Every year in July, TUVRheinland sends auditors to Liaoning KANGYI Medical Equipment Co., Ltd to conduct a factory audit. This audit is a customized assessment that evaluates the quality systems, work environment, and capabilities of the facility, following the standards defined by TÜV SÜD. The purpose of this audit is to ensure that the factory has the necessary abilities to fulfill specific orders according to the clients’ expectations.
An annual factory inspection ensures that the products being manufactured or certified meet the necessary requirements. This inspection allows you to assess the factory’s structure, organization, quality processes, and experience, which in turn helps you compare different suppliers and choose a reliable source. It’s like checking if the factory has what it takes to fulfill your needs and meet your standards.
This year marks the third annual audit per the Medical Device Regulation (MDR) requirements. The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The audit is being led by Mr. Lizhi Kong, the lead auditor, and Ms. Sha Li. To ensure a comprehensive assessment, representatives from various departments of the company, including the quality, technical, administration, production, and management departments, are actively participating in the audit.
By engaging in this audit, KANGYI Medical is demonstrating its commitment to maintaining high standards of quality and compliance with the MDR. It also provides an opportunity for the company to identify any areas for improvement and implement corrective actions.
Audit Criteria
The audit criteria for this assessment are based on the standards EN ISO 13485:2016, REGULATION (EU) 2017/745 (MDR) Annex IX Chapter I, and the company’s internally defined processes and Quality Management (QM) system documentation.
EN ISO 13485:2016 is an internationally recognized standard that sets the requirements for the quality management systems of organizations involved in the design, development, production, installation, and servicing of medical devices. This standard ensures that companies adhere to strict quality control measures and consistently meet regulatory and customer requirements.
REGULATION (EU) 2017/745, commonly referred to as the Medical Device Regulation (MDR), is a comprehensive regulatory framework within the European Union (EU) that governs the manufacturing, marketing, and usage of medical devices. Annex IX Chapter I of the MDR specifically outlines the requirements for the assessment of the technical documentation for Class I medical devices.
In addition to these external standards and regulations, the audit will also consider the company’s internally defined processes and Quality Management (QM) system documentation. These internal guidelines and procedures are designed and implemented by the company to ensure consistent quality, efficiency, and compliance with applicable standards and regulations.
Audit objectives
The primary objectives of this audit are to assess various aspects of the factory’s management system, ensuring its conformity with the specified audit criteria and evaluating its ability to meet applicable statutory, regulatory, and contractual requirements. Additionally, the audit aims to determine the effectiveness of the management system in helping the factory achieve its specified objectives.
The first objective focuses on determining the conformity of the factory’s management system or specific parts of it with the established audit criteria. The auditors will thoroughly examine the documented processes, procedures, and practices to ensure that the factory meets relevant standards, regulations, and contractual obligations. This objective provides assurance that the management system is designed and implemented in accordance with recognized industry-specific guidelines and best practices.
The second objective emphasizes the assessment of the management system’s ability to ensure the factory’s compliance with applicable statutory, regulatory, and contractual requirements. The auditors will verify that the company is meeting all the necessary legal obligations, regulations, and industry-specific guidelines. This objective ensures that the factory is operating within the defined legal framework, mitigating potential risks and liabilities associated with non-compliance.
The third objective revolves around evaluating the effectiveness of the factory’s management system. This involves analyzing how well the management system enables the factory to achieve its specified objectives. The auditors will assess the effectiveness of the management system, the auditors will consider various factors. They will review the factory’s objectives and targets, ensuring they are clearly defined, measurable, and aligned with the overall business strategy. The auditors will then examine how the management system translates these objectives into actionable plans, processes, and procedures.
Audit result
We successfully pass the audit. This successful outcome is a testament to our commitment to maintaining high standards of quality, compliance, and continuous improvement. It reflects KANGYI Medical’s dedication to implementing and maintaining a robust management system that aligns with industry best practices and meets the expectations of relevant standards and regulations.
The successful audit result reflects positively on KANGYI Medical’s reputation and credibility, demonstrating its commitment to excellence and its ability to meet the needs of its customers. As a manufacturer of disposable IV sets and syringes, Liaoning KANGYI Medical has 30 years of professional production experience in China. Our company produces over 100 million pieces yearly which are sold both locally and internationally, reaching destinations such as Europe, South America, Russia, Africa, and the Middle East. With over 300 employees, a considerable percentage of its staff comprises 50 experts in engineering and technical management. Its premises occupy an area of 20,000 square meters, with a massive 100,000-class purification workshop that covers 8,000 square meters.
