NATIONAL TECHNOLOGY OF MEXICO

ZACATEPEC TECHNOLOGICAL INSTITUTE

COMPARISON TABLE ISO 9001:2015 – IATF 16949:2016

SUBJECT:
INTEGRATED MANAGEMENT SYSTEMS
UNIT 1
INDUSTRIAL ENGINEERING

TEACHER:

TEAM MEMBERS:
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 COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015
CHAPTER 4 “CONTEXT OF THE ORGANIZATION”
ISO 9001:2015 IATF 16949
4.1 Knowledge of the organization and its context 4.1 Knowledge of the organization and its context
The organization must determine the external and internal issues that The standard refers to the requirements of the ISO 9001:2015 standard.
are relevant to its purpose and strategic direction and that affect its
ability to achieve the intended results of its quality management
system.

The organization must track and review information on these external

and internal issues.
4.2 Understanding the needs and expectations of interested parties 4.2 Understanding the needs and expectations of interested parties
The organization must determine: The standard refers to the requirements of the ISO 9001:2015 standard.
a) interested parties who are relevant to the quality management
system;
b) the relevant requirements of these interested parties for the quality
management system.
The organization must track and review information about these
interested parties and their relevant requirements.
4.3 Determination of the scope of the quality management system 4.3 Determination of the scope of the quality management system
The organization must determine the limits and applicability of the The standard refers to the requirements of the ISO 9001:2015 standard.
quality management system to establish its scope.
When determining this scope, the organization must consider:
a) the external and internal issues referred to in section 4.1;
b) the requirements of relevant interested parties indicated in section
4.2;
c) the organization's products and services.
Furthermore, if all the requirements according to its QMS are
applicable, the organization must comply with all of the international
standards.
4.3.1 Determination of the scope of the quality management system –
Supplement
Support functions, located on-site or off-site (such as design centers,
company cooperative offices, and distribution centers), should be included
in the quality management system's portfolio (560).

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 4 “CONTEXT OF THE ORGANIZATION”
ISO 9001:2015 IATF 16949
4.3.2 Customer specific requirements
Specific customer requirements must be evaluated and included in the
scope of the organization's management system
4.4 Quality management system and its processes 4.4 Quality management system and its processes
4.4.1 The organization shall establish, implement, maintain and 4.4.1
continually improve a quality management system, including the The standard refers to the requirements of the ISO 9001:2015 standard.
necessary processes and their interactions, in accordance with the
requirements of this International Standard.
a) determine the required inputs and expected outputs of these
processes;
b) determine the sequence and interaction of these processes;
c) determine and apply criteria and methods (including monitoring,
measurements and
related performance indicators) necessary to ensure effective operation
and
control of these processes;
d) determine the resources necessary for these processes and ensure
their availability;
e) assign responsibilities and authorities for these processes;
f) address the risks and opportunities determined in accordance with
the requirements of section 6.1:
g) evaluate these processes and implement any necessary changes to
ensure that these
processes achieve intended results;
h) improve processes and the quality management system.
4.4.1.1 Compliance of products and processes
The organization shall ensure the conformity of all products and processes,
including service parts and processes that are outsourced, with all customer
requirements and applicable legal and regulatory requirements.
4.4.1.2 Product Safety
The organization shall have a documented process for managing product
safety in manufacturing processes and related products.
4.4.2 To the extent necessary, the organization must: 4.4.2
a) maintain documented information to support the operation of its The standard refers to the requirements of the ISO 9001:2015 standard.
processes;
b) preserve documented information to have confidence that the
processes are carried out as planned.

