Shandong Provincial Quality Supervision and Administration Bureau's Quality Safety Plan for Medical Device Manufacturers

In order to strengthen the awareness of the main responsibility of the quality and safety of the medical device manufacturers, urge the enterprises to continue to comply with the medical device production quality management standards, guide the enterprises to continuously improve the quality management level, and ensure the safety of public equipment, this plan is formulated in combination with the actual work.

一、 Active theme

Meet the standards and keep improving.

二、 Guiding ideology

三、 Main objectives

Urge medical device manufacturers to establish a quality management system that meets the requirements to ensure compliance through the "Year of Standardization" activity; Guide the qualified enterprises to continuously improve the quality management level and strive for advancement; Encourage up to standard, advanced enterprises to benchmark higher standards, continue to improve, and strive to become a benchmark.

四、 Task Steps

This activity is divided into three stages from May to November 2018, which can be carried out by stubble pressing. The specific tasks and steps are as follows:

（一） Enterprise self inspection stage (May). Since January 1 of this year, all manufacturers should meet the requirements of the Medical Device Production Quality Management Specification (hereinafter referred to as the Specification). On the basis of the 2017 "Year of Implementation of the Specification" activity, the municipal bureaus should organize medical device manufacturers within their jurisdiction to conduct a comprehensive self inspection against the requirements of the Specification. If they fail to meet the requirements of the Specification, they should stop production and report to the local municipal bureaus.

（二） Supervision and inspection stage (June October). Each municipal bureau shall organize and carry out supervision and inspection on the implementation of the specification in accordance with the 2018 provincial supervision and inspection plan for medical device manufacturers and in combination with the self inspection of enterprises. Enterprises with defective items shall be required to rectify within a time limit or stop production for rectification, and those passing the follow-up review shall be deemed as qualified enterprises; Guide the qualified enterprises to benchmark "2017 Shandong Medical Device Production Quality Management Standard Implementation Demonstration Enterprise", continuously improve the quality management system, and strive to be an advanced enterprise in standard implementation; Encourage up to standard and advanced enterprises to benchmark higher standards, continuously improve the quality management system, constantly improve the quality management level, strive to be a benchmark enterprise for standardized implementation, and drive the high-quality development of the medical device industry in the province.

（三） Overall acceptance stage (November). The provincial bureau carried out a comprehensive acceptance of the implementation of the "Year of Standardization and Improvement" activity of each municipal bureau, organized supervision and inspection, checked the implementation of the "Year of Standardization and Improvement" activity of each city by consulting the activity deployment, supervision and inspection, tracking and review and other materials, and randomly selected some enterprises in production, and incorporated the inspection and acceptance into the annual assessment to ensure the effectiveness of the activity.

五、 Job requirements

（一） Strengthen organizational leadership. All municipal bureaus should attach great importance to the "Year of Standardization and Improvement" activity, fully understand the importance of enterprises' implementing the standards, earnestly strengthen the organization and leadership, and formulate specific implementation plans in combination with the actual situation of the area under their jurisdiction to ensure that all tasks of the activity are implemented.

（二） Focus on overall planning and integration. All municipal bureaus should combine the activities of the "Year of Standardization and Improvement" with the supervision tasks throughout the year, carry out publicity and training, supervision and inspection, special rectification, supervision and random inspection, and other work as a whole, effectively implement the supervision responsibilities, and ensure that the activities of the "Year of Standardization and Improvement" and various supervision work are coordinated, complementary, and mutually reinforcing.

（三） Timely summarize. All municipal bureaus should carefully summarize the implementation of the "Standardization and Promotion Year" activity, which should include organization and leadership, activity development, experience and practice, etc., to fully reflect the effectiveness of the activity. Please submit the work summary to the provincial bureau before November 30.

Shandong Zhushi Pharmaceutical Group Co., Ltd., founded in 2003, has more than 5000 registered employees. After years of development, it has developed into a diversified industrial cluster integrating medical devices, polymers, cosmetics, health food, daily necessities and biological reagent production, enterprise management consulting and training, real estate economy, pharmaceutical transportation, pharmaceutical printing, etc.

Adhering to the concept of life, health and happiness, the Group provides you with full chain health services.

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