PHDS HEALTHCARE RESEARCH Co., Ltd.
ISO9001:2008 Quality Management System Certification Review Report
Release time:
2013-07-05
The expert group from the authorized agency conducted a comprehensive two-day audit of Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd., passed the audit, and learned the following objective facts:
The authorized agency's review expert group conducted a comprehensive audit of Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd. for two days, passed the audit, and learned the following objective facts:
Boshi Zhixing began planning and establishing a quality management system in 2007, and in 2010, it passed the audit certification of a professional quality certification agency in Beijing, obtaining the quality management system certification. This year is the renewal year for the certificate, and the company has passed higher standard audit requirements, obtaining the new version of the ISO9001:2008 quality management system certification.
The company's current office space, personnel allocation, rules and regulations, instruments and equipment, office computers, servers, audio equipment, communication devices, data management, product storage, etc., fully meet the operational requirements of the company and comply with relevant regulations.
All employees of the company currently hold a university degree or higher, with over 50% holding a graduate degree. Registered specialists and clinical monitors have all undergone training by the National Food and Drug Administration and obtained relevant qualifications, and the human resources situation meets the service requirements of the company.
The company's organizational structure includes the board of directors, leadership, general office, product registration department, clinical medicine department, business department, customer service department, etc., which aligns with the actual operation of the company, and the distribution of personnel responsibilities and authorities is reasonable.
The quality policy formulated by the company aligns with the actual situation of the company, and the quality objectives have been quantified and broken down into various departments. The quality objectives for 2012 have been completed as checked and counted, and have been input into the management review system.
Boshi Zhixing's products include registration services for drugs, biological products, medical devices, and health-related products, as well as services for Phase I, II, III, and IV clinical trials (research), with service regulations and requirements standardized and regulated according to the relevant requirements of the National Food and Drug Administration.
The company conducted an internal audit from October 22 to 23, 2012, with no non-conformities issued. On January 4, 2013, a management review was conducted, chaired by the general manager, summarizing the work situation of 2012 and looking forward to the company's development prospects in 2013.
In summary, the audit team believes that the quality management system established by Beijing Boshi Zhixing Pharmaceutical Technology Co., Ltd. meets the requirements of the GB/T19001-2008 standard and operates effectively.
(PHDS CHINA CRO Registration Declaration)
(GB/T19001-2008 IDT ISO9001:2008)
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