomparison samples, contracting with an employment agency to

provide supplemental support workers, or similar activities. Subcontractors shall be required

to demonstrate the same level of competence as that of the accredited laboratory that is

serving as prime contractor. This can be accomplished either by the subcontractor holding an

equivalent accreditation in its own right or by the prime contractor completing a quality

system audit of the subcontractor’s operation.

9.8. ISO17025 requires that accredited laboratories proposing to subcontract tests and

calibrations inform affected clients of the arrangement in writing and, when appropriate, gain

the approval of the client; preferably in writing.

9.9. The laboratory is responsible to the client for the subcontractor’s work except in the

case where the client or a regulatory body specifies which subcontractor is to be used. In the

case of a deficiency or non-conformance attributable to a subcontractor, the laboratory has the

same responsibility to notify its clients and issue corrected reports as if the deficiency or non-

conformance had occurred within its own facility.

9.10. The laboratory shall maintain a register of all subcontractors that it uses for tests or

calibrations and a record of the evidence of compliance with this international standard for the

work in question.

Purchasing services and supplies (§4.6, ISO17025)

9.11. The general requirements of ISO9001 apply to laboratories accredited under ISO17025.

In addition, the laboratory shall evaluate suppliers of critical consumables, supplies and

47

services that affect the quality of testing and calibration, and maintain records of these

evaluations.

Service to the client (§4.7, ISO17025)

9.12. In addition to maintaining good communication with clients, accredited laboratories are

required by ISO17025 to allow clients to monitor their performance. This can be

accomplished by allowing the client reasonable access to the laboratory for purpose of

witnessing tests or calibrations, providing the client an opportunity to submit items for

verification purposes, using client feedback surveys, or other activities. All activities

involving monitoring by clients shall be conducted in a manner that preserves the

confidentiality of the laboratory’s relationship with other clients. Feedback from client

monitoring should be documented and used to improve the quality system.

Complaints (§4.8, ISO17025)

9.13. The laboratory shall have a policy and procedure for the resolution of complaints

received from clients or other parties. Records shall be maintained of all complaints and of the

investigations and corrective actions taken by the laboratory (see also §4.10).

Control of non-conforming testing and/or calibration work (§4.9, ISO17025)

9.14. Calibration and testing laboratories shall, as a matter of policy, have procedures that are

invoked when any aspect of their testing or calibration work, or the results of this work, do not

conform to their own procedures or the agreed requirements of the client. §4.9, ISO17025

establishes explicit requirements for actions that shall be taken under such circumstances.

Control of records (§4.12, ISO17025)

9.15. Differences to the requirements for certification relate to technical records.

9.16. The laboratory shall retain records of original observations, derived data and sufficient

information to establish an audit trail, calibration records and a copy of each test report or

calibration certificate issued for a defined period. The records for each test or calibration shall

contain sufficient information to facilitate, if necessary, identification of factors affecting

uncertainty and to enable the test or calibration to be repeated under conditions as close as

possible to the original. The records shall include the identity of personnel responsible for

sampling, performing each test or calibration and checking results.

48

9.17. In certain fields, it may be impossible or impractical to retain records of all original

observations.

9.18. Technical records are accumulations of data and information that result from carrying

out tests or calibrations and which indicate whether specified quality or process parameters

were achieved. They may include forms, contracts, worksheets, workbooks, checklists, work

notes, control graphs, external and internal test reports and calibration certificates, clients’

notes, papers and feedback. Observations, data and calculations shall be recorded at the time

they are made and shall be linkable to the specific task.

9.19. When mistakes occur in records, each mistake shall be crossed out, not erased, made

illegible or deleted, and the correct value entered alongside. All such alterations to records

shall be signed or initialled by the person making the correction. In the case of records stored

electronically, equivalent measures shall be taken to avoid loss or change of original data.

Internal audit (§4.13, ISO17025)

9.20. The internal audit programme, contrary to the requirements for certification, shall

address all elements of the quality system, including testing or calibration activities.

9.21. It is the responsibility of the quality manager to plan and organize audits as required by

the schedule and requested by management. Whenever resources permit, audits shall be

carried out by personnel who are independent of the activity to be audited. Individuals

conducting audits shall receive training appropriate to the task.

9.22. When audit findings cast doubt on the effectiveness of the operations or on the

correctness or validity of the laboratory’s test or calibration results, the laboratory shall take

timely corrective action, and shall notify clients in writing if investigations show that the

laboratory results may have been affected.

