Checklist of Mandatory Documentation
Required by IATF 16949:2016
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Table of Contents
Executive Summary ...................................................................................................................................... 3
Introduction .................................................................................................................................................. 4
Which Documents and Records are Required? ............................................................................................ 5
Commonly Used Non-Mandatory Documents ............................................................................................. 9
Criteria for Deciding which Other Documents are to be Written .............................................................. 10
How to Structure Documents and Records ................................................................................................ 12
Conclusion................................................................................................................................................... 19
Sample documentation templates ............................................................................................................. 19
References .................................................................................................................................................. 19
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Executive Summary
The latest version of IATF 16949 was published in 2016 and the transition from the previous version is
ahead. One of the most important steps in the transition process, as well as in the initial implementation,
is determining what documents and records are needed for an effective Quality Management System
(QMS) based on IATF 16949. This white paper is designed to help top management and employees
involved in an IATF 16949 implementation or transition. It will also help to clear up any misunderstandings
regarding documents required by the standard.
In this document, you will find an explanation of which documents are mandatory according to the IATF
16949:2016 standard, and which non-mandatory documents are commonly used in the QMS
implementation, in the same order and numbered clauses as in IATF 16949.
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Introduction
Documentation that is needed for implementation of IATF 16949 is that which is required explicitly by the
standard plus whatever the company determines as necessary for effective maintenance of the QMS
based on IATF 16949. Many companies go overboard with documentation in the belief that they need to
document every single process that is in place in their organization. Often, they do not realize that this is
not necessary to meet the requirements of the IATF 16949 standard. While trying to fulfill standard
requirements, organizations tend to generate too many documents to be on the “safe side.”
Although it is sometimes helpful, this can be counterproductive, because it makes the implemented
processes and respective QMS hard to use and maintain, as well as making the QMS a bureaucratic
burden. While taking such an approach, organizations are missing a chance to improve their processes
for their own benefit, as well as that of their customers.
This white paper is written in plain English to help you learn the minimum IATF 16949 requirements for
the documentation. It also provides a list of documents that are commonly in place and can help you
make your QMS more efficient.
Since IATF 16949 is referring to requirements of ISO 9001:2015, mandatory documents required by ISO
9001 will also be included so, the organization will have the full picture of what is required regarding
documented information.
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Which Documents and Records are
Required?
Mandatory documents
Mandatory documents
Scope of the Quality Management System
Documented process for the management of product safety related
products and manufacturing processes
Clause of IATF 16949:2016
4.3
4.4.1.2
Quality Policy
5.2
Responsibilities and authorities to ensure that customer requirements
are met
5.3.1
Quality Objectives and Plans for Achieving Them
6.2
Documented process for managing calibration/verification records
7.1.5.2.1
Documented process for identification of training needs including
awareness and achieving awareness
7.2.1
Documented process to verify competence of internal auditors
7.2.3
Documented process to motivate employees
7.3.2
Quality manual
7.5.1.1
Record retention policy
7.5.3.2.1
Documented process for review, distribution and implementation of
customer engineering standards/specifications
7.5.3.2.2
Procedure for design and development
8.3.1.1
Documented process to identify special characteristics
8.3.3.3
Documented supplier selection process
8.4.1.2
Documented process to identify and control externally provided
processes, products and services
8.4.2.1
Documented process to ensure compliance with statutory and regulatory
requirements of purchased processes, products and services
8.4.2.2
Documented process and criteria for supplier evaluation
8.4.2.4
Documented process to control and react to changes in product
realization
8.5.6.1
Documented process for management of the use of alternate control
methods
8.5.6.1.1
Documented process for rework confirmation
