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What materials need to be prepared before ISO9001 audit, you will know after reading!
Date：2020/10/14 Clicks：1181
What materials need to be prepared during the audit of the ISO9001 quality management system is a headache for many quality people. Below, we will enumerate and explain what materials need to be prepared when doing an ISO9001 quality management system audit for your reference. Every quality person can make adjustments according to the actual situation of your company.
1、Management of documents and records
1. The office must have a list of blank forms for all documents and records;
2. List of external documents (quality management, standards related to product quality, technical documents, materials, etc.), especially national mandatory laws and regulations, and records of controlled release;
3. Document issuance records (all departments must have)
4. List of controlled documents of each department. Including: quality manuals, procedural documents, supporting documents from various departments, external documents (national, industry, and other standards; materials that affect product quality, etc.);
5. List of quality records of each department;
6. List of technical documents (drawings, process regulations, inspection procedures and release records);
7. All kinds of documents must be reviewed, approved and dated;
8. The signatures of all quality records must be complete;
2、Management review
9. Management review plan;
10. The "sign-in form" of the management review meeting;
11. Management review records (management representatives’ reports, participants’ discussion speeches or written materials);
12. Management review report (see "Procedural Documents" for the content);
13. Corrective plan and measures after management review; record of corrective, preventive and improvement measures.
14. Track verification records.
3、Internal audit
15. Annual internal audit plan;
16. Internal audit plan and schedule
17. The appointment letter of the leader of the internal audit team;
18. Copy of internal audit membership certificate;
19. Minutes of the first meeting;
20. Internal audit checklist (record);
21. Minutes of the last meeting;
22. Internal audit report;
23. Non-conformity report and corrective action verification record;
24. Relevant records of data analysis;
4、sales
25. Contract review record; (Order review)
26. Customer account;
27. Customer satisfaction survey results, customer complaints, complaints and feedback information, account, record, and statistical analysis, whether the quality target is achieved;
28. After-sales service records;
5、 procurement
29. Qualified supplier evaluation records (including evaluation records of outsourcing agents); and materials for the performance evaluation of the supply;
30. Qualified supplier evaluation quality account (how many materials have been purchased by a certain supplier, and whether it is qualified), statistical analysis of procurement quality, and whether the quality goal is achieved;
31. Purchasing ledger (including outsourcing product ledger)
32. Procurement list (with approval procedures);
33. Contract (should be approved by the person in charge of the department);
6、Warehousing and Logistics Department
34. Detailed account 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. Entry and exit procedures; first-in first-out management.
7、 Quality Department
37. Control of unqualified measuring tools and tools (scrap procedures);
38. Measuring tool verification record;
39. The integrity of the quality records of each workshop
40. Detailed account of tool name;
41. The detailed account of measuring tools (should include measuring tool verification status, verification date, re-inspection date) and the preservation of verification certificates;
8、Equipment
41. Equipment list;
42. Maintenance plan;
43. Equipment maintenance records;
44. Special process equipment approval record;
45. Identification (including equipment identification and equipment intact status identification);
9、production
46. Production plan; and planning (meeting) records for the realization of production and service processes;
47. The list of items to complete the production plan (account);
48. Non-conforming product ledger;
49. Disposal records of nonconforming products;
50. Inspection records and statistical analysis of semi-finished products and finished products (whether the qualified rate reaches the quality target);
51. Product protection, storage regulations, labels, safety, etc.;
52. Training plans and records of various departments (business technical training, quality awareness training, etc.);
53. Operating documents (drawings, process regulations, inspection procedures, operating procedures to the site);
54. The key process must have process regulations;
55. Site identification (product identification, status identification, equipment identification);
56. There should be no unverified measuring tools at the production site;
57. Each type of work record of each department should be bound into a book for easy retrieval;
10、Product delivery
58. Delivery plan;
59. Delivery list;
60. The evaluation record of the transporter (also belongs to the evaluation of qualified suppliers);
61. The record of the customer receiving the goods;
11、Personnel Administration Department
62. Requirements for position personnel;
63. Training needs of various departments;
64. Annual training plan;
65. Training records (including: internal auditor training records, quality policy and target training records, quality awareness training records, quality management department document training records, skills training records, and inspector induction training records, all should have corresponding assessment and evaluation results )
66. List of special types of work (approved by the relevant person in charge and related certificates);
67. List of inspectors (appointed by the relevant person in charge, and stipulated responsibilities and authorities);
12、Safety management
68. Various safety regulations (regulations related to countries, industries and the company, etc.);
69. List of fire fighting equipment and facilities;
1、Management of documents and records
1. The office must have a list of blank forms for all documents and records;
2. List of external documents (quality management, standards related to product quality, technical documents, materials, etc.), especially national mandatory laws and regulations, and records of controlled release;
3. Document issuance records (all departments must have)
4. List of controlled documents of each department. Including: quality manuals, procedural documents, supporting documents from various departments, external documents (national, industry, and other standards; materials that affect product quality, etc.);
5. List of quality records of each department;
6. List of technical documents (drawings, process regulations, inspection procedures and release records);
7. All kinds of documents must be reviewed, approved and dated;
8. The signatures of all quality records must be complete;
2、Management review
9. Management review plan;
10. The "sign-in form" of the management review meeting;
11. Management review records (management representatives’ reports, participants’ discussion speeches or written materials);
