Materials required for ISO system certification

II. How to Apply for ISO Three System Certifications?

After gaining a basic understanding of the ISO three systems, the next step is to proceed with the certification process. What types of enterprises are eligible for the three system certifications? What materials are required for the certification? And what is recertification? Let’s continue reading:

Requirements for Enterprises

Not all enterprises are eligible to apply for ISO three system certifications. The following conditions must be met simultaneously:

1. Possess independent legal person status or be an organization authorized by an independent legal person;

2. Establish a documented management system in accordance with the standards of the applied system and operate according to the system documentation for three months or more (the enterprise must have been established for three months or more). Before the certification audit, at least one management review and one internal system audit must be completed (conducted in accordance with the documentation requirements).

Required Materials

A significant amount of documentation is required for ISO certification. Below is a simplified list for reference, but specific requirements may vary based on actual circumstances.

Materials Required for ISO 9001

1. Certification application form, including a description of the scope and activities of the production, operation, or service for which certification is sought.

2. Latest organizational chart and quality manual.

3. Latest list of procedure documents, third-level operational documents, and fourth-level record documents.

4. Product process flowchart and QC engineering diagram.

5. List of external documents.

6. Organizational knowledge list.

7. Organizational risk and opportunity control list.

8. Monitoring and review form for internal and external organizational environment and stakeholders.

9. Latest internal audit plan checklist, non-conformance reports, and summary report.

10. Latest management review plan, report, and quality objective achievement statistics.

11. List of qualified suppliers and initial evaluation form, annual review form.

12. Latest customer satisfaction survey and analysis report.

13. Full set of design, development planning inputs, outputs, reviews, verification, and validation materials for products within the certification scope for the past year.

14. Customer complaint handling statistics and 8D reports.

15. List of production equipment and testing instruments.

16. Business orders and contract review materials for the past year within the certification scope.

17. IQC, IPQC, OQC, QA inspection records, non-conforming product handling records, corrective and preventive actions, and continuous improvement records.

18. Daily production reports, production schedules, SOP training and practical consistency for production processes, annual equipment maintenance inspection forms, and special process confirmation forms.

19. Annual training plan, training assessment records, special工种 training assessments, qualifications, and work permits.

Materials Required for ISO 14001

1. Environmental impact assessment and approval.

2. Pollution discharge monitoring report (must be issued by a qualified authority).

3. "Three Simultaneities" acceptance report (if applicable).

4. Pollution discharge permit.

5. Fire safety acceptance report.

6. Hazardous waste disposal contract and transfer manifests (essential, primarily the five-part manifest; records of regular waste disposal, including light bulbs, toner, waste oil, waste paper, scrap metal, etc., must also be maintained).

7. Environmental aspects list and significant environmental aspects list.

8. Objectives, targets, and management plans.

9. Monitoring records for objectives, targets, and management plans.

10. List of applicable environmental laws, regulations, and other requirements (must include all laws and regulations related to the enterprise’s products; for electronics enterprises, note EU ROHS and China ROHS; ensure all laws and regulations are updated to the latest versions; collect any local regulations if applicable).

11. System monitoring records (e.g., regular 5S or 7S inspection records).

12. Compliance evaluation of laws, regulations, and other requirements.

13. Environmental training plan (including training plans for key positions).

14. Emergency facility files/inventory.

15. Emergency facility inspection records.

16. Emergency drill plans/reports.

17. Mandatory inspection reports for special equipment and safety accessories (e.g., forklifts, cranes, elevators, air compressors, air tanks and pressure gauges/safety valves, aerial ropeways, boilers and pressure gauges/safety valves, pressure pipelines, other pressure vessels, etc.).

18. Special equipment usage permits (e.g., forklifts, elevators, cranes, air tanks, etc.).

19. Certificates or copies of qualifications for special工种 operators.

20. Internal audit and management review-related records.

21. Calibration of measuring equipment.

22. Activity plans and records (photos) for fire safety, production safety, first aid, anti-terrorism drills, etc.

Materials Required for ISO 45001

1. Business license.

2. Organization code certificate.

3. Work safety permit.

4. Production process flowchart and description.

5. Company profile and description of the scope of system certification.

6. Organizational chart for the occupational health and safety management system.

7. Appointment letter for the management representative of the occupational health and safety management system.

8. Records of employee participation in occupational health and safety management.

9. Appointment letter and election records for employee representatives.

10. Site plan of the company (including pipeline network diagram).

11. Circuit layout plan of the company.

12. Emergency evacuation plans for each floor and assembly points for personnel safety.

13. Hazard source location map of the company (indicating key locations such as generators, air compressors, oil depots, hazardous material warehouses, special workstations, and other sources of waste gas, noise, dust, etc.).

14. Documents related to the occupational health and safety management system (e.g., management manual, procedure documents, work instructions, etc.).

15. Development, understanding, and dissemination of the occupational health and safety management system policy.

16. Fire safety acceptance report.

17. Proof of compliance with work safety laws (required for high-risk production enterprises).

18. Internal/external information feedback forms (e.g., for raw material suppliers, transportation service providers, canteen contractors, etc.).

19. Internal/external information feedback materials (with suppliers and customers).

20. Internal/external information feedback materials (with employees and government agencies).

21. ISO 45001 occupational health and safety awareness training.

22. Basic knowledge of occupational health and safety.

23. Emergency drill plans for incidents such as fires (emergency preparedness and response).

24. Materials for three-level safety education.

25. List of personnel in special positions (occupational disease-related positions).

26. Training records for special工种.

27. On-site 5S management and work safety management.

28. Safety management of hazardous chemicals (usage and protection management).

29. Training on on-site safety signage.

30. Training on the use of personal protective equipment (PPE).

31. Training on laws, regulations, and other requirements.

32. Training for personnel on hazard identification and risk assessment.

33. Training on occupational health and safety responsibilities and authorities (job description documents).

34. Distribution of major hazard sources and risk control requirements.

35. List of applicable occupational health and safety laws, regulations, and other requirements.

36. Summary of applicable occupational health and safety regulation clauses.

37. Compliance evaluation plan.

38. Compliance evaluation report.

39. Departmental hazard identification and assessment form.

40. Summary list of hazard sources.

41. List of major hazard sources.

42. Control measures for major hazard sources.

43. Incident handling records (following the "four no's" principle).

44. Hazard identification and assessment form for relevant parties (e.g., hazardous chemical carriers, canteen contractors, vehicle service providers, etc.).

45. Proof of influence on relevant parties (e.g., neighboring factories, residents, etc.).

46. Occupational health and safety agreements with relevant parties (e.g., hazardous chemical carriers, transportation service providers, canteen contractors, etc.).

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