8.7.1.4
Documented process for repair confirmation
8.7.1.5
Documented process for disposition of nonconforming product
8.7.1.7
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Mandatory documents
Clause of IATF 16949:2016
Documented internal audit process
9.2.2.1
Documented process for problem solving
10.2.3
Documented process to determine the use of error-proofing
methodologies
10.2.4
Documented process for continual improvement
10.3.1
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Mandatory Records
Mandatory records
Clause of ISO 13485:2016
Results of risk analysis
6.1.2.1
Preventive action record
6.1.2.2
Contingency plan
6.1.2.3
Records of customer acceptance of alternative measurement methods
7.1.5.1.1
Maintenance and calibration record
7.1.5.2.1
Competence Records
7.2
List of qualified internal auditors
7.2.3
Documented information on trainer’s competency
7.2.3
Documented information on employee’s awareness
7.3.1
Registry of customer complaints
8.2
Product/service requirements review records
8.2.3.2
Record about design and development outputs review
8.3.2
Documented information on software development capability selfassessment
8.3.2.3
Records about product design and development inputs
8.3.3.1
Records about manufacturing process design input requirements
8.3.3.2
Records of design and development controls
8.3.4
Documented product approval
8.3.4.4
Records of design and development outputs
8.3.5
Manufacturing process design output
8.3.5.2
Design and development changes records
8.3.6
Documented approval or waiver of the customer regarding the changes
in design
8.3.6.1
Documented revision level of software and hardware as part of the
change record
8.3.6.1
Records of second-party audit reports
8.4.2.4.1
Characteristics of product to be produced and service to be provided
8.5.1
Control plan
8.5.1.1
Total productive maintenance system
8.5.1.5
Records of traceability
8.5.2.1
Records about customer property
8.5.3
Production/service provision change control records
8.5.6
Documented approval by the customer prior to implementation of the
change
8.5.6.1
Record of conformity of product/service with acceptance criteria
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8.6
7
Mandatory records
Clause of ISO 13485:2016
Record of expiration date or quantity authorized under concession
8.7.1.1
Record on disposition of reworked product
8.7.1.4
Record of customer authorization for concession of the product to be
repaired
8.7.1.5
Notification to the customer about the nonconformity
8.7.1.6
Record of nonconforming outputs
8.7.2
Monitoring and measurement results
9.1.1
Internal audit program
9.2
Results of internal audits
9.2
Results of the management review
9.3
Action plan when customer performance targets are not met
9.3.3.1
Results of corrective actions
10.1
These are the documents and records that are required to be maintained for the IATF 16949 Quality
Management System. You should also maintain any other records that you have identified as necessary
to ensure that your management system can function, be maintained, and improve over time.
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Commonly Used Non-Mandatory
Documents
While IATF 16949 does not require that you document all of the procedures, there are several processes
which are mandatory to be established in order to generate the required records outlined in the first
section.
Remember, these processes and procedures are not required to be documented; however, many
companies choose to do so. One rule of thumb when deciding if you want to document a process is this:
if there is a chance that the process won’t be carried out as planned, then you should document it. In
many cases this is the best way to ensure that your Quality Management System is reliably implemented.
Non-Mandatory Procedures
Clause of ISO 13485:2016
Procedure for Determining Context of the Organization and Interested
Parties
4.1 and 4.2
Procedure for Addressing Risks and Opportunities
6.1
FMEA Procedure
6.1.2.1
Sales Procedure
8.2
Workplace Organization Procedure
7.1.4
Procedure for Control of Gauges
7.1.5.1.1
Procedure for Equipment Maintenance and Measuring Equipment
Laboratory Management Procedure
7.1.5.2; 8.5.1.5; 8.5.1.6
7.5.1.3
Procedure for Purchasing
8.4
Procedure for Production and Service Provision
8.5
Warehousing Procedure
8.5.4
Procedure for Measuring Customer Satisfaction
9.1.2
Procedure for Management Review
9.3
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Criteria for Deciding which Other
Documents are to be Written
In addition to the mandatory procedure and records, there is a requirement to create documented
procedures when non-conformities would occur if the procedure was not written down. Simply put, if
required, have a written procedure to make sure that mistakes are not made. There are a few simple
things to think about when deciding if a documented procedure is needed, and those listed below are a
good start.
Does the order of operations matter? If there are several ways to get the same outcome, and the
important thing is the outcome, then there is no need to write down what process to use. An example
would be certain design analyses. There are several ways to analyze the mechanical design of a product,
and many different computer design tools to use, but all give very similar results. If the result of any of
the available processes is acceptable, then why prescribe which one to use?
