2Normative References and Related Bibliography

INDEX

INTRODUCTION

1Scope

2Normative references and related bibliography.

3List of terms and definitions and abbreviations used in this Manual.

4Management requirements

4.1Organization

4.1.1General

4.1.2Responsibilities

4.1.3Organizational chart

4.1.4Address

4.2Quality system

4.2.1Mission

4.2.2Quality policy

4.2.3Quality objectives

4.2.4Quality commitment

4.2.5Structure of the Quality System

4.3Document control

4.3.1General

4.3.2Document approval and issue

4.3.3Document changes

4.4Review of requests, tenders and contracts

4.5Subcontracting of tests and calibrations.

4.6Purchasing services and supplies.

4.7Service to the customer.

4.8Customer complaints.

4.9Control of nonconforming results and/or calibration work.

4.10Improvement.

4.11Corrective action.

4.11.1General.

4.11.2Cause analysis.

4.11.3Selection and implementation of corrective actions.

4.11.4Additional audits.

4.12Preventive action.

4.13Control of records.

4.13.1General.

4.13.2Technical records.

4.14Internal audits.

4.14.1Compliance with procedures.

4.14.2Quality audit.

4.14.3Periodic checks.

4.15Management reviews.

5Staff, accommodation and technical requirements

5.1General

5.2Personnel

5.2.1Technical competence.

5.2.2Job description.

5.2.3Continuity of work

5.3Accommodation and environmental conditions

5.3.1Radioactive Reference Sources.

5.4Calibration methods and method validation

5.4.1General

5.4.2Selection of methods.

5.4.3Validation of calibration instructions

5.4.4Estimation of uncertainty

5.4.5Control of data

5.5Maintenance and repair services

5.5.1General

5.5.2Definition of the scope of the work.

5.5.3Design, planning and development of the work.

5.5.4Modifications to the request.

5.5.5Customer satisfaction.

5.6Equipment

5.7Measurement traceability

5.7.1General

5.7.2Specific requirements

5.8Handling of serviced instrumentation

5.8.1Instrument reception and storage

5.8.2Instrument troubleshooting

5.8.3Communication with the customer

5.9Handling of instruments for calibration.

5.10Assuring the quality of the results.

5.10.1Calibration results

5.10.2Results of repair/maintenance services

5.11Reporting the results

5.11.1General

5.11.2Reports of services.

5.11.3Opinions and interpretations

5.11.4Results obtained from subcontractors

5.11.5Format of reports and certificates.

ANNEX 1.Staff members currently working in the Electronics Group and their responsibilities:

ANNEX 2.List of responsibilities of staff members of the Electronics Group:

ANNEX 3.QS Documentation in effect.

INTRODUCTION

It is the policy of theINSERT ORGANIZATION NAMEto operate under an established Quality Management programme. The purpose of such programme is two fold, to help ensure the quality of the provided services through documented policies and procedures, and to achieve the maximal satisfaction of its customers. For the purposes of quality assurance of electrical calibration, as well as for repair/maintenance worksit is essential that the Quality Management System can comply with the internationally adopted regulations.

One of the key elements of the Quality Management programme is the Quality Manual. Such Manual describes the policy and responsibilities for the operation of the INSERT ORGANIZATION NAMEand the details of all of the associated activities in practice. The Manual is meant to create an element of trust in the quality of the services provided by the INSERT ORGANIZATION NAME.

Since the electrical calibration of equipment and nuclear instruments constitutes a basic premise to ensure the quality of electronic design/development, as well as of repair/maintenance works, this Quality Manual is based on the ISO Standard 17025:2005 “General requirements for the competence of testing and calibration laboratories”.

As specified in the ISO/IEC 17025:2005, the conformity to this Standard does not imply conformity of the quality management system to all requirements of ISO 9001:2000. Therefore, some sections have been added to the ISO/IEC 17025:2005 contents layoutin this Manual,and some additional operational procedures and managerial organization actions have been implemented in the Quality Management System as to comply to ISO 9001:2000 standard as well. In particular, and to emphasize the importance of achieving the customer satisfaction, some actions and processes required for understanding and clearly stating customer requirements in repair/maintenance service are clearly addressed in the operational procedures, thus allowing to achieve a clear definition of the indicators for internal quality control. The importance of direct communication with the customer to facilitate any adjustments and modifications in the initial request specifications is emphasized as well.Continual improvement in repair/capabilities is ensured by keeping a continuous program for personnel qualification training.