ADDITIONAL TECHNICAL REQUIREMENTS (Chapter 5, ISO17025)

Personnel (human resource planning) (§5.2, ISO17025)

9.23. The laboratory shall ensure that only competent personnel:

a) use the equipment (responsible for measurement results)

b) perform tests and calibrations

49

c) evaluate and interpret measurement results

d) sign the measurement results

e) supervise staff training

9.24. To ensure the above requirements, staff shall have appropriate education, training and

demonstrated skills (experience). Additional qualification requirements shall be evaluated, the

training planned, carried out and validated. Valuable help for these tasks can be provided by

establishing:

a) a table for all tasks (processes, job description / responsibility)

b) a table for possible (task-relevant) training courses (internal/external)

c) a table on attended training courses (including course validation)

d) a timetable for the training programme.

9.25. Finally, there is a need for a method to recognize the effect of the training for each staff.

Management has to ensure that enough personnel is employed to do the work under good

conditions (number of personnel shall correspond to the number of contracts). A useful help

can be to supervise the planning using a database.

Laboratory facilities (accommodation and environmental conditions) (§5.3, ISO17025)

9.26. Management has to provide adequate laboratory facilities to perform all processes under

consistent and familiar conditions. The management has to ensure that:

a) technical standards and requirements are fulfilled, (facilities, computers, programs);

b) adequate technical documentation is available (handbooks, tables, manuals);

c) necessary environmental conditions (influencing results) are well known, correctly

upheld, documented, monitored and recorded (thresholds and responsibility for stopping

a task shall be defined);

d) access to the facilities is restricted and monitored (who goes in an out?);

e) procedures for a good housekeeping have been defined and documented;

50

f) work in one room shall not disturb the process in the adjoining room.

Test and calibration methods and method validation (§5.4, ISO17025)

9.27. Each measurement method needs to be well documented in a procedure, describing the

task, if deemed necessary, step by step. The management shall ensure that staff is using an up-

to-date method and carries out the daily work guided by these documented methods. The

selected method shall be well known (accuracy, correctness, repeatability, reproducibility,

robustness, etc.) and the range of measurement uncertainty known and shown on the

measurement report.

9.28. Considering the following points may help in fulfilling the above requirements:

a) Methods shall be planned methodically, documented in a form suitable to the working

style of the laboratory.

b) This documentation could describe the measurement method on a step-by-step basis and

shall include guidance on how to keep necessary records.

c) As a first method of validation, the newly developed measurement method shall be

tested with different parameters (results shall be documented and interpreted).

d) An additional step of validation providing a go/no go decision could be incorporated

into the method.

e) Determine the actions to be taken when a deviation (error) occurs (who has to do what

and when?).

f) Organize the dataflow of measurement results (who needs which information when, in

which form and how can data backup be ensured?).

Equipment (equipment used for calibration or testing) (§5.5, ISO17025)

9.29. The laboratory shall possess adequate equipment to perform the services to the

customer, including sampling, sample preparation, measurement or calibration, calculations

and reporting. The equipment to produce the measurement results shall be functional and able

to be used for day-to-day measurements.

9.30. The following activities may help to ascertain that the requirements are fulfilled:

51

a) Periodic and documented calibrations shall be performed to guarantee correct

measurement results.

b) Periodic and documented function tests shall be performed between the calibration

times to test the correct functioning of the equipment.

c) All maintenance work provided for by the equipment manufacturer shall be done and

documented it in an equipment file.

d) Training and periodic retraining of every equipment user shall be completed to keep the

staff familiar with the equipment.

e) All equipment and self-designed software shall be clearly identified. This may be

accomplished through documentation sufficient to ensure software validation and proper

equipment set-up.

f) Outgoing and incoming equipment checks are required if a piece of equipment is used

outside the laboratory.

g) All calculations, including those performed by common off the shelf software (e.g.

spreadsheets) in respect to the equipment shall be documented and validated.

Measurement traceability (calibration and testing) (§5.6, ISO17025)

9.31. To be sure that the measurement results will comply with international standards, each

measurement device (which has an influence on the result) shall be calibrated before being put

into service and in defined intervals afterwards. The standards used for these calibrations shall

be traceable to the International System of Units (SI).

9.32. In some cases — e.g. in connection with 222Rn — the only means of providing

confidence in measurements is through participation in suitable international intercomparison

exercises.

