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retention must be considered and adequate recording media must be selected in order to withstand deterioration and damage during the retention period.

  1. The record handling rules must be formulated for presentation, receipt, modification, addition, retrieval or reference. The record handlers must be aware of the importance of records and make sure not to lose or damage them upon presentation and receipt

  2. The types and retention periods of records must be clarified and the control rules must be formulated for retention. The retention period is the period when the evidence of conformity to the requirements and effective operation of the QMS must be keep. Examples of graded retention periods are shown below.

i )Philosophy of retention periods is summarized as follows: periods are pursuant to the “Rules for the Installation, Operation, etc. of Commercial Nuclear Power Reactors” (retained for 5 years) or periods are chosen in view of the final timing when the organization is required to prove its achievement of nuclear safety (retained for more than 5years).

iiJExamples of record retention periods are shown in the following table.

  1. Management Responsibility (Top Management)

Top management must take an important role in the QMS management, since ISO 9001:2000 is a QMS model operated under the leadership of the top management over the whole organization. Furthermore, the JEAG4121-2005 requires the

commitments of top management in the whole activities to achieve the goal “achievement of nuclear safety,” as interpreting it as the “customer focus” required in the ISO 9001:2000, including the compliance.

Top management must commit themselves to the development and implementation of the QMS, and its continual improvement by :

  1. Complying with legal and regulatory requirements and satisfying the customer’ s requirements (this entails making the importance of nuclear safety known to everybody concerned in the organization);

  2. Establishing the quality policy;

  3. Ensuring the establishment of the quality objectives;

  4. Conducting management reviews; and

  5. Ensuring the availability of management resources of personnel, infrastructures and working environment, etc.

The first, second and fourth items above are the role of top management itself. For the third and fifth items, top management arranges it so that the departments in charge are able to implement the work. Top management must ensure that the responsibilities and authorities as well as their cross­relations are well known to everybody concerned in the organization.

When the achievement of nuclear safety is placed as the top priority goal, it is most important that the organization as a whole recognizes correctly the work requirements which are input to the system, and that the organization takes integrated actions in the same direction, in order to achieve nuclear safety under the top management leadership. Top management must ensure that the work requirements are defined and the defined

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NSRA, Japan