What materials are needed to prepare before the ISO9001 management system certification audit?

When auditing the ISO9001 quality management system, preparing the necessary materials is a headache for many enterprises. Below, we list and explain the materials that need to be prepared during the ISO9001:2015 quality management system certification audit for your reference. Each unit can adjust according to their company's actual situation.

What materials need to be prepared during the ISO9001:2015 quality management system certification audit

I. Management of documents and records:

1. The office should have a complete list of all blank forms for documents and records;

2. List of external documents (related to quality management, product quality standards, technical documents, materials, etc.), especially documents of mandatory national laws and regulations and records of their controlled distribution;

3. Document distribution records (each department must have them)

4. Controlled document list for each department, including: quality manual, procedure documents, supporting documents of each department, external documents (national, industry standards, etc.; materials affecting product quality, etc.);

5. Quality record list for each department;

6. Technical document list (drawings, process regulations, inspection regulations, and distribution records);

7. All types of documents must be reviewed, approved, and dated;

8. All quality records must have complete signatures;

II. Management review:

9. Management review plan;

10. "Sign-in sheet" for management review meetings;

11. Management review records (reports from management representatives, discussions or written materials from participants);

12. Management review report (contents are detailed in the "Procedure Document");

13. Rectification plans and measures after management review; records of corrective, preventive, and improvement actions.

14. Follow-up verification records.

III. Internal audit:

15. Annual internal audit plan;

16. Internal audit plan and schedule;

17. Appointment letter for internal audit team leader;

18. Copy of internal auditor qualification certificates;

19. Initial meeting records;

20. Internal audit checklists (records);

21. Final meeting records;

22. Internal audit reports;

23. Nonconformance reports and verification records of corrective actions;

24. Records related to data analysis;

IV. Sales:

25. Contract review records; (order review)

26. Customer ledger;

27. Customer satisfaction survey results, customer complaints, grievances, and feedback information, ledgers, records, and statistical analysis to determine if quality objectives are met;

28. After-sales service records;

V. Procurement:

29. Qualified supplier evaluation records (including evaluation records of subcontractors); and materials evaluating supplier performance;

30. Qualified supplier quality ledger (how much material was purchased from a certain supplier and whether it was qualified), procurement quality statistical analysis, and whether Guangzhou Xinneng Enterprise Management Consulting Co., Ltd. has met quality objectives;

31. Procurement ledger (including subcontracted product ledger)

32. Procurement list (should have approval procedures);

33. Contracts (should be approved by department heads);

VI. Warehousing and logistics department:

34. Detailed ledger of raw materials, semi-finished products, and finished products;

35. Identification of raw materials, semi-finished products, and finished products (including product identification and status identification);

36. Inbound and outbound procedures; management of first-in, first-out.

VII. Quality inspection department:

37. Control of nonconforming measuring tools and instruments (scrapping procedures);

38. Measuring instrument calibration records;

39. Completeness of quality records in each workshop;

40. Detailed ledger of tools;

41. Detailed ledger of measuring instruments (should include calibration status, calibration date, re-calibration date) and preservation of calibration certificates;

VIII. Equipment management:

41. Equipment list;

42. Maintenance plan;

43. Equipment maintenance records;

44. Special process equipment approval records;

45. Identification (including equipment identification and equipment integrity status identification);

IX. Production management:

46. Production plan; and records of planning for production and service process realization (meetings);

47. List of completed production plan items (ledger);

48. Nonconforming product ledger;

49. Records of handling nonconforming products;

50. Inspection records and statistical analysis of semi-finished and finished products (whether the pass rate meets quality objectives);

51. Product protection, warehousing regulations, identification, safety, etc.;

52. Training plans and records for each department (business technical training, quality awareness training, etc.);

53. Operating documents (drawings, process regulations, inspection regulations, operation procedures on site);

54. Key processes must have process instructions;

55. On-site identification (product identification, status identification, equipment identification);

56. Uncalibrated measuring tools must not appear on the production site;

57. Each type of work record from all departments should be bound into volumes for easy retrieval;

10. Product Delivery:

58. Shipping plan;

59. Shipping list;

60. Evaluation records of the carrier (also part of qualified supplier evaluation);

61. Records of customer receipt of goods;

11. Human Resources and Administration Department:

62. Job position requirements;

63. Training needs of each department;

64. Annual training plan;

65. Training records (including: internal auditor training records, quality policy and objectives training records, quality awareness training records, quality management system document training records, skills training records, inspector on-the-job training records, all should have corresponding assessment results);

66. List of special types of work (approved by relevant responsible persons for on-the-job, and related certificates);

67. List of inspectors (appointed by relevant responsible persons, with defined duties and authorities);

12. Safety Management:

68. Various safety regulations (including national, industry, and company regulations, etc.);

69. List of fire-fighting equipment and facilities;