9.33. Calibration services have to trace their standards and measuring instruments to the SI by

means of an unbroken chain of calibrations or comparisons linking them to relevant primary

standards of the SI units of measurement. For measurement services this traceability can be

gained by using a calibration service.

9.34. To keep a calibration or measurement service operational it may be helpful to:

52

a) organize information on all calibration standards used into a database file, giving

— calibration data,

— serial number of units calibrated,

— date of last/next calibration,

— location and name of tester;

b) store all calibration procedures and their outcome, the calibration certificates in the

laboratory;

c) support the periodical calibration with a time-schedule program;

d) keep calibrated spare parts available for important devices to shorten downtime in case

of a malfunction.

Sampling (§5.7, ISO17025)

9.35. If a testing laboratory is also sampling, it shall do so according to accepted standards or

documented procedures. If a sub contractor or customer is sampling, it shall be ensured that

the same restrictions and conditions apply as for the laboratory.

9.36. Considering the following points may help in implementing a procedure for sampling:

a) Requirements of applicable standards and of customers (sampling location, sampling

time, name of sampling person, technical conditions…) shall be addressed.

b) Any possible negative influence on the samples during sampling, sample transport,

handling, storage and analyzing shall be avoided.

c) Procedures shall be well documented and may use statistical methods as a basis for

providing well identified samples and sample data for the measurement process.

d) Information shall be given to the customer if the sampling process reveals some

problems or errors or in the case that the sampling was performed incorrectly.

53

Handling of test and calibration items (§5.8, ISO17025)

9.37. Test and calibration items have to be handled with extreme care to maintain their

identity and never to lose the connection between the item and its description.

9.38. The laboratory, therefore, shall have a procedure in place, that provides:

a) identification and labelling of incoming test and calibration items;

b) reporting of any abnormalities found on the items handled;

c) instructions for handling, storage, transport and necessary environmental conditions to

maintain for the testing or calibration items;

d) instructions on the returning of the items to the customer or any kind of approved

disposal routine.

Assuring quality of test and calibration results (§5.9, ISO17025)

9.39. The laboratory needs to have a procedure in place to ensure continuous control of

quality of the services rendered to the customer.

9.40. When designing such a procedure, consider:

a) using only certified (reference) materials for calibration and internal quality control;

b) carrying out all measurements and calibrations according to the applicable

documentation;

c) participating in interlaboratory comparison or proficiency-testing programme;

d) replicating tests or calibrations using the same or different methods;

e) retesting or recalibration of retained items;

f) correlation of results for different characteristics of an item;

g) using statistical methods, like control charts, to determine the quality of calibration

results over a longer time period to find trends of possible instrument degradation.

54

Reporting results (§5.10, ISO17025)

9.41. Results shall be reported to the customer in an understandable and accurate way so that

the requirements of the regulation bodies and customers needs are fulfilled.

9.42. The laboratory shall devise a layout of its reports recognizing:

a) requirements of regulating bodies

b) requirements of standards

c) internal rules of reporting within the organization

(For more detailed information about the necessary contents of test and calibration reports see

ISO17025 §5.10)

9.43. Care shall be taken to clearly designate data coming from subcontractor.

9.44. The laboratory shall have a procedure in place describing the routine for changing

reports in the case that there are errors detected in the original version.

9.45. All reports issued shall be regarded as records and treated according to procedures

specified according to §5.6.4.

55

REFERENCES

[1] FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, NUCLEAR ENERGY AGENCY OF THE ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, PAN AMERICAN HEALTH ORGANISATION, WORLD HEALTH ORGANISATION, Radiation Protection and the Safety of Radiation Sources, Safety Series No. 120, IAEA, Vienna (1996).

[2] INTERNATIONAL ATOMIC ENERGY AGENCY, The Safety of Nuclear Installations, Safety Series No 110, IAEA, Vienna (1993).

[3] INTERNATIONAL ATOMIC ENERGY AGENCY, The Principles of Radioactive Waste Management, Safety Series No 111-F, IAEA, Vienna (1995).

[4] FOOD AND AGRICULTURE ORGANISATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, NUCLEAR ENERGY AGENCY OF THE ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, PAN AMERICAN HEALTH ORGANISATION, WORLD HEALTH ORGANISATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, Safety Series No. 115, IAEA, Vienna (1996).