Can any simple requirements be covered by training or forms? As a corollary to the first question, there
are other ways to ensure things are done properly. If you have a standard form (paper or electronic) for
purchasing that highlights all the required information to be sent to a supplier for the purchase of product,
do you really need a written procedure to tell someone how to fill out the form to place the order? If the
important thing is for the required information to be there, the form can stand for itself. Any additional
information, such as how to find a part number in your system, may be acquired through training, without
needing to write a document.
Does the process need the same level of change control that is afforded Quality Management System
documents? Some companies like to document all of their Human Resource Policies as part of the Quality
Management System, but you need to consider the costs of having a procedure as part of that system.
Does the procedure need to have change control that is as strict as other documents, or could having
controlled change access on a computer drive be just as effective? Does every detail of the procedure
need to be audited, or is it there mostly for the information of employees when they need it (such as a
travel policy)?
Remember that, just because some information is important, it doesn’t mean that it needs to be
controlled in the Quality Management System documentation; other avenues are also available. This is
also a good thing to consider when deciding if something needs to be a controlled form or not. Often, a
company’s Documentation Procedure will specify the change control on forms. Some checklists, however,
can be more effective if their content is easily controlled by the few people who use instead of a more
complicated change control system. For example, the shipping department may have a checklist for what
they need to do to ship product. If a problem occurs, and they all agree to add an additional check to
make sure the problem doesn’t happen again, this change can happen more quickly and can help prevent
the same problem from recurring in the future.
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How many people are doing the job? Using purchasing as an example again, if you only have a few people
doing the job, then they can very likely ensure that, between them, the process outputs are consistent.
This means that the information going to the suppliers is always similar enough to ensure that good
product is received. This also allows those few people to share process improvements to help the process
flow better.
Does competence of the workers make a written procedure unnecessary? One beneficial addition to the
ISO 9001 standard, and consequently in IATF 16949, is the separation of Competence from Training. If
your hiring practices for a machine shop comprise only hiring licensed machinists or their apprentices,
then you don’t really need written instructions on how to use a lathe. This is part of the competence of a
machinist. The old version of the standard adage of “write what you do, do what you write” need not
apply.
Why written documentation for every process may be bad? When you document a specific order of
operations for a process, you can limit the participants in the process from having any flexibility in how
they do their job. This can potentially lower job satisfaction, employee engagement and indeed can hinder
any efforts to find process improvements. In the worst cases, the effort to try to change the process for
the better can be seen as greater than just continuing to use the flawed or imperfect process. Sharing of
best practices should be encouraged, and by writing a prescriptive process, you may hinder employees’
desire to improve what they do.
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How to Structure Documents and
Records
Procedure for Determining Context of the Organization and Interested Parties. This is a new
requirement of the standard that can bring some ambiguities. Since this is being done for the first time,
it is a good idea to document the process of determining the context and identifying interested parties
and their expectations. This document should contain all internal and external issues to be considered, as
well as the process and responsibilities for identification of interested parties and their needs and
expectations. A Procedure for Determining Context of the Organization and Interested Parties can be of
great help in implementation of these new requirements.
For more information, see: How to define the context of the organization in IATF 16949:2016.
Scope of the Quality Management System. This document is usually rather short, and written at the
beginning of the implementation. Its purpose is to define the boundaries of the QMS and to determine
which parts of the organization the QMS will apply. Normally, it is a standalone document called Scope of
the QMS, although it can be merged into a Quality Manual.
For more information, see: How to define scope of the QMS according to IATF 16949:2016.
Documented process for the management of product safety related products and manufacturing
processes. The standard requires an organization to document the procedure which ensures its products
are safe for the end user. The procedure needs to cover various topics, from identification of product
safety regulations to product traceability and lessons learned for new product introduction. Although it
is meant to control the manufacturing process, it is often merged with the Procedure for Addressing Risks
and Opportunities, since the product and manufacturing process should be designed in a way that ensures
product safety.
Quality Policy. The Quality Policy is intended to be a company’s documented intention to comply with
appropriate requirements, increase customer satisfaction, and continually improve. The policy is the
focus for the company and should readily convey the goal of the organization. It is a standalone document,
but is often documented in a Quality Manual. It is also sometimes posted throughout the organization as
a way of communicating to all employees, since it is important that every employee understand how the
policy relates to his or her job.
