IATF 16949 (0`10 clause)

FOR TRAINING PURPOSE ONLY
Faculty Credentials:
 B.Tech (Mechanical)
 Honored by IIT Guwahati for Techniche Representative in Year 2011
 Certified ‘Internal Auditor for Quality Management System i.e. ISO

9001 : 2015 & IATF 16949 : 2016’.
 Certified ‘Internal Auditor for EHS Standards i.e. ISO 14001 : 2015,
OHSAS 18001 :2007 & ISO 45001 : 2018.
 Certified for NPD related documents (APQP, PPAP & FMEA).
 Certified for Auto Cad 2012.
Jaideep Gupta  7+ Years of Experience in Automobile Industry (QC,QA & QMS).
IATF 16949 : 2016 – AUTOMOTIVE QUALITY MANAGEMENT SYSTEM
1 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements
Development of IATF 16949
2016
2009 1st Edition
3rd Edition
2002 IATF 16949
2nd Edition
1999
1st Edition ISO/TS 16949
ISO/TS 16949 : 2009 vs IATF 16949 : 2016 Structure New Structure
Clause No. ISO/TS 16949 : 2009 Clause No. IATF 16949 : 2016 Standards
0 Introduction 0 Introduction
1 Scope 1 Scope MINOR

CHANGE
2 Normative Reference 2 Normative References
3 Terms and Definitions 3 Terms and Definitions
4 General Requirements 4 Context of the Organization
5 Leadership
5 Management Responsibility
6 Planning
6 Resource Management 7 Support MAJOR

CHANGE
7 Product Realization 8 Operation
Measurement, Analysis and 9 Performance Evaluation

8
Improvement 10 Improvement
0. Introduction
0.1 General
See ISO 9001:2015 requirements (Refer our study material on ISO 9001:2015 standards)
0.2 Quality Management Principles

0.3 Process Approach

0.3.1 General
0.3.2 Plan-Do-Check-Act Cycle

0.3.3 Risk-based thinking

0.4 Relationship with other management system standards

1. Scope
Scope - Supplemental
This Automotive QMS Standard is applicable to sites of the automotive organization where
manufacturing of :
1. Customer-specified production parts,
2. Service parts, and/or
3. Accessory parts, occur.

2. Normative References
2.1 Normative and informative references
Annex A (Control Plan) is a normative part of this Automotive QMS standard.
Annex B (Bibliography - automotive supplemental) is informative, which provides
additional information intended to assist the understanding or use of this Automotive
QMS standard.
3. Terms and definitions (Important Only)

Accessory part :
Customer-specified additional component(s) that are either mechanically or electronically
connected to the vehicle or powertrain before (or after) delivery to the final customer
(e.g., custom floor mats, wheel covers, sound system enhancements, sunroofs, etc.)
3. Terms and definitions

Aftermarket part :
Replacement part(s) not procured or released by an OEM for service part applications,
which may or may not be produced to original equipment specifications
Design for assembly (DFA):

Process by which products are designed with ease of assembly considerations. (e.g., if a
product contains fewer parts it will take less time to assemble, thereby reducing assembly
costs)
Design for manufacturing (DFM):
Integration of product design and process planning to design a product that is easily
and economically manufactured
Design for manufacturing and assembly (DFMA):

Combination of two methodologies: Design for Manufacture (DFM) and Design for
Assembly (DFA).
3. Terms and definitions

Periodic overhaul:
Maintenance methodology to prevent a major unplanned breakdown where, based on
fault or interruption history, a piece of equipment, or subsystem of the equipment, is
proactively taken out of service and disassembled, repaired, parts replaced, reassembled,
and then returned to service
Product safety:
Standards relating to the design and manufacturing of products to ensure they do not
represent harm or hazards to customers
Service part:
Replacement part(s) manufactured to OEM specifications that are procured or released
by the OEM for service part applications, including remanufactured parts .

4. Context of the organization

4.1. Understanding the organization and its context
General requirements - Supplemental

• Ensuring control over outsourced processes shall not absolve the organization, for the
responsibility of conformity to all customer requirements.
4.2. Understanding the needs and expectations of interested parties



4.3. Determining the scope of the quality management system
4.3.1. Determining the scope of the quality management system - Supplemental :
• All Supporting functions, whether on-site or remote, shall be covered in the scope.
• The only permitted exclusion for this Automotive QMS Standard relates to the product
design and development requirements. The exclusion shall be justified and
maintained as documented information. Permitted exclusions do not include
manufacturing process design.
4.3.2. Customer-specific requirements:
• Customer specific requirements shall be evaluated and included in the scope of the
organization's quality management system.


4.4. Quality management system and its processes
4.4.1.1. Conformance of products and processes :

Product
Requirement
Process
Requirement Applicable customer,
statutory & regulatory
Service Part requirements.
Requirement
Outsource part
11
Requirement For more details, Please refer original IATF 16949:2016 standard

4.3.1.2. Product Safety :
The organization shall have documented processes for the management of product safety related
products and manufacturing processes, which shall include :-
Identification by the organization of statutory and regulatory product-safety requirements;
Customer notification of requirements in item
Identification of product safety-related characteristics; Special approvals for design FMEA
Identification of product safety-related characteristics;
Special approval of control plans and process FMEAs;
Reaction plans
(Continue…)

4.3.1.2. Product Safety (…Continue):
Training identified for personal involved in product-safety related products and associated manufacturing
processes;
Defined responsibilities.
Changes of product or process shall be approved prior to implementation, including evaluation of potential effects
on product safety from process and product changes.
Transfer of requirements with regard to product safety throughout the supply chain, including customer-
designated sources
Product traceability by manufactured lot (at a minimum) throughout the supply chain.
4.4.2.
5. Leadership
5.1. Leadership and commitment .
5.1.1. General
5.1.1.1. Corporate responsibility

The organization shall define and implement corporate responsibility policies, including:
• Anti-bribery policy,
• Employee code of conduct, and
• Ethics escalation policy ("whistle-blowing policy"). etc.
5.1.1.2. Process effectiveness and efficiency
• Top management shall review the product realization and support processes to evaluate and
improve their effectiveness and efficiency.
• The results of the process review activities shall be included as input to the management
review.
5. Leadership
5.1. Leadership and commitment .
5.1.1.3. Process owners
• Top management shall identify process owners who are responsible for managing the
organization's processes and related outputs.
• Process owners shall understand their roles and be competent to perform those .
5.1.2. Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus
by ensuring that:
• Customer, applicable statutory and regulatory requirements are determined, understood
and consistently met;
• The risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed;
• The focus on enhancing customer satisfaction is maintained.
5. Leadership
5.2. Policy
5.2.1. Establishing the quality policy
5.2.2. Communicating the quality policy

