Glossary Term
Supplier Quality Agreement
Definition
A Supplier Quality Agreement (SQA) is a formal, written document that defines the expectations, responsibilities, and quality standards between a company (typically a medical device manufacturer) and its suppliers. The agreement outlines the quality requirements for the products or services being supplied, including specifications, testing, inspections, regulatory compliance, and documentation. It also addresses the procedures for audits, corrective actions, and the management of non-conformances. The SQA ensures that the supplier’s processes align with the purchasing company’s quality standards, regulatory requirements, and customer expectations, and it serves as a critical component in maintaining the overall quality of the final product.
Relevance to the MedTech Industry
Supplier Quality Agreements are essential for ensuring that components and raw materials meet the rigorous standards required for medical devices. Since medical devices must meet strict regulatory requirements (such as those set by the FDA or ISO 13485), maintaining a robust quality management system is vital. The SQA serves as a safeguard to ensure that suppliers adhere to these regulations and provide products that are safe, effective, and compliant. This document helps mitigate risks related to product defects, regulatory non-compliance, and safety issues by establishing clear expectations for quality control. Additionally, SQAs can play a key role in preventing product recalls or legal actions due to defective components or processes.
Additional Information & Related Terms
Related Terms
ISO 13485: An international standard for quality management systems in the medical device industry, ensuring compliance with regulatory requirements and effective manufacturing processes.
Corrective and Preventive Action (CAPA): A systematic approach to addressing and preventing quality issues, often outlined in supplier quality agreements to address non-conformances.
Supplier Audits: Regular evaluations of a supplier’s processes and operations to ensure compliance with quality standards, often outlined in SQAs to maintain ongoing quality.
Regulatory Compliance: The adherence to laws, regulations, and guidelines established by regulatory agencies like the FDA, essential in the context of supplier quality agreements for medical devices.
Quality Management System (QMS): A comprehensive system of policies, processes, and procedures to ensure that a company’s products consistently meet quality standards and regulatory requirements.