Checklist of Mandatory Documentation as per IATF 16949:2016

List of Mandatory Documented Process

S.No. Documented Process Clause Number Reference Clause Detail

Documented Process for management of product safety The organization shall have documented processes for the management of product-
1 4.4.1.2 Product Safety
related to Products and manufacturing processes safety related products and manufacturing processes

Documented Process for Managing Calibration / Verification 7.1.5.2.1 Calibration / verification The organization shall have a documented process for managing calibration /
2
records records verification records.

The organization shall establish and maintain a documented process(es) for identifying
Documented Process for Identification of training needs
training needs including awareness (see section 7.3.1) and achieving competence of all
3 including awareness and competency (7.2.1) 7.2.1 Competence - supplement
personnel performing activities affecting conformity to product and process
requirements.

The organization shall have a documented process(es) to verify that internal auditors
4 Documented Process to verify Internal auditors competency 7.2.3 Internal auditor competency
are competent, taking into account any customer-specific requirements.

The organization shall maintain a documented process(es) to motivate employees to

7.3.2 Employee motivation and achieve quality objectives, to make continual improvements, and to create an
5 Documented Process for employee motivation
empowerment environment that promotes innovation.

Documented Process for review, distribution and The organization shall have a documented process describing the review, distribution,
6 implementation of customer engineering 7.5.3.2.2 Engineering specifications and implementation of all customer engineering standards/specifications and related
standards/specification revisions based on customer schedules, as required.
The organization shall document the design and development process.
8.3.1.1 Design and development of
7 Documented Process for design & development
products and services - supplemental

The organization shall use a multidisciplinary approach to establish, document, and

8 Documented Process to identify the special characteristics 8.3.3.3 Special characteristics
implement its process(es) to identify special characteristics

9 Documented Supplier Selection Process 8.4.1.2 Supplier selection process The organization shall have a documented supplier selection process.

The organization shall have a documented process to identify outsourced processes

Documented Process to identify and control to verify
8.4.2.1 Type and extent of control - and to select the types and extent of controls used to verify conformity of externally
10 conformity of externally provided products, processes and
supplemental provided products, processes, and services to internal (organizational) and external
services
customer requirements.

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List of Mandatory Documented Process … Continued

S.No. Documented Process Clause Number Reference Clause Detail

The organization shall document their process to ensure that purchased products,
Documented Process to ensure the compliance of statutory
8.4.2.2 Statutory and regulatory processes, and services conform to the current applicable statutory and regulatory
11 and regulatory requirements for purchased products,
requirements requirements in the country of receipt, the country of shipment, and the customer-
process and services
identified country of destination, if provided.
The organization shall have a documented process and criteria to evaluate supplier
Documented Process and criteria to evaluate supplier
12 8.4.2.4 Supplier monitoring performance in order to ensure conformity of externally provided products, processes,
performance
and services to internal and external customer requirements.

Documented Process to control and reacts to changes in the 8.5.6.1 Control of changes - The organization shall have a documented process to control and react to changes
13
product realization supplemental that impact product realization.

Documented Process to manage the use of alternate control 8.5.6.1.1 Temporary change of process The organization shall document the process that manages the use of alternate
14
methods controls control methods.

The organization shall have a documented process for rework confirmation in

15 Documented Process control of rework confirmation 8.7.1.4 Control of reworked product accordance with the control plan or other relevant documented information to verify
compliance to original specifications.

The organization shall have a documented process for repair confirmation in

16 Documented Process for control of repair confirmation 8.7.1.5 Control of repaired product
accordance with the control plan or other relevant documented information.

Documented Process for disposition of nonconfirming 8.7.1.7 Nonconforming product The organization shall have a documented process for disposition of nonconforming
17
product disposition product not subject to rework or repair.

18 Documented internal audit process 9.2.2.1 Internal audit programme The organization shall have a documented internal audit process.

19 Documented process for problem solving 10.2.3 Problem solving The organization shall have a documented process(es) for problem solving

Documented process to determine the use of appropriate The organization shall have a documented process to determine the use of
20 10.2.4 Error-proofing
error-proofing methodologies appropriate error-proofing methodologies.

10.3.1 Continual improvement-

21 Documented Process for continual improvement The organization shall have a documented process for continual improvement.
supplemental

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List of Non-Mandatory Documented Process

S.No. Documented Process Clause Number Reference Clause Detail

4.1 Understanding the organization & it's The organization shall determine external and internal issues that are relevant to its
Documented Process for determining the context of the context purpose and its strategic direction
1
organization and Interested Parties
4.2 Understanding the needs and The organization shall determine the a) interested parties that are relevant to the
Determine the risk and opportunities that need to be addressed .. The organization
6.1 Actions to address risk and shall plan a) action to address these risk and opportunites, b) how to : 1) integrate and
2 Documented Process for addressing risk & opportunities
opportunities implement the actions into its quality management system processes, 2) evaluate the
effectiveness of these actions.

