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Quality Management system

General Requirements

Establish and maintain a quality management system (QMS) according to relevant international standards (e.g., ISO 9001).

Define the scope of the QMS and identify applicable processes.

Identify and document organizational roles, responsibilities, and authorities related to quality management.

Conduct regular management reviews to evaluate the QMS effectiveness and identify areas for improvement.

Documentation Requirements

Develop a Quality Manual that outlines the QMS framework and describes the interaction of its processes.

Establish documented procedures to address critical activities, including control of documents, control of records, and internal audits.

Maintain records to demonstrate effective implementation and operation of the QMS.

Management Responsibility

Define and communicate the organization's quality policy and objectives.

Ensure that quality objectives are measurable, consistent with the quality policy, and reviewed periodically.

Conduct regular management reviews to assess the QMS's continued suitability, adequacy, and effectiveness.

Ensure that resources (e.g., personnel, infrastructure, equipment) necessary for achieving quality objectives are available.

Identify and address risks and opportunities that could impact the QMS's ability to achieve desired outcomes.

Promote a culture of customer focus, continual improvement, and adherence to quality requirements.

Resource Management

Determine and provide the necessary resources for the effective operation of the QMS.

Identify and provide appropriate training, education, and skills development opportunities for personnel.

Establish and maintain an environment suitable for achieving product conformity and customer satisfaction.

Product Realization

Develop and maintain a product realization process that encompasses all stages, from customer requirements to product delivery.

Establish clear criteria for product acceptance, including quality objectives, customer expectations, and applicable regulations.

Monitor and control product design and development activities to ensure compliance with specified requirements.

Implement effective control measures for purchasing, production, and service provision processes.

Establish and maintain processes for identification, traceability, and preservation of products to prevent damage or deterioration.

Measurement, Analysis, and Improvement

Establish and implement a process for monitoring customer satisfaction and collecting feedback.

Conduct regular internal audits to assess the effectiveness of the QMS and identify areas for improvement.

Establish and monitor key performance indicators (KPIs) to measure the QMS's performance and identify trends.

Implement corrective actions to address nonconformities and prevent their recurrence.

Continually improve the QMS through the use of data analysis, root cause analysis, and implementation of preventive actions.

Conduct periodic management reviews to evaluate the QMS's continued suitability, adequacy, and effectiveness.

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