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Quality Management System

Have all necessary documents been developed, reviewed, approved, and controlled?

Are all documents properly identified, accessible, and up to date?

Have all changes to documents been properly documented and communicated?

Is there a document control procedure in place and followed?

Has top management demonstrated commitment to the quality management system?

Have quality objectives been established and communicated?

Are roles, responsibilities, and authorities defined for all personnel?

Are there processes in place to ensure effective communication within the organization?

Are resources (human, infrastructure, and equipment) adequate to meet quality objectives?

Are personnel adequately trained and competent to perform their assigned tasks?

Is there a process for identifying training needs and providing necessary training?

Are resources properly maintained and calibrated?

Are there documented procedures for design and development activities?

Is there a process in place to ensure that customer requirements are properly defined and met?

Are there controls in place for purchasing and procurement activities?

Is there a process for monitoring and measuring product characteristics?

Are there procedures for monitoring, measuring, and analyzing key quality indicators?

Are there processes in place for identifying and addressing nonconformities and taking corrective actions?

Is there a system for managing customer feedback and complaints?

Are there processes for conducting internal audits and management reviews?

Is there a process for identifying opportunities for improvement?

Are there mechanisms in place to encourage employee suggestions and involvement in improvement initiatives?

Are improvement actions monitored and evaluated for effectiveness?

Is a culture of continual improvement fostered within the organization?

Note: This checklist is not exhaustive and may need to be tailored to the specific requirements of each organization.

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