Responsibilities and authorities. The standard requires responsibilities and authorities within the QMS
to be defined, communicated and documented. This can be done in two ways: the organization can have
a separate document that contains information about all roles and responsibilities, or it can list the roles
and responsibilities within the documents that describe processes and activities, e.g. procedures and
work instructions.
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Procedure for Addressing Risks and Opportunities. This is a new requirement that introduces significant
changes to the QMS. According to the new version, the risks and opportunities regarding the QMS must
be identified and addressed. There is no requirement, however, to use any methodology or write a
procedure. The process of addressing risks and opportunities includes consideration of internal and
external issues relevant to the QMS, interested parties, and scope of the QMS.
Considering the importance of this new requirement and the fact that it introduces a completely new
process into the organization, it is recommended that it be documented in the form of a procedure.
FMEA Procedure. Failure Mode Effect Analysis (FMEA) is a widely used risk assessment methodology in
automotive quality management system and the standard mentions it in several places. In order to ensure
consistent results from the risk assessment, organizations document procedure for FMEA risk assessment
methodology. With this documentation, everyone who uses it is familiar with the methodology and
criteria that the organization has adopted.
For more information about the FMEA risk assessment methodology, see: What is FMEA, and how to
apply it in IATF 16949.
Quality Objectives and Plans for Achieving Them. The requirements regarding setting the quality
objectives remained as they were in the previous version of the standard; they still need to be measurable
and timed. However, the standard now requires plans for achieving the objectives, meaning that the
organization will have to assign responsibilities and dedicate resources for achieving the objectives. These
requirements can be met in separate documents, but it is much easier to create a Quality Objectives
document and fulfill all the above-mentioned requirements.
For more information, see: How to Write IATF 16949 Quality Objectives.
Workplace Organization Procedure. The environment where the processes are conducted can
significantly influence their effectiveness and the conformity of the products. Some organizations find it
useful to document the procedure to ensure that occupational health and safety, state of order,
cleanliness, and repair is consistent with the product and manufacturing process needs.
Procedure for Control of Gauges. Application of appropriate measuring methods and fitness of the
gauges used is crucial for ensuring compliance of the product with the requirements. Documenting this
Procedure for control of gauges aims to ensure that appropriate methods are applied and the instruments
used are fit for the purpose.
Procedure for Equipment Maintenance and Measuring Equipment. The purpose of the monitoring and
measuring is to provide evidence of conformity of the product to determined requirements. In order to
ensure that monitoring and measuring can be carried out and are conducted properly, the organization
needs to document Procedure for Equipment Maintenance and Measurement Equipment.
Documented process for managing calibration/verification records. Keeping records of calibration
ensures the traceability of measuring instruments and enables the organization to keep track of the
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calibration schedules. This procedure is rarely documented separately but it is instead merged with the
Procedure for Equipment Maintenance and Measuring Equipment.
Documented process for identification of training needs including awareness and achieving awareness.
This procedure should describe how the process of identification and achieving necessary competence is
performed as well as how the company raises awareness of its employees regarding the QMS. This
procedure is usually part of Procedure for Competence, Training and Awareness.
Documented process to verify competence of internal auditors. Internal audit is one of the key tools to
determine the compliance of the QMS to IATF 16949 and the overall state of the QMS. To achieve this,
the auditor must be competent to perform the audit and add value to the organization. Since there are
so many different requirements in the standard, it makes sense to define and document the necessary
competencies of the auditors and how those competencies are verified. This procedure can be easily
merged with Procedure for Competence, Training and Awareness.
For more information, see: Requirements for competence of IATF 16949 internal auditors.
Documented process to motivate employees. Motivation of employees is important for productivity and
effectiveness of the process and the organization as a whole. Therefore, the standard requires the
organization to document procedures to motivate employees. The document describes responsibilities
and methods for motivating employees and, in order to decrease amount of documentation, the
organization can merge it with the Procedure for Competence, Training and Awareness.