An organization's internal laboratory facility shall have a defined scope that includes its
3 Documented Process for laboratory management 7.5.1.3 Laboratory requirements
capability to perform the required inspection, test, or calibration services.

The organization shall include a second-party audit process in their supplier

4 Documented Process for second-party audits 8.4.2.4.1 Second-party audits
management approach.

The organization shall develop, implement, and maintain a documented total

5 Documented Process for Equipment Maintenance 8.5.1.5 Total productive maintenance
productive maintenance system.

8.5.1.6 Management of production

The organization shall establish and implement a system for production tooling
6 Documented Process for Tooling Management tooling and manufacturing, test,
management, whether owned by the organization or the customer.
inspection tooling and equipment

8.6.4 Verification and acceptance of

Documented Process for verification and acceptance of The organization shall have a process to ensure the quality of externally provided
7 conformity of externally provided
conformity of externally provided products and services processes, products, and services
products and services

The organization shall monitor customers perception of the degree to which their
8 Documented Process for customer satisfaction monitoring 9.1.2 Customer Satisfaction
needs and expectations have been fulfilled.

Top Management shall review the organizations quality management systems, at

9 Documented Process for management review 9.3 Management Review
planned interval

When the organization is required to provide warranty for their product(s), the
10 Documented Process for warranty management process 10.2.5 Warranty management systems
organization shall implement a warranty management process.

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List of Mandatory Documented Information - Documents

S.No. Document Name Clause Number Reference Clause Detail

The only permitted exclusion for this Automotive QMS Standard relates to the product
4.3 Determining the scope of the quality
1 Scope of QMS design and development requirements within ISO 9001, Section 8.3. The exclusion
management system
shall be justified and maintained as documented information
The organization shall define and implement corporate responsibility policies,
including at a minimum an anti-bribery policy, an employee code of conduct, and an
2 Corporate responsibility policies 5.1.1.1 Corporate responsibility
ethics escalation policy ("whistle-blowing policy").

3 Quality policy 5.2 quality policy be available and be maintained as documented information

5.3.1 Organizational roles,

Top management shall assign personnel with responsibility and authority to ensure
4 Roles & responsibilities responsibilities and authorities -
that customer requirements are met. These assignments shall be documented.
supplemental

6.2 Quality objectives and planning to

5 Quality objectives and action plan for quality objectives The organization shall maintain documented information on the quality objectives.
achieve them

External/commercial/independent laboratory facilities used for inspection, test, or

6 Laboratory scope 7.1.5.3.2 External laboratory calibration services by the organization shall have defined laboratory scope that
includes the capability to perform the required inspection, test, or calibration

The organization shall determine the knowledge necessary for the operation of its
7 Organization knowledge (library, standards, trainings, LMS) 7.1.6 Organizational knowledge processes and to achieve conformity of products and services. This knowledge shall be
maintained and be made available to the extent necessary.

8 List of qualified internal auditors 7.2.3 Internal auditor competency The organization shall maintain a list of qualified internal auditors

The organization shall maintain documented information that demonstrates that all
employees are aware of their impact on product quality and the importance of their
9 Employee awareness (control plan, fmea, work instruction) 7.3.1 Awareness - supplemental
activities in achieving, maintaining, and improving quality, including customer
requirements and the risks involved for the customer with nonconforming product.
document (i.e. matrix) indicating where within the organization's quality management
10 Customer specific requirement matrix 7.5.1.1 Quality Manual system their customer specific requirements are addressed, process interaction,
reference to list of organization process

11 Record retention policy 7.5.3.2.1 Record retention The organization shall define, document and implement a record retention policy

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List of Mandatory Documented Information - Documents …. Continued

S.No. Document Name Clause Number Reference Clause Detail

documentation of all special characteristics in the drawings (as required), risk analysis
12 List of special characteristics 8.3.3.3 Special characteristics
(such as FMEA), control plans, and standard work/operator instructions

The organization shall conform to customer requirements for designation, approval

8.2.3.1.2 Customer-designated special documentation, and control of special characteristics.
13 Customer designated special characteristics
characteristics

The organization shall develop control plans at the system, subsystem, component
14 Control plan 8.5.1.1 Control plan and/or material level for the relevant manufacturing site and all product supplied,
including those for processes producing bulk materials as well as parts.