5.3. Organizational roles, responsibilities and authorities

16
For more details, Please refer original IATF 16949:2016 standard
5. Leadership
5.3.1. Organizational roles, responsibilities, and authorities – supplemental
• Top management shall assign personnel with the responsibility and authority to ensure that
customer requirements are met and shall be documented. This includes but is not limited
to the selection of special characteristics, setting quality objectives and related training,
corrective and preventive actions, product design and development, capacity analysis,
logistics information, customer scorecards, and customer portals.
5.3.2. Responsibility and authority for product requirements and corrective actions
Top management shall ensure that:
• Personnel responsible for conformity to product requirements have the authority to stop
shipment and stop production to correct quality problems;
• Personnel with authority and responsibility for corrective action are promptly informed of
products or processes that do not conform to requirements to ensure that nonconforming
product is not shipped to the customer
• Production operations across all shifts are staffed with personnel in charge of, or delegated
responsibility for, ensuring conformity to product requirements.
17
6. Planning
6.1. Actions to address risks and opportunities
6.1.1.
6.1.2.
6.1.2.1. Risk analysis

• The organization shall include in risk analysis, at a minimum, lessons learned from product
recalls, product audits, field returns and repairs,' complaints, scrap, and rework.
• The organization shall retain documented information as evidence of the results of risk
analysis.
18
6. Planning
6.1.2.2. Preventive action
• Determining potential nonconformities and their causes;
• Evaluating the need for action to prevent occurrence of nonconformities;
• Determining and implementing action needed;
• Documented information of action taken;
• Reviewing the effectiveness of the preventive action taken;
• Utilizing lessons learned to prevent recurrence in similar processes.
6.1.2.3. Contingency Plans (Continue…)
The organization shall:
• Identify and evaluate internal and external risks to all manufacturing processes and
infrastructure equipment essential to maintain production and customer requirements ;
• Define contingency plans according to risk and impact to the customer;
• Prepare contingency plans for continuity of supply in the event of any of the following: key
equipment failures; interruption from externally provided products / processes / services;
recurring natural disasters; fire; utility / infrastructure interruptions; labor shortages;
19
6. Planning
6.1.2.3. Contingency Plans (…Continue)
• Include, a notification process to the customer and other interested parties for the extent
and duration of any situation impacting customer.
• Periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);
• Conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team
including top management, and update as required;
• Document the contingency plans and retain documented information describing any
revision(s), including the person(s) who authorized the change(s).
The contingency plans shall include provisions to validate that the manufactured product
continues to meet customer specifications after the re-start of production following an
emergency in which production stopped .
6.2. Quality objectives and planning to achieve them
6.2.1.
20
6. Planning
6.2.2.
6.2.2.1. Quality objectives and planning to achieve them – supplemental

• Top management shall ensure that quality objectives to meet customer requirements are
defined, established, and maintained throughout the organization.
• The results of the organization's review regarding interested parties and their relevant
requirements shall be considered when the organization establishes its annual (at a
minimum) quality objectives and related performance targets (internal and external).
6.3. Planning of Change

21
7. Support
7.1. Resources
7.1.1. General
7.1.2. People
7.1.3. Infrastructure
7.1.3.1. Plant, facility, and equipment planning
The organization shall use a multidisciplinary approach including risk identification and risk
mitigation methods for developing and improving plant, facility, and equipment plans. ln
designing plant layouts, the organization shall:

7. Support
7.1.3.1. Plant, facility, and equipment planning (…Continue)
• Optimize material flow, material handling, and value-added use of floor space including
control of nonconforming product and
• Facilitate synchronous material flow, as applicable.
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs
to management reviews
7.1.4. Environment for the operation of processes
7.1.4.1. Environment for the operation of processes – Supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is
consistent with the product and manufacturing process needs.

7. Support
7.1.5. Monitoring and Measuring resources
7.1.5.1. General
7.1.5.1.1. Measurement System Analysis

• Statistical studies shall be conducted to analyze the variation present in the results of
each type of inspection, measurement, and test equipment system identified in the
control plan.
• The analytical methods and acceptance criteria used shall conform to those in
reference manuals on measurement systems analysis. Other analytical methods and
acceptance criteria may be used if approved by the customer.
Note: Prioritization of MSA studies should focus on critical or special product or process
characteristics.

7. Support
7.1.5.2. Measurement Traceability
7.1.5.2.1. Calibration/ verification records
• The organization shall have a documented process for managing calibration/verification
records.
• Records of the calibration/verification activity for all gauges and measuring and test
equipment shall be retained.
The organization shall ensure that calibration/verification activities and records shall include:
• Revisions following engineering changes that impact measurement systems;
• Any out-of-specification readings as received for calibration/verification;
• When the test equipment is found to be out of calibration or defective during its planned
verification or calibration or during its use.
(Continue…)
7. Support
7.1.5.2.1. Calibration/ verification records (…Continue)
• Notification to the customer if suspect product or material has been shipped;
• Statements of conformity to specification after calibration/verification;
• Verification that the software version used for product and process control is as specified;
• Records of the calibration and maintenance activities for all gauging (including employee-
owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
7.1.5.3. Laboratory requirements
7.1.5.3.1. lnternal laboratory
• An organization's internal laboratory facility shall have a defined scope that includes its
capability to perform the required inspection, test, or calibration services.
• This laboratory scope shall be included in the quality management system documentation.

7. Support
7.1.5.3.1. lnternal laboratory
• The laboratory shall specify and implement, as a minimum, requirements for:
 Adequacy of the laboratory technical procedures;
 Competency of the laboratory personnel;
 Testing of the product;
 Capability to perform these services correctly, traceable to the relevant process standard
(such as ASTM, EN, etc.); when no national or international standard(s) is available, the
organization shall define and implement a methodology to verify measurement system;
 Customer requirements, if any;
 Review of the related records.
Note: Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate
the organization's in-house laboratory conformity to this requirement.

