ISO9001 system certification

What materials should be prepared for the review of various ISO systems is a headache for many quality personnel. Next, we will list and explain what materials need to be prepared for system certification audit for your reference. Each quality person can adjust according to the actual situation of his company.

ISO9001:2015 Quality Management System

1、 Management of documents and records:

1. The office shall have a list of all documents and blank forms of records;

2. List of external documents (quality management, standards related to product quality, technical documents, data, etc.), especially the documents of national mandatory laws and regulations and the records of control distribution; 3. Document distribution records (all departments shall have them) 4. List of controlled documents of all departments. Including: quality manual, procedure documents, supporting documents of all departments, external documents (national, industrial, and other standards; data that have an impact on product quality, etc.); 5. List of quality records of each department; 6. List of technical documents (drawings, process procedures, inspection procedures and distribution records); 7. All kinds of documents shall be reviewed, approved and dated; 8. The signatures of various quality records shall be complete;

2、 Management review:

9. Management review plan;

10. "Sign in form" of management review meeting; 11. Management review records (reports of management representatives, discussion speeches of participants or written materials); 12. Management review report (see the Procedure Document for the contents); 13. Rectification plans and measures after management review; Records of corrective, preventive and improvement measures. 14. Tracking and verification records.

3、 Internal audit:

15. Annual internal audit plan;

16. Internal audit plan and schedule 17. Letter of appointment of internal audit team leader; 18. Copies of qualification certificates of internal audit members; 19. Minutes of the first meeting; 20. Internal audit checklist (record); 21. Minutes of the last meeting; 22. Internal audit report; 23. Non conformance report and corrective action verification record; 24. Relevant records of data analysis;

4、 Sales:

25. Contract review records; (Order review)

26. Customer account; 27. Customer satisfaction survey results, customer complaints, complaints and feedback information, standing books, records, statistical analysis, and whether the quality objectives have been achieved; 28. After sales service records;

5、 Procurement:

29. Evaluation records of qualified suppliers (including the evaluation records of outsourcing agents); And materials for performance evaluation of supply;

30. Quality evaluation standing book of qualified suppliers (how many materials have been purchased from a supplier, and whether they are qualified), statistical analysis of procurement quality, and whether the quality objectives have been achieved; 31. Purchase account (including outsourced product account) 32. Purchase list (with approval procedures); 33. Contract (subject to the approval of the department head);

6、 Warehouse Logistics Department:

34. Detailed accounts 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; First in first out management

7、 Quality Department

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

38. Measuring tool verification record; 39. Integrity of quality records of each workshop 40. Detailed machine account of tool name; 41. Detailed account of measuring tools (including measuring tool verification status, verification date and re inspection date) and preservation of verification certificate;

8、 Equipment:

41. Equipment list;

42. Maintenance plan; 43. Equipment maintenance records; 44. Approval records of special process equipment; 45. Identification (including equipment identification and equipment integrity identification);

9、 Production:

46. Production plan; And planning (meeting) records of production and service process realization;

47. List of items (standing book) for completing the production plan; 48. Nonconforming product account; 49. Handling records of nonconforming products; 50. Inspection records and statistical analysis of semi-finished products and finished products (whether the percent of pass reaches the quality target); 51. Rules and regulations, identification, safety, etc. for product protection and storage;

52. Training plans and records of each department (business technology training, quality awareness training, etc.); 53. Operation documents (drawings, process procedures, inspection procedures, operation procedures to the site); 54. Key processes must have process procedures; 55. Site identification (product identification, status identification, equipment identification); 56. No measuring tools without verification shall be available on the production site; 57. Each type of work record of each department shall be bound into a volume for easy retrieval;

10、 Product delivery:

58. Delivery plan;

59. Delivery list; 60. Evaluation records of the transporter (also the evaluation of qualified suppliers); 61. Records of goods received by customers;

11、 Personnel Administration Department:

62. Job requirements for post holders;

63. Training needs of each department; 64. Annual training plan; 65. Training records (including: internal auditor training records, quality policy and objective training records, quality awareness training records, quality management department document training records, skills training records, inspector induction training records, all of which should have corresponding assessment and evaluation results) 66. List of special types of work (those who have been approved by the relevant person in charge and relevant certificates); 67. List of inspectors (appointed by relevant responsible person, with responsibilities and authorities specified);

12、 Safety management:

68. Various rules and regulations on safety (relevant national, industrial and enterprise regulations, etc.);

69. List of fire-fighting equipment and facilities;