Quality documents required for IATF16949

Mandatory documents and records required by IATF 16949:2016

1. Scope of the quality management system (clause 4.3)
2. Documented process for the management of product safety related products and manufacturing processes (clause 4.4.1.2)
3. Quality policy (clause 5.2)
4. Responsibilities and authorities to ensure that customer requirements are met (clause 5.3.1)
5. Results of risk analysis (clause 6.1.2.1)
6. Preventive action record (clause 6.1.2.2)
7. Contingency plan (clause 6.1.2.3)
8. Quality objectives (clause 6.2)
9. Records of customer acceptance of alternative measurement methods (clause 7.1.5.1.1)
10. Documented process for managing calibration/verification records (clause 7.1.5.2.1)
11. Maintenance and calibration record (clause 7.1.5.2.1)
12. Documented process for identification of training needs including awareness and achieving awareness (clause 7.2.1)
13. Documented process to verify competence of internal auditors (clause 7.2.3)
14. List of qualified internal auditors (clause 7.2.3)
15. Documented information on trainer’s competency (clause 7.2.3)
16. Documented information on employee’s awareness (clause 7.3.1)
17. Documented process to motivate employees (clause 7.3.2)
18. Quality manual (clause 7.5.1.1)
19. Record retention policy (clause 7.5.3.2.1)
20. Documented process for review, distribution and implementation of customer engineering standards/specifications (clause 7.5.3.2.2)
21. Registry of customer complaints (clause 8.2)
22. Product/service requirements review records (clause 8.2.3.2)
23. Procedure for design and development (clause 8.3.1.1)
24. Record about design and development outputs review (clause 8.3.2)
25. Documented information on software development capability self-assessment (clause 8.3.2.3)
26. Records about product design and development inputs (clause 8.3.3.1)
27. Records about manufacturing process design input requirements (clause 8.3.3.2)
28. Document a process to identify special characteristics (clause 8.3.3.3)
29. Records of design and development controls (clause 8.3.4)
30. Documented product approval (clause 8.3.4.4)
31. Records of design and development outputs (clause 8.3.5)
32. Manufacturing process design output (clause 8.3.5.2)
33. Design and development changes records (clause 8.3.6)
34. Documented approval or waiver of the customer regarding the changes in design (clause 8.3.6.1)
35. Documented revision level of software and hardware as part of the change record (clause 8.3.6.1)
36. Documented supplier selection process (clause 8.4.1.2)
37. Documented process to identify and control externally provided processes, products and services (clause 8.4.2.1)
38. Documented process to ensure compliance with statutory and regulatory requirements of purchased processes, products and services (clause 8.4.2.2)
39. Documented process and criteria for supplier evaluation (clause 8.4.2.4)
40. Records of second-party audit reports (clause 8.4.2.4.1)
41. Characteristics of product to be produced and service to be provided (clause 8.5.1)
42. Control plan (8.5.1.1)
43. Total productive maintenance system (clause 8.5.1.5)
44. Records of traceability (clause 8.5.2.1)
45. Records about customer property (clause 8.5.3)
46. Production/service provision change control records (clause 8.5.6)
47. Documented process to control and react to changes in product realization (clause 8.5.6.1)
48. Documented approval by the customer prior to implementation of the change (clause 8.5.6.1)
49. Documented process for management of the use of alternate control methods (clause 8.5.6.1.1)
50. Record of conformity of product/service with acceptance criteria (clause 8.6)
51. Record of expiration date or quantity authorized under concession (clause 8.7.1.1)
52. Documented process for rework confirmation (clause 8.7.1.4)
53. Record on disposition of reworked product (clause 8.7.1.4)
54. Documented process for repair confirmation (clause 8.7.1.5)
55. Record of customer authorization for concession of the product to be repaired (clause 8.7.1.5)
56. Notification to the customer about the nonconformity (clause 8.7.1.6)
57. Documented process for disposition of nonconforming product (clause 8.7.1.7)
58. Record of nonconforming outputs (clause 8.7.2)
59. Monitoring and measurement results (clause 9.1.1)
60. Internal audit program (clause 9.2)
61. Results of internal audits (clause 9.2)
62. Documented internal audit process (clause 9.2.2.1)
63. Results of the management review (clause 9.3)
64. Action plan when customer performance targets are not met (clause 9.3.3.1)
65. Results of corrective actions (clause 10.1)
66. Documented process for problem solving (clause 10.2.3)
67. Documented process to determine the use of error-proofing methodologies (clause 10.2.4)
68. Documented process for continual improvement (clause 10.3.1)