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iso 9001 management responsibility

Leadership and Commitment

Top management commitment

Has top management demonstrated their commitment to the QMS?

Do they regularly communicate the importance of meeting customer requirements and continually improving the system?

Quality policy

Is a quality policy established and communicated to all employees?

Does the quality policy align with the organization's objectives?

Is the quality policy regularly reviewed and updated as needed?

Organizational Roles, Responsibilities, and Authorities

Roles and responsibilities

Are roles and responsibilities defined and documented for each key position within the organization?

Are the necessary authorities granted to individuals responsible for specific QMS processes?

Competence, awareness, and training

Is there a system in place to determine the necessary competence for each job?

Are employees provided with training and development opportunities to enhance their skills?

Is awareness of the quality policy and objectives communicated to all employees?

Customer Focus

Customer requirements determination

Are mechanisms in place to identify and understand customer requirements?

Is there a process to handle customer feedback and complaints effectively?

Customer satisfaction measurement

Are methods established to measure customer satisfaction?

Is customer satisfaction data regularly collected, analyzed, and acted upon to improve the QMS?

Quality Planning

Quality objectives

Are quality objectives established at relevant functions and levels?

Are these objectives measurable, monitored, and reviewed for progress?

Quality planning process

Is there a systematic approach to develop quality plans?

Do quality plans consider the necessary resources, risks, and opportunities?

Process Management

Process identification and interaction

Are all key processes identified and documented within the QMS?

Are the interactions between processes clearly defined and understood?

Process performance monitoring and measurement

Is there a system in place to monitor and measure process performance?

Are appropriate indicators used to assess process effectiveness and efficiency?

Process improvement

Is there a mechanism to identify and implement process improvements?

Are non-conformities and opportunities for improvement recorded and addressed?

Resource Management

Resource availability

Are resources (human, infrastructure, technology, etc.) available to support the QMS effectively?

Infrastructure and work environment

Is the work environment suitable for achieving conformity to product requirements?

Is the infrastructure adequately maintained and updated as necessary?

Communication and Documentation

Internal communication

Is there a system in place to ensure effective communication within the organization?

Are employees informed about relevant QMS changes and updates?

Documented information control

Are procedures established for controlling documented information?

Is there a clear structure for document control, including version control, approval, and distribution?

Management Review

Management review meetings

Are regular management review meetings held to assess the QMS performance?

Are inputs, such as process performance data and customer feedback, considered during these meetings?

Management review outputs

Are actions and decisions from management review meetings recorded and communicated to relevant parties?

Are resources allocated to address improvement opportunities identified during the review?

Note: This checklist serves as a general guideline, and specific requirements may vary based on the organization's context and ISO 9001 version.

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