7. Support
7.1.5.3.2. External laboratory
External/commercial/independent laboratory facilities used for inspection, test, or calibration
services by the organization shall have a defined laboratory scope that includes the capability to
perform the required inspection, test, or calibration, and either:
• The laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the
relevant inspection, test, or calibration service in the scope of the accreditation (certificate);
the certificate of calibration or test report shall include the mark of a national accreditation
body; or
• There shall be evidence that the external laboratory is acceptable to the customer.
Note: Calibration services may be performed by the equipment manufacturer when a qualified
laboratory is not available for a given piece of equipment. ln such cases, the organization shall
ensure that the requirements listed in Section 7.1.5.3.1 have been met.

7. Support
7.1.6. Organizational knowledge
7.2. Competence
7.2.1. Competence – Supplemental

• The organization shall establish and maintain a documented process for identifying training
needs including awareness and achieving competence.
• Personnel performing specific assigned tasks shall be qualified, as required, with particular
attention to the satisfaction of customer requirements

7. Support
7.2.2. Competence - on-the-job training
• The organization shall provide on-the-job training (which shall include customer
requirements training) for personnel in any new or modified responsibilities affecting
conformity to quality requirements, internal requirements, regulatory or legislative
requirements; this shall include contract or agency personnel.
• Persons whose work can affect quality shall be informed about the consequences of
nonconformity to customer requirements.
7.2.3. Internal auditor competency
• The organization shall have a documented process (es) to verify that internal auditors are
competent. For additional guidance on auditor competencies, refer to ISO 19011. The
organization shall maintain a list of qualified internal auditors.
• Quality management system auditors, manufacturing process auditors, and product
auditors shall all be able to demonstrate the following minimum competencies:
(Continue…)

7. Support
7.2.3. Internal auditor competency (…Continue)
 Understanding the automotive process approach for auditing, including risk-based thinking;
 Understanding of applicable customer-specific requirements;
 Understanding of applicable ISO 9001 and IATF 16949 requirements ;
 Understanding of applicable core tool requirements related to the scope of the audit;
 Understanding how to plan, conduct, report, and close out audit findings.
Additionally, manufacturing process auditors shall demonstrate technical understanding of the
relevant manufacturing process (es) to be audited, including process risk analysis (such as PFMEA)
and control plan.
Product auditors shall demonstrate competence in understanding product requirements and use
of relevant measuring and test equipment to verify product conformity.
Maintenance and improvement in internal auditor competence shall be demonstrated through:

 Executing a minimum number of audits per year, as defined by the organization; and
 Maintaining knowledge of relevant requirements based on the changes.
7. Support
7.2.4. Second-party auditor competency
The organization shall demonstrate the competence of the auditors undertaking the second-
party audits. Second-party auditors shall meet customer specific requirements for auditor
qualification and demonstrate the minimum following core competencies, including
understanding of:
• The automotive process approach to auditing, including risk based thinking;

• Applicable customer and organization specific requirements;
• Applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
• Applicable manufacturing process (es) to be audited, including PFMEA and control plan;
• Applicable core tool requirements related to the scope of the audit;
• How to plan, conduct, prepare audit reports, and close out audit findings.

7. Support
7.3. Awareness
7.3.1. Awareness – Supplemental

The organization shall maintain documented information that demonstrates that all employees
are aware of :
• Their impact on product quality
• The importance of their activities in achieving, maintaining, and improving Quality
• Customer requirements and the risks involved for the customer with NC product.
7.3.2. Employee motivation and empowerment
The organization shall maintain a documented process (es) to motivate employees :
• To achieve quality objectives,
• To make continual improvements, and
• To create an environment that promotes innovation.
7. Support
7.4. Communication
7.5. Documented Information

7.5.1. General
7.5.1.1. Quality management system documentation

• The organization's quality management system shall be documented and include a quality
manual, which can be a series of documents (electronic or hard copy).
• The format and structure of the quality manual depend on the organization's size, culture,
and complexity.
(Continue…)

7. Support
7.5.1.1. Quality management system documentation (…Continue)
• The quality manual shall include, at a minimum, the following:
 The scope of the quality management system, including details and justification for exclusions;
 Documented processes established for the quality management system;
 The organization's processes and their sequence and interactions (inputs and outputs),
including type and extent of control of any outsourced processes;
 A document (i.e., matrix) indicating where within the organization's quality management
system their customer-specific requirements are addressed.
7.5.2. Creating and updating

7.5.3. Control of documented information

7. Support
7.5.3.1.
7.5.3.2.
7.5.3.2.1. Record retention

• The organization shall define, document, and implement a record retention policy.
• The control of records shall satisfy statutory, regulatory, organizational, and customer
requirements.
Production part approvals, tooling records, product and process design records, purchase
orders (if applicable), or contracts and amendments shall be retained for the length of time that
the product is active for production and service requirements, plus one calendar year, unless
otherwise specified by the customer or regulatory agency.
7. Support
7.5.3.2.2. Engineering Specifications
• The organization shall have a documented process describing the review, distribution, and
implementation of all customer engineering standards/specifications and related revisions
based on customer schedules, as required.
• The organization shall retain a record of the date on which engineering standard / specification
change is implemented in production. Implementation shall include updated documents.
• Review should be completed within 10 working days of receipt of notification of engineering
standards/ specifications changes.
Note: A change in these standards/specifications may require an updated record of customer

production part approval when these specifications are referenced on the design record or if they
affect documents of the production part approval process, such as control plan, risk analysis (such
as FMEAs) etc.

8. Operation
8.1. Operational planning and control
8.1.1. Operational planning and control – Supplemental
When planning for product realization, the following topics shall be included:
• Customer product requirements and technical specifications;
• Logistics requirements;
• Manufacturing feasibility;
• Project planning ;
• Acceptance criteria.
The resources identified refer to the required verification, validation, monitoring, measurement,
inspection, and test activities specific to the product and the criteria for product acceptance
8.1.2. Confidentiality
The organization shall ensure the confidentiality of customer-contracted products and projects
under development, including related product information.
8. Operation
8.2. Requirements for products and services
8.2.1. Customer Communication
8.2.1.1. Customer communication – Supplemental
• Written or verbal communication shall be in the language agreed with the customer.
• The organization shall have the ability to communicate necessary information, including
data in a customer-specified computer language and format (e.g., computer-aided design
data, electronic data interchange).
8.2.2. Determining the requirements for products and services

8. Operation
8.2.2.1. Determining the requirements for products and services – Supplemental
• These requirements shall include recycling, environmental impact, and characteristics
identified as a result of the organization's knowledge of the product and processes. E.g. All
applicable government, safety, and environmental regulations related to acquisition, storage,
handling, recycling, elimination, or disposal of material.
8.2.3. Review of the requirements for products and services

8.2.3.1.
8.2.3.1.1. Review of the requirements for products and services – Supplemental

• The organization shall retain documented evidence of a customer-authorized waiver for the
requirements stated in ISO 9001, for a formal review.

