Mandatory Documents IATF 16949

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Of the 28 main sections of ISO 9001:2015, the IATF 16949 Standard adds requirements under 22 of them.

Section Section Title Topic of Additional Requriements

4 Context of the organization

4.1

ü

4.2

ü

4.3

ü

4.4

ü

Conformance of products and processes, Product safety

5 Leadership

5.1

ü

5.2 Policy

ü

5.3

ü

6 Planning

6.1

ü

Risk analysis, Preventative action, Contingency plans

6.2

ü

Quality objectives - Supplemental

6.3 Planning of changes

ü

7 Support 7.1 Resources

ü

7.2 Competence

ü

7.3 Awareness

ü

7.4 Communnication

ü

ISO 9001:2015 Reqt. IATF 16949 Additions Understanding the

organization and its context Understanding the needs and expectations of interested parties Determining the scope of the qualiity management system

Determining the scope - Supplemental, Customer specific requirements

Quality management system and its processes Leadership

commitment Corporate responsibility,Process effectiveness and efficiency, Process owners, Customer focus

Organizational roles, responsibilites and authorities

Organizational roles - Supplemental, Responsibility and authority for product requirements and corrective action

Actions to address risks and opportunities Quality objectives and planning to achieve them

Plant, facility, and equipment planning, Environment for the operation of processes, Environment for the operation of processes, Measurement systems analysis, Measurement traceability, Calibration/verification records, Laboratory requirements

Compentence - Supplemental, On-the job training, Internal auditor competency, Second-party auditor compency Awareness - Supplemental, Employee motivation and empowerment

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7.5

ü

8 Operation

8.1

ü

Operational planning - Supplemental, Confidentiality

8.2

ü

8.3

ü

8.4

ü

8.5

ü

8.6

ü

Documented

Information Quality management system documentation, Record retention, Engineering specifications

Operational planning and control

Requirements for products and services

Customer communication - Supplemental, Determining the requirements -Supplemental, Customer - designated special charateristics, Organization manufacturing feasibility

Design and development of products and services

Design and development - Supplemental, Design planning - Supplemental, Product design skills, Development of products with embedded software, Product design input, Manufacturing process design input, Special characteristics, Monitoring, Design and development validation, Prototype program, Product approval process, Design and development outputs,

Manufacturing process design output, Design and development changes - Supplemental

Control of externally provided processes, products and services

General - Supplemental, Supplier selection process, Customer-directed sources, Control - Supplemental, Statutory and regulatory requirements, Supplier quality management system development, Automotive product- related software, Supplier monitoring, Second-party audits, Supplier development, External providers - Supplemental

Production and service provision

Control plan, Standardized work, Verification of job set-up, Verification after shutdown, Total productive maintenance, Management of production tooling, Production scheduling, Identification and traceability - Supplemental, Preservation - Supplemental, Feedback from service, Service agreement with customer, Control of changes - Supplemental, Temporary change of process controls

Release of products and services

Release - Supplemental, Layout inspection and functional testing, Appearance items, Verification of conformity of externally provided products and services, Statutory and regulatory conformity, Acceptance criteria

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8.7

ü

9 9.1

ü

9.2 Internal audit

ü

9.3 Management review

ü

10 Improvement 10.1 General

ü

10.2

ü

10.3

ü

Continual improvement - Supplemental

Control of nonconforming outputs

Customer authorization for concession, Customer specified process, Control of suspect product, Control of reworked product, Control of repaired product, Customer notification, Nonconforming product disposition

Performance evaluation Monitoring, measurement, analysis and evaluation

Monitoring and measurement of manufacturing processes, Identification of statistical tools, Application of statistical concepts, Customer satisfaction - Supplemental, Prioritization

Internal audit program, Quality management system audit, Manufacturing process audit, Product audit

Management review - Supplemental, Managemennt review inputs - Suppliemental, Management review outputs - Supplemental

Nonconformity and

corrective action Problem solving, Error-proofing, Warranty management systems, Customer complaints and field failure test analysis Continual

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Mandatory documents and records required by IATF 16949:2016

S.No List of Mandatory documents Clause

1 Scope of the quality management system (clause 4.3) 4.3

2 4.4.1.2

3 Quality policy (clause 5.2) 5.2

4 5.3.1

5 Results of risk analysis (clause 6.1.2.1) 6.1.2.1 6 Preventive action record (clause 6.1.2.2) 6.1.2.2

7 Contingency plan (clause 6.1.2.3) 6.1.23

8 Quality objectives (clause 6.2) 6.2

9 7.1.5.2.1

10 7.1.5.2.1

11 Maintenance and calibration record (clause 7.1.5.2.1) 7.1.5.2.1

12 7.2.1

13 7.2.3

14 List of qualified internal auditors (clause 7.2.3) 7.2.3 15 Documented information on trainer’s competency (clause 7.2.3) 7.2.3 16 Documented information on employee’s awareness (clause 7.3.1) 7.3.1 17 Documented process to motivate employees (clause 7.3.2) 7.3.2

18 Quality manual (clause 7.5.1.1) 7.5.1.1

19 Record retention policy (clause 7.5.3.2.1) 7.5.3.2.1

20 7.5.3.2.2

21 Registry of customer complaints (clause 8.2) 8.2 22 Product/service requirements review records (clause 8.2.3.2) 8.2.3.2 23 Procedure for design and development (clause 8.3.1.1) 8.3.1.1 24 Record about design and development outputs review (clause 8.3.2) 8.3.2

