Mandatory documents and records required by IATF 16949:2016

Department Document reff. at

Sr.no Name Clause No format responsible ICL Status
1 Scope of the quality management system 4.3 Document
Documented process for the management of product safety related products and
2 manufacturing processes 4.4.1.2 Procedure
3 Quality policy 5.2 Document
4 Responsibilities and authorities to ensure that customer requirements are met 5.3.1 Document
5 Results of risk analysis 6.1.2.1 Document
Document
6 Preventive action record 6.1.2.2 /Record
Document
7 Contingency plan 6.1.2.3 /Record
Document
8 Quality objectives 6.2 /Record
Document
9 Records of customer acceptance of alternative measurement methods 7.1.5.1.1 /Record
10 Documented process for managing calibration/verification records 7.1.5.2.1 Record/doc
11 Maintenance and calibration record 7.1.5.2.1 Record/doc
Documented process for identification of training needs including awareness and
12 achieving awareness 7.2.1 Procedure
13 Documented process to verify competence of internal auditors 7.2.3 Procedure
14 List of qualified internal auditors 7.2.3 Record/doc
15 Documented information on trainer’s competency 7.2.3 Record/doc
16 Documented information on employee’s awareness 7.3.1 Record/doc
17 Documented process to motivate employees 7.3.2 Record/doc
18 Quality manual 7.5.1.1 Document
19 Record retention policy 7.5.3.2.1 record/doc
Documented process for review, distribution and implementation of customer
20 engineering standards/specifications 7.5.3.2.2 Procedure
21 Registry of customer complaints 8.2
22 Product/service requirements review records 8.2.3.2
23 Procedure for design and development 8.3.1.1 Procedure
Document/
24 Record about design and development outputs review 8.3.2 Record
Document/
25 Documented information on software development capability self-assessment 8.3.2.3 Record
Document/
26 Records about product design and development inputs 8.3.3.1 Record
Document/
27 Records about manufacturing process design input requirements 8.3.3.2 Record
28 Document a process to identify special characteristics 8.3.3.3 Procedure
Document/
29 Records of design and development controls 8.3.4 Record
Document/
30 Documented product approval 8.3.4.4 Record
Document/
31 Records of design and development outputs 8.3.5 Record
Document/
32 Manufacturing process design output 8.3.5.2 Record
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33 Design and development changes records 8.3.6 Record
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34 Documented approval or waiver of the customer regarding the changes in design 8.3.6.1 Record
Document/
35 Documented revision level of software and hardware as part of the change record 8.3.6.1 Record
36 Documented supplier selection process 8.4.1.2 Procedure
Documented process to identify and control externally provided processes,
37 products and services 8.4.2.1 Procedure
Documented process to ensure compliance with statutory and regulatory requirements
38 of purchased processes, products and services 8.4.2.2 Procedure
39 Documented process and criteria for supplier evaluation 8.4.2.4 Procedure
 Document/
40 Records of second-party audit reports 8.4.2.4.1 Record
Document/
41 Characteristics of product to be produced and service to be provided 8.5.1 Record
Document/
42 Control plan 8.5.1.1 Record
Document/
43 Total productive maintenance system 8.5.1.5 Record
44 Records of traceability 8.5.2.1 Procedure
Document/
45 Records about customer property 8.5.3 Record
Document/
46 Production/service provision change control records 8.5.6 Record
47 Documented process to control and react to changes in product realization 8.5.6.1 Procedure
48 Documented approval by the customer prior to implementation of the change 8.5.6.1 Procedure
49 Documented process for management of the use of alternate control methods 8.5.6.1.1 Procedure
Document/
50 Record of conformity of product/service with acceptance criteria 8.6 Record
Document/
51 Record of expiration date or quantity authorized under concession 8.7.1.1 Record
52 Documented process for rework confirmation 8.7.1.4 Procedure
Document/
53 Record on disposition of reworked product 8.7.1.4 Record
54 Documented process for repair confirmation 8.7.1.5 Procedure
Document/
55 Record of customer authorization for concession of the product to be repaired 8.7.1.5 Record
Document/
56 Notification to the customer about the nonconformity 8.7.1.6 Record
57 Documented process for disposition of nonconforming product 8.7.1.7 Procedure
Document/
58 Record of nonconforming outputs 8.7.2 Record
 Document/
59 Monitoring and measurement results 9.1.1 Record
Document/
60 Internal audit program 9.2 Record
Document/
61 Results of internal audits 9.2 Record