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 5 “LEADERSHIP”
ISO 9001:2015 IATF 16949
5.1 Leadership and commitment 5.1 Leadership and commitment
5.1.1 Generalities 5.1.1 Generalities
Senior management must demonstrate leadership and commitment to the The standard refers to the requirements of the ISO 9001:2015
quality management system: standard.
a) assuming responsibility and obligation regarding the effectiveness of the
QMS
b) establishing quality policy, objectives for the QMS in accordance with the
context and strategic direction of the organization
c) integrating QMS requirements into the organization's business processes
d) promoting the use of the process approach and risk-based thinking
e) ensuring QMS resources are available
f)communicating the importance of an effective QMS
g) ensuring that the QMS achieves the intended results
h) with commitment and support to people
i) promoting improvement
j) with management leadership.
5.1.1.1 Corporate responsibility
The organization must define and implement corporate responsibility
policies, including, at a minimum, a corruption prevention policy, a
code of conduct for employees, and an ethical escalation policy
(“warning policy”).
5.1.1.2 Process effectiveness and efficiency
Top management should review product realization processes and
supporting processes to evaluate and improve their effectiveness. The
results of the activities of this review process should be included as an
input to the management review (see section 9.3.3.2.1).
5.1.1.3 Process owners
Top management should designate process owners who are
responsible for managing the organization's processes and their
related outputs. Process owners must understand their roles and be
competent to carry out these roles (see section 7.2 of ISO 9001).
5.1.2 Customer focus 5.1.2 Customer focus
Senior management must demonstrate leadership and commitment to The standard refers to the requirements of the ISO 9001:2015
customer focus standard.
ensuring that:
a) applicable customer, legal and regulatory requirements are determined,
understood and met
b) risks and opportunities that can affect products and increase customer
satisfaction are determined
c) focus is maintained on increasing customer satisfaction
5.2 Policy 5.2 Policy
5.2.1 Establishment of the quality policy 5.2.1 Establishment of the quality policy
Top management must establish, implement and maintain a quality policy The standard refers to the requirements of the ISO 9001:2015
that: is appropriate to the purpose and context of the organization and standard.
supports its strategic direction; provide a framework for establishing quality
objectives; includes a commitment to comply with applicable requirements;
include a commitment to continuous improvement of the quality
management system.
COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015
CHAPTER 5 “LEADERSHIP”
ISO 9001:2015 IATF 16949
5.2.2 Communication of the quality policy 5.2.2 Communication of the quality policy
The quality policy must: The standard refers to the requirements of the ISO 9001:2015
a) be available documented; standard.
b) communicate, understand and apply within the organization;
c) be available to relevant interested parties; as appropriate.
5.3 Roles, responsibilities and authorities in the organization 5.3 Roles, responsibilities and authorities in the organization
Senior management must ensure that responsibilities and authorities for The standard refers to the requirements of the ISO 9001:2015
relevant roles are assigned, communicated and understood throughout the standard.
organization.
Senior management must assign responsibility and authority to:
a) ensure that the QMS complies with the ISO standard.
b) ensure that the processes generate the expected outputs
c) report on the performance of the QMS and possible opportunities for
improvement
d) ensure that customer focus is promoted in the organization.
e) ensure that the integrity of the QMS is maintained even if there are
changes to the QMS.
 ISO 9001:2015
Chapter 6.1
Actions to address risks and opportunities
Chapter 6.1.1
When planning the quality management system, the organization must
determine the risks and opportunities that need to be addressed in order to
ensure that the quality management system can achieve its intended
results; increase desirable effects, prevent or reduce undesirable effects to
achieve improvement through actions to address these risks and
opportunities by looking for ways to integrate and implement the actions
in their quality management system processes, evaluate the effectiveness
of these actions.
Does not have
Does not have
Does not have
6.2 Quality objectives and planning to achieve them
6.2.1 The organization must establish quality objectives for the relevant
functions and levels and the processes necessary for the quality
management system, being consistent with the quality policy, measurable,
taking into account applicable requirements, being relevant to conformity
of products and services and to increase customer satisfaction, be
monitored, communicated, updated as appropriate The organization must
maintain documented information on quality objectives.
6.2.2 When planning how to achieve its quality objectives, the
organization must determine: What it will do, what resources will be
required, who will be responsible, when it will be completed, how the
results will be evaluated.
Does not have
IATF 16949:2016
Chapter 6.1
Actions to address risks and opportunities
6.1.1 and 6.1.2
See ISO 9001:2015 requirements
6.1.2.1 Risk analysis
The organization must conclude in its risk analysis, at a minimum, the
lessons learned from product recalls in the market, product audits, returns
and repairs in the market, complaints, waste and rework.
6.1.2.2 Preventive action
The organization must determine and implement one or more actions to
eliminate the causes of potential nonconformities to prevent their
occurrence, and must establish a process to mitigate the impact of the
negative effects of the risk, which includes:
Determine potential nonconformities and their causes, evaluate the need
to act to prevent the occurrence of nonconformities, determine and
implement necessary actions, retain documented information of actions
taken, review the effectiveness of preventive actions taken, use lessons
learned to prevent recurrence in similar processes.
6.1.2.3 Contingency plans
The organization must:
a) identify and evaluate internal and external risks in all manufacturing
processes and infrastructure equipment that are essential to maintain
production outputs and ensure that customer requirements are met;
b) define contingency plans according to the risks and impact on the
client;
c) prepare contingency plans for continuity of supply in the event of any
of these events: failures of key equipment, stoppages caused by
processes, products and services supplied externally; recurring natural
disasters; fires; interruption of public services; labor shortages or
infrastructure disruptions;
d) include, as a supplement to contingency plans, a process of notifying
the client and other interested parties about the duration and scope of any
situation that is impacting the client's operations;
e) periodically test contingency plans to confirm their effectiveness (for
example, simulations, where appropriate);
f) carry out reviews and, if required, updates to the contingency plan
(annually, at a minimum), using a multidisciplinary team that includes
senior management;
g) document contingency plans and retain documented information
describing any updates, including the person(s) who authorized any
changes. Contingency plans should include provisions to validate that the
manufactured product continues to meet customer specifications after
restarting production.
6.2 Quality objectives and planning to achieve them
6.2.1 and 6.2.2
See ISO 9001:2015 requirements
6.2.2.1 Quality objectives and planning to achieve them —
supplement

