At PCI Portal, we are dedicated to helping you establish and maintain robust quality management systems that comply with global regulatory requirements.
a. Determine Relevant Quality Management System Requirements
We identify and define the specific quality management system requirements applicable to your organization, ensuring that all processes and procedures meet industry standards.
b. Implement a New Quality Management System
Our team assists in the implementation of new quality management systems, adhering to global regulatory requirements such as ISO 9001, ISO 13485, and FDA 21 CFR 820, to ensure compliance and operational excellence.
c. Internal Audits and Gap Assessments
We conduct thorough internal audits and gap assessments to identify areas for improvement within your quality management system, providing actionable insights to enhance overall performance.
d. Supplier Audits
Our supplier audit services evaluate the quality and compliance of your suppliers, ensuring that they meet the necessary standards and contribute to the quality of your final products.
e. Support Customer Audits
We provide comprehensive support for customer audits, helping you prepare for and successfully navigate the audit process, demonstrating your commitment to quality and compliance.
f. Quality Management System Remediation
Our quality management system remediation services address any deficiencies within your existing system, implementing corrective actions to bring your processes into full compliance with regulatory standards.
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