英文回答：
Management Review Procedure.
Purpose.
The purpose of this procedure is to establish the requirements for conducting management reviews of the quality management system (QMS). Management reviews are a key element of the QMS and are essential for ensuring that the QMS is effective and aligned with the organization's strategic direction.
Scope.
This procedure applies to all levels of management within the organization.
Responsibilities.
The following individuals are responsible for implementing and maintaining this procedure:
Top management.
Management representatives.
All managers.
Procedure.
管理者代表 Management reviews shall be conducted at least annually, or more frequently if deemed necessary by top management. The review shall be conducted by top management and shall include the following elements:
Review of the QMS.
The review shall include an assessment of the effectiveness of the QMS in meeting the organization's requirements and objectives. The review shall also include an assessment of the QMS's compliance with applicable regulatory and industry standards.
Review of the organization's strategic direction.
The review shall include an assessment of the organization's strategic direction and how the QMS supports the achievement of the organization's strategic goals.
Review of internal and external issues.
The review shall include an assessment of the internal and external issues that may affect the QMS. The review shall also include an assessment of the organization's risk management processes.
Review of resources.
The review shall include an assessment of the resources that are available to support the QMS. The review shall also include an assessment of the organization's training and development programs.
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