[5] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO / IEC GUIDE 2:1996 , Standardization and related activities -- General vocabulary, ISO, Geneva (1996).

[6] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO 9001:2000, Quality management systems — Requirements, ISO, Geneva (2000).

[7] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO/IEC 17025 (1999), General requirements for the competence of testing and calibration laboratories, ISO, Geneva (1998).

[8] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE, Occupational Radiation Protection, Safety Standards Series No. RS-G-1.1, IAEA, Vienna (1999).

[9] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE, Assessment of Occupational Exposure due to Intakes of Radionuclides, Safety Standards Series, No. RS-G-1.2, IAEA, Vienna (1999).

[10] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE, Assessment of Occupational Exposure due to External Sources of Radiation, Safety Standards Series, No. RS-G-1.3, IAEA, Vienna (1999).

[11] INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, WORLD HEALTH ORGANISATION, Health Surveillance of Persons Occupationally Exposed to Ionizing Radiation: Guidance for Occupational Physicians, Safety Reports Series No.5, IAEA, Vienna (1998).

56

[12] INTERNATIONAL ATOMIC ENERGY AGENCY, Optimization of Radiation Protection in Occupational Exposure, Safety Reports Series No. 21, IAEA, Vienna (2002).

[13] INTERNATIONAL ATOMIC ENERGY AGENCY, Direct methods for measuring radionuclides in the human body, Safety Series No. 114, IAEA, Vienna (1996).

[14] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Report on Indirect methods for assessing intakes of radionuclides causing occupational exposure, Safety Reports Series No. 18, IAEA, Vienna (2000).

[15] INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Report on Assessment of radiation doses from intakes of radionuclides by workers, Safety Report (in preparation), IAEA, Vienna (2003).

[16] INTERNATIONAL ATOMIC ENERGY AGENCY, Calibration of Radiation Protection Monitoring Instruments, Safety Reports Series No. 16, IAEA, Vienna (2000).

[17] INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation and Waste Safety in the Oil and Gas Industry, Safety Reports Series (in preparation), IAEA, Vienna.

[18] INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation Protection against Radon in Workplaces other than Mines, Safety Reports Series (in preparation), IAEA, Vienna.

[19] INTERNATIONAL ATOMIC ENERGY AGENCY, Methods for Reducing Occupational Exposure during Decommissioning of Nuclear Facilities, Technical Reports Series No. 278, IAEA, Vienna (1987).

[20] INTERNATIONAL ATOMIC ENERGY AGENCY, Neutron Monitoring in Radiation Protection, Technical Reports Series No. 252, IAEA, Vienna (1985).

[21] INTERNATIONAL ATOMIC ENERGY AGENCY, Compendium of Neutron Spectra and Detector Responses for Radiation Protection Purposes, Technical Reports Series No. 318, IAEA, Vienna (1990).

[22] INTERNATIONAL ATOMIC ENERGY AGENCY, Compendium of Neutron Spectra, Detector Responses for Radiation Protection Purposes. Supplement to Technical Reports Series No. 318, Technical Reports Series No. 403, IAEA, Vienna (2001).

[23] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO9000:2000, Quality management systems - Fundamentals and vocabulary, ISO, Geneva (2000).

[24] INTERNATIONAL ATOMIC ENERGY AGENCY, Practical Radiation Technical Manual on Personal Monitoring, IAEA, Vienna (1995).

[25] INTERNATIONAL ATOMIC ENERGY AGENCY, Practical Radiation Technical Manual on Workplace Monitoring for Radiation and Contamination, IAEA, Vienna (1995).

[26] INTERNATIONAL ATOMIC ENERGY AGENCY, Practical Radiation Technical Manual on Personal Protective Equipment (in preparation), IAEA, Vienna.

57

[27] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO9004:2000, Quality management systems — Guidelines for performance improvements, ISO, Geneva (2000).

58

BIBLIOGRAPHY

[1] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, General Principles for the Radiation Protection of Workers, Publication No. 75, Pergamon Press, Oxford and New York (1997).

[2] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publication No. 60, Pergamon Press, Oxford and New York (1991).

[3] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Conversion Coefficients for Use in Radiological Protection Against External Radiation, Report of the Joint Task Group, ICRP Publication No. 74, ICRU Report No. 57 (1997).

[4] INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Quantities and Units in Radiation Protection Dosimetry, Report No. 51, ICRU, Bethesda, MD (1993).

