On-site Audit Core Documentation Checklist

On-site Audit Core Document Checklist

On-site audit is a critical step in certification. The following documents are required (categorized by type):

1. Quality Management System Documents

Quality Manual: Covers quality policy, objectives, organizational structure, responsibilities and authorities, etc.;

Procedure Documents: Includes at least the 25 procedure documents required by the standard (e.g., design and development, procurement control, production process control, etc.);

Work Instructions: Specific operational specifications (e.g., process procedures, inspection standards, etc.);

Record Form Templates: Such as quality record forms, non-conforming product handling forms, etc.

2. Record-Type Documents

System Operation Records

- Internal audit reports and corrective action records;

- Management review reports and improvement measures;

- Quality objective achievement statistics.

Design and Development Records

- Product requirement specifications;

- Design verification/validation reports;

- Technical configuration change records.

Production Process Records

- Process flowcharts, work instructions;

- Key process parameter monitoring records;

- Product inspection records (first article inspection, in-process inspection, final inspection).

Procurement and Outsourcing Records

- List of qualified suppliers and evaluation records;

- Procurement contracts/technical agreements;

- Outsourcing process control records (e.g., subcontract processing, testing services).

Equipment and Measuring Instrument Management

- Equipment ledger and maintenance records;

- Metrology equipment calibration/certification records.

Non-Conforming Product Control

- Non-conforming product handling forms;

- Corrective action implementation records;

- Customer complaints and handling reports.

Training Records

- Employee job competency list;

- Training plans and assessment records;

- Special position qualification certificates (e.g., welding, non-destructive testing).

3. Product-Related Documents

- Product technical specifications, drawings;

- Product acceptance standards (including military requirements);

- Product delivery records and customer feedback.

4. Special Requirement Documents

Military Confidentiality Management

- Confidentiality qualification certificates (e.g., Level 2, Level 3 confidentiality qualifications);

- Confidentiality management system and training records;

- Classified carrier management ledger.

Reliability Management

- Reliability design analysis reports (e.g., FMEA, FTA);

- Environmental test reports (vibration, high/low temperature, salt spray, etc.);

- Life test data.

Software Engineering Management (if applicable)

- Software requirement specifications;

- Software test reports;

- Configuration management records.

5. On-Site Management Documents

- Production site 6S management records (Sort, Set in order, Shine, Standardize, Sustain, Safety);

- Key process control point labels and work instructions;

- Records of partitioned storage for work-in-progress, semi-finished, and finished products.

6. Laws, Regulations, and Standards

- List of applicable national military standards (e.g., GJB 368B, GJB 450A, etc.);

- Legal and regulatory compliance evaluation reports;

- Mandatory product certification certificates (if required).

For any questions or business inquiries, please call Ms. Huang at 15513049001. Jinding Yucheng Certification will provide you with services.