1. Sort out the secondary files of each process, change the file mode to the form format, and manage each process in a list. 2. Implement system internal audits according to the annual audit plan.

1. Process audit focuses on key processes and product special characteristics processes - formulate corresponding key audit checklists and conduct random on-site inspections 2. The system course conducts a process difference review of the same product based on the process.

1. Periodic process audits (SOP/CP/field operation consistency) are inspected by the on-site PQE, and audit reports are submitted in accordance with the periodic plan of the system class.

1. The system specialist formulates the plan and the QE executes it (or sets up a full-time product analyst). Because the system specialist does not have strong product analysis capabilities, this work is done in the hands of the system specialist, which is a coping job.

According to the standard requirements, organize and review each indicator of quality management requirements every year - periodic work

1. Periodic work: Responsible for the review, issuance, sorting and storage of controlled documents of each system, recycling and scrapping of old documents, etc.

1. Identify the requirements of the customer audit checklist, analyze customer requirements, and translate customer requirements into company language

2. Lead and organize various departments to prepare for the audit requirements

3. Plan the audit process, assign audit tasks, and coordinate the collection of audit materials provided at the audit site to ensure the validity and completeness of the data.

4. Based on the review results, supervise and track responses that are not in line with project improvement

5. Establish a customer review database and maintain and manage the database

1. Respond to customer audits and provide valid documents and information related to the system

2. Cooperate with on-site response audits and conduct internal audits before audits

Responsible Person: System Specialist

System specialists need to assist organizations or enterprises in completing the preparations for third-party certification audits, including determining the scope of the audit, formulating audit plans, preparing relevant documents, etc.

Before the audit, the system specialist needs to review the organization's quality management system documents (such as quality manuals, procedure documents, records, etc.) to confirm whether they comply with relevant standards and requirements.

Audit execution: During the audit process, the system specialist needs to conduct on-site audits of the organization's quality management system in accordance with the audit plan, including inspection of documents, records, on-site operations, etc., to verify its effectiveness and compliance.

Supervision and audit: For organizations that have passed certification, system specialists also need to conduct regular supervision and audits to ensure that they continue to comply with certification standards.

Problem discovery: During the audit process, system specialists need to be good at finding problems, including non-conformities, potential risk points, etc.

Improvement suggestions: In response to the discovered problems, system specialists need to put forward practical improvement suggestions and track and verify the implementation effects of the improvement measures.

Audit report: After the audit, the system specialist needs to prepare an audit report to record the audit process, problems found and improvement suggestions in detail for reference by the certification body.

Certification decision: Based on the audit report, the certification body will decide whether to approve the organization's certification application. The system specialist is required to assist the organization in understanding and accepting the audit results and making subsequent improvements as necessary.

Internal communication: System specialists need to communicate effectively with relevant departments and personnel within the organization to ensure the smooth progress of the audit work

External coordination: At the same time, system specialists also need to maintain good communication and coordination with third-party certification agencies to ensure the fairness and objectivity of the audit process.

Document Control Assistant

Responsible person: On-site Coordinator: System Specialist

Responsible Person: System Specialist

1. Submit hazardous material data for parts and environmental protection data for spare parts, mainly RoHS/REACH/MSDS data for homogeneous materials of products.

2. Submit information on hazardous substances in finished products

Responsible Person: System Specialist

Responsible Person: System Specialist

Responsible Person: System Specialist

1. Develop goal management requirement documents and share the goal achievement status of each business department 2. Organize regular reviews of projects that do not meet standards and share management methods 3. Accept the rectification plan on site when necessary, and develop excellent improvement plans horizontally