Up to date, ISO 9001:2008 has been the most mature quality framework worldwide, which is used by more than 750,000 organizations from 161 countries or regions. ISO9001 provides a framework suitable for any fields—not only for quality management system but also setting up a general standard for enterprise overall management.
PHDS is one of the few domestic CRO companies certified by ISO 9001:2008 System in China. During its rapid development, PHDS realizes that the key to development is not just how to build up the quality management system, but how to operate it efficiently. In the daily operation, the company checks up at all levels, excluding any illegal operations to make sure the efficient operation of ISO 9001, which has become the catalyst guaranteeing the fast development of the company.
As we all know, ISO 9001 Quality Management System, since first issued in 1987, has been revised in 1994 and 2000, and has undergone four versions until the latest one released on November 14, 2008. Now PHDS has been executing the latest edition. As the saying goes, every procedure of system updating is a new process of “people reviewing and system improving”.
Ultimately, the operation of quality management system is how to make sure the continuous effectiveness of “such system”. In order to realize this goal, the company takes the following measures:
1. Create an internal atmosphere of striving for sustainable excellence
“Anything exists in a specific environment.”Similarly, a management system also has its required environment for existence: 1. Insisting in eight principles of quality management so as to continuously improve management concept and enhance the supervisors’ ideas on management and behavior. 2. Achieving multi-win. When designing, setting up and operating the quality management system or improving its efficiency, the company fully considers the requirements and expectations of its clients and creates its business philosophy and mechanism accordingly to actively identify, understand and satisfy these various requirements and expectations. 3. Educating and cultivating all personnel to be highly efficient so as to shorten the time of realizing the company goal. 4. Encouraging personnel to be creative and active in finding solutions; creating an atmosphere allowing personnel to actively find problems and produce solutions so as to improve the performance of the company.
2. Continuously enhance the maturity of the quality management system and the execution process through self-assessment
Through self-assessment, PHDS can identify its own status, then continuously improve the situation and realize a sustainable and efficient development. The generated effects are as follows: 1. the company’s efficiency and the maturity of the execution of quality management system reaches an unprecedented level; 2.progress has been made concerning reaching the development goal of the company and the company has been adapting greatly; 3. the continuous improvement on maturity of quality management system operation makes the goal completed, responsibility clear, resources allocated, risk avoided, cost reduced and effectiveness and efficiency guaranteed.
3. Set up a series of organization measures based on ISO9001
a. Setting up a customer-centered quality service system, regulating the service process and strict quality controlling;
b. Improving service awareness of the personnel and enhancing service quality;
c. Excluding and reducing working errors and rapidly improving working efficiency;
d. Improving internal communication and coordination between departments;
e. Establishing a comprehensive set of scientific, systemic and applicable internal operation system including management and working routine and service and operation standard in order to monitor the entire process of the business activities and preclude any problems.
Currently, a precise, systematic and scientific “PHDS Enterprise Management System”will be put into operation. The installment of office automation and comprehensive digitalized management with process optimization implies another great stride along the strategies of PHDS.