Successful Completion of ISO

Yichuang Medical Are Full ISO Standard Compliant Including ISO 9001 Quality Management System, ISO 14001 Environmental Management System, ISO 45001 Occupational Health and Safety Management System, and ISO 13485 Medical Device Industry Quality Management System.All these systems are important standards for enhancing organizational management and driving quality improvement.

 

Hunan Yi Chuang Medical Technology Company Limited

ISO 9001/ 14001 / 45001 / ISO 13485 Medical Certification Audit

 

ISO 9001 Quality Management System, ISO 14001 Environmental Management System, ISO 45001 Occupational Health and Safety Management System, and ISO 13485 Medical Device Industry Quality Management System are important standards for enhancing organizational management and driving quality improvement. They serve as indicators of a company's adoption of scientific, systematic, and standardized management practices.

 

 

Hunan Yi Chuang Medical Technology Co., Ltd. (hereinafter referred to as Yichuang Medical) has always attached great importance to the establishment and operation of the ISO system. Experienced a 6-day certification audit process since Dec 2nd, Yichuang Medical (Easetak) successfully certified as ISO9001, ISO14001, ISO45001, and ISO13485 compliance, marking a new milestone in the company's refined, systematic, standardized, and professional management.

 

Preparatory stage

To ensure the successful certification audit of the various systems, Hunan Yichuang Medical factory conducted multiple preparatory works with high attention at the effort of all staff. Internal audits were conducted for all departments, elements, and business activities involved in the management system operation. Self-examination and self-correction were carried out extensively, with corrective measures implemented to promote quality improvement.

 

At the same time, the Factory organized knowledge dissemination sessions on ISO system certification for department management and staff, taking the opportunity to deepen the integration of management system operation with daily work from documents, records, reports, and other related materials according to the audit plan, aiming to actively cooperate with the 3rd party ACM certification authority in completing this system certification, continually improving work standardization, and ensuring product quality.

 

 

Audit

On November 28th, the audit of the various systems officially began. This audit consisted of the first and second-stage on-site audits conducted by ACM Certification (Shanghai) Co., Ltd.Ms. Dai Qiuxiang, as Hunan Yichuang Medical management representative and other department heads participated in the audit meetings.

During the audit process, the ACM audit team investigated the operational management systems and various comprehensive works of Yichuang Medical conducted in-depth inspections of production workshops, thoroughly inquired and reviewed relevant documents and materials, and conducted detailed evaluations of the factory's management operations.

 

After in-depth communication with department heads and employees of the factory, the audit team highly praised the active cooperation of the departments under review and the effective operation of the management system. They confirmed that Yichuang Medical ISO systems all met the certification requirements. During the certification process, two representatives from the Tao Jiang County Market Supervision Administration conducted on-site inspections of factory, verifying the qualifications of the audit agency andproposed guidance for improvement to ensure a smooth certification process.The smooth certification audit by the Market Supervision Administration fully validated factory high standards and strict requirements in terms of product quality and production norms.

 

 

Conclusion

Through the establishment and implementation of the ISO9001:2015 Quality Management System, ISO14001:2015 Environmental Management System, ISO45001:2018 Occupational Health and Safety Management System, and ISO13485:2016 Medical Device Quality Management System, Hunan Yi Chuang Medical Technology Co. Ltd will continuously improve risk prevention awareness, enhance product quality management and service levels, and promote scientific management and standardized development of the company.