1Scope

This Manual is aimed to delineate the quality policy of the INSERT ORGANIZATION NAME and to describe its Quality Management System, compliant with the requirements of the ISO 9001:2000 and the ISO IEC 17025:2005standards.

The scope of the implemented Quality Management System is the provision of:

• Repair and maintenance of electronic equipment.
• Electrical calibration of testing equipment and nuclear instruments, and
• Design/development of interfaces/adaptors for scientific equipment and instruments not available commercially.

The implementation of this system has been performed through adopting general procedures to ensure consistency in overall system operation. An effort has been made to organize the documentation in a way that harmonization among general procedures is guaranteed.

2Normative references and related bibliography.

• ISO 9000:2000, Quality Management Systems- Fundamentals and vocabulary.
• ISO/IEC 17025:2005(E) – General requirements for the competence of testing and calibration laboratories.
• ISO 9001:2000, Quality Management Systems- Requirements.
• ISO GUM: 1995, Guide to the expression of uncertainty in measurement.
• EA-4/02, Expression of the uncertainty of measurement in calibration, European Co-operation for accreditation, December 1999.

3List of terms and definitions and abbreviations used in this Manual.

Terms and definitions related to Quality Management are compliant with ISO 9000:2000.

Specific abbreviations included in this Manual are:

INSERT PARENT ORGANIZATION ACRONYM:Insert Parent organization name

DIR-INSERT PARENT ORGANIZATION ACRONYM:Director of Insert Parent organization name

INSERT ORGANIZATION'S ACRONYM- insert organization name

H-EG:Head of Electronics Group

QM-EG:Quality Manager of Electronics Group

TL-EG:Technical Leader of Electronics Group

Complete the list with other acronyms and respective staff positions, if necessary

4Management requirements

4.1Organization

4.1.1General

In the INSERT PARENT ORGANIZATION ACRONYMorganizational structure the INSERT ORGANIZATION'S ACRONYM is adescribe the organizational category of the organization with respect to the Parent organization. An overall view of this organizational structure is provided in 4.1.3.

The Electronics Groupis a workgroup comprising the List the management positions in the organization and technical grade staff (G-staff). The names of the currently active personnel are provided in Annex 1.

4.1.2Responsibilities

The Quality System of the Electronics Group is integrated into the Quality Management System (QMS) of the INSERT ORGANIZATION'S ACRONYMunder the authority of its top management. DIR-INSERT ORGANIZATION'S ACRONYM has the overall responsibility to ensure that laboratories, as appropriate, within INSERT ORGANIZATION'S ACRONYM have a QMS that is consistent with the standard for such laboratories and that their operation is compliant with their QMS. The INSERT ORGANIZATION'S ACRONYM Quality Systems Manager assists the H-EG in this regard.The H-EG of the INSERT ORGANIZATION'S ACRONYMholds the responsibility for all of the activities in the Electronics Group, including the technical support.

The H-EG has designated the TL-EG as the Technical Leader of the QS. The TL-EG is responsible for proper operation of the group, revision of the work flow and keeping a direct communication with the customers during the performance of all services, surveillance of the implementation and validation of new calibration instructions and operational procedures, as well as for reviewing and approving results reports. The TL-EG is responsible for creating and maintaining the Quality System as well, ensuring that all of the activities covered by the scope of the Quality System are preformed in compliance with it.

A Senior Electronics Specialist is assigned the function of Quality Manager of EG. He/she has the responsibility for implementing and maintaining this QM Programme in co-operation with the TL-EG and the Quality Systems Manager of the PARENT ORGANIZATION, within their respective remit of responsibilities. The QM-EG has the authority and resources needed to carry out his/her duties and to identify the occurrence of departures from the quality system or from the laboratory procedures, and to initiate actions to prevent or minimize such departures. He/she is also responsible for maintaining updated the list of active documents and for keeping the internal quality control.

