Mandatory Documents IATF 16949

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

4 4.1 4.2 4.3 4.4 5

Section Title

ISO 9001:2015 Reqt.

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

IATF 16949 Additions

Topic of Additional Requriements

ü ü ü

ü

Determining the scope - Supplemental, Customer specific requirements

ü

ü

Conformance of products and processes, Product safety

ü

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

5.1

Leadership commitment

ü

5.2

Policy

ü

5.3

Organizational roles, responsibilites and authorities

ü

ü

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

ü

ü

Risk analysis, Preventative action, Contingency plans

ü ü

ü

Quality objectives - Supplemental

6 6.1 6.2 6.3 7

Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Support

7.1

Resources

ü

ü

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

7.2

Competence

ü

ü

Compentence - Supplemental, On-the job training, Internal auditor competency, Second-party auditor compency

7.3

Awareness

ü

Awareness - Supplemental, Employee motivation and empowerment

7.4

Communnication

ü ü

7.5

Documented Information

8

Operation

8.1

Operational planning and control

8.2

Requirements for products and services

8.3

8.4

Design and development of products and services

Control of externally provided processes, products and services

8.5

Production and service provision

8.6

Release of products and services

ü

ü

Quality management system documentation, Record retention, Engineering specifications

ü

ü

Operational planning - Supplemental, Confidentiality

ü

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

ü

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

ü

General - Supplemental, Supplier selection process, Customerdirected 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

ü

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

ü

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

ü

ü

ü

ü

ü

8.7

9

Control of nonconforming outputs

ü

ü

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

9.1

Monitoring, measurement, analysis and evaluation

ü

ü

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

9.2

Internal audit

ü

ü

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

9.3

Management review

ü

ü

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

10 10.1

Improvement General

ü

10.2

Nonconformity and corrective action

ü

ü

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

10.3

Continual improvement

ü

ü

Continual improvement - Supplemental

Mandatory documents and records required by IATF 16949:2016 S.No

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

List of Mandatory documents

Clause

Scope of the quality management system (clause 4.3) 4.3 Documented process for the management of product safety related products 4.4.1.2 and manufacturing processes (clause 4.4.1.2) Quality policy (clause 5.2) 5.2 Responsibilities and authorities to ensure that customer requirements are 5.3.1 met (clause 5.3.1) Results of risk analysis (clause 6.1.2.1) 6.1.2.1 Preventive action record (clause 6.1.2.2) 6.1.2.2 Contingency plan (clause 6.1.2.3) 6.1.23 Quality objectives (clause 6.2) 6.2 Records of customer acceptance of alternative measurement methods 7.1.5.2.1 (clause 7.1.5.1.1) Documented process for managing calibration/verification records (clause 7.1.5.2.1 7.1.5.2.1) Maintenance and calibration record (clause 7.1.5.2.1) 7.1.5.2.1 Documented process for identification of training needs including 7.2.1 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 (clause 7.5.3.2.2) 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 selfassessment (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)

7.2.3 7.2.3 7.2.3 7.3.1 7.3.2 7.5.1.1 7.5.3.2.1 7.5.3.2.2 8.2 8.2.3.2 8.3.1.1 8.3.2 8.3.2.3 8.3.3.1 8.3.3.2 8.3.3.3 8.3.4 8.3.4.4 8.3.5 8.3.5.2 8.3.6 8.3.6.1 8.3.6.1 8.4.1.2

Documented information Procedure/Recor d

37

Documented process to identify and control externally provided processes, 8.4.2.1 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) 8.4.2.2

39

Documented process and criteria for supplier evaluation (clause 8.4.2.4)

40

47

Records of second-party audit reports (clause 8.4.2.4.1) 8.4.2.4.1 Characteristics of product to be produced and service to be provided (clause 8.5.1 8.5.1) Control plan (8.5.1.1) 8.5.1.1 Total productive maintenance system (clause 8.5.1.5) 8.5.1.5 Records of traceability (clause 8.5.2.1) 8.5.2.1 Records about customer property (clause 8.5.3) 8.5.3 Production/service provision change control records (clause 8.5.6) 8.5.6 Documented process to control and react to changes in product realization 8.5.6.1 (clause 8.5.6.1)

48

Documented approval by the customer prior to implementation of the change (clause 8.8.5.6.1)

8.8.5.6.1

49

Documented process for management of the use of alternate control methods (clause 8.5.6.1.1)

8.5.6.1.1

50

Record of conformity of product/service with acceptance criteria (clause 8.6)

8.6

51

8.7.1.1

58 59 60 61 62 63

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)

64

Action plan when customer performance targets are not met (clause 9.3.3.1) 9.3.3.1

65 66

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)

41 42 43 44 45 46

52 53 54 55 56 57

67 68

8.4.2.4

8.7.1.4 8.7.1.4 8.7.1.5 8.7.1.5 8.7.1.6 8.7.1.7 8.7.2 9.1.1 9.2 9.2 9.2.2.1 9.3

10.1 10.2.3 10.2.4 10.3.1

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

Description

S.No 1

Scope of the EMS (clause 4.3)

2

Environmental policy (clause 5.2)

3

Risk and opportunities to be addressed and processes needed (clause 6.1.1)

4

Criteria for evaluation of significant environmental aspects (clause 6.1.2)

5

Environmental aspects with associated environmental impacts (clause 6.1.2)

6

Significant environmental aspects (clause 6.1.2)

7

Environmental objectives and plans for achieving them (clause 6.2)

8

Operational control (clause 8.1)

9

Emergency preparedness and response (clause 8.2)

Mandatory records: 1

Compliance obligations record (clause 6.1.3)

2

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

3

Evidence of communication (clause 7.4)

4

Monitoring and measurement results (clause 9.1.1)

5

Internal audit program (clause 9.2)

6

Results of internal audits (clause 9.2)

7

Results of the management review (clause 9.3)

8

Results of corrective actions (clause 10.1)

Non-mandatory documents 1

Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2)

2

Procedure for identification and evaluation of environmental aspects and risks (clauses 6.1.1 and 6.1.2)

3

Competence, training and awareness procedure (clauses 7.2 and 7.3)

4

Procedure for communication (clause 7.4)

5

Procedure for document and record control (clause 7.5)

6

Procedure for internal audit (clause 9.2)

7

Procedure for management review (clause 9.3)

8

Procedure for management of nonconformities and corrective actions (clause 10.2)

ISO/TS 16949 Clause

Descriptions

IATF 16949 Clause

1

Scope

1

2

Normative references

2

3

Terms & Definitions

3 4

4

Quality management system

5

Management responsibility

5

6

Resource management

7

7

Product realization

8

8

Measurement, analysis, and improvement

6

9 10

IATF 16949 Descriptions

Previous clause

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

ISO/TS 16949 Clause

Descriptions

IATF 16949 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

IATF 16949 Descriptions

Previous clause

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