Recommended Reading | Practice and Application Combining the Generality of ISO 9001 with the Specificity of Management Requirements for Certification Bodies

　　The Guangdong Provincial Drug Administration Review and Certification Center (hereinafter referred to as the "Center") is the technical department mainly responsible for the review of drugs, medical devices, and cosmetic products, as well as on-site production inspections in Guangdong Province. In 2013, the Center introduced a quality management system into its daily management work. After nearly 10 years of operation, it has played a positive role in effectively improving the quality management level of the Center's technical review and on-site production inspections. This article analyzes the operation of the unit's quality management system, briefly discusses the experiences and shortcomings during its operation, and combines personal understanding of some clauses to present individual views on how to integrate the unit's management particularities with the universality of ISO 9001 clauses.

　　1. The Significance of Introducing a Quality Management System in Review and Certification Agencies

　　Introducing ISO 9001 into review and certification work can further clarify work processes, strengthen process control, and enhance continuous improvement. It establishes a sound working mechanism with clear responsibilities, coordinated order, unified standards, standardized behavior, and effective supervision, forming an operating mechanism governed by systems and procedures. This leads to a transition from arbitrary to standardized work, from scattered to systematic work, thereby improving work efficiency and execution; at the same time, it plays a crucial role in risk control during review and inspection work.

　　In international exchange activities such as the World Health Organization's evaluation of China's vaccine regulatory system and the National Medical Products Administration's participation in the Pharmaceutical Inspection Cooperation Scheme (PIC/S), it is required that national and provincial drug regulatory departments establish quality management systems based on ISO 9001. It is evident that a quality management system established according to ISO 9001 standards is also an important prerequisite for China's international cooperation and exchange in drug regulatory work.

　　2. Basic Situation of the Center's Quality Management

　　The core of FDA review quality management is to ensure consistency and high efficiency in the review and approval process, including timely information disclosure, clear work deadlines, clear work processes, work standards, guidelines, monitoring of the review and inspection process, continuous assessment and training, smooth communication mechanisms, and regular satisfaction surveys. According to the requirements of the quality management system, it promotes continuous improvement and upgrading of the quality management system.

　　(1) Establishing a relatively complete quality management system

　　Currently, the Center has 978 documents and forms, including 1 quality manual, 26 procedure documents, 147 work procedures and standards, 696 various work forms, and 1 set of job descriptions, covering the Center's review and inspection functions, discipline inspection, finance, party office, personnel, and other aspects. This is more detailed and complete compared to the 603 documents and forms at the system's establishment in 2013.

　　(2) Achieving systematic management of documents

　　Over more than 10 years, the Center has continuously adjusted various documents based on work function changes, customer satisfaction survey results, internal audits, etc. In 2013, there were 64 document modification requests; by 2022, there were 38 document modifications, 87 new documents, and 24 abolished documents. The large volume of document creation, modification, and abolition work cannot be updated in a short time by manpower alone to ensure timely and effective documents. Therefore, we introduced a document management system, realizing electronic processing of the entire process from drafting to issuance, archiving, and consultation.

　　(3) Strict monitoring of review deadlines

　　The review deadline system imposes time limits on the behaviors of reviewers and applicants during the drug review process, effectively ensuring review efficiency and the legitimate rights of applicants. Therefore, according to national regulations such as the "Drug Registration Management Measures" and "Medical Device Registration Management Measures" and relevant provincial regulations promoting industrial development, clear time limits are set for various application matters and published on the website as service guides. To effectively monitor work deadlines, relevant business processes have been largely paperless, with clear time requirements for each step from acceptance to review and completion. The system automatically issues early warnings as deadlines approach and alarms if overdue, ensuring all tasks are completed within the time limits.

　　3. The Particularity of Implementing a Quality Management System in a Review Agency Center

　　The quality management system fully reflects the basic principles and ideas of modern management. Applying these principles can guide different organizations to establish and operate quality management systems and improve overall organizational management levels. However, due to its universality, it inevitably lacks specificity in different fields. Therefore, during the implementation of the quality management system, it is necessary to combine some unique management requirements of government departments with ISO standards to form a management system that fits the characteristics of review and inspection agencies, avoiding the phenomenon of "two skins".