The EG technical staff has responsibility for maintaining the services at the highest possible quality level. They are also responsible for keeping the functioning of the instrumentation in conditions that ensure the traceability of the measurements and calibration results. EG staff is responsible for implementing the operational procedures and instructions, as well as to contribute to the preparation of new ones whenever it might be needed.

A list of the incumbent staff and held responsibilities for the different aspects of the QA Programme of the EG is provided in Annex 2.

4.1.3Organizational chart

The organizational chart provided in Figure 1 shows the general structure of the ORGANIZATION NAMEin the structure of the PARENT ORGANIZATION.

Figure 1. Hierarchical position of the Electronics Group in the PARENT ORGANIZATION organizational chart.

4.1.4Address

The official address of the ElectronicsGroupis:

ElectronicsGroup

ORGANIZATION NAME

Mail address

Contact information:

Tel: +CCACPhone number

Fax: ++CCACFax number

e-mail:

4.2Quality system

4.2.1Mission

PLEASE, DEFINE THE MISSION OF THE PARENT ORGANIZATION, if any.

In particular, the main mission of the Electronics Group is focussed on the design, maintenance and repair of nuclear instrumentation and scientific equipment in general. The Group accomplishes this mission by providing repair / electrical calibration services forDEFINE CUSTOMERS TYPE, as well as designs and develops interfaces/adaptors for scientific equipment and instruments not available commercially and which are requested byDEFINE CUSTOMERS TYPE.All these activities require the provision of reliable electrical calibrations of testing equipment and nuclear instruments, in order to contribute to improve the quality of the work (INCLUDE LAST SENTENCE IF APPROPRIATE).

4.2.2Quality policy

It is the policy of the Electronics Group that its service support achieves a level of quality in execution and delivery of results that is commensurate with the requirements of its quality system. The Electronics Group will endeavour to carry out electrical calibration of testing equipment and nuclear instruments and provide results that are at a quality level consistent with the international requirements.

To achieve this, the Electronics Group will establish a Quality System in compliance with the ISO 9001 and the ISO/IEC 17025:2005 standards. The H-EGwill ensure that all the members of the staff will be acquainted with the Quality System and the implemented procedures. The members of the EG will perform their work as to fulfil the requirements of the Quality Policy and will remain free of any kind of commitments or motivations other than those explicitly declared by the ORGANIZATION NAME.

4.2.3Quality objectives

The quality policy represents the commitment of the Electronic Group to fully satisfy the requirements of the DEFINE CUSTOMERS TYPE. Its general quality objectives are:

a)To ensure that the management of the group and the service support provided to its customers are maintained and performed in accordance with the principles of a quality system established in compliance with ISO/IEC 17025:2005 and ISO 9001:2000;

b)To ensure that the calibration measurements are performed following validated calibration instructions and that the provided electrical calibration results are traceable to SI units and comply to ISO/IEC 17025:2005 requirements.

c)To ensure that all the repair/maintenance services are performed following established and validated procedures agreed to by its customers, and in compliance with the ISO 9001:2000;

d)To ensure that all staff members involved in activities within the scope of the quality management system are aware of the quality policy, its documentation and implementation, and continuously evaluate opportunities for improving the group’s performance;

e)To provide the Group personnel with a stimulating and rewarding environment; and

f)To achieve these objectives in a safe, efficient and effective manner.

4.2.4Quality commitment

The Electronics Group is committed to achieve these objectives through the implementation of a quality system structured to address, as applicable, the criteria given in international standards of the ISO 9001, the ISO/IEC 17025:2005 and other relevant international standards and guides. The quality system shall be further developed to meet international best practice in the activities carried out.

The group management at all hierarchical levels, hereby represented by the H-EG, is fully committed to endorsing the quality policy, to achieving the quality objectives and to implementing the quality system. Overall responsibility for the implementation of the quality system resides with the H-EG, supported by a proper quality organisational structure.