25 8.3.2.3

26 Records about product design and development inputs (clause 8.3.3.1) 8.3.3.1

27 8.3.3.2

28 Document a process to identify special characteristics (clause 8.3.3.3) 8.3.3.3 29 Records of design and development controls (clause 8.3.4) 8.3.4 30 Documented product approval (clause 8.3.4.4) 8.3.4.4 31 Records of design and development outputs (clause 8.3.5) 8.3.5 32 Manufacturing process design output (clause 8.3.5.2) 8.3.5.2 33 Design and development changes records (clause 8.3.6) 8.3.6

34 8.3.6.1

35 8.3.6.1

36 Documented supplier selection process (clause 8.4.1.2) 8.4.1.2

Documented information Procedure/Recor

d

Documented process for the management of product safety related products and manufacturing processes (clause 4.4.1.2)

Responsibilities and authorities to ensure that customer requirements are met (clause 5.3.1)

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)

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)

Documented process for review, distribution and implementation of customer engineering standards/specifications (clause 7.5.3.2.2)

Documented information on software development capability self-assessment (clause 8.3.2.3)

Records about manufacturing process design input requirements (clause 8.3.3.2)

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)

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37 8.4.2.1

38 8.4.2.2

39 Documented process and criteria for supplier evaluation (clause 8.4.2.4) 8.4.2.4 40 Records of second-party audit reports (clause 8.4.2.4.1) 8.4.2.4.1

41 8.5.1

42 Control plan (8.5.1.1) 8.5.1.1

43 Total productive maintenance system (clause 8.5.1.5) 8.5.1.5 44 Records of traceability (clause 8.5.2.1) 8.5.2.1 45 Records about customer property (clause 8.5.3) 8.5.3 46 Production/service provision change control records (clause 8.5.6) 8.5.6

47 8.5.6.1

48 8.8.5.6.1

49 8.5.6.1.1

50 8.6

51 8.7.1.1

52 Documented process for rework confirmation (clause 8.7.1.4) 8.7.1.4 53 Record on disposition of reworked product (clause 8.7.1.4) 8.7.1.4 54 Documented process for repair confirmation (clause 8.7.1.5) 8.7.1.5

55 8.7.1.5

56 Notification to the customer about the nonconformity (clause 8.7.1.6) 8.7.1.6

57 8.7.1.7

58 Record of nonconforming outputs (clause 8.7.2) 8.7.2 59 Monitoring and measurement results (clause 9.1.1) 9.1.1

60 Internal audit program (clause 9.2) 9.2

61 Results of internal audits (clause 9.2) 9.2 62 Documented internal audit process (clause 9.2.2.1) 9.2.2.1 63 Results of the management review (clause 9.3) 9.3 64 Action plan when customer performance targets are not met (clause 9.3.3.1) 9.3.3.1 65 Results of corrective actions (clause 10.1) 10.1 66 Documented process for problem solving (clause 10.2.3) 10.2.3

67 10.2.4

68 Documented process for continual improvement (clause 10.3.1) 10.3.1 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 and services (clause 8.4.2.2)

Characteristics of product to be produced and service to be provided (clause 8.5.1)

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 8.8.5.6.1)

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)

Record of customer authorization for concession of the product to be repaired (clause 8.7.1.5)

Documented process for disposition of nonconforming product (clause 8.7.1.7)

Documented process to determine the use of error-proofing methodologies (clause 10.2.4)

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List of mandatory documents & records required by ISO 14001:2015

S.No

Description

1 2 3 4 5 6 7 8 9

Mandatory records:

1 2 3 4 5 6 7 8

Non-mandatory documents

1 2 3 4 5 6 7 8

Scope of the EMS (clause 4.3) Environmental policy (clause 5.2)

Risk and opportunities to be addressed and processes needed (clause 6.1.1) Criteria for evaluation of significant environmental aspects (clause 6.1.2) Environmental aspects with associated environmental impacts (clause 6.1.2) Significant environmental aspects (clause 6.1.2)

Environmental objectives and plans for achieving them (clause 6.2) Operational control (clause 8.1)

Emergency preparedness and response (clause 8.2)

Compliance obligations record (clause 6.1.3)

Records of training, skills, experience and qualifications (clause 7.2) Evidence of communication (clause 7.4)

Monitoring and measurement results (clause 9.1.1) Internal audit program (clause 9.2)

Results of internal audits (clause 9.2)

Results of the management review (clause 9.3) Results of corrective actions (clause 10.1)

Procedure for determining context of the organization and interested parties (clauses 4.1 and

4.2)

Procedure for identification and evaluation of environmental aspects and risks (clauses 6.1.1

and 6.1.2)

Competence, training and awareness procedure (clauses 7.2 and 7.3) Procedure for communication (clause 7.4)

Procedure for document and record control (clause 7.5) Procedure for internal audit (clause 9.2)

Procedure for management review (clause 9.3)

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ISO/TS 16949

IATF 16949

Clause Descriptions Clause

1 Scope 1

2 Normative references 2

3 Terms & Definitions 3

4 Quality management system 4

6

5 Management responsibility 5

6 Resource management 7

7 Product realization 8

8 Measurement, analysis, and improvement 9 10

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IATF 16949

Descriptions

Scope 1

Normative references 2

Terms & Definitions 3

Context of the organization 4

Planning 4 Leadership 5 Support 6 Operation 7 Performance evaluation 8 Improvement 8 Previous clause

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ISO/TS 16949

IATF 16949

Clause Descriptions Clause

1 Scope 1

2 Normative references 2

3 Terms & Definitions 3

4 Quality management system 4

5 Management responsibility 5

6 Resource management 6

7 Product realization 7

8 Measurement, analysis, and improvement 8 9 10

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IATF 16949

Descriptions

Scope 1

Normative references 2

Terms & Definitions 3

Context of the organization 4

Leadership 5 Planning 4 Support 6 Operation 7 Performance evaluation 8 Improvement 8 Previous clause