12. Management review report (see "Procedural Documents" for the content);
13. Corrective plan and measures after management review; record of corrective, preventive and improvement measures.
14. Track verification records.
3、Internal audit
15. Annual internal audit plan;
16. Internal audit plan and schedule
17. The appointment letter of the leader of the internal audit team;
18. Copy of internal audit membership certificate;
19. Minutes of the first meeting;
20. Internal audit checklist (record);
21. Minutes of the last meeting;
22. Internal audit report;
23. Non-conformity report and corrective action verification record;
24. Relevant records of data analysis;
4、sales
25. Contract review record; (Order review)
26. Customer account;
27. Customer satisfaction survey results, customer complaints, complaints and feedback information, account, record, and statistical analysis, whether the quality target is achieved;
28. After-sales service records;
5、 procurement
29. Qualified supplier evaluation records (including evaluation records of outsourcing agents); and materials for the performance evaluation of the supply;
30. Qualified supplier evaluation quality account (how many materials have been purchased by a certain supplier, and whether it is qualified), statistical analysis of procurement quality, and whether the quality goal is achieved;
31. Purchasing ledger (including outsourcing product ledger)
32. Procurement list (with approval procedures);
33. Contract (should be approved by the person in charge of the department);
6、Warehousing and Logistics Department
34. Detailed account 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. Entry and exit procedures; first-in first-out management.
7、 Quality Department
37. Control of unqualified measuring tools and tools (scrap procedures);
38. Measuring tool verification record;
39. The integrity of the quality records of each workshop
40. Detailed account of tool name;
41. The detailed account of measuring tools (should include measuring tool verification status, verification date, re-inspection date) and the preservation of verification certificates;
8、Equipment
41. Equipment list;
42. Maintenance plan;
43. Equipment maintenance records;
44. Special process equipment approval record;
45. Identification (including equipment identification and equipment intact status identification);
9、production
46. Production plan; and planning (meeting) records for the realization of production and service processes;
47. The list of items to complete the production plan (account);
48. Non-conforming product ledger;
49. Disposal records of nonconforming products;
50. Inspection records and statistical analysis of semi-finished products and finished products (whether the qualified rate reaches the quality target);
51. Product protection, storage regulations, labels, safety, etc.;
52. Training plans and records of various departments (business technical training, quality awareness training, etc.);
53. Operating documents (drawings, process regulations, inspection procedures, operating procedures to the site);
54. The key process must have process regulations;
55. Site identification (product identification, status identification, equipment identification);
56. There should be no unverified measuring tools at the production site;
57. Each type of work record of each department should be bound into a book for easy retrieval;
10、Product delivery
58. Delivery plan;
59. Delivery list;
60. The evaluation record of the transporter (also belongs to the evaluation of qualified suppliers);
61. The record of the customer receiving the goods;
11、Personnel Administration Department
62. Requirements for position personnel;
63. Training needs of various departments;
64. Annual training plan;
65. Training records (including: internal auditor training records, quality policy and target training records, quality awareness training records, quality management department document training records, skills training records, and inspector induction training records, all should have corresponding assessment and evaluation results )
66. List of special types of work (approved by the relevant person in charge and related certificates);
67. List of inspectors (appointed by the relevant person in charge, and stipulated responsibilities and authorities);
12、Safety management
68. Various safety regulations (regulations related to countries, industries and the company, etc.);
69. List of fire fighting equipment and facilities;
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