Quality System of the Secondary Standard Dosimetry Laboratory (SSDL) of Cuba

1. CPHR Quality System of the Secondary Standard Dosimetry Laboratory (SSDL) of Cuba Center for Radiation Protection and Hygiene (CPHR)

2. CPHR The Center for Radiation Protection and Hygiene (CPHR) it is a Scientific, Investigation, Technological Innovation, Productions and Specialized Services institution. The specialization level and excellence that demand this services, imply that are also carried out development - investigation projects. The CPHR is subordinated to the Nuclear Energy Agency that is subordinated to the Ministry Of Science, Technology And Environment (CITMA).

3. CPHR GENERAL STRUCTURE Ministry of Science and Technology (CITMA) Nuclear Energy Agency CPHR

4. CPHR CPHR’S STRUCTURE SSDL

5. CPHR Since 1996 the Laboratory has carrying out its work with the parallel action of a Quality Assurance System. In its beginning that system had a simple structure that was able to assure an acceptable quality in the execution of scientific - technical services. In 1997, with the accumulated experience of a year of work this system was improved with the objective of achieving long term competition levels comparable to those shown by the most noted SSDL in the International Network IAEA/WHO. It was necessary for this process a total implementation of Guide ISO/IEC 25 “General requirements for the competence of testing and calibration laboratories". With the implementation of these requirements was granted to the laboratory the condition of ACCREDITED LABORATORY (Reg. No. 014) for the realization of test and calibrations by the National Accreditation Office of the Republic of Cuba in May of the same year. This office is applying as full member of the International Laboratory Accreditation Cooperation (ILAC). In the year 2001 the laboratory was reaccredited for meeting requirements of ISO/IEC 17025: “General requirements for the competence of testing and calibration laboratories".

6. Responsibilities of SSDL • The responsibilities of SSDL include: • Maintaining of Cuban reference standards for dosimetry in agreement with the international measurement system. • Performing calibrations of radiation measurement equipment and issuing calibration certificates with all necessary information, including the estimated uncertainties. • Organizing dose comparisons for radiation therapy for institutions within the country or region, and participating in measurement comparisons within the IAEA/WHO SSDL Network, and with other standardizing laboratories. • Co-operating with the IAEA/WHO Network and with other metrological laboratories in the exchange of information and improvement of measurement instruments and techniques.

7. Responsibilities of SSDL (cont.) • Documenting and preserving records of all procedures and the results of calibrations. • Keeping up to date on progress in radiation measurements techniques, so as to improve calibration techniques as required, and thereby provide a better service to the users of radiation. • Providing training in radiation measurements and calibration techniques and in the use and maintenance of the relevant instrumentation, appropriate to the users of radiation served by the SSDL. • Performing legal verification of dosimetrics instruments • Reporting , at least annually, on the status of its secondary standards, radiation sources, calibrations performed and related activities.

8. CPHR Quality Assurance System Main data The Secondary Standard Dosimetry Laboratory (SSDL) of the Center for Radiation Protection and Hygiene (CPHR) has a total of 5 workers, of them, 4 specialists and 1 technician. In the year 2003, a total of 100 Verification Certificates, 18 Irradiation Certificates and 42 Calibration Certificates have been emitted. Quality Policy: General policies related to personnel responsibilities, measuring standards, and calibration and testing services. A list of those policies comprises :

9. Quality Policy: • · SSDL’s Head is maximum responsible for well implementation of Quality System (QS), its maintenance and System improvement. • · Policies, documented quality requirements and procedures are expected to be followed by every staff , visitors and trainee of the SSDL • · A high ethic and discretion concerning calibration and testing results are expected from every SSDL staff • · Every activity related to calibration and testing services should be carried out following a valid method and documented procedure CPHR

10. Quality Policy • · Each SSDL reference standard should be supervised by designated a person that is its responsible. Supervision comprises storage, maintenance and use of standard. As a general practice transport of standard outside laboratory areas should be authorized by SSDL’s Head. • · Laboratory should keep abreast of recent technical advance and published information in the field of metrology and dosimetry of ionizing radiation • · Instruments used in calibration processes have to be periodically calibrated and kept under a quality control program CPHR

11. CPHR • Quality Policy • · Participation of SSDL in national or international dosimetric intercomparison is encouraged. • · Calibration services which end in calibration certificate should only be carried out by qualified SSDL permanent staff . • · All calibration and testing data, records and certificates have to be maintained at least for two years • · A high attention to user claims and suggestions is expected from the Head and all staff of SSDL.