[5] INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Measurement of Dose Equivalents from External Photon and Electron Radiations, Report No. 47, ICRU, Bethesda, MD (1992).

[6] INTERNATIONAL LABOUR OFFICE, Radiation Protection of Workers (ionising radiations) and ILO Code of Practice, ILO, Geneva (1987).

[7] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Protection Against Radon-222 at Home and at Work, Publication No. 65, Pergamon Press, Oxford and New York (1993).

[8] UNITED NATIONS SCIENTIFIC COMMITTEE ON THE EFFECTS OF ATOMIC RADIATION, Sources and Effects of Ionizing Radiation: 1993 Report to the General Assembly with Scientific Annexes, United Nations, New York (1993).

[9] EURADOS, Exposure of Air Crew to Cosmic Radiation: A Report of EURADOS Working Group 11, Radiation Protection No. 85, European Commission, Luxembourg (1996).

[10] INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Dose Coefficients for Intakes of Radionuclides by Workers, Publication No. 68, Pergamon Press, Oxford and New York (1994).

[11] NUCLEAR ENERGY AGENCY OF THE ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, Work Management in the Nuclear Power Industry: A Manual prepared for the NEA Committee on Radiation Protection and Public Health by the ISOE Expert Group on the Impact of Work Management on Occupational Exposure, OECD/NEA, Paris (1997).

[12] NUCLEAR ENERGY AGENCY OF THE ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, Considerations on the Concept of Dose

59

Constraint: A Report by a Joint Group of Experts from the OECD Nuclear Energy Agency and the European Commission, OECD/NEA, Paris (1996).

[13] INTERNATIONAL ATOMIC ENERGY AGENCY, The Safety of Radiation Sources, Safety Standards Series, (in preparation), IAEA, Vienna.

[14] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, Quality Management and Quality Assurance Standards, Part 1: Guidelines for Selection and Use, ISO 9000-1, Geneva (1994).

[15] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations, Safety Series No. 50-C/SG-Q, IAEA, Vienna (1996).

[16] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, INTERNATIONAL ELECTROTECHNICAL COMMISSION, General Requirements for the Competence of Calibration and Testing Laboratories, ISO/IEC Guide 25, Geneva (1990).

[17] INTERNATIONAL ATOMIC ENERGY AGENCY, Intervention Criteria in a Nuclear or Radiation Emergency, Safety Series No. 109, IAEA, Vienna (1994).

[18] INTERNATIONAL ATOMIC ENERGY AGENCY, WORLD HEALTH ORGANISATION, Diagnosis and Treatment of Radiation Injuries, Safety Reports Series No. 2, IAEA, Vienna (1998).

[19] INTERNATIONAL ATOMIC ENERGY AGENCY, WORLD HEALTH ORGANISATION, Planning the Medical Response to Radiological Accidents, Safety Reports Series No. 4, IAEA, Vienna (1998).

[20] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO10005: 1995, Quality management - Guidelines for quality plans, ISO, Geneva (1995).

[21] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO10007: 1995, Quality management - Guidelines for configuration management, ISO, Geneva (1995).

[22] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO100011-1: 1990, Guidelines for auditing quality systems.-Part 1: Auditing, ISO, Geneva (1990).

[23] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO/DIS10012-1:1992, Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment, ISO, Geneva (1992).

[24] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO10012-2:1997, Quality assurance for measuring equipment — Part 2: Guidelines for control of measurement of processes, ISO, Geneva (1997).

[25] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO10013:1995, Guidelines for developing quality manuals, ISO, Geneva (1995).

[26] INTERNATIONAL ORGANISATION FOR STANDARDIZATION. ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems — General requirements for operation and recognition, ISO/IEC, Geneva (1993).

60

[27] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons — Part 1: Development and operation of proficiency testing schemes, ISO/IEC, Geneva (1994).

[28] INTERNATIONAL ORGANISATION FOR STANDARDIZATION, ISO/IEC Guide 43-2, Proficiency testing by interlaboratory comparisons — Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies, ISO/IEC, Geneva (1994).

61

ANNEX I

GROUPED PROCESSES LIST

It is advisable to group all processes and actions needed according to Section 4.3.5.