8. Operation
8.2.3.1.2. Customer- designated special characteristics
• The organization shall conform to customer requirements for designation, approval
documentation, and control of special characteristics.
8.2.3.1.3. Organization manufacturing feasibility

• The organization shall conduct the feasibility analysis for any manufacturing or product
technology new to the organization and for any changed manufacturing process (as
suggested by the customer) or product design using multidisciplinary approach .
Additionally, the organization should validate through production runs, benchmarking studies, or
other appropriate methods, their ability to make product to specifications at the required rate.
8.2.3.2.

8. Operation
8.2.4. Changes to requirements for products and services
8.3. Design and development of products and services

8.3.1. General
8.3.1.1. Design and development of products and services – supplemental

The requirements of ISO 9001, shall apply to product and manufacturing process design and
development and shall focus on error prevention rather than detection.
The organization shall document the design and development process.

8. Operation
8.3.2. Design and development planning
8.3.2.1. Design and development planning - supplemental
Using of a multidisciplinary approach include but are not limited to the following:
• Project management (for example, APQP or VDA-RGA);
• Product and manufacturing process design activities (for example, DFM and DFA)
• Development and review of product design risk analysis (FMEAS), including actions to
reduce;
• Development and review of manufacturing process risk analysis (for example, FMEAS,
process flows, control plans, and standard work instructions).
Note: A multidisciplinary approach typically includes the organization's design, manufacturing,

engineering, quality, production, purchasing, supplier, maintenance, and other appropriate
functions.
8. Operation
8.3.2.2. Product design skills
• The organization shall ensure that personnel with product design responsibility are
competent to achieve design requirements and are skilled in applicable product design tools
and techniques.
• Applicable tools and techniques shall be identified by the organization.
8.3.2.3. Development of products with embedded software
• The organization shall use a process for quality assurance for their products with internally
developed embedded software.
• The organization shall include software development within the scope of their internal audit
programme.
8.3.3. Design and development inputs

8. Operation
8.3.3.1. Product Design input
Product design input requirements include but are not limited to the following:
• Product specifications including but not limited to special characteristics.
• Identification, traceability, and packaging;
• Consideration of design alternatives;
• Assessment of risks with the input requirements and the organization’s ability to mitigate/
manage the risks, including from the feasibility analysis;
• Targets for conformity to product requirements including preservation, reliability,
durability, serviceability, health, safety, environmental, development timing, and cost;
• Applicable statutory and regulatory requirements of the customer-identified country of
destination, if provided;
• Embedded software requirements.
The organization shall have a process to deploy information gained from previous design
projects, competitive product analysis (benchmarking), supplier feedback, internal input,
field data, and other relevant sources for current and future projects of a similar nature.
8. Operation
8.3.3.2. Manufacturing process design input
The organization shall identify, document, and review manufacturing process design input
requirements including but not limited to the following:
• Product design output data including special characteristics;
• Targets for productivity, process capability, timing, and cost;
• Manufacturing technology alternatives;
• Customer requirements, if any;
• Experience from previous developments;
• New materials;
• Product handling and ergonomic requirements; and
• Design for manufacturing and design for assembly.
The manufacturing process design shall include the use of error-proofing methods to a
degree appropriate to the magnitude of the problem(s) and commensurate with the risks
encountered.
8. Operation
8.3.3.3. Special characteristics
The organization shall include the following:
• Documentation of all special characteristics in the drawings, risk analysis (such as FMEA),
control plans, and standard work operator instructions; special characteristics are identified
with specific markings and are cascaded through each of these documents;
• Development of control and monitoring strategies for special characteristics of products and
production processes;
• Customer-specified approvals, when required;
• Compliance with customer-specified definitions and symbols or the organization's
equivalent symbols or notations, as defined in a symbol conversion table. The symbol
conversion table shall be submitted to the customer, if required.
8.3.4. Design and development controls

8. Operation
8.3.4.1. Monitoring
• Measurements at specified stages during the design and development of products and
processes shall be defined, analyzed, and reported with summary results as an input to
management review.
• When required by the customer, measurements of the product and process development
activity shall be reported to the customer at stages specified, or agreed to, by the customer.
8.3.4.2. Design and development validation

• Design and development validation shall be performed in accordance with customer
requirements, including any applicable industry and governmental agency-issued regulatory
standards. The timing of design and development validation shall be planned in alignment
with customer-specified timing, as applicable.
• Where contractually agreed with the customer, this shall include evaluation of the
interaction of the organization's product, including embedded software, within the system
of the final customer's product.
8. Operation
8.3.4.3. Prototype programme
• When required by the customer, the organization shall have a prototype programme and
control plan.
• The organization shall use, whenever possible, the same suppliers, tooling, and
manufacturing processes as will be used in production.
8.3.4.4. Product Approval Process

• The organization shall obtain documented product approval prior to shipment, if required by
the customer. Records of such approval shall be retained.
• The organization shall approve externally provided products and services, prior to submission
of their part approval to the customer.

8. Operation
8.3.5. Design and development outputs
8.3.5.1. Design and development outputs – supplemental
The product design output shall include but is not limited to the following, as applicable:
a) Design risk analysis (FMEA); b) Reliability study results;
c) Product special characteristics;
d) Results of product design error-proofing, such as DFSS, DFMA, and FTA;
f) 2D drawings, product mfg. information, and geometric dimensioning & tolerancing (GD&T);
g) Product design review results;
h) Service diagnostic guidelines and repair and serviceability instructions;
i) Service part requirements;
j) Packaging and labeling requirements for shipping.
Note: Interim design outputs should include any engineering problems being resolved

8. Operation
8.3.5.2. Manufacturing process design output
The organization shall document the manufacturing process design output in a manner that
enables verification against the manufacturing process design inputs.
The manufacturing process design output shall include but is not limited to the following:
a) Specifications and drawings; b) Special characteristics for product and process;
c) Tooling and equipment for production and control, including capability studies of equipment
and process (es);
d) Manufacturing process flow e) Capacity analysis;
f) Manufacturing process FMEA; g) Maintenance plans and instructions;
h) Control plan (see Annex A); i) Standard work and work instructions;
j) Process Acceptance criteria; k) Data for quality, reliability, and measurability;
l) Results of error-proofing identification and verification, as appropriate;
m) Methods of rapid detection, feedback, and correction of product/manufacturing process
nonconformities.
8. Operation
8.3.6. Design and development changes
8.3.6.1. Design and development changes – supplemental

• The organization shall evaluate all design changes after initial product approval, including
those proposed by the organization or its suppliers, for potential impact on fit, form,
function, performance, and/or durability. These changes shall be validated against customer
requirements and approved internally, prior to production implementation.
• lf required by the customer, the organization shall obtain documented approval, or a
documented waiver, from the customer prior to production implementation.
• For products with embedded software, the organization shall document the revision level of
software and hardware as part of the change record.

