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Quality Management and accreditation of Non-destructive

testing laboratories

C. Hakan GÜRMiddle East Technical University,

Metallurgical and Materials Engineering Department, Welding Technology and NDT Center, 06531 Ankara -

TurkeyTel: 00-90-312-2105916, Fax :00-90-312-2101267

Email : chgur@metu.edu.tr Contact

ABSTRACT

This paper presents the main points for the establishment of a quality management system and accreditation of non-destructive testing laboratories, in accordance with EN 45001 and ISO 17025.

Accreditation is defined as a confirmation procedure of the competence of the testing laboratories to carry out their specific tasks. In order to be accredited, a NDT laboratory should demonstrate its technical and organisational competence and its areas of application. Implementation of a quality management system in the NDT laboratories promotes better and easier management, and development in testing, then accreditation as a testing laboratory promotes worldwide recognition of test results, and technical competence and competitiveness in the market.

An application example is given from the quality system of the non-destructive testing laboratories in the Middle East Technical University Welding Technology & NDT Centre that have been accredited according to EN 45001. Detailed information about the content of the quality manual and procedures are also included.

1   INTRODUCTION

1.1  Quality Management in Testing Laboratories

The quality will be achieved by a system of procedures that is in accordance with the requirements of laws, legal regulations, customer requests, the standards, and the market. Accreditation is a confirmation procedure of the competence of the testing laboratories to carry out their specific tasks. It is based on the implementation of appropriate quality management procedures.

The previous quality systems were based on the EN 45001, ISO/IEC Guide 49, and ISO/IEC Guide 25. However, recently ISO/DIS 17025 "General requirements for the competence of testing and calibration laboratories" has been produced as the result of extensive experience of the implementation of ISO/IEC Guide 25 and EN 45001. It contains all of the requirements tha testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results.

The growth in use of quality systems has increased the need to ensure that laboratories that form part of larger organizations or offer other services can operate to a quality system that is seen as compliant with ISO 9001 or ISO 9002. In this standard, care has been taken to incorporate all of those requirements of ISO 9001 and ISO 9002 that are relevant to the scope of testing and calibration services that are covered by the quality system of the laboratory. In other words, testing laboratories that comply with this standard also operate in accordance with ISO 9001 or ISO 9002 and are able to implement a single quality system meeting the requirements of both standards if they so wish.

1.2   Accreditation of NDT Laboratories

The quality system of an NDT laboratory must be adequate to the type, range, and volume of the work performed. The elements of the system should be documented in a quality manual that is available by the laboratory personnel.

Non-destructive testing laboratories should demonstrate their competences in following fields:

Technical competence (use of NDT methods based on knowledge and experience; development, modification, and updating of testing methods; deployment of qualified and certified personnel; use of suitable testing, measuring, and other necessary equipment

Organisational competence (assurance of the overall traceability of testing procedures and supporting processes in the review of contract, and method validation; regarding technical and personnel realisation).

Areas of application (availability of complete verifiable documentation and of processes under operational conditions).

After establishing the quality system, the accreditation procedure consists of four stages: application, assessment, accreditation, and surveillance (inter-laboratory comparisons, proficiency tests, documentation; re-accreditation after five years).

2   AN APPLICATION EXAMPLE: NDT LABORATORIES AT METU

Aiming the accreditation as a testing laboratory, the Middle East Technical University - Welding Technology and Non-destructive Testing Centre started to implement a quality assurance system based on EN 45001 in 1995. After fulfilling the requirements, in November 1996, the NDT laboratories were audited and accredited by DAR-Germany.

2.1  Quality System

The Centre guarantees that its organisational and technical activities are planned, supervised and controlled. The staff members of the laboratories and all units of the Centre which are directly or indirectly involved are bound to carry out the tasks in accordance with the quality policy stated in the quality manual. All the staff has the right to detect deviations and inadequacies in the quality system, to request corrections and to make suggestions for the improvement of the quality level.

The laboratories have documented instructions on the use and operation of all relevant NDT equipment, on the handling and preparation of test items, and on standard testing techniques. All instructions, standards, manuals and reference data are maintained up-to-date and are readily available to the personnel.

The NDT laboratories are furnished with equipment required for correct performance of the tests. Where the laboratory is obliged to use outside equipment, it should ensure the fitness of that equipment.

