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

Required Materials

The materials required for ISO certification are extensive. Below is a simplified list for reference, but specific requirements may vary.

Materials Required for ISO 9001

1. Certification application form, including a description of the scope and activities of the production, operation, or services 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 lists.

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 environments 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 report and 8D report.

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 plan, SOP training and implementation consistency for production processes, annual equipment maintenance inspection form, special process confirmation form.

19. Annual training plan, training assessment records, special工种 training assessment, and qualification certificates, 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 treatment contract and transfer manifests (essential, including five-part manifests; records of regular waste treatment, such as light bulbs, toner, waste oil, paper, scrap iron, etc.).

7. Environmental aspects list, significant environmental aspects list.

8. Objectives, targets, and management programs.

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

10. List of applicable environmental法律法规 and other requirements (must include all product-related法律法规; for electronics companies, note EU RoHS and China RoHS; ensure法律法规 are up-to-date; collect local regulations if applicable).

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

12. Compliance evaluation with法律法规/other requirements.

13. Environmental training plan (including key positions).

14. Emergency facility files/list.

15. Emergency facility inspection records.

16. Emergency drill plan/report.

17. Mandatory inspection reports for special equipment and safety accessories (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 (forklifts, elevators, cranes, air tanks, etc.).

19. Certificates or copies 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-terror 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 scope description for system certification.

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

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

8. Employee participation in occupational health and safety management.

9. Appointment letter and election records for employee representatives.

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

11. Circuit layout plan of the company.

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

13. Hazard source location map (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 occupational health and safety management system (manual, procedure documents, work instructions, etc.).

15. Development, understanding, and promotion of occupational health and safety policy.

16. Fire safety acceptance report.

17. Work safety compliance certificate (required for high-risk production enterprises).

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

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

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 like fires (emergency preparedness and response).

24. Materials for three-level safety education.

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

26. Training status of special工种.

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

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

29. Training on on-site safety signage knowledge.

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

31. Training on法律法规 and other requirements.

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

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

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

35. List of applicable occupational health and safety法律法规 and other requirements.

36. Summary of applicable occupational health and safety regulatory 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 (four no's principle).

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

45. Evidence of influence on relevant parties (neighboring factories, residents, etc.).

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

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