8. Operation
8.4. Control of externally provided processes, products and services
8.4.1. General
8.4.1.1. General - supplemental
The organization shall include all products and services that affect customer requirements such
as subassembly, sequencing, sorting, rework, and calibration services in the scope of their
definition of externally provided products, processes, and services.
8.4.1.2. Supplier selection process
The organization shall have a documented supplier selection process. The selection process
shall include:
• An assessment of the selected supplier's risk to product conformity and uninterrupted
supply of the organization's product to their customers;
• Relevant quality and delivery performance;
8. Operation
8.4.1.2. Supplier Selection Process (…Continue)
• An evaluation of the supplier’s quality management system;
• Multidisciplinary decision making: and
• An assessment of software development capabilities, if applicable.
Other supplier selection criteria that should be considered, includes the following:
- Volume of automotive business (absolute and as a percentage of total business);
- Financial stability;
- Purchased product, material, or service complexity;
- Adequacy of available resources & technology (e.g., people, infrastructure);
- Design and development capabilities (including project management);
- Manufacturing capability;
- Change management process;
- Business continuity planning (e.g., disaster preparedness, contingency planning);
- Logistics process;
- Customer
54 service. For more details, Please refer original IATF 16949:2016 standard
8. Operation
8.4.1.3. Customer-directed sources (also known as " Directed-Buy")
• When specified by the customer, the organization shall purchase products, materials, or
services from customer-directed sources
• All requirements of Section 8.4 (except Section 8.4.1.2) are applicable to the organization's
control of customer directed sources unless specific agreements are otherwise defined by the
contract between the organization and the customer.
8.4.2. Type and extent of control
8.4.2.1 Type and extent of control - Supplemental
• The organization shall have a documented process to identify outsourced processes and to
select the types and extent of controls used to verify conformity of externally provided
products, processes, and services to organizational and external customer requirements.
• The process shall include the criteria and actions to reduce the types and extent of controls
and development activities based on supplier performance and related risks involved.
8. Operation
8.4.2.2. Statutory and regulatory requirements
• The organization shall document their process to ensure that purchased products,
processes, and services conform to the current applicable statutory and regulatory
requirements in the country of receipt, the country of shipment, and the customer-
identified country of destination, if provided.
• lf the customer defines special controls for certain products with statutory and regulatory
requirements, the organization shall ensure they are implemented and maintained as
defined, including at suppliers.
8.4.2.3. Supplier quality management system development
• The organization shall require their suppliers of automotive products and services to
develop, implement, and improve a quality management system certified to ISO 9001,
unless otherwise authorized by the customer, with the ultimate objective of becoming
certified to this Automotive QMS Standard (IATF 16949).

8. Operation
8.4.2.3.1. Automotive product - related software or automotive products with
embedded software
• The organization shall require their suppliers of automotive product-related software, or
automotive products with embedded software, to implement and maintain a process for
software quality assurance for their products.
8.4.2.4 Supplier Monitoring

At a minimum, the following supplier performance indicators shall be monitored:
• Delivered product conformity to requirements;
• Customer disruptions at the receiving plant, including yard holds and stop ships;
• Delivery schedule performance;
• Number of occurrences of premium freight.
• Special status customer notifications related to quality or delivery issues;
• Dealer returns, warranty, field actions, and recalls.

8. Operation
8.4.2.4.1. Second-party audits
The organization shall include a second-party audit process in their supplier management
approach.
Second-party audits may be used for the following:
• Supplier risk assessment;
• Supplier monitoring;
• Supplier QMS development;
• Product audits;
• Process audits.
Based on a risk analysis, including product safety/regulatory requirements, performance of the

supplier, and QMS certification level, at a minimum, the organization shall document the criteria
for determining the need, type, frequency, and scope of second-party audits.
The organization shall retain records of the second-party audit reports.
8. Operation
8.4.2.5. Supplier Development
The organization shall determine the priority, type, extent, and timing of required supplier
development actions for its active suppliers. Determination inputs shall include the following:
• Performance issued identified through supplier monitoring;
• Second-party audit findings;
• Third-party quality management system certification status;
• Risk analysis,
8.4.3. Information for external providers

8.4.3.1. Information for external providers – supplemental
• The organization shall pass down all applicable statutory and regulatory requirements and
special product and process characteristics to their suppliers and require the suppliers to
cascade all applicable requirements down the supply chain to the point of manufacture.
8. Operation
8.5. Production and service provision
8.5.1. Control of production and service provision
8.5.1.1. Control plan
• The organization shall develop control plans (in accordance with Annex A) at the system,
subsystem, component, and/or material level for the relevant manufacturing site
• Family control plans are acceptable for bulk material and similar parts using a common
manufacturing process.
• The organization shall have a control plan for pre-launch and production that shows linkage
and incorporates information from the design risk analysis (if provided by the customer),
process flow diagram, and manufacturing process risk analysis outputs (such as FMEA).