　　(1) How to maintain the effectiveness of management reviews

　　Management review, as a comprehensive evaluation activity conducted by top management to assess the suitability, adequacy, and effectiveness of the management system, is of great significance in the development and management process of enterprises. However, as a government department, the Center has its particularities. Firstly, the "three majors and one large" in the unit's development and management process, namely: major decision-making, important cadre appointments and removals, major project investment decisions, and large fund usage, must be decided collectively. According to recent management review meetings, the actual issues discussed by departments still need to be resolved at the "Party Committee Meeting" and "Leadership Team Meeting." Therefore, if management review is simply understood as holding a management review meeting where departments raise work issues or discuss quality policies or objectives, it will be difficult to play the real role of management review. Breaking the formality of management review, integrating the substantive content of management review with the Party Committee and Leadership Team meetings, effectively solving major issues in the unit's development, and implementing quality goals and requirements from management to every employee is the effective way to ensure the effectiveness of management reviews.

　　(2) Effectively strengthening nonconformance management through informatization

　　In enterprises, the quality department conducts quality testing of raw materials, intermediate products, and finished products to assess product conformity. The "Center's" product is presented in the form of reports, each of which must go through multiple steps such as initial review, re-examination, and audit, and if necessary, expert panel review before issuance. Due to the characteristics of technical review work, the re-examination position will propose certain modifications to reports submitted by the initial review position, and the audit position will propose further modifications to the re-examined reports. There are certain modification opinions at different stages of the report, but they are not necessarily "fundamental" major errors. There are no very clear judgment standards or quantitative indicators for determining whether "nonconformance" is minor or moderate. After years of practice, many reviewers misunderstand that modifications caused by individual risk analysis focus differences or wording differences are considered nonconformance, and departments are reluctant to implement this. Therefore, at the system's establishment, we developed an OA office system according to various business processes. The information system fixes time limits for each stage, sets reminders and alarms to ensure tasks are completed on time and according to procedures; at the same time, modification and change records at each stage are traceable in the system for evidence. Through statistical analysis of common problems, fixed in writing through collective discussions and meeting minutes, and training to ensure unified review and inspection standards, effectively preventing recurrence of similar errors. Combining product characteristics and actual management needs, aided by informatization systems, it prevents production of nonconforming "products" and provides a basis and direction for corrective and preventive measures to avoid recurrence of nonconformance.

　　(3) Integration of internal audits, satisfaction surveys, and discipline inspection and supervision departments

　　ISO 9001 stipulates that organizations should conduct internal (first-party) audits at planned intervals to determine whether the quality management system conforms to standard requirements and is effectively implemented and maintained. However, through years of internal audit practice, it has been found that auditors' enthusiasm for participating in audits is low, and the number of issues found during audits is decreasing. Therefore, improving the effectiveness of internal audits is key to ensuring the system is effectively implemented and maintained.

　　In recent years, with the continuous deepening of strict party governance and the rectification of work style and discipline, the importance of disciplinary inspection and supervision departments in government agencies has become increasingly prominent. How to integrate disciplinary inspection and supervision with internal audit work is also a question worth deep consideration. Internal audit mainly reviews the suitability, effectiveness, and adequacy of the system's operation process. Disciplinary inspection departments often supervise customer satisfaction, review and inspection procedures, timelines, and staff performance, and accept complaints and reports from enterprises. The disciplinary inspection department plays an increasingly important role in unit management and improving work style. Therefore, internal audit and satisfaction survey work cannot rely solely on the quality management department to conduct internal audits in various business sections. By combining disciplinary inspection departments with quality management departments and conducting internal audits from the perspective of serving the public, simplifying workflows, and improving work efficiency, the strength and effectiveness of problem detection in internal audits can be enhanced, rather than merely making minor textual or tabular adjustments. This approach can effectively solve substantive problems found in internal audit work. At the same time, the previous form of concentrating a dozen or so auditors to conduct internal audits across different departments of the entire unit in a short period is transformed into targeted internal audits based on the business characteristics of different departments. The content of internal audits has also shifted from focusing mainly on document review to a combination of document review and on-site practical operations, with an appropriate extension of audit time, which is more conducive to problem detection and allows internal audits to truly play their due role.

　　Conclusion

　　Quality management is an eternal theme. Establishing an effective management system is the only way for pharmaceutical review and inspection agencies to standardize their own construction, improve inspection quality, ensure public medication safety, and serve the development of the pharmaceutical industry. After many years of operation and practice, the system has evolved from merely building a system for the sake of building one to establishing a "practical, easy-to-use, and effective" system that safeguards the "good, fast, and safe" development of review and inspection work.