6.3 Planning changes
When the organization determines the need for changes in the quality
management system, these changes must be carried out in a planned
manner considering;
The purpose of the changes and their potential consequences, the integrity
of the quality management system, the availability of resources, the
assignment or reassignment of responsibilities and authorities.
7.1 Resources
7.1.1 Generalities
The organization must determine and provide the resources necessary for
the establishment, implementation, maintenance and continuous
improvement of the quality management system and consider:
a) the capabilities and limitations of existing internal resources; b) what
needs to be obtained from external suppliers.
7.1.2 People
The organization must determine and provide the people necessary for the
effective implementation of its quality management system and for the
operation and control of its processes.
7.1.3 Infrastructure
The organization must determine, provide and maintain the infrastructure
necessary for the operation of its processes and achieve conformity of
products and services.
Infrastructure may include:
Buildings and associated services, equipment, including hardware and
software, transportation resources, information and communication
technology.
Does not have
7.1.4 Environment for the operation of the processes
The organization must determine, provide and maintain the environment
necessary for the operation of its processes and to achieve conformity of
products and services.
NOTE A suitable environment can be a combination of human and
physical factors, such as: social, psychological, physical. These factors
may differ substantially depending on the products and services supplied.
Does not have
7.1.5 Monitoring and measurement resources
Top management must ensure that quality objectives are defined,
established and maintained to meet customer requirements at relevant
processes, functions and levels throughout the organization.
The results of the organization's review of interested parties and their
relevant requirements should be considered when the organization
establishes its quality objectives and corresponding performance targets
each year.
6.3 Planning changes See the requirements of ISO 9001:2015.
7.1 Resources
7.1.1 General See the requirements of ISO 9001:2015.
7.1.2 People See the requirements of ISO 9001:2015.
7.1.3 Infrastructure See the requirements of ISO 9001:2015.
7.1.3.1 Planning of plant, facilities and equipment
The organization shall use a multidisciplinary approach, including
methods for risk determination and risk mitigation, to develop and
improve plant, facility and equipment plans.
In the design of the plant layout, the organization must optimize the flow
of materials, material handling and the added value in the use of the used
surface, including the control of non-conforming product, and facilitate
the synchronized flow of the materials, when applicable.
Methods must be developed and implemented to evaluate manufacturing
feasibility for new products or operations. Manufacturing feasibility
assessments should include capacity planning. These methods should
also be applied to evaluate proposed changes to existing operations.
The organization must maintain the effectiveness of the process,
including periodic risk-related reassessment to incorporate any changes
made during process approval, maintenance of the control plan and
verification of commissioning work. Manufacturing feasibility
assessments and capacity planning assessment should be inputs for
management review.
NOTE 1 These requirements should include the application of lean
manufacturing principles.
NOTE 2 These requirements should apply to the on-site activities of
third-party providers, where applicable.
7.1.4 Environment for the operation of the processes
See the requirements of ISO 9001:2015.
NOTE Where third-party certification to ISO 45001 (or equivalent) is
available, the organization may use it to demonstrate compliance with the
life safety aspects of these requirements.
7.1.4.1 Environment for the operation of processes — supplement
The organization must maintain its facilities in a state of order,
cleanliness and repair in accordance with the product and the needs of the
manufacturing process.
7.1.5 Monitoring and measurement resources
7.1.5.1 General
The organization shall determine and provide the resources necessary to
ensure the validity and reliability of the results when monitoring or
measurement is carried out to verify the conformity of products and