8. Operation
8.5.1.1. Control plan (…Continue)
The organization shall include in the control plan:
• Controls used for the manufacturing process control, including verification of job setups;
• First-off/ last-off part validation, as applicable;
• Methods for monitoring of control exercised over special characteristics (see Annex A)
• The customer-required information, if any;
• Specified reaction plan (see Annex A); when nonconforming product is detected, the process
becomes statistically unstable or not statistically capable.
The organization shall review control plans, and update as required, for any of the following:
• The organization determines it has shipped nonconforming product to the customer;
• When any change occurs affecting product, manufacturing process, measurement, logistics,
supply sources, production volume changes, or risk analysis (FMEA) (see Annex A);
• After Implementation of the corrective action, when applicable;
8. Operation
8.5.1.2. Standardized work - operator instructions and visual standards
The organization shall ensure that standardized work documents are:
• Communicated to and understood by the employees who are responsible for performing work;
• Legible;
• Presented in the language(s) understood by the personnel responsible to follow them;
• Accessible for use at the designated work area(s).
The standardized work documents shall also include rules for operator safety.
8.5.1.3. Verification of job set-ups
• Verify job set-ups when performed, such as an initial run of a job, material changeover, or
job change that requires a new set-up;
• Maintain documented information for set-up personnel;
• Use statistical methods of verification, where applicable; (Continue…)

8. Operation
8.5.1.3. Verification of job set-ups (…Continue)
• Perform first-off/last-off part validation, as applicable; where appropriate, first-off parts
should be retained for comparison with the last-off parts; where appropriate, last-off-parts
should be retained for comparison with first-off parts in subsequent runs;
• Retain records of process and product approval following set-up and first-off/last-off part
validations.
8.5.1.4. Verification after shutdown
• The organization shall define and implement the necessary actions to ensure product
compliance with requirements after a planned or unplanned production shutdown period.
8.5.1.5. Total productive maintenance
• The organization shall develop, implement, and maintain a documented total productive
maintenance system.
At a minimum, the system shall include the following:
(Continue…)

8. Operation
8.5.1.5. Total productive maintenance (…Continue)
• Identification of process equipment
• Availability of replacement parts for the equipment's
• Provision of resource for machine, equipment, and facility maintenance;
• Packaging and preservation of equipment, tooling, and gauging;
• Applicable customer-specific requirements;
• Documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness),
MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair), and Preventive
Maintenance compliance metrics. Performance to the maintenance objectives shall form an
input into management review;
• Regular review of maintenance plan and objectives and a documented action plan to address
corrective actions where objectives are not achieved;
• Use of preventive maintenance methods;
• Use of predictive maintenance methods, as applicable;
• Periodic overhaul.
8. Operation
8.5.1.6. Management of production tooling and manufacturing, test, inspection
tooling and equipment
The organization shall establish and implement a system for production tooling management,
whether owned by the organization or the customer, including:
• Maintenance, repair facilities and personnel;
• Storage and recovery;
• Set-up;
• Tool-change programmers for perishable tools;
• Tool design modification documentation, inducing engineering change level of the product;
• Tool modification and revision to documentation;
• Tool identification, such as serial or asset number the status, such as production, repair or
disposal; ownership; and location.
The organization shall verify that customer owned tools, manufacturing equipment, and test
inspection equipment are permanently marked in a visible location so that the ownership and
application of each item can be determined.
8. Operation
8.5.1.7. Production scheduling
• The organization shall ensure that production is scheduled in order to meet customer orders
/ demands such as Just-ln-Time (JIT)
• The organization shall include relevant planning information during production scheduling,
e.g., customer orders, supplier on-time delivery performance, capacity, shared loading (multi-
part station), lead time, inventory level, preventive maintenance, and calibration.
8.5.2. Identification and traceability
8.5.2.1. Identification and traceability – supplemental

• The purpose of traceability is to support identification of clear start and stop points for
product received by the customer or in the field that may contain quality and/or safety-
related nonconformities.
(Continue…)
8. Operation
8.5.2.1. Identification and traceability – supplemental (…Continue)
Therefore, the organization shall implement identification and traceability processes as described
below:
 Enable the organization to identify nonconforming and/or suspect product;
 Enable the organization to segregate nonconforming and/or suspect product;
 Ensure the ability to meet the customer and/or regulatory response time requirements;
 Ensure serialized identification of individual products, if specified by the customer or
regulatory standards;
 Ensure the identification and traceability requirements are extended to externally provided
products with safety / regulatory characteristics.
8.5.3. Property belonging to customers or external providers


8. Operation
8.5.4. Preservation
8.5.4.1. Preservation – supplemental

• Preservation shall include identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection until delivery to/acceptance by the customer.
• The organization shall use an inventory management system to optimize inventory turns over
time and ensure stock rotation, such as "first-in-first-out" (FIFO).
• ln order to detect deterioration, the organization shall assess at appropriate planned
intervals the condition of product in stock, the place/type of storage container, and the
storage environment.
• The organization shall ensure that obsolete product is controlled in a manner similar to that
of nonconforming product.

8. Operation
8.5.5. Post-delivery activities
8.5.5.1. Feedback of information from service

• The organization shall ensure that a process for communication of information on service
concerns to manufacturing, material handling, logistics, engineering, and design activities is
established, implemented, and maintained.
NOTE: 1. The intent of the addition of "service concerns" to this sub-clause is to ensure that the
organization is aware of nonconforming product(s) and material(s) that may be identified at the
customer location or in the field.
NOTE: 2. "service concerns" should include the results of field failure test analysis (see Section
10.2.6) where applicable.

8. Operation
8.5.5.1. Service agreement with customer
When there is a service agreement with the customer, the organization shall:
• Verify that the relevant service centers comply with applicable requirements;
• Verify the effectiveness of any special purpose tools or measurement equipment;
• Ensure that all service personnel are trained in applicable requirements.
8.5.6. Control of changes

8.5.6.1. Control of changes – supplemental

The organization shall have a documented process to control and react to changes that impact
product realization. The effects of any change, including those changes caused by the
organization, the customer, or any supplier, shall be assessed.
(Continue…)
8. Operation
8.5.6.1. Control of changes – Supplemental (….Continue)
• Define verification and validation activities to ensure compliance with customer requirements;
• Validate changes before implementation;
• Document the evidence of related risk analysis;
• Retain records of verification and validation.
When required by the customer, the organization shall:

• Notify the customer of any planned product realization changes after the most recent product
approval;
• Obtain documented approval, prior to implementation of the change;
• Complete additional verification
Changes, including those made at suppliers, should require a production trial run for verification
of changes (such as changes to part design, manufacturing location, or manufacturing process) to
validate the impact of any changes on the manufacturing process.
8. Operation
8.5.6.1.1. Temporary change of process controls
• The organization shall identify, document, and maintain a list of the process controls,
including inspection, measuring, test, and error-proofing devices, that includes the primary
process control and the approved back-up or alternate methods.
• The organization shall document the process that manages the use of alternate control
methods. The organization shall include in this process, based on risk analysis (such as
FMEA), severity, and the internal approvals to be obtained prior to production
implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required,
the organization shall obtain approval from the customer(s).
8.6. Release of products and services


