requirements are met, including the duties to be borne by top management itself.

1. Quality Policy and Quality Objectives

Top management must show the direction the organization must take, based on the quality policy, and provide a framework in which the individual departments in the organization will be able to perform their activities in line with the quality policy. Under this framework, the organization must define, for the purpose of setting concrete goals, the quality objectives of the relevant departments in the organization.

Top management must define directly the quality policy for the whole organizational direction, including that the quality policy,

1. is appropriate to the organizational mission;

2. includes commitments to comply with the requirements and to continually improve the QMS effectiveness;

3. provides a framework for establishing and reviewing quality objectives;

4. is communicated and understood throughout the whole organization; and

5. is reviewed for continuing appropriateness.

The third item in particular is important in the context that the quality objectives are carefully and reliably defined in the framework and reviewed. By satisfying these items and by continuously implementing necessary actions, the QMS effectiveness including the quality policy and the quality objectives can be continually improved. The quality objectives are not necessarily numeric, but the achievement needs to be measurable and consistent with the quality policy. Otherwise, effective QA activities are hard to implement.

2. Management Representative

Top management may appoint a deputy to provide necessary instructions and supervision concerning the important duties of establishing, implementing and maintaining the QMS. When appointing the deputy, top management authorizes the deputy for those duties as a representative of top management, irrespective of the responsibilities the deputy already bears. In return, the deputy must bear the responsibilities of reporting to the top management on the QMS performance or the needs for its

improvement, and of ensuring higher awareness throughout the organization, of improving the customer satisfaction or achieving nuclear safety.

3. Review by Management (Management Review)

Top management must assess the QMS effectiveness through management review which is an activity for extracting the items (output) for improvement activities from the present status (input). The management review is not necessarily executed at fixed periodical intervals, but is executed at pre-scheduled intervals and with pre­defined contents which the top management judge necessary for ensuring standing QMS appropriateness. The management review must also include the review of whether the quality policy and the quality objectives need adjustment. Thus, the quality policy and the quality objectives are prevented from becoming a mere facade, and the QMS effectiveness can be improved continually.

1. Input

Information on the QMS effectiveness, information for judging the necessity of improving the QMS and the results of data analysis are essential needs for the management review (Table 10.3.1).

2. Output

Among various possible outputs, the key minimum outputs from management review are the following as specified in IS09001:2000: effectiveness improvement of the QMS and its processes, product improvement to meet the customer requirements, and needs for resources. The JEAG4111-2003 specifies the second item as the improvement to achieve nuclear safety. In some cases the improvement of the work itself is more meaningful for nuclear safety than the QMS system. These outputs must be documented and maintained for reliably repeating the PCDA cycle (Ta ble 10.3.2).

NSRA, Japan

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Chapter 10 Quality Assurance (QA)

Table 10.3.1 Seven inputs on management review

1. results of audits,

2. customer feedback from customer,

3. process performance and product conformity,

4. status of preventive and corrective actions,

5. follow-up actions from previous management reviews,

6. changes that could affect the quality management system, and

7. recommendations for improvement.

Table 10.3.2 Three outputs on management review

1. improvement of the effectiveness of the quality management system and its processes,

2. improvement of product needed to customer requirements, and

3. needs of resource.

Management Resources The organization must plan and establish processes for QMS and then act on their basis in order to operate an effective QMS and provide products meeting the customer’s requirements. In implementing the processes, the needed resources must be clearly identified, provided, maintained and controlled. It is not overstating to say that how resources are managed determines the product quality and therefore ensuring their management is done properly is an important responsibility of the organization’s top management. The resources generally include: personnel, goods, money, information, time, etc. IS09001:2000 clearly requires the identification and provision of resources, especially those requiring good management, such as human resources, infrastructures and working environment Human resources	management of personnel
Infrastructures	management of goods needed for product provision, such as utilities, buildings, facilities and support work (transportation, communications, etc.)
Working environment	management of working environment needed for product provision