MANAGEMENT RESPONSIBILITY

In the frame of management responsibility processes the following issues and related

actions shall be covered:

a) Management commitment (ISO9001 – 5.1) Define a quality policy, quality objectives

and applicable performance indicators for all processes.

b) Customer focus (ISO9001 – 5.2) Define methods of determining customer needs and

enhancing customer satisfaction.

c) Quality policy (ISO9001 – 5.3) Define a policy according to organization purpose.

Define methods to:

— make all staff comply with and improve the QMS;

— communicate the quality policy within the organization; and

— review the quality policy to keep it suitable to the organizational purpose.

d) Planning (ISO9001 – 5.4) Define methods to produce, maintain and improve a quality

manual.

Set-up rules for controlling relevant documents, including those supporting methods:

— for approving, issuing, reviewing and updating existing documents;

— for ensuring that existing documents are up to date;

— for preventing the use of obsolete documents.

Define ways of treating quality records deriving from procedures, including:

— establishing an identification system;

62

— devising storage and retrieval methods;

— guaranteeing adequate minimum protection period to the records;

— imposing an adequate time for retention of the records; and

— defining a method of disposal after the retention-time has run out.

e) Responsibility, Authority and Communication (ISO9001 – 5.5) Define the

organizational structure; set up responsibilities and authorities (job description); appoint

a quality manager and define ways of communication within the organization.

f) Management review (ISO9001 – 5.6) Define the method for assessment of the QMS

through a management review4, for assessment of the performance of the organization

and for dealing with regulatory bodies.

RESOURCE MANAGEMENT

In the frame of resource management processes the following issues (discussed in

greater detail in section 6) shall be covered:

a) Provision of resources (ISO9001– 6.1) Implement, maintain and improve the QMS and

to enhance customer satisfaction.

b) Human resources (ISO9001– 6.2) Define the provision of human resources including:

developing methods of job evaluation; identifying competency needs for personnel;

devising training plans for personnel and evaluating the effectiveness of training.

c) Infrastructure (ISO9001– 6.3) Define the provision of working facilities including:

— safe handling, transport, storage, use and planned maintenance of equipment;

— provision of working equipment (hardware and software);

— ensuring proper calibration of measuring instruments; and

4 An activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject

matter to achieve established objectives (see ISO9000 2.8.6)

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— maintaining and servicing facilities and equipment.

d) Work environment (ISO9001 – 6.4) Define ways to control the working environment.

PRODUCT REALIZATION

In the frame of product realization processes, the following issues (discussed in greater

detail in section 0) shall be covered:

a) Planning of product realization (ISO9001-7.1) Define quality objectives and

requirements for the product, the necessary processes and process descriptions, control

processes needed for the production process including acceptance criteria and records

necessary to document the production process.

b) Customer-related processes (ISO9001 – 7.2) Define methods to determine customer

requirements, including those:

— specified for the product by the customer;

— not specified by the customer, but necessary;

— stipulated by legal and regulatory authorities related to the products.

Define methods to establish and review the customer contracts and to ensure the ability

of the organization to meet the contracted requirements.

Define arrangements for communication with the customer.

c) Design and development (ISO9001 – 7.3) Define methods to design the product for the

customer including definition of design process stages; definition of adequate review,

verification and validation activities; definition of responsibilities and authorities for the

activities.

d) Purchasing (ISO9001 – 7.4) Define arrangements for purchasing goods, including

necessary approvals and activities to verify the purchased products.

e) Production and service provision (ISO9001 – 7.3) Define methods to realize the

designed product including monitoring and recording the realization process; caring for

customer property needed for the realization process and using qualified personnel and

equipment.

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f) Control of monitoring and measuring devices (ISO9001 – 7.6) Define methods of

controlling necessary measuring devices including establishment of adequate calibration

procedures and calibration plans; and protection of all instruments from damage,

deterioration and maladjustment. Define the necessary corrective actions if measuring

devices malfunction.

MEASUREMENT, ANALYSIS AND IMPROVEMENT

In the frame of measurement, analysis and improvement processes, the following issues

(discussed in greater detail in section 0) shall be covered:

a) General (ISO9001 – 8.1) Define methods of measurement, analysis, monitoring and

improvement including adequate statistical data analysis.

b) Monitoring and measurement (ISO9001 – 8.2) Define the arrangement of internal audits

and a method to monitor and evaluate customer satisfaction.

c) Control of non-conforming product (ISO9001 – 8.3) Define ways of controlling

nonconformities.

d) Analysis of data (ISO9001 – 8.4) Define methods to identify, collect and analyse data to

demonstrate the effectiveness of the QMS, including data on customer satisfaction,

product compliance, and process and supplier performance.

e) Improvement (ISO9001 – 8.5) Define procedures to correctly carry out corrective and

preventive actions.