services with the requirements, ensure that the resources provided are
appropriate for the type specific monitoring and measurement activities
performed, are maintained to ensure continued fitness for purpose.
The organization shall retain appropriate documented information as
evidence that monitoring and measurement resources are fit for purpose.
7.1.5.2 Traceability of measurements
When traceability of measurements is a requirement, or is considered by
the organization to be essential to providing confidence in the validity of
measurement results, measuring equipment shall be calibrated or verified,
or both, at specified intervals, or before of its use, against measurement
standards traceable to international or national measurement standards;
Where such standards do not exist, the basis used for calibration or
verification should be retained as documented information and identified
to determine its status and to protect against adjustments, damage or
deterioration that could invalidate the calibration status and subsequent
measurement results. The organization shall determine whether the
validity of previous measurement results has been adversely affected when
measurement equipment is deemed unfit for its intended purpose, and shall
take appropriate action where necessary.
Does not have
Does not have
Does not have
7.1.5.1 General See the requirements of ISO 9001:2015.
7.1.5.1.1 Analysis of the measurement system
Statistical studies must be carried out to analyze the variation present in
the results of each type of inspection, measurement system and testing
equipment identified in the control plan. The analytical methods and
acceptance criteria used must comply with those indicated in the
reference manuals related to the analysis of measurement systems.
Records of the customer's acceptance of the alternative methods should
be maintained along with the results of the analysis of the alternative
measurement systems.
NOTE The priority of MSA studies should focus on special or critical
characteristics of the product or process.
7.1.5.2 Traceability of measurements
See the requirements of ISO 9001:2015.
NOTE A number or other identification that allows the calibration record
of the equipment to be traced meets the purpose of the requirements in
ISO 9001:2015
7.1.5.2.1 Calibration/verification records
The organization must have a documented process for managing
calibration/verification records. Records of calibration/verification
activity must be maintained for all gauges and necessary measurement
and testing equipment to provide evidence of conformity with internal
requirements, legal and regulatory requirements, and customer-defined
requirements.
You must ensure that calibration/verification activities and records
include updates as a result of engineering changes that have an effect on
the measurement systems, any readings that are out of specification at the
time received for calibration/verification, an evaluation of the risks in the
intended use of the product caused by an out-of-specification condition,
when a piece of measurement, testing and inspection equipment is found
to be out of calibration or defective during its planned verification or
calibration or during its For use, documented information must be
retained regarding the validity of previous measurement results obtained
with this measuring, testing and inspection equipment, including the date
of the last calibration with the associated measurement standard and the
next expiration date indicated on the report. calibration; e) notification to
the customer if suspicious product or material has been sent; f)
declarations of conformity with the specification after
calibration/verification; g) verification that the software version used for
product and process control is the one specified; h) records of calibration
and maintenance activities of all equipment, verification of production-
related software used for product and process control.
7.1.5.3 Requirements applicable to the laboratory
7.1.5.3.1 Internal laboratory
The organization's internal laboratory facilities must have a defined
laboratory scope that includes its ability to perform required inspection,
testing, or calibration services. This laboratory scope must be included
within the quality management system documentation. The laboratory
must specify and implement, at a minimum, requirements for the
adequacy of the laboratory's technical procedures, the competence of
laboratory people, product testing, the ability to perform these services
correctly, in a manner traceable to the standard. of the corresponding