8.5.1.2 Standardized work - operator

15 Work Instructions The standardized work documents shall also include rules for operator safety.
instructions and visual standards

16 Maintenance objectives 8.5.1.5 Total productive maintenance documented maintenance objective

8.5.1.6 Management of production

tool design modification documentation, including engineering change level of the
17 Tool design tooling and manufacturing, test,
product; tool modification and revision to documentation
inspection tooling and equipment

The organization shall identify, document, and maintain a list of the process controls,
8.5.6.1.1 Temporary change of process
18 list of alternate process control / method including inspection, measuring, test, and error-proofing devices, that includes the
controls
primary process control and the approved back-up or alternate methods.
documented information to verify compliance to original specifications.
19 Control plan / drawings, work instruction 8.7.1.4 Control of reworked product
Instruction for disassembly or rework, including re-inspection and traceability
requirements, shall be accessible and utilized by the appropriate personnel
repair confirmation in accordance with the control plan or other relevant documented
information
20 Control Plan, work instruction 8.7.1.5 Control of repaired product
Instruction for disassembly or rework, including re-inspection and traceability

The organization shall conduct internal audits at planned intervals to provide

21 Internal Audit Plan with scope and critieria 9.2 Internal audit
information

reviewing and, where necessary, updating the appropriate documented information

22 Control Plan, FMEA 10.2.3 Problem solving
(e.g., PFMEA, control plan).

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List of Mandatory Documented Information - Records

S.No. Records Name Clause Number Reference Clause Detail

The organization shall retain documented information as evidence of the results of

1 Risk analysis 6.1.2.1 Risk analysis
risk analysis.

2 Preventive action 6.1.2.2 Preventive action documented information of action taken & evaluate effectiveness

document the contingency plans and retain documented information describing any
3 Contingency plan 6.1.2.3 Contingency plans
revision(s), including the person(s) who authorized the change(s)

Records of customer acceptance of alternative methods shall be retained along with

4 MSA Study 7.1.5.1.1 Measurement systems analysis
results from alternative measurement systems analysis

the basis used for calibration or verification shall be retained as documented

5 Calibration Certificate of Master Equipment 7.1.5.2 Measurement traceability
information

The organization shall ensure that calibration / verification activities and records
7.1.5.2.1 Calibration / verification
6 Calibration / verification records of gauges and equipments
records records of the calibration and maintenance activities for all gauging (including
employee-owned equipment, customer-owned equipment, or on-site supplier-owned

7 Test reports, laboratory personnel competence 7.1.5.3.1 Internal laboratory review of related records

8 Training records, education, experience record 7.2 Competence retain appropriate documented information as evidence of competence.

If the organization's personnel provide the training to achieve competency,

List of qualified internal auditors, Internal trainer
9 7.2.3 Internal auditor competency documented information shall be retained to demonstrate the trainer's competency
competency records
with the above requirements.

Production part approval documented information may include product, applicable

10 Sample inspection reports, test records 7.5.3.2.1 Record retention
test equipment records, or approved test data.

The organization shall retain record of the date on which each change is implemented
11 Engineering change records 7.5.3.2.2 Engineering specifications
in production. Implementation shall include updated documents.

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List of Mandatory Documented Information - Records … Continued

S.No. Records Name Clause Number Reference Clause Detail

determining, maintaining and retaining documented information to the extent

necessary: 1.) to have confidence that the process have been carried out as planned:
12 Patrol inspection records, pre-dispatch inspection record 8.1 Operation planning and control
2.) to demonstrate the conformity of product and services for the organization's
operations.

Communication with customers shall include : Obtaining customer feedback related to

13 Customer complaints 8.2.1 Customer communication
product & services, including customer complaints

The organization shall retain documented information, as applicable : a) on the result

14 Contract review 8.2.3.2 No Tittle
of the review; b) on any new requirements of the product and services

8.2.3.1.1 Review of the requirements for

15 Customer deviation The organization shall retain documented evidence of a customer-authorized waiver
products and services - supplemental

Using prioritization based on risk and potential impact to the customer, the
8.3.2.3 Development of products with
16 software development capability self-assessment record organization shall retain documented information of a software development
embedded software
capability self-assessment.
The organization shall ensure that relevant documented information is amended, and
8.2.4 Changes to requirements for that relevant persons are made aware of the changed requirements, when the
17 Process / engineering change records
products and services requirements for products and services are changed.

the documented information needed to demonstrate that design and development

18 Design review records 8.3.2 Design and development planning
requirements have been met.

The organization shall retain documented information on design and development

19 Design review records 8.3.3 Design and development inputs
inputs.

The organization shall identify, document, and review product design input
20 Design review records 8.3.3.1 Product input
requirements as a result of contract review.

The organization shall identify, document, and review manufacturing process design
21 Manufacturing process input review 8.3.3.2 Manufacturing process input
input requirements

22 Design review, verification & validation records 8.3.4 Design and development controls documented information of these activities is retained.