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ANNEX II

QUALITY POLICY

This Annex presents an example of quality policy example.

QUALITY POLICY OF OUR ORGANIZATION

We are fully committed to meeting or exceeding our customers’ expectations, and

achieving our objective of being a preferred supplier.

We believe quality consists of services provided on time and in conformance with

customer requirements. We believe in effective service definition with our customers (‘doing

it right the first time’).

In order to meet the requirement of our customers our organization applies well

established good professional praxis to all services and has developed a quality management

system (QMS) based on ISO9001:2000 and ISO/IEC17025 which applies to all operational

services. The aim of this QMS is to ensure the highest quality of services to our customers.

Management commits itself, in the course of its own work, to complying with the

quality system it has endorsed and to improving the quality of operations.

All staff members of our organization shall be familiar with the QMS and it is their

responsibility to ensure full compliance with this System. In order to support staff in this

endeavour, the management commits itself to identifying and meeting current and anticipated

training needs.

As a company, we are committed to continuous improvement in the quality of all our

services. We are also committed to continuous improvement and enhancement of our

relationships with customers, shareholders, employees, suppliers and partners.

Meeting this commitment requires management and employees to work together as a

team, establish objectives to support this quality commitment, and continually review

performance to these objectives.

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ANNEX III

QUALITY OBJECTIVES

This Annex presents examples of quality objectives. First an example that may be valid

for an organization during initial implementation of a quality management system (QMS).

QUALITY OBJECTIVES OF OUR ORGANIZATION

supplying our customers with reliable and consistent services, and to this end

implementing a QMS complying with the international standards ISO9001:2000

and ISO/IEC 17025;

operating our advisory groups and/or laboratories under full implementation of QMS;

acquiring accreditation for all services rendered by our laboratories.

For an organization running a well established QMS, the quality objectives may look

different as a result of management reviews already performed, where quality objectives have

been adapted:

QUALITY OBJECTIVES OF OUR ORGANIZATION

endeavouring, at any time, to maximize customer satisfaction with the services provided;

promoting customer/supplier relationships through fulfilling customer needs by providing the

necessary service delivered on time;

continuously improving quality and productivity and by that obtaining and maintaining market

leadership;

promoting, developing and improving the skills of our staff at all levels in order to enhance

quality awareness and maintain a highly motivated and competitive team;

maintaining the high standard of our quality system through the application of regular audits

and reviews;

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ANNEX IV

DUTIES OF QUALITY MANAGER

QUALITY MANUAL

To establish and update the quality management system

To ensure compliance with the relevant standards of any documents within the QA system

To keep all records (e.g. internal and external audit reports, quality policy, quality goals,

protocols of management reviews, reports of non-compliance, equipment list) originating

within the QA system if not otherwise stated within a procedure

To organize and supervise the quality audits, to write a quality report annually and to organize

the management review

To provide training and assistance in quality matters to all members of OP staff

To report on any non-compliance with the established procedures within the work of the

organization.

DOCUMENT CONTROL

To keep the documentation in compliance with applicable standards

To update the list of internal and external documents in force

To archive one copy of all distributed versions of documents.

To distribute the quality documentation to all staff members.

To perform a review of the documentation status every two years.

REQUESTS AND CONTRACTS

To keep the records of denied requests for further evaluation.

SUBCONTRACTING

To keep the records of subcontractor evaluation

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To keep a list of competent subcontractors used by the testing laboratory

PURCHASING SERVICES AND SUPPLIES

To validate the acceptability of documents of compliance received from suppliers

To keep a list of acceptable suppliers.

SERVICE TO CUSTOMERS

To keep a list of customer visits to the laboratory

To keep records of customer feedback

To help gather feedback from the customers at regular (annual) intervals.

COMPLAINTS

To keep the ensuing records.

CONTROL OF NONCONFORMITIES

To keep the records

To assist in processing the corrective action procedure.

CORRECTIVE AND PREVENTIVE ACTION

To keep the ensuing records

CONTROL OF RECORDS

As author of a procedure

To identify necessary records

To propose a record keeper

To define how records are stored (optional).