Does not have
7.1.6 Knowledge of the organization
The organization must determine the knowledge necessary for the
operation of its processes and to achieve conformity of products and
services and must be maintained and made available to the extent
necessary. When addressing changing needs and trends, the organization
must consider its current knowledge and determine how to acquire or
access the necessary additional knowledge and/or required updates.
7.2 Competition
The organization shall determine the necessary competence of persons
who perform, under its control, work that affects the performance and
effectiveness of the quality management system, and ensure that these
persons are competent, based on appropriate education, training or
experience. where applicable, take actions to acquire the necessary
competency and evaluate the effectiveness of the actions taken AND retain
appropriate documented information as evidence of competency.
Does not have
Does not have
Does not have
process, when one or more national or international standards are not
available, the organization must define and implement a methodology to
verify the capability of the measurement system, customer requirements,
if any, and review of related records.
NOTE Third-party accreditation to ISO/IEC 17025 may be used to
demonstrate compliance of the organization's internal laboratory with this
requirement.
7.1.5.3.2 External laboratory
External/commercial/independent laboratory facilities used by the
organization for inspection, testing or calibration services must have a
defined laboratory scope that includes their ability to perform the
required inspection, testing or calibration, and the laboratory must be
accredited according to ISO/IEC 17025 or its national equivalent and
include in the scope of accreditation the relevant inspection, testing or
calibration services; The calibration certificate or test report must include
the mark of the national accreditation body; or, there must be evidence
that the external laboratory is acceptable to the client.
When a qualified laboratory is not available to treat given equipment,
calibration services can be performed by the equipment manufacturer.
The use of calibration services other than qualified laboratories may be
subject to government regulatory confirmation, if required.
7.1.6 Knowledge of the organization See the requirements of ISO
9001:2015.
7.2 Competition
See ISO 9001:2015 requirements
7.2.1 Competition — supplement
The organization shall establish and maintain one or more documented
processes to identify training needs, including raising awareness and
achieving competency of all persons performing activities that affect
conformity with product and process requirements. Persons performing
specific tasks assigned to them must be qualified, as required, with
particular attention to meeting customer requirements.
7.2.2 Competence — training for the job
The organization must provide on-the-job training to individuals with
any new or modified responsibilities that affect compliance with quality
requirements, internal requirements, and legal and regulatory
requirements; This should include temporary or subcontracted people.
The level of detail required in training for the job should be proportional
to the level of education that people have and the complexity of the tasks
that they are required to carry out in their daily work. People whose work
can affect quality must be informed about the consequences of
nonconformities with customer requirements.
7.2.3 Competence of the internal auditor
The organization must have one or more documented processes to verify
that internal auditors are competent, taking into account any specific
client requirements. The organization must maintain a list of qualified
internal auditors.
Quality management system auditors, manufacturing process auditors
and product auditors must all have the ability to demonstrate
understanding of the automotive process approach to auditing, including
risk-based thinking and understanding of requirements. applicable client-
specific requirements, understanding the requirements of applicable ISO
9001 and IATF 16949 that are related to the scope of the audit,
understanding the requirements of the applicable basic tools that are
related to the scope of the audit, understanding how to plan, perform and
report an audit and follow up on closing audit findings.
Additionally, manufacturing process auditors must demonstrate technical
understanding of one or more of the manufacturing processes to be