8. Operation
8.6.1. Release of products and services – supplemental
• The organization shall ensure that the planned arrangements to verify that the product and
service requirements have been met encompass the control plan and are documented as
specified in the control plan (see Annex A).
8.6.2. Layout inspection and functional testing
• A layout inspection and a functional verification to applicable customer engineering
material and performance standards shall be performed for each product as specified in the
control plans. Results shall be available for customer review.
Note: 1 Layout inspection is the complete measurement of all product dimensions shown on
the design record(s).
Note: 2 The frequency of layout inspection is determined by the customer.
8.6.3. Appearance items
• For organizations manufacturing parts designated by the customer as "appearance items,"
the organization shall provide the following:
8. Operation
8.6.3. Appearance items
 Appropriate resources, inducing lighting, for evaluation;
 Masters for color, grain, gloss, texture, distinctness of image (DOl), as appropriate;
 Maintenance and control of appearance masters and evaluation equipment;
 Verification that personnel making appearance evaluations are competent and qualified to do.
8.6.4. Verification and acceptance of conformity of externally provided products
and services
• The organization shall have a process to ensure the quality of externally provided processes,
products, and services utilizing one or more of the following methods:
 Receipt and evaluation of statistical data provided by the supplier to the organization;
 Receiving inspection and/or testing, such as sampling based on performance;
 Second-party or third-party assessments or audits of supplier sites when coupled with
records of acceptable delivered product conformance to requirements;
 Part evaluation by a designated laboratory;
 74Another method agreed with the customer.
8. Operation
8.6.5. Statutory and regulatory conformity
• Prior to release of externally provided products into its production flow, the organization
shall confirm and be able to provide evidence that externally provided processes, products,
and services conform to the latest applicable statutory, regulatory, and other requirements in
the countries where they are manufactured and in the customer-identified countries of
destination, if provided
8.6.6. Acceptance criteria

• Acceptance criteria shall be defined by the organization and, where appropriate or required,
approved by the customer. For attribute data sampling, the acceptance level shall be zero
defects.

8. Operation
8.7. Control of Nonconforming Outputs
8.7.1.
8.7.1.1. Customer authorization for concession
• The organization shall obtain a customer concession or deviation permit prior to further
processing whenever the product or manufacturing process is different from that which is
currently approved.
• lf sub-components are reused in the manufacturing process, that sub-component reuse shall
be clearly communicated to the customer in the concession or deviation permit.
• The organization shall maintain a record of the expiration date or quantity authorized under
concession. Material shipped under concession shall be properly identified on each shipping
container (this applies equally to purchased product). The organization shall approve any
requests from suppliers before submission to the customer.
8. Operation
8.7.1.2. Control of nonconforming product - customer-specified process
• The organization shall comply with applicable customer-specified controls for nonconforming
product(s).
8.7.1.3. Control of suspect product
• The organization shall ensure that product with unidentified or suspect status is classified
and controlled as nonconforming product.
• The organization shall ensure that all appropriate manufacturing personnel receive training
for containment of suspect and nonconforming product.
8.7.1.4. Control of reworked product
• The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the
rework process prior to a decision to rework the product. lf required by the customer, the
organization shall obtain approval from the customer prior to commencing rework of the
product.
(Continue…)

8. Operation
8.7.1.4. Control of rework product (…Continue)
• The organization shall have a documented process for rework confirmation in accordance with
the control plan or other relevant documented information to verify compliance to original
specifications.
• The organization shall retain documented information on rework, disposition of reworked
product including quantity, disposition, disposition date, and applicable traceability information.
8.7.1.5. Control of repaired product
• The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the
repair process prior to a decision to repair the product. The organization shall obtain
approval from the customer before commencing repair of the product.
• The organization shall have a documented process for repair confirmation in accordance with
the control plan or other relevant documented information.

8. Operation
8.7.1.6. Customer notification
• The organization shall immediately notify the customer(s) in the event that nonconforming
product has been shipped.
• Initial communication should be followed with detailed documentation of the event.
8.7.1.7. Nonconforming product disposition

• The organization shall have a documented process for disposition of nonconforming product
not subject to rework or repair.
• The organization shall not divert nonconforming product to service or other use without
prior customer approval.
8.7.2.

9. Performance evaluation
9.1. Monitoring, measurement analysis and evaluation
9.1.1. General
9.1.1.1. Monitoring and Measurement of manufacturing processes

• The organization shall perform process study on all new manufacturing (including assembly
or sequencing) processes to verify process capability and to provide additional input for
process control, including those for special characteristics.
• The organization shall verify that the process flow diagram, PFMEA, and control plan are
implemented, including adherence to the following:
 Measurement techniques;
 Sampling plans;
 Acceptance criteria;
 Records of actual measurement values and/or test results for variable data;
 Reaction plans and escalation process when acceptance criteria are not met. (Continue…)
9.1.1.1. Monitoring and Measurement of manufacturing processes (…Continue)
• Significant process events, such as tool change or machine repair, shall be recorded and
retained as documented information.
• The organization shall maintain records of effective dates of process changes.
9.1.1.2. Identification of statistical tools

• The organization shall determine the appropriate use of statistical tools. The organization shall
verify that appropriate statistical tools are included in APQP, DFMEA (where applicable),
PFMEA , and Control plan.
9.1.1.3. Application of statistical concepts
• Statistical concepts, such as variation, control (stability), process capability, and the
consequences of over-adjustment, shall be understood and used by employees involved in the
collection, analysis, and management of statistical data.

9.1.2. Customer Satisfaction
9.1.2.1. Customer satisfaction – supplemental
• Customer satisfaction with the organization shall be monitored through continual evaluation
of internal and external performance indicators
• Performance indicators shall be based on objective evidence and include but not be limited
to the following:
 Delivered part quality performance;
 Customer disruptions;
 Field returns, recalls, and warranty (where applicable);
 Delivery schedule performance (including incidents of premium freight);
 Customer notifications related to quality or delivery issues, including special status.

9.1.3. Analysis and evaluation
9.1.3.1. Prioritization
• Trends in quality and operational performance shall be compared with progress toward
objectives and lead to action to support prioritization of actions for improving customer
satisfaction.
9.2. Internal audit
9.2.1.
9.2.2.