Reliability is the basic principle of the quality system. Internal audits, corrective actions, preparation of documents, revision of present documents are carried out in accordance with the procedures and instructions written in the quality manual.

The director of the Centre coordinates on his behalf the planning, execution and review of quality system in the Centre. He is responsible for the preparation, maintenance and control of the Centre's quality manual. A quality manager is authorized for the quality issues.

The documentation structure of the Centre consists of the quality manual, quality procedures, instructions, and forms.

2.2   Quality Manual

The quality manual describes the structure of the Centre and process organisation as regards quality assurance in the services rendered by it. This is the main unit that has the main and general topics. For the detailed information on any subject, it refers to the annexes, procedures or instructions. The content of the quality manual is summarized in Figure-1.

First chapter includes definitions related to the quality system and specific to the Centre, abbreviations, and the coding system used for forms and instructions. In the second chapter, the objective and the field of application, and legal identity of the Centre is explained. The impartiality, independence and integrity statement is also involved such that "The Centre and its personnel are free from any commercial, financial and other pressures which might influence their technical judgement. Any influence on the results of tests and examinations exercised by persons or organisations external to the Centre shall be excluded. The Centre shall not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing activities. The re-numeration of the personnel engaged in testing activities shall not depend on the results of tests. When products are tested by bodies, who have been concerned with their design, manufacture or sale, provision for a clear separation of different responsibilities and appropriate statement shall be made". Then, the statement on the confidentiality of test results is written.

Third chapter includes

Quality policy of the Centre Organisation: The general organisation of the Centre is given in a chart.

The name of the personnel responsible for each position is given in the annex (A.1). Information about the functioning of the organisation system is given in the Quality System Procedure (P.2);

Personnel, duties and responsibilities: Personnel files are kept by the section head. New personnel attend to an orientation program that is planned by the respective section head. This program includes understanding of the quality system and the documents. All staff works according to their duties and responsibilities, which are explained in the annex (A.2), under control of the section heads. Their physical fitness relevant for the performed non-destructive test is observed and recorded such that annual eye examination for all personnel is documented on the related form. In the case of temporary absence of any personnel due to various reasons his/her duties and responsibilities are transferred to another who is authorised by the section head. After approval, the proxy is declared in written form.

Qualification and training of the staff: All staff has the necessary education, training, technical knowledge and experience for the assigned functions. The laboratory management ensures that the training of the personnel is kept up-to-date. All the activities, such as training, to improve the quality level of the services given by the Centre are carried out according to the Training Procedure (P.3). All activities within this frame are planned and realised annually by the section heads by filling the related form.

Chapter four defines the quality system; the structure of documentation; distribution of documents; maintenance of documents; internal and external audits.

Premises and effect of environment on the tests are explained in Chapter five. Entrance to the premises is also formulated. Environmental conditions in which the activities are undertaken should not invalidate the results or adversely affect the required accuracy. The premises are protected from adverse conditions that are explained for each individual test method in the annex. Other parameters, such as displacement, vibration and external magnetic fields were taken into account on siting and project planning. The requirements on the environmental conditions are observed in the laboratories. Long-term behaviour is recorded by regular measurement of the environmental parameters on the related form.

Chapter six is related to the equipment. All equipment and necessary accessories in the Centre are registered and administered in equipment records using the respective forms. Equipment lists are classified according to the methods. The managers of the related laboratories keep these lists. All equipment is properly maintained by the authorised technical personal according to the maintenance instructions. Details of maintenance are available in the equipment files in the respective laboratories of each section. Instruments that are out of service and required to be repaired are labelled accordingly and stored in an area. For the maintenance and repair of the equipment the Maintenance and Repair Procedure (P.6) is applied. All equipment that need calibration and calibration control are properly calibrated or controlled either by the authorised technical staff according to the calibration/ calibration control instructions or by outside agencies. The instruments used in the laboratories are provided with calibration control forms indicating the dates of the last and the next check. Details of calibration and calibration control are available in the equipment files in the respective laboratories of each Section. For the calibration and calibration control of the equipment the Calibration Procedure (P.7) is applied. The equipment is used only by the authorised technical personal according to the operating instructions and manuals that are placed in the equipment files. In special cases, the authorised personal contacts with the representative of the manufacturer or directly with the manufacturer.

Handling of industrial jobs is explained in Chapter seven. The tests are initiated by the written application of the client. The client specifies the information related to the test object, the test and defect assessment method. The section head informs the client about the possibility of performing the tests, cost and tentative time schedule of the tests by an official letter. Then, he/she assigns a job-number and forwards the necessary information to the assigned test personnel. The section head properly informs the director about the test assignments and submits the necessary documents for his signature.

In the laboratory, the test specimens are accepted with a "Specimen Acceptance and Return Form", and are also recorded on the log-sheets. Before testing, the specimens are numbered and marked for clearly identification. Care must be exercised for the proper handling and storage of specimens so that they are not damaged in any way during their presence in the premises. Also, necessary precautions are taken for the prevention of the exposure of test specimens to the third parties. Similar measures are taken for tests performed outside the premises of the Centre. The authorised staff performs the tests according to the specifications of the client. The necessary confidentiality with respect to the test results is obeyed. The reports are prepared by the level-I test operator and signed by the NDT level-II or level-III personnel. In the case of the tests that will be performed outside the Centre, the necessary equipment and accessories are taken from the related laboratory. Before going outside the Centre for testing, the test operator checks the method-related list given in the annex (A.7) and completes the equipment and accessories. The test reports prepared and signed by the respective test personnel are submitted to the related section head. The section head prepares a cover page for the reports giving brief information about the test. Sample test reports are given in the annex (A.6). The section head signs this cover page enclosing the corresponding test reports. If the personnel of Centre perform only supervision, then a single report may be issued carrying the signatures of the section head and the person who performed the supervision. The originals of the reports are given to the client, and copies of them are kept in the Centre. Rules of confidentiality are obeyed with the personnel and test reports will not be disclosed to third parties without written approval of the client. Reports are stored for a period of five years.

Industrial jobs can be subcontracted to other institutions performing similar activities in accordance with EN 45001, after acceptance of the client. If the tests are subcontracted partly or fully, first the client should be informed. After the acceptance of the client, the Centre conducts the supervision and/or monitoring of activities subcontracted. The director and the respective section head jointly decide on subcontracting and its terms. Detailed information on subcontracting is written on the test reports. The respective section head keeps records of all subcontracted work done.

Chapter eight formulates the handling of complaints by the Centre. Finally, recording and filing system is explained in Chapter nine. All records are treated as confidential and must not be passed on to person not being involved in the matter without the consent of the section head. The survey of the filing system is summarised in a table to indicate records, responsible person, storage mode, place of retention, and retention period.

1   Definitions

2  Identification of the Centre

3  Management

4  Quality system

5  Premises and environment

6  Equipment

7  Handling of Industrial Jobs

8  Handling of complaints

9  Recording and filing system

ANNEX

A.0  Distribution List of Quality Manual

A.1  Organisation Charts

A.2  Duties and responsibilities

A.3  Premises

A.4  Environment

A.5  Sample of Contract

A.6  Sample Test Reports

A.7  Check Lists for Application of NDT Methods in the Field

A.8  Radiation Protection Rules

A.9  Declarations for impartiality and independence of the Centre

QUALITY PROCEDURES

P.1  Quality Procedure

P.2  Quality System Procedure

P.3  Training Procedure

P.4  New Document Preparation and Revision Procedure

P.5  Internal Audit Procedure

P.6  Maintenance-Repair Procedure

P.7  Calibration Procedure

P.8  Purchasing Procedure

P.9  Instruction Preparation Procedure

INSTRUCTIONS

OI   List of Operating Instructions

MI  List of Maintenance Instructions

CI  List of Calibration/Calibration Control Instructions

TI  List of Test Instructions/Standards

LIST OF FORMS Table 1: Contents of the Quality Manual of METU-Welding Technology

and NDT Centre

3   CONCLUSION

Establishment of a quality management system, and accreditation is an important task for the NDT laboratories. It provides the better and easier management, the worldwide recognition of test results, the development in testing, the technical competence, and the competitiveness in the market. The acceptance of non-destructive test results between countries will be facilitated if laboratories comply with the related international standards and if they obtain accreditation from bodies who have entered into mutual recognition agreements with equivalent bodies in other countries using these standards. Besides, accreditation will facilitate cooperation between laboratories and other bodies to assist in the exchange of information and experience, and in the harmonisation of standards and procedures.

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