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List of Mandatory Documented Information - Records … Continued

S.No. Records Name Clause Number Reference Clause Detail

The organization shall obtain documented product approval prior to shipment, if

23 Part submission warrant / product approval record 8.3.4.4 Product approval process
required by the customer.

The organization shall retain documented information on design and development

24 Design review records 8.3.5 Design and development outputs
outputs.

The organization shall document the manufacturing process design output in a manner
25 Manufacturing process output review 8.3.5.2 Manufacturing process output
that enables verification against the manufacturing process design inputs.

26 Engineering change records 8.3.6 Design and development changes The organization shall retain documented information

If required by the customer, the organization shall obtain documented approval, or a

Customer deviation, revision level of hardware / software in 8.3.6.1 Design and development changes - documented waiver, from the customer prior to production implementation.
27
change records (for embedded software only) supplemental
For products with embedded software, the organization shall document the revision
8.4 Control of external provided
The organization shall retain documented information for any necessary actions
28 Supplier audit / evaluation report processes, products and services / 8.4.1
arising from the evaluations.
General

8.4.2.3.1 Automotive product-related

The organization shall require the supplier to retain documented information or a
29 Software development capability self-assessment record software or automotive products with
software development capability self-assessment.
embedded software

30 Second-party audit report 8.4.2.4.1 Second-party audits The organization shall retain records of the second-party audit reports.

retain records of process and product approval following set-up and first-off/ last-off
31 Job setup records 8.5.1.3 Verification of job set-ups
part validations.

ensure documented information is retained in the formal (electronic, hardcopy,

Traceability records (Invoice, Pre-dispatch inspection records, 8.5.2.1 Identification and traceability-
32 archive) that enables the organization to meet the response time requirements (For
production and quality records) supplemental
Traceability)

When the property of a customer or external provider is lost, damaged or otherwise

8.5.3 Property belonging to customers or
33 Customer property record and status found to be unsuitable for use, the organization shall report this to the customer or
external providers
external provider and retain documented information on what has occurred.

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List of Mandatory Documented Information - Records … Continued

S.No. Records Name Clause Number Reference Clause Detail

The organization shall retain documented information describing the results of the
34 Process / engineering change records 8.5.6 Control of changes review of changes, the person(s) authorizing the change, and any necessary actions
arising from the review.

8.5.6.1 Control of changes - retain records of verification and validation, retain documented approval, prior to
35 Process / engineering change records
supplemental implementation of the change;

Records of conformity of product and services with The organization shall retain documented information on the release of products and
36 8.6 Release of products and services
acceptance criteria services.

A layout inspection and a functional verification to applicable customer engineering

8.6.2 Layout inspection and functional
37 Layout inspection and functional testing records material and performance standards shall be performed for each product as specified
testing
in the control plans. Results shall be available for customer review.

8.6.4 Verification and acceptance of

second-party or third-party assessments or audits of supplier sites when coupled with
38 Second party auditor report, third party audit report conformity of externally provided
records of acceptable delivered product conformance to requirements;
products and services

8.7.1.1 Customer authorization for The organization shall maintain a record of the expiration date or quantity authorized
39 Customer deviation
concession under concession.

retain documented information on the disposition of reworked product including

40 Rework record 8.7.1.4 Control of reworked product
quantity, disposition, disposition date, and applicable traceability information.

The organization shall obtain a documented customer authorization for concession for
41 Customer deviation 8.7.1.5 Control of repaired product
the product to be repaired.

The organization shall retain documented information on the disposition of repaired

42 Repair record 8.7.1.5 Control of repaired product product including quantity, disposition, disposition date, and applicable traceability
information.

Notify the customer(s) in the event that nonconforming product has been shipped.
43 Customer notification 8.7.1.6 Customer notification
Initial communication shall be followed with detailed documentation of the event.

44 Nonconformity records with action plan 8.7.2 Control of nonconforming outputs The organization shall retain documented information

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List of Mandatory Documented Information - Records … Continued

S.No. Records Name Clause Number Reference Clause Detail

records of actual measurement values and/or test results for variable data
9.1.1.1 Monitoring and measurement of
45 SPC study, process change records
manufacturing processes Significant process events, such as tool change or machine repair, shall be recorded
and retained as documented information, maintain records of effective dates of

retain documented information as evidence of the implementation of the audit

46 Internal audit Plan Vs Actual, Internal audit reports 9.2 Internal audit
programme and the audit results.

The organization shall retain documented information as evidence of the results of

47 MRM minutes of meeting 9.3.3 Management review outputs
management reviews.

9.3.3.1 Management review outputs - Top management shall document and implement an action plan when customer
48 Action plan when customer performance targets not met
supplemental performance targets are not met.

10.2 Nonconformity and corrective

49 Nonconformity records with action plan The organization shall retain documented information
action

shall include the testing of error-proofing devices for failure or simulated failure.
50 Error-proofing testing records 10.2.4 Error-proofing
Records shall be maintained.

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