Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland

Anna Wyszomirska; Jerzy Sowiński

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Contemporary Oncology/Współczesna Onkologia

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8/2002
vol. 6

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abstract:

Compliance of the activity of the Laboratory of Nuclear Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland

Anna Wyszomirska

,

Jerzy Sowiński

Współcz Onkol (2002), vol. 6, 8, 515-518

Online publish date: 2003/03/26

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AMA

Wyszomirska A, Sowiński J. Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland. Contemporary Oncology/Współczesna Onkologia. 2002;6(8):515-518.

APA

Wyszomirska, A.,  & Sowiński, J. (2002). Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland. Contemporary Oncology/Współczesna Onkologia, 6(8), 515-518.

Chicago

Wyszomirska, Anna,  and Jerzy Sowiński. 2002. "Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland". Contemporary Oncology/Współczesna Onkologia 6 (8): 515-518.

Harvard

Wyszomirska, A.,  and Sowiński, J. (2002). Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland. Contemporary Oncology/Współczesna Onkologia, 6(8), pp.515-518.

MLA

Wyszomirska, Anna et al. "Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland." Contemporary Oncology/Współczesna Onkologia, vol. 6, no. 8, 2002, pp. 515-518.

Vancouver

Wyszomirska A, Sowiński J. Compliance of the activity of the Laboratory of Nuclear 	Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland. Contemporary Oncology/Współczesna Onkologia. 2002;6(8):515-518.

Introduction: The Atomic Legislation requires that organizations which have a license for the use of radioactive sources with ionization radiation should have a program of quality assurance been drafted and implemented. ISO is a worldwide federation of national standard bodies, which prepares international standards. Its normative settlements deal with quality, too.
Methods: The International Standard ISO requires drafting and implementing quality systems. The quality assurance model of the broadest scope is described by the standard ISO 9001:2000. The standard doesn't include any detailed guidelines or obligations, which apply to activities in an organization. Building the whole quality system mainly depends on the organization which creates this system. The draft of the quality assurance system (QAS) doesn't mean total changes in work of an organization. QAS creates only necessary frames and conditions, allows to regulate activities, to improve used methods of work, to formulate procedures and - what is the most important - requires to document every activity in an organization. The basis of QAS documentation are instructions and procedures. The standard ISO 9001:2000 requires to establish six documented procedures, of course number of procedures may be increased depending on individual need of an organization.
Results: The Laboratory of Nuclear Medicine (LNM) in Poznań hasn't drafted a QAS but proper activities have been initiated. Analysis of processes in LNM in relation to the requirements of ISO standard allowed to define the extent of the LNM's compliance with the International Standard ISO 9001:2000. LNM in great extent fulfills following items of the standard: 4.2. Documentation requirements, 6. Resource management, 6.2. Human resources, 6.2.2. Competence, awareness and training, 6.3. Infrasructure, 6.4. Work enviroment, 8.3. Control of nonconforming product, 8.5.2. Corrective action, 8.5.3. Preventive action. In other items of the standard there is a small extent of the conformity and there is need to intensify activities in order to fulfill the requirements.
Conclusion: Acitivity of LNM in Poznan is characterized by the moderate extent of the LNM's compliance with the International Standard ISO 9001:2000. LNM is going to continually improve activities, to complete the draft (the end of 2002) and to start implement QAS according to the standard ISO 9001:2000 (beginning of 2003).

keywords:

International Standard ISO 9001:2000, Laboratory of Nuclear Medicine, extent of compliance

Compliance of the activity of the Laboratory of Nuclear Medicine* with the International Standard ISO 9001:2000. *Department of Endocrinology and Metabolism, School of Medical Sciences, Poznań, Poland

Anna Wyszomirska , Jerzy Sowiński

International Standard ISO 9001:2000, Laboratory of Nuclear Medicine, extent of compliance

Anna Wyszomirska

,

Jerzy Sowiński