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Quality Policy
At SIDAPHARM P.C., we are committed to manufacturing and delivering safe, effective, and reliable medical devices that meet the highest standards of quality. We strive to achieve and maintain compliance with ISO 13485:2016, ISO 9001:2015, Ministerial Decision 1348/2004, regulatory requirements, and customer expectations by continuously improving our quality management system (QMS).
Our quality policy is based on the following core principles:
Customer Focus:
We are dedicated to understanding and meeting the needs and expectations of our customers. Our products are designed and manufactured with patient safety and user satisfaction as our primary goals.
Regulatory Compliance:
We are committed to complying with all applicable regulatory requirements, industry standards, and guidelines to ensure the safety, performance, and efficacy of our medical devices.
Risk Management:
We proactively identify, assess, and mitigate risks throughout the design, production, and post-production phases to ensure the safety and reliability of our products.
Continuous Improvement:
We continually evaluate and improve our processes and products to enhance customer satisfaction and ensure the highest level of quality. We encourage a culture of continuous learning and innovation throughout the organization.
Employee Engagement and Competence:
We invest in the training, development, and empowerment of our employees to maintain a highly skilled workforce. Each team member is responsible for upholding our quality standards and contributing to the success of our QMS.
Supplier and Partner Relationships:
We collaborate with suppliers and external partners to ensure that materials, components, and products meet our quality standards and support our commitment to product excellence.
Quality Objectives:
We establish measurable quality objectives at all levels of the organization to monitor progress, assess performance, and drive improvement initiatives. These objectives are aligned with our overall business goals and reviewed annually.
Review
This policy shall be reviewed annually or when significant legal, organizational, or operational changes occur.
The Quality Policy is communicated within the organization.
By adhering to this quality policy, SIDAPHARM P.C. will continue to provide medical devices that meet or exceed the expectations of regulatory bodies, customers, and stakeholders, while maintaining the highest level of patient safety and care.
Our quality policy is based on the following core principles:
Customer Focus:
We are dedicated to understanding and meeting the needs and expectations of our customers. Our products are designed and manufactured with patient safety and user satisfaction as our primary goals.
Regulatory Compliance:
We are committed to complying with all applicable regulatory requirements, industry standards, and guidelines to ensure the safety, performance, and efficacy of our medical devices.
Risk Management:
We proactively identify, assess, and mitigate risks throughout the design, production, and post-production phases to ensure the safety and reliability of our products.
Continuous Improvement:
We continually evaluate and improve our processes and products to enhance customer satisfaction and ensure the highest level of quality. We encourage a culture of continuous learning and innovation throughout the organization.
Employee Engagement and Competence:
We invest in the training, development, and empowerment of our employees to maintain a highly skilled workforce. Each team member is responsible for upholding our quality standards and contributing to the success of our QMS.
Supplier and Partner Relationships:
We collaborate with suppliers and external partners to ensure that materials, components, and products meet our quality standards and support our commitment to product excellence.
Quality Objectives:
We establish measurable quality objectives at all levels of the organization to monitor progress, assess performance, and drive improvement initiatives. These objectives are aligned with our overall business goals and reviewed annually.
Review
This policy shall be reviewed annually or when significant legal, organizational, or operational changes occur.
The Quality Policy is communicated within the organization.
By adhering to this quality policy, SIDAPHARM P.C. will continue to provide medical devices that meet or exceed the expectations of regulatory bodies, customers, and stakeholders, while maintaining the highest level of patient safety and care.