Does not have
7.3 Awareness
The organization shall ensure that persons performing work under the
control of the organization are aware of the quality policy, the relevant
quality objectives, their contribution to the effectiveness of the quality
management system, including the benefits of improved performance and
the implications of non-compliance with quality management system
requirements.
Does not have
Does not have
7.4 Communication
The organization must determine internal and external communications
relevant to the quality management system, including what to
communicate, when to communicate, who to communicate, how to
communicate, who communicates.
7.5 Documented information
7.5.1 Generalities
The organization's quality management system shall include the
documented information required by this International Standard,
documented information that the organization determines is necessary for
the effectiveness of the quality management system.
Does not have
7.5.2 Creation and update
When creating and updating documented information, the organization
must ensure that the identification, description, supporting media format,
audited, including the process risk analysis and control plan. Product
auditors must demonstrate their competence in understanding product
requirements and using relevant measurement and testing equipment to
verify product conformity. When training is provided to achieve
competency, documented information must be maintained that
demonstrates the instructor's competency with the above requirements.
Maintaining and improving the internal auditor's competence must be
demonstrated by performing a minimum number of audits per year, as
defined by the organization; and maintaining knowledge of relevant
requirements based on internal changes and external changes.
7.2.4 Competence of the second-party auditor
The organization must demonstrate the competence of the auditors who
perform second-party audits. Second-party auditors must meet client-
specific requirements for auditor qualification and demonstrate the
following minimum key competency, including an understanding of the
automotive process approach to auditing, including risk-based thinking
and client-specific requirements. applicable customer and organization
requirements of the applicable ISO 9001 and IATF 16949 Standards that
are related to the scope of the audit of the applicable manufacturing
process(es) to be audited, including the PFMEA and the control plan, the
the requirements of the applicable basic tools that are related to the scope
of the audit, how to plan, perform, prepare audit reports and follow up on
the closure of the audit findings.
7.3 Awareness
See the requirements of ISO 9001:2015.
7.3.1 Awareness-supplement
The organization must maintain documented information that
demonstrates that all employees are aware of their impact on product
quality and the importance of their activities to achieve, maintain and
improve quality, including customer requirements and the risks involved
towards the customer. for non-compliant products.
7.3.2 Motivation of people and granting of authority
The organization must maintain one or more documented processes to
motivate employees to achieve quality objectives, make continuous
improvements, and create an environment that promotes innovation. The
process should include promoting quality and technology awareness
throughout the organization.
7.4 Communication See the requirements of ISO 9001:2015.
7.5 Documented information
7.5.1 Generalities
See the requirements of ISO 9001:2015.
7.51.1 Documentation of the quality management system
The organization's quality management system must be documented and
include a quality manual, which may be made up of a series of
documents. If a series of documents is used, then a list of the documents
that make up the organization's quality manual must be maintained.
The quality manual should include, as a minimum, the scope of the
quality management system, including details and justification for any
exclusions, the documented processes established for the quality
management system, or reference to them, the organization's processes
and their sequence and interaction, including the type and scope of
control of any outsourced processes, a document indicating where in the
organization's quality management system specific customer
requirements are considered.
7.5.2 Creation and update
See the requirements of ISO 9001:2015.
review and approval with respect to suitability and adequacy.
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management
system and by this International Standard shall be controlled to ensure that
it is available and suitable for use, where and when it is needed, and that it
is adequately protected.
7.5.3.2 To control documented information , the organization must
address distribution, access, retrieval, use, storage and preservation,
including preservation of readability, change control, conservation and
disposition.
Documented information of external origin must be identified, as
appropriate, and controlled. Documented information retained as evidence
of conformity must be protected against unintentional modification.
Does not have
Does not have
COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015
CHAPTER 9 “PERFORMANCE EVALUATION”
ISO 9001:2015
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 Generalities
The organization must determine:
a) what needs monitoring and measurement;
b) the monitoring, measurement, analysis and evaluation methods necessary
to ensure valid results;
c) when monitoring and measurement should be carried out;
d) when monitoring and measurement results should be analyzed and
evaluated.
The organization must evaluate the performance and effectiveness of the
quality management system.
7.5.3 Control of documented information
7.5.3.1 and 7.5.3.2
See ISO 9001:2015 requirements
7.5.3.1 and 7.5.3.2
See ISO 9001:2015 requirements
7.5.3.2.1 Record retention
The organization must define, document and implement a records
retention policy. Records control must satisfy legal, regulatory,
organizational, and customer requirements.
Production part approvals, tooling records, product and process design
records, purchase orders, or controls and modifications must be
maintained for as long as the product is active in accordance with
production requirements and service with an additional common year,
unless otherwise specified by the customer or a regulatory agency
7.5.3.2.2 Engineering specifications
The organization shall have a documented process that describes the
review, dissemination and implementation of all customer engineering
standards/specifications and related updates based, as required, on
customer programs.
The organization must keep a record of the date on which each change is
implemented in production. The implementation must include updated
documents.
The review should be completed within 10 business days of receiving
notification of the change in engineering standards/specifications.
NOTE Change to these standards/specifications may require
updating the customer's production parts approval record when these
specifications are cited in the design record or if they affect production
part approval process documents, such as the control plan, risk analysis
(such as FMEA), etc.
IATF 16949
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 Generalities
The standard refers to the requirements of the ISO 9001 standard
The organization must retain appropriate documented information as
evidence of results.
9.1.1.1 Monitoring and measurement of manufacturing processes
The organization shall conduct process studies of all new
manufacturing processes (including assembly or sequencing
processes) to verify process proficiency and provide additional inputs
to process control.