62 Documented internal audit process 9.2.2.1 Procedure
Document/
63 Results of the management review 9.3 Record
Document/
64 Action plan when customer performance targets are not met 9.3.3.1 Record
Document/
65 Results of corrective actions 10.1 Record
66 Documented process for problem solving 10.2.3 Procedure
67 Documented process to determine the use of error-proofing methodologies 10.2.4 Procedure
68 Documented process for continual improvement 10.3.1 Procedure
Documented process for the management of product safety related products and manufacturing processes (clause 4.4.1.2
Quality policy (clause 5.2)
Responsibilities and authorities to ensure that customer requirements are met (clause 5.3.1)
Results of risk analysis (clause 6.1.2.1)
Preventive action record (clause 6.1.2.2)
Contingency plan (clause 6.1.2.3)
Quality objectives (clause 6.2)
Records of customer acceptance of alternative measurement methods (clause 7.1.5.1.1)
Documented process for managing calibration/verification records (clause 7.1.5.2.1)
Maintenance and calibration record (clause 7.1.5.2.1)
Documented process for identification of training needs including awareness and achieving awareness (clause 7.2.1)
Documented process to verify competence of internal auditors (clause 7.2.3)
List of qualified internal auditors (clause 7.2.3)
Documented information on trainer’s competency (clause 7.2.3)
Documented information on employee’s awareness (clause 7.3.1)
Documented process to motivate employees (clause 7.3.2)
Quality manual (clause 7.5.1.1)
Record retention policy (clause 7.5.3.2.1)
Documented process for review, distribution and implementation of customer engineering standards/specifications (clau
Registry of customer complaints (clause 8.2)
Product/service requirements review records (clause 8.2.3.2)
Procedure for design and development (clause 8.3.1.1)
Record about design and development outputs review (clause 8.3.2)
Documented information on software development capability self-assessment (clause 8.3.2.3)
Records about product design and development inputs (clause 8.3.3.1)
Records about manufacturing process design input requirements (clause 8.3.3.2)
Document a process to identify special characteristics (clause 8.3.3.3)
Records of design and development controls (clause 8.3.4)
Documented product approval (clause 8.3.4.4)
Records of design and development outputs (clause 8.3.5)
Manufacturing process design output (clause 8.3.5.2)
Design and development changes records (clause 8.3.6)
Documented approval or waiver of the customer regarding the changes in design (clause 8.3.6.1)
Documented revision level of software and hardware as part of the change record (clause 8.3.6.1)
Documented supplier selection process (clause 8.4.1.2)
Documented process to identify and control externally provided processes, products and services (clause 8.4.2.1)
Documented process to ensure compliance with statutory and regulatory requirements of purchased processes, products
Documented process and criteria for supplier evaluation (clause 8.4.2.4)
Records of second-party audit reports (clause 8.4.2.4.1)
Characteristics of product to be produced and service to be provided (clause 8.5.1)
Control plan (8.5.1.1)
Total productive maintenance system (clause 8.5.1.5)
Records of traceability (clause 8.5.2.1)
Records about customer property (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Documented process to control and react to changes in product realization (clause 8.5.6.1)
Documented approval by the customer prior to implementation of the change (clause 8.5.6.1)
Documented process for management of the use of alternate control methods (clause 8.5.6.1.1)
Record of conformity of product/service with acceptance criteria (clause 8.6)
Record of expiration date or quantity authorized under concession (clause 8.7.1.1)
Documented process for rework confirmation (clause 8.7.1.4)
Record on disposition of reworked product (clause 8.7.1.4)
Documented process for repair confirmation (clause 8.7.1.5)
Record of customer authorization for concession of the product to be repaired (clause 8.7.1.5)
Notification to the customer about the nonconformity (clause 8.7.1.6)
Documented process for disposition of nonconforming product (clause 8.7.1.7)
Record of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Documented internal audit process (clause 9.2.2.1)
Results of the management review (clause 9.3)
Action plan when customer performance targets are not met (clause 9.3.3.1)
Results of corrective actions (clause 10.1)
Documented process for problem solving (clause 10.2.3)
Documented process to determine the use of error-proofing methodologies (clause 10.2.4)
Documented process for continual improvement (clause 10.3.1)