Drugdu.com expert's response:

The establishment of a quality management system (QMS) for sterile in vitro diagnostic (IVD) medical devices is a complex and systematic process aimed at ensuring product safety, effectiveness, and compliance with regulatory requirements. Below is a detailed, professional step-by-step approach, referencing the Medical Device Manufacturing Practice and relevant regulatory mandates:

I. Define Quality Policy and Objectives

1.Establish Quality Policy: The enterprise shall articulate a quality policy that embodies its commitment to medical device quality and patient safety.

2.Set Quality Objectives: Based on the quality policy, set specific, measurable quality objectives, such as product conformity rates and customer satisfaction levels.

II. Establish Organizational Structure and Responsibilities

1.Setup Management Organization: Create a management structure tailored to medical device production, clearly defining the responsibilities and authorities of each department.

2.Appoint Management Representative: The corporate leader should designate a management representative responsible for establishing, implementing, and maintaining the QMS.

3.Clarify Responsibilities and Authorities: Ensure that production and quality management department heads do not concurrently hold positions, allowing the quality management department to exercise its functions independently.

III. Develop QMS Documentation

1.Quality Manual: Compile a quality manual serving as the regulatory and programmatic foundation for quality assurance activities.

2.Procedure Documents: Establish procedure documents outlining the methods and pathways for implementing quality activities and processes across QMS elements.

3.Third-Level Documents: For more specific operational procedures not conveniently covered in procedure documents, utilize third-tier documents such as administrative, technical, and temporary files.

IV. Personnel Training and Health Management

1.Personnel Training:

（1）Regularly train personnel working in clean rooms on hygiene, microbiology basics, and clean operations.

（2）Provide guidance and supervision for temporary access to clean rooms.

2.Health Management:

（1）Establish health requirements and maintain personnel health records.

（2）Personnel directly involved with materials and products must undergo an annual health checkup; those with contagious or infectious diseases are prohibited from direct product contact.

V.Production Environment Control

1.Premises and Facilities: Design, layout, and utilize facilities according to product characteristics, process flows, and required cleanliness levels.

2.Clean Room Management:

（1）Formulate hygiene codes for clean room staff, standardizing entry/exit procedures and gowning.

（2）Control particle and microorganism dispersion, effectively reducing contaminant concentrations in clean rooms.

VI. Raw Material and Production Process Control

1.Raw Material Control: Establish procurement evaluation and management systems for raw materials, selecting reliable suppliers and conducting rigorous inspections and evaluations.

2.Production Process Control:

（1）Implement stringent standardized management of production processes, including standard operating procedures, production flowcharts, and equipment validation.

（2）Operators who handle products barehanded must regularly disinfect their hands and rotate disinfectant types.

VII. Quality Inspection and Verification

1.Quality Inspection: Conduct multiple quality inspections and verifications, covering physicochemical properties, functional performance, stability, contaminant detection, etc.

2.Batch Record Management: Maintain complete and accurate batch records, documenting operations and outcomes at each production stage.

VIII. Adverse Event Reporting and Follow-up Management

1.Adverse Event Reporting: Implement an adverse event reporting system to report any anomalies or quality issues encountered during product usage.

2.Follow-up Management: Further investigate and manage adverse events to ensure corrective actions are taken and recurrences are prevented.

Ⅸ. Continuous Improvement and Internal Audit

1.Management Review: Corporate leaders should regularly organize management reviews to assess QMS performance and pursue continuous improvement.

2.Internal Audit: Conduct internal audits to examine QMS operations, ensuring effective implementation of all requirements.

In summary, the construction of a QMS for sterile IVD medical devices necessitates a multifaceted approach encompassing quality policy and objectives, organizational structure and responsibilities, QMS documentation, personnel training and health management, production environment control, raw material and production process control, quality inspection and verification, adverse event reporting and follow-up management, as well as continuous improvement and internal audits. These measures collectively form a comprehensive QMS that ensures the safety and effectiveness of sterile IVD medical devices.