The organization must maintain process ability or performance

results.

9.1.2 Customer satisfaction
The organization should track customers' perceptions of the degree to which
their needs and expectations are met. The organization must determine
methods to obtain, track, and review this information.
The organization must verify that the process flow diagram, AMEFP
and CP are implemented with: measurement techniques, sampling
plans, acceptance criteria, records of current values, reaction plans
and escalation process when the requirements are not met. criteria of
acceptance.
The organization must retain records of the dates on which process
changes are made.
9.1.1.2 Identification of statistical techniques
The organization must determine the appropriate use of statistical
techniques. FMEA (DESIGN AND PROCESS) and CP.
9.1.1.3 Application of statistical concepts
Statistical concepts, such as variation, control (stability), process skill,
and the consequences of overfitting, must be understood and used by
employees involved in obtaining, analyzing, and managing statistical
data.
9.1.2 Customer satisfaction
The standard refers to the requirements of the ISO 9001 standard
9.1.2.1 Customer satisfaction – supplement
Customer satisfaction with the organization must be monitored
through continuous evaluation of internal and external performance
indicators.

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 9 “PERFORMANCE EVALUATION”

ISO 9001:2015 IATF 16949

9.1.3 Analysis and evaluation 9.1.3 Analysis and evaluation

The organization must analyze and evaluate the appropriate data and The standard refers to the requirements of the ISO 9001 standard
information arising from monitoring and measurement.
The analysis results should be used to evaluate:
a) the conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management system;
d) whether what was planned has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external suppliers;
g) the need for improvements in the quality management system.
9.2 Internal audit 9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to The standard refers to the requirements of the ISO 9001 standard
provide
information about whether the quality management system:
a) is in accordance with:
 the organization's own requirements for its quality management
system;
 the requirements of this International Standard;
b) is implemented and maintained effectively.
9.2.2 The organization must: 9.2.2
a) plan, establish, implement and maintain one or more audit programs that The standard refers to the requirements of the ISO 9001 standard
include the
frequency, methods, responsibilities, planning requirements and preparation
of
reports, which must take into consideration the importance of the processes
involved, the changes
that affect the organization and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and carry out audits to ensure objectivity and
d) impartiality of the audit process;
e) ensure that the results of audits are reported to the relevant management;
f) make corrections and take appropriate corrective actions without undue
delay;
g) preserve documented information
COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015
CHAPTER 9 “PERFORMANCE EVALUATION”
ISO 9001:2015
9.3 Management review
9.3.1 Generalities
Top management should review the organization's quality management
system at planned intervals to ensure its continued suitability, adequacy,
effectiveness and alignment with the organization's strategic direction.
9.3.2 Management review inputs
The management review should be planned and carried out including
consideration of:
9.2.2.1 Internal audit program
The organization must have a documented internal audit process. The
process must include the development and implementation of an
internal audit program that includes the entire QMS, manufacturing
processes and the product.
The audit program should be prioritized based on risks, internal and
external performance trends and the criticality of the processes as well
as the quality of the development of the software developed itself.
IATF 16949
9.2.2.2 Audit of the quality management system
The organization must audit all quality management system processes
in each common three-year period, according to an annual program,
using the process approach to verify compliance with this Automotive
QMS Standard. As part of these audits, the organization must conduct
sampling to verify the effective implementation of specific customer
requirements for the quality management system.
9.2.2.2 Manufacturing process audit
The organization must audit all manufacturing processes in each
common three-year period to determine their effectiveness and
efficiency using the customer-specific approach required for
manufacturing process audits. When not defined by the client, the
organization must determine the approach that will be used.
As part of each individual audit plan, each manufacturing process
should be audited on all shifts where it is performed, including
appropriate shift change sampling.
The manufacturing process audit should include an audit of the
effective implementation of the process risk analysis (such as the
AMEFP), the control plan and associated documents.
9.2.2.3 Product audit
The organization shall audit products using the customer-specific
approach required at the appropriate stages of production and delivery
to verify conformity with specified requirements. When not defined
by the client, the organization must define the approach that will be
used.
9.3 Management review
9.3.1 Generalities
The standard refers to the requirements of the ISO 9001 standard
9.3.1.1 Management review - supplement
The management review must be carried out at least annually. The
frequency of management reviews should be increased based on the
risks to meeting customer requirements resulting from performance
issues and internal or external changes that impact the quality
management system.
9.3.2 Management review inputs
The standard refers to the requirements of the ISO 9001 standard
the status of actions, changes in external and internal issues that are relevant
to the quality management system; information on the performance and
effectiveness of the quality management system, the adequacy of resources;
the effectiveness of actions taken to address risks and opportunities (see 6.1);
the opportunities for improvement.

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 9 “PERFORMANCE EVALUATION”

ISO 9001:2015 IATF 16949

9.3.2.1 Management review entries - supplement

Management review inputs should include:
a) the cost of poor quality (cost of internal and external non-
conformity);
b) measurements of process effectiveness;
c) process efficiency measurements;
d) the conformity of the product;
e) manufacturing feasibility assessments carried out for changes to
existing operations and for new facilities or new products (see section
7.1.3.1);
f) customer satisfaction (see section 9.1.2 of ISO 9001);
g) the review of maintenance objectives against their performance;
h) the performance of guarantees (when applicable);
i) review of client performance reports (when applicable);
j) the identification of potential market failures identified through risk
analysis (such as the FMEA);
k) current market failures and their impact on safety or the
environment.