Quality manual. This is a roof document for your QMS, it usually includes the QMS scope, role(s)
undertaken by the organization, exclusions from the standard, references to relevant documents, and the
business process model. For more information on how to write the Quality Manual, see: How to write the
IATF 16949 Quality Manual.
Procedure for Document and Record Control. Managing documented information is defined by many
requirements within clause 7.5 in the standard. Activities of approval, update, managing changes, and
ensuring that the relevant version of the document is in use are best to be defined and documented in a
Procedure for document and record control.
The company must also define rules to maintain its records that show the QMS is implemented and
maintained. The records must also include how they identify, store, and protect the records so that they
can be retrieved as necessary, for the correct amount of time, and destroyed when no longer needed, but
not before. If you need more information, see A new approach to document and record control in IATF
16949.
Laboratory Management Procedure. This procedure should describe the laboratory technical
procedures, competencies of personnel, methods of testing the product, and requirements for external
laboratories.
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Record retention policy. Records are the backbone of the QMS. They demonstrate compliance with the
standard and organizational procedures and ensure traceability. This policy is often part of the Procedure
for Document and Record Control.
Documented process for review, distribution and implementation of customer engineering
standards/specifications. Engineering specifications are crucial for designing and manufacturing of the
product. The organization must ensure that appropriate engineering specifications are available where
and when they are needed. Since this is a subject similar to record control, this procedure is often merged
with Procedure for Document and Record Control.
Sales Procedure. Although it is not a mandatory procedure, the standard prescribes numerous rules
regarding communication with customers, determining requirements related to product and services, and
activities regarding review of these requirements. The best way to conform to all these requirements is
to document them, together with responsibilities.
Procedure for design and development. Requirements regarding the design and development process
are among the most demanding in the standard. Every step of the process needs to be documented in
the form of a record, from design and development inputs, controls, and outputs, to changes in design
and development. Considering all the requirements regarding this process, it is best to document the
Procedure for Design and Development and define all mandatory records that should accompany the
procedure.
Documented process to identify special characteristics. The organization needs to establish, document
and implement a process to identify special characteristics including the ones determined by the
customer or risk analysis. Special characteristics are important input for the design and development of
processes and products. They are usually a part of the Procedure for Design and Development.
Procedure for Purchasing. Creators of the standard decided to use this rather robust formulation of what
is basically the Procedure for Purchasing and Evaluation of Suppliers. Although the purchasing process
doesn’t have to be documented, the standard requires companies to establish control over its externally
provided processes, products, and services. The standard does require the criteria for evaluation,
selection, monitoring, and reevaluation of the suppliers to be documented, and the best way to do this is
through the procedure.
Documented supplier selection process. Considering the importance of supplier reliability in the
automotive industry, it seems reasonable for an organization to document the selection process as well
as the criteria for the selection. In the case of smaller organizations, or organizations with a smaller or
limited number of suppliers, this procedure can be merged to Procedure for Purchasing and Evaluation
of Suppliers.
Documented process to identify and control externally provided processes, products and services. It is
the organization’s responsibility to ensure that the products, services or processes provided by suppliers
are compliant with its requirements. Depending on the nature of the product, process and service or the
relationship with the supplier, the organization needs to define the type and amount of control to be
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enforced on the supplier and this process needs to be documented. In more simple cases, it is
recommended to make this procedure part of the Procedure for Purchasing and Evaluation of Suppliers.
Documented process to ensure compliance with statutory and regulatory requirements of purchased
processes, products and services. Just as with the previous procedure, this one aims to ensure that the
processes, services or products provided by suppliers are compliant to requirements, not of the
organization itself, but of the statutory and regulatory bodies. Again, it can be merged with the Procedure
for Purchasing and Evaluation of Suppliers.
Documented process and criteria for supplier evaluation. Keeping in mind how important the supplier is
to automotive industry, it is no wonder there are so many requirements to document different segments
of interaction with the supplier. The standard requires an organization to document procedures for
supplier evaluation. This can be easily merged with the purchasing process and documented in one single
Procedure for Purchasing and Evaluation of Suppliers.
Procedure for Production and Service Provision. The standard requires production and service provision
processes to be controlled in terms of: availability of necessary documented information regarding
product or service characteristics, intended results, availability of needed resources, monitoring and
measurement activities, etc. This rather complex process will not achieve the intended outcomes without
clearly defined rules. These rules are documented in the Procedure for Production and Service Provision.
Warehousing Procedure. The importance and necessity of this procedure will vary depending on the type
of business the company performs. In cases where the storage conditions can have great influence on the
product quality, rules for preservation of the product during storage should be documented in the
Warehousing Procedure.
Documented process to control and react to changes in product realization. In case of changes to the
product or the manufacturing process, the organization must remain compliant with requirements,
regardless of the source of change. The sources of change can include the organization itself, customers
or suppliers. This procedure aims to achieve its goal by describing how the organization reacts to the
change, verification, validation and other aspects that impact the product. Considering this to be a part
of the production process, this procedure is often amended to Procedure for Production and Service
Provision.
Documented process for management of the use of alternate control methods. In cases where the
adopted process controls cannot be enforced, the organization needs to identify, document and maintain
a process that manages the use of alternate control methods. Keeping in mind that normal operational
controls are part of the production process, this procedure can be merged with the Procedure for
Production and Service Provision.
Documented process for rework confirmation. The organization needs to define and document the
process of obtaining confirmation that any rework is in accordance with the control plan or other relevant
documented information. This will help to verify that conformance with original specifications will be
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maintained. This procedure can be part of Procedure for Production and Service Provision or documented
as a separate procedure.
Documented process for repair confirmation. As in case of reworking, the organization must obtain
confirmation for repair by the customer and this process must be fully documented. Similar to the
procedure for rework confirmation, this procedure can be either part of the Procedure for Production
and Service Provision or documented as a separate procedure.
Documented process for disposition of nonconforming product. What actions are in place, and who is
responsible for making sure that a nonconformity is addressed? How do you ensure that corrections are
made, and what process records are kept? How do you review nonconformities, determine causes, and
evaluate the need for actions to correct them? How do you implement the necessary actions, review that
the actions were effective, and keep records of the actions taken? With the Quality Management System,
you will find non-conformances within your processes must be corrected. When you investigate the root
cause of these problems, you will take corrective actions. You will also need to keep records of these
activities to show improvement.
Procedure for Measuring Customer Satisfaction. Although not required by IATF 16949, it is very common
for organizations to have a documented Procedure for measuring of customer satisfaction. Customer
satisfaction surveys allow an organization to learn more about the needs and expectations of its
customers. It also helps them to understand how customers perceive the organization, and this can be a
valuable input for improvement of the QMS.
Documented internal audit process. How do you audit your Quality Management System to make sure
that it is performing as planned and is effective? Who is responsible for planning and carrying out the
audits? How do you report the results, and what records are kept? How do you follow up on corrective
actions noted in audits? Learn more in this article about the Five Main Steps in an IATF 16949:2016
Internal Audit. You must also keep records of these activities and document a procedure to show QMS
conformance and improvement.
Procedure for Management Review. Management review as a process hasn’t undergone any changes in
in terms of how, and how often, it should be conducted. However, the mandatory inputs and outputs of
the management review have changed. It is now a requirement for the top management to review
internal and external issues relevant to the QMS, as well as the effectiveness of actions taken to address
risks and opportunities. As a result of the management review, there should be decisions regarding
opportunities for improvement of the QMS, the need for changes to the system, and resources needed.
The best way to keep track of what must be reviewed, and the expected results of the management
review, is to document the Procedure for Management Review.
Documented process for problem solving. As a part of conducting corrective actions, an organization
needs to apply a problem-solving process that has defined approaches to different types and scales of
processes, root cause analysis and other activities. The procedure can be documented separately or as a
part of Procedure for Management of Nonconformities and Corrective Actions.
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Documented process to determine the use of error-proofing methodologies. An organization needs to
document a procedure that helps eliminate defects by preventing, correcting, or drawing attention to
human errors as they occur. It is common to merge this procedure with Procedure for Management of
Nonconformities and Corrective Actions.
To learn more about error-proofing, see: How to establish an error-proofing process according to IATF