As nominated record keeper (by procedure)

To collect, file and store the records

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To maintain the legibility of records

To facilitate access to the records for authorized persons.

To decide how to dispose of managerial records when the period of storage has expired.

Internal audits

To plan the audit at the prescribed intervals

To select, train and appoint the auditor(s)

To prepare an audit questionnaire

To ascertain that the audit has been successfully completed

To collect the individual audit reports.

Acting as Auditor

To be informed about the scope of the audit

To read and check the relevant quality documentation

To adapt, if deemed necessary, the audit questionnaire

To adhere strictly to the scope and time frame of the audit

To record audit questions, answers and controlled documentation

To prepare an audit report.

MANAGEMENT REVIEW

To prepare all necessary input documents

To document the results of the review.

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ANNEX V

CHECKLIST TO EVALUATE REQUESTS FOR CONTRACTS

Are the requirements of the request well defined ? yes no n/a

Is there already a validated, documented and authorized method

of delivering the service in force ? yes no n/a

Does the method reach the necessary accuracy and

precision (limits of uncertainty) ? yes no n/a

Does the method reach the necessary limits of detection

according to the customer’s requirements ? yes no n/a

Is the necessary equipment physically available

within the timeframe of the request ? yes no n/a

Do we have a valid calibration for the equipment ? yes no n/a

Do we have time to do a calibration ? yes no n/a

Do we have standards to do a calibration ? yes no n/a

Is a technician available to do the calibration in time ? yes no n/a

Are all the necessary supplies available ? yes no n/a

Do we have time to purchase them ? yes no n/a

Do we have funding to purchase them ? yes no n/a

Is a technician available to do the work within the customers timeframe ? yes no n/a

Is this technician experienced in the work to be done ? yes no n/a

Can the available technician be trained in time ? yes no n/a

To approve a request, ‘NO’ is acceptable for a main question if it is compensated by ‘YES’

for all the subsidiary questions !!

Date Name Signature

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ANNEX VI

EXAMPLE OF A JOB DESCRIPTION

JOB DESCRIPTION FOR PROFESSIONAL POSTS

Working out the following requirements will result in a thorough description of any job in a

testing laboratory

Functional title and current grade of post

Incumbent’s supervisor

Functional title

State the main purposes (objectives) of the post (Overall role/functions of the post with stress

being placed on the more important aspects):

Summarize the major duties and responsibilities of the position in order of importance and

indicate in the margin the percentage of time spent on each (most jobs contain no more than 5

or 6 major responsibilities). First state what is being done, then how it is being done:

Describe the minimum knowledge requirements of the job:

Level and field of study of university degree (or the equivalent acquired through training or

self-study):

Minimum length and type of practical experience required:

at national level

at international level

Language(s):

proficiency required

other languages preferred

Work Role: What the job requires the incumbent to do (i.e. describe the analysis,

interpretation, adaptation, innovation, planning, co-ordination, and directing that the job

requires):

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Describe the control exercised or guidance given by the supervisor in terms of planning,

controlling and reviewing the incumbent’s work, e.g. how often do you meet, how are

priorities handled, how is work achieved, how are instructions given

Indicate which regulations, manuals, precedents, policies, or other administrative and

technical guidelines apply to the incumbent’s work, and to what extent the incumbent is

permitted to interpret, deviate from, or establish new guidelines:

With whom (indicate title only), for what purpose, and how often is the incumbent required to

have contacts in the job? (Describe the most typical, not the most unusual, contacts) :

Describe the most important type(s) of decisions the incumbent is authorized to take and why

these are important

Describe the most important types of proposals expected of the incumbent in the job and why

these are important

Describe the most damaging involuntary error(s) that could be made in the work and the

effect(s) that would result:

Total staff in organizational units supervised by incumbent. (Note: ‘supervised’ means ‘held

accountable for the work.’)

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CONTRIBUTORS TO DRAFTING AND REVIEW

Baehrle, H. Paul Scherrer Institute, Switzerland

Cruz-Suarez, R. International Atomic Energy Agency

Dias Acar, M.E. Instituto de Radioprotecảo e Dosimetria, Brazil

Dicey, B. Air Force Center for Radiation Dosimetry, United States of America

Fantuzzi, E. Radiation Protection Institute, Italy; EURADOS WG 2.

Zeger, J. ARC Seibersdorf Research, Austria

Prendes-Alonso, M. Centro de Proteccion e Higiene de las Radiaciones, Cuba