9.3.3 Management review outputs 9.3.3 Management review outputs

Management review outputs should include decisions and actions related to: The standard refers to the requirements of the ISO 9001 standard
a) opportunities for improvement;
b) any need for change in the quality management system;
c) resource needs.
The organization must retain documented information as evidence of the
results of management reviews.
9.3.3.1 Management review outputs - supplement
Senior management must document and implement an action plan
when customer performance goals are not achieved.

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 10 “IMPROVEMENT”

ISO 9001:2015 IATF 16949

10 Improvement 10 Improvement
10.1 Generalities 10.1 Generalities
The organization must determine and select improvement opportunities and The standard refers to the requirements of the ISO 9001 standard
implement any necessary actions to meet customer requirements and increase
customer satisfaction.
These should include:
a) improve products and services to meet requirements, as well as consider
the needs and
future expectations;
b) correct, prevent or reduce unwanted effects;
c) improve the performance and effectiveness of the quality management
system.
10.2 Non-conformity and corrective action 10.2 Non-conformity and corrective action
10.2.1 When a nonconformity occurs, including any arising from complaints, 10.2.1
the organization The standard refers to the requirements of the ISO 9001 standard
has to:
a) react to non-conformity and, where applicable:
1) take actions to control and correct it;
2) deal with the consequences;
b) evaluate the need for actions to eliminate the causes of non-conformity, in
order to avoid
occur again or occur elsewhere, by:
1) review and analysis of non-conformity;
2) determination of the causes of non-conformity;
3) determining whether similar nonconformities exist, or potentially may
occur;
c) implement any necessary action;
d) review the effectiveness of any corrective action taken;
e) if necessary, update the risks and opportunities determined during
planning; and
f) if necessary, make changes to the quality management system.,
Corrective actions must be appropriate to the effects of the nonconformities
found.
10.2.3 Troubleshooting
The organization must have one or more documented problem-
solving processes that include:
a) the defined approaches for different types of problems and their
escalation (e.g. new product development, audit findings);
b) containment, interim actions and related activities that are
necessary to control non-compliant outputs (see ISO 9001, section
8.7);
c) root cause analysis
d) the implementation of systematic corrective actions, including
consideration of their impact on similar processes and products;
e) verification of the efficiency of the corrective actions implemented;
f) reviewing and, where necessary, updating appropriate documented
information (e.g. PFMEA, control plan).

COMPARISON TABLE IATF 16949:2016 – ISO 9001:2015

CHAPTER 10 “IMPROVEMENT”

ISO 9001:2015 IATF 16949

10.2.4 Failsafe
The organization must have a documented process to determine the
use of appropriate error-proofing methodologies. The details of the
method used should be documented in the process risk analysis (such
as the PFMEA) and the frequency of testing should be documented in
the control plan.
The process should include failure testing or failure simulation of fail-
safe equipment. Records must be kept. Master parts, when used, must
be identified, controlled, verified and calibrated where feasible.
Failures in error-proof equipment must have a reaction plan
10.2.5 Warranty management system
Where the organization is required to provide a warranty for its

10.3 Continuous improvement
The organization must continually improve the suitability, adequacy and
effectiveness of the quality management system.
The organization should consider the results of the analysis and evaluation,
and the outputs of the management review, to determine if there are needs or
opportunities that should be considered as part of continuous improvement.
products, the organization must implement a warranty management
process. The organization should include in the process a method for
analyzing warranty parts, including actions such as “No problems
found” or NTF. Where specified by the client, the organization shall
implement the required collateral management process.
10.2.6 Customer complaints and market failure analysis/testing
The organization must conduct an analysis of customer complaints
and market failures, including any rejected parts, and must initiate
problem solving and corrective action to prevent recurrence.
When requested by the customer, an analysis of the interaction of the
organization's product's embedded software with the end customer's
product system should be included.
The organization must communicate the results of the analysis/test to
the client and also within the organization
10.3 Continuous improvement
The standard refers to the requirements of the ISO 9001 standard
10.3.1 Continuous improvement – supplement
The organization must have a documented process for continuous
improvement. The organization must be included in this process:
a) identification of the methodology used, objectives, measurement,
efficiency and documented information:
b) a manufacturing process improvement action plan with emphasis
on reducing process variation and waste;
c) risk analysis (such as FMEA)