4.2.5Structure of the Quality System

The Quality System includes the following key elements:

• A Quality Manual for the Electronics Group.
• A system for keeping documented and validated calibration instructions, well documented operational procedures and corresponding records.
• Instrumentation that is periodically calibrated and checked to ensure traceability of the calibration results and the quality of the maintenance/repair services.
• A clear and comprehensive statement of uncertainty in the measured quantities and in the reported values resulting from the calibrations.

The structure of the documentation of the EG Quality System including the document levels and the coding system is shown in Figure 2.

Figure 2. Quality system documentation

4.3Document control

4.3.1General

EG has established and maintains procedures to control all documents that form part of its quality system. A master list identifying the current revision status of the documents has been established and is provided in Annex 3. The Quality Manager of the EG is responsible for maintaining the list updated and for the conservation of all the documents. Hard copies of all the documents are kept in room DEFINE ROOM CODEin a locked archive. Whenever major changes are made in the Quality Documentation, which modify its structure or imply the addition of new operational procedures, calibration instructions, forms or records, the QS documentation is updated with hard copies made by the EG-QM. Authorised copies of the relevant QM documents are available to the relevant staff for use in work and are kept in the respective working places.

Electronic records are kept by the Quality Manager of the EG in two CD copies, which are updated twice per year and kept in room DEFINE ROOM CODE.

4.3.2Document approval and issue

All documents issued to staff as part of the QMS have been reviewed and approved prior to issue by the professional staff, the Quality Manager of the EG, the PARENT ORGANIZATIONQuality Systems Manager and finally approved by the H-EG.

Quality system documents issued by the EG shall comply with the general instructions and recommendations specified in EG.OP.01 and EG.OP.02. All the documents are uniquely identified and dated, including the date of issue and the revision identification, page numbering, the total number of pages and the issuing authority. The status of each document is marked on its cover page, i.e., the documents in use are marked ‘Active’ and those that are no longer in use but are stored in the archive are marked as ‘Obsolete’.

4.3.3Document changes

Changes in the documentation, arising from the implementation of new operational procedures, calibration instructions or changes in already validated ones, as well as due to changes in the QS shall be revised by the Quality Manager of the EG, supervised by the PARENT ORGANIZATIONQuality Systems Manager and finally approved by the H-EG.

Any changes or amendments in documentation, including logbooks or records are done in hard copies and are clearly annotated. Revised documents are formally reissued as soon as possible. The cover page contains information on the revision history, i.e., first valid effective date and revision number, and the latest revision effective date and revision number. A history record of the performed changes is kept in electronic format (DCH.doc) and in a hard copy with the general QS documentation (DCH).

4.4Review of requests, tenders and contracts

The EG technical services to customersareeither formally established in the frame of bilateral collaborative links or agreed by contracts. Information about the EG and the main services provided is available from the EG webpage in the PARENT ORGANIZATION website

The EG ascertains the capability of fulfilling the requirements of its customers, as it possesses the necessary physical, personnel and information resources, and the staff has the skills and the expertise necessary for the performance of electronic service support.

Requests from customers are revised by the TL-EG as to judge if the request can be accepted. Requests can be accepted by the TL-EG if the performance of the calibration implies the use of validated calibration instructions, or if the performance of maintenance/repair services implies the use of well established operational procedures. The TL-EG keeps a direct communication with the customer whenever new issues arise during the performance of a given service work, in order to agree modifications in the original request or taking decisions for the completion of the assignment. The TL-EG ensures that EG-staff involved in the completion of a given service work is promptly informed in case that modifications or amendments have been made to the original work assignments.

In the event that the required service requires the implementation of a new procedure(s), the service can be performed if the implementation and validation of such procedure(s) is granted. The TL-EG will discuss in details with the staff if the intended implementation is feasible. If a positive consensus is reached in respect to the technical feasibility, the TL-EG will discuss with the H-EG if such implementation is useful for the further work of the EG.

Customers shall submit an official request using the form EG.OF.01. A template of this form is available for download from the Electronic Group webpage at the PARENT ORGANIZATION website can be submitted electronically to the customers. Customers with difficult access to Internet can request the EG.OF.01 form by sending an empty e-mail to with Subject line “SEND REQUEST FOR ELECTRONICS SERVICE FORM”.