9.2.2.1. Internal audit programme
• The organization shall have a documented internal audit process. The process shall include
the development and implementation of an internal audit programme that covers quality
management system audits, manufacturing process audits, and product audits.
• The audit programme shall be prioritized based upon risk, internal and external performance
trends, and criticality of the process (es).
• Where the organization is responsible for software development, the organization shall
include software development capability assessments in their internal audit programme.
• The frequency of audits shall be reviewed and, where appropriate, adjusted based on
occurrence of process changes, internal and external nonconformities, and/or customer
complaints. The effectiveness of the audit programme shall be reviewed as a part of
management review.

9.2.2.2. Quality management system audit
• The organization shall audit all quality management system processes over each three-year
calendar period, according to an annual programme, using the process approach to verify
compliance with this Automotive QMS Standard & Customer-specific quality management
system requirements .
9.2.2.3. Manufacturing Process audit
• The organization shall audit all manufacturing processes over each three-year calendar
period to determine their effectiveness and efficiency using customer-specific required
approaches for process audits.
• Within each individual audit plan, each manufacturing process shall be audited on all shifts
where it occurs, including the appropriate sampling of the shift handover.
• The manufacturing process audit shall include an audit of the effective implementation of the
process risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4. Product audit
• The organization shall audit products at appropriate stages of production and delivery to
verify conformity to specified requirements (Prefer customer-specific required approaches
over internal) .
9.3. Management review
9.3.1. General
9.3.1.1. Management review – supplemental

• Management review shall be conducted at least annually. The frequency of management
review(s) shall be increased based on risk to compliance with customer or quality
management system requirements resulting from internal or external change.

9.3.2. Management review inputs
9.3.2.1. Management review inputs – supplemental
 Cost of poor quality (cost of internal and external nonconformance);
 Measures of process effectiveness;
 Measures of process efficiency
 Product conformance;
 Assessments of mfg. feasibility made for changes to existing operations and for new
product;
 Customer satisfaction (see ISO 9001, Section 9.1.2);
 Review of performance against objectives & Customer scorecard;
 Warranty performance (where applicable);
 Identification of potential field failure identified through risk analysis (such as FMEA);
 Actual field failures and their impact on safety or the environment.
9.3.3. Management review outputs
9.3.3.1. Management review outputs – supplemental
• Top management shall document and implement an action plan when customer
performance targets are not met.
10. Improvement
10.1. General
10.2. Nonconformity and corrective action

10.2.1.
10. Improvement
10.2.2.
10.2.3. Problem solving

• The organization shall have a documented process (es) for problem solving including:
 Defined approaches for various types and scale of problems (e.g., new product development,
current manufacturing issues, field failures, audit findings);
 Containment / interim actions, and related activities necessary for control of NC outputs;
 Root cause analysis and results;
 Implementation of corrective actions, including consideration of similar process / products;
 Verification of the effectiveness of implemented corrective actions;
 Reviewing and updating the appr. documented information (e.g., PFMEA, control plan).
Where the customer has specific processes or systems for problem solving, the organization
shall use those processes or systems unless otherwise approved by the customer.
10. Improvement
10.2.4. Error-proofing
• The organization shall have a documented process to determine the use of appropriate error-
proofing methodologies. Details of the method used shall be documented in the process risk
analysis (such as PFMEA)
• The process shall include the testing of error-proofing devices for failure or simulated failure.
Records shall be maintained. Challenge parts, when used, shall be identified, controlled,
verified, and calibrated where feasible. Error-proofing device failures shall have a reaction
plan.
10.2.5. Warranty management systems

• When the organization is required to provide warranty for their product(s), the organization
shall implement a warranty management process.
• The organization shall include in the process a method for warranty part analysis, including
NTF (no trouble found). When specified by the customer, the organization shall implement the
required warranty management process.
10. Improvement
10.2.6. Customer complaints and field failure test analysis
• The organization shall perform analysis on customer complaints and field failures, including
any returned parts, and shall initiate problem solving and corrective action to prevent
recurrence.
• The organization shall communicate the results of testing/analysis to the customer and also
within the organization.
10.3. Continual improvement

10.3.1. Continual improvement – supplemental
• The organization shall have a documented process for continual improvement. The
organization shall include in this process the following:
(Continue…)

10. Improvement
10.3.1. Continual improvement – supplemental (…Continue)
 Identification of the methodology used, objectives, measurement, effectiveness, and

documented information;
 A manufacturing process improvement action plan with emphasis on the reduction of
process variation and waste;
 Risk analysis (such as FMEA).
Note: Continual improvement is implemented once manufacturing processes are statistically

capable and stable or when product characteristics are predictable and meet customer
requirements.

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FOR TRAINING PURPOSE ONLY

 Honored by IIT Guwahati for Techniche Representative in Year 2011

 Certified ‘Internal Auditor for Quality Management System i.e. ISO

 Certified for Auto Cad 2012.

Jaideep Gupta  7+ Years of Experience in Automobile Industry (QC,QA & QMS).

IATF 16949 : 2016 – AUTOMOTIVE QUALITY MANAGEMENT SYSTEM

1 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

Development of IATF 16949

ISO/TS 16949 : 2009 vs IATF 16949 : 2016 Structure New Structure

1 Scope 1 Scope MINOR

3 Terms and Definitions 3 Terms and Definitions

4 General Requirements 4 Context of the Organization

6 Resource Management 7 Support MAJOR

Measurement, Analysis and 9 Performance Evaluation

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

0.2 Quality Management Principles

0.3 Process Approach

4 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

0.3.3 Risk-based thinking

0.4 Relationship with other management system standards

5 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

3. Terms and definitions (Important Only)

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

3. Terms and definitions

Design for assembly (DFA):

Design for manufacturing and assembly (DFMA):

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

3. Terms and definitions

8 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

4. Context of the organization

General requirements - Supplemental

4.2. Understanding the needs and expectations of interested parties

9 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

4. Context of the organization

10 For more details, Please refer original IATF 16949:2016 standard

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

4. Context of the organization

4.4.1.1. Conformance of products and processes :

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

4. Context of the organization

Customer notification of requirements in item

Identification of product safety-related characteristics; Special approvals for design FMEA

Identification of product safety-related characteristics;

Special approval of control plans and process FMEAs;

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

4. Context of the organization

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

5.1.1.1. Corporate responsibility

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

5.1.2. Customer focus

Automotive Quality management systems (IATF 16949 : 2016) — Requirements

5.2.2. Communicating the quality policy

5.3. Organizational roles, responsibilities and authorities