Documentation Required by IATF 16949 (Automotive QMS)

[O'Leary]

Here is a list of the required documents for IATF 16949. This was sent to me from our registrar.

I hope this helps.

 

[risk_experts]

Thank you.

 

[risk_experts]

Here is a list of the required documents for IATF 16949. This List was published the registrar SRI.

 

[ly song]

it's a good standpoint

 

[Sherry Gill]

1. I thought the forum disappeared - so glad it's back!
2. I use a QMS database to document much of the required information related to required documentation; e.g., corrective actions and other problem-solving activities, training/competency, PPAP, control plans, change control, audits, etc. We also have an electronic traceability system (MES) to track manufacturing batch information.

I do NOT have a specific documented process for product safety, although applicable requirements are embedded in the product planning information (forms). I also am not sure that we are sufficiently documenting reworked products. Any suggestions on this?

My quality manual expanded from 2 pages to 6 with the new standard, mainly due to extra document citations to cover all of the requirements I found.

 

[Edustrial]

Guys.

I have attached a file that shows a clear image of the comparison between TS and IATF.


Enjoy and spread...

 

[techlady]

I have went through both ISO9001 and IATF16949 here is a list of 68 areas that are required as "documented processes" and the necessary evidence of "documented information" with associated clauses that your 3rd party auditor will be looking for when you go through your Transition Audit.

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 8.8.5.6.1)
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)

 

[dnapier]

I have attached the form that our CB sent showing the IATF required documented processes.

They also stated the these processes must:

• Be Documented
• Have inputs and outputs
• Be measured for effectiveness

They also stated that the IAOB has taken position that failure to do the items above, should result in a major nonconformance.

View attachment Copy of Documented-Processes.xlsx

 

[rkk2014]

I have a question about implementation part, have identified organization issues, interested parties, their requirements, developed risk analysis for every process. Now I am stuck up what to do next. Can anyone help on macro level structure of IATF 16949. We are already ISo/ TS certified company, preparing for IATF 16949

 

[Blaest]

They also stated the these processes must:

• Be Documented
• Have inputs and outputs
• Be measured for effectiveness

Meassure for effectiveness and efficiency goes for [FONT=&quot]product realization processes [/FONT][FONT=&quot]and support processes according to clause 5.1.1.2[/FONT]
[FONT=&quot]According to clause 9.2.2.2 there is a reference to [FONT=&quot]quality management system processes, which leaves us with 3 kind of processes.[/FONT][/FONT]
[FONT=&quot][FONT=&quot]Could you argue that clause 8.4.2.4 Supplier Monitoring (and maybe others) would be a [/FONT][/FONT][FONT=&quot][FONT=&quot]quality management system process and hence not necessary to measure for effectiveness?[/FONT][/FONT]