12. CPHR • SSDL structure • Location. • The LSCD is located in areas of the Center for Radiation Protection and Hygiene that is in Carretera de la Cantera Victoria II Km. 3½ Guanabacoa, Ciudad de la Habana. • Organizational structure. • The organizational structure of the SSDL is presented

13. Organizational structure of SSDL CPHR SSDL’s Head Head Substitute Quality Supervisor Personnel

14. CPHR • Quality System structure • Organization and Responsibilities • The guarantee of the quality of the SSDL works rests in the Organizational Structure of the same one. • Administration • SSDL’s Head • Establish quality policies and objectives • Promote the introduction of scientific and technical advances • Approve new services • Give proper attention to training needs of SSDL staff • Organize with established periodicity revision of the Quality Program

15. Quality Supervisor • Keep Quality Manual versions and its distribution updated • Supervise good order of laboratory ambient conditions • Keep trace of non compliance detected and the implementation of corrective actions • Organize and participate in internal quality revisions • Technical departments • The Laboratory complies the IAEA design criteria for establishing an SSDL. It has three calibration rooms, in one of those are carried out the calibration at radiation protection levels with a gamma irradiator and a X rays equipment and in the other one the calibration at radiotherapy levels using a Co-60 unit. CPHR

16. CPHR • Laboratory administration description. • The responsibilities in Quality Assurance System of the SSDL’s Head, of their Substitute and of Quality Supervisor. • As for Laboratory operations, equipment and sources, the same ones are: • · SSDL’s Head: has responsibilities and authorization for working in all SSDL services, equipment, reference standards, working standards and calibration sources. • · Other specialists: have access to some services and to equipment, sources and working standards linked to the same ones.

17. CPHR • Functional structure • The SSDL functional structure coincides with its organizational structure. • Quality Assurance System documentation • Structure of Quality Assurance System Documentation • The documentation of the System of Quality consists of: • Quality Manual: contains the policies and objectives of quality and describes the organization, procedures, requirements and

18. CPHR • System has been designed to satisfy the requirements of Standard ISO/IEC 17025:2000 “General requirements for the competence of testing and calibration laboratories". • Procedure Manual: contains the Administration Quality Procedures and Technical Procedures of the Laboratory. • Records Manuals: contain the quality and technical records. • The hierarchical structure of Quality System of the Laboratory has three levels, the Level I includes the Quality Manual, the Level II includes the Procedure Manual and the Level III contains the rest of the documentation (all records manuals).

19. CPHR • Distribution and Control • Generally, the documentation of Quality System stays in areas of Laboratory. In case that it is necessary the distribution of copies, the same one are controlled through a record. • Emphasis should be made in register for Control of Softwares, that includes its validation and controls of its use depending on service to which is dedicated. • Quality Manual content. • The Quality Manual of Laboratory contains 8 chapters, which are: • Special dispositions. • Terms and definitions. • Introduction

20. CPHR • Summary • Objective • Scope • Commitment the Quality. • Management Requirements. • Organization and Administration • Quality system • Documents Control • Review of requests, tenders and contracts. • Subcontracting of tests and calibrations. • Purchasing services and supplies. • Service to the customer. • Complaints. • Control of nonconforming work.

21. Corrective action. • Preventive action. • Records. • Internal audits. • Managements reviews. • Technical requirements. • Personnel. • Accommodation and environmental conditions. • Test methods. • Equipment. • Traceability. • Sampling. • Handling of calibration items. • Assuring the quality of calibration results. • Reporting the results. • Bibliography. • Annexes CPHR

22. List of administrative documents and normative. • Quality Manual. • Quality Procedures: • Documental Administration. • Control and Record of Data. • Treatment of Non Compliances and taking of corrective and preventive actions. • Treatment of complaints and customer feedback. • Subcontracting of Services. • Elaboration and control of certificates and reports. • Control of customer items. • Control of equipment, the standard, reference samples and facilities. • Control of Software. • Participation in intercomparison exercises. • For the file and conservation of Quality Documentation of Laboratory and control of reference data. CPHR

23. Internal Quality Control of equipment and calibration processes. • Control of Certificates. • Control of external supplies and services. • Physical control and control of documentation • Control of the environmental conditions. • List of normative and technical documents. • Technical Procedures: • Calibration of area dosemeters and ratedosementers at radiation protection levels. • Calibration of working standard at radiation protection level • Calibration of brachytherapy sources. • Calibration of ionization chambers at radioprotection levels. CPHR

24. CPHR • Irradiation of Integral Dosimeters using Cs-137 source. • Calibration of dosimetric installations. • Operation of X rays installation. • Irradiation of Integral Dosimeters using X rays beams. • Air Kerma Calibration of radiotherapy dosimeters in Cobalt-60 beam (PHOENIX-20). • Air Kerma Calibration of radiotherapy dosimeters at X rays beams (PANTAK-160C). • Calibration of radiodiagnosis dosimeters at conventional X rays beams. • Calibration using Cs-137 source of stationary area dosimeters under operation conditions. • Calibration of radiotherapy dosimeters in terms of Absorbed Dose to Water at Cobalt-60 beam (PHOENIX-20).

25. Normative documents. • ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories • “Guide to the Expression of Uncertainty in Measurement”. BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML 1995 • ISO 4037 Parts 1, 2 y 3. X and gamma reference radiation for calibrating dosimeters and doserate meters and for determining their response as a function of photon energy. 1996. • Calibration of Dosimeters used in Radiotherapy.TRS-374. IAEA, Vienna, 1994. • Calibration of radiation protection monitoring instruments. Safety Reports series n° 16. IAEA, Vienna 2000. • Calibration of photon and beta ray sources used in brachytherapy: Guidelines on standardized procedures at Secondary Standards Dosimetry Laboratories (SSDLs) and hospitals. TECDOC-1274. IAEA, Vienna 2002. CPHR

26. Complaints The Quality Manual of Laboratory includes a chapter dedicated to the treatment of complaints of customers. In same one is made reference to procedure that describes this process and its record. Corrective actions. The Quality Manual of Laboratory contains a chapter in which the established dispositions are described for the process of taking of corrective actions guided to guarantee a non repetition of those associate non compliance. The control includes all the actions related with the correction of all non compliance registered in Laboratory. In this paragraph is made reference to the procedures that are used in the taking of these actions as well as to its record. CPHR

27. CPHR Internal control. The SSDL has a Quality Assurance Programme which includes Internal Quality Assurance including redundancy checks on the reference and working instrumentation and its documentation and record keeping. Reviews The Quality Manual contains a paragraph where are described the dispositions relating to management review process, which will be directed to guarantee the continuous adaptation, effectiveness and improves of implanted Quality System. The reviews will include any aspect of the quality system and services.

28. CPHR Accreditation certificate issued in the year 2001

29. CPHR • Important remarks • Accreditation in 1997 by ISO guide 25. First SSDL in the network that has been accredited by a national accreditation body. • Organization in 1999 of IAEA interregional training course on calibration procedures and quality assurance in SSDLs. • Accreditation in 2001 by ISO/IEC 17025. • Visit to laboratory of ILAC/IAAC experts in the year 2003.

30. Advantages of implementation of quality system • More organization and coordination of the work • More satisfaction of the clients • Work according international recommendations • More knowledge of the internal needs and of the clients. • Disadvantages • Hard works with documents and registers. • Cost involved in accreditation procedure • Principal problem • All services are included in the quality assurance system but not all are accredited. In the near future the SSDL plan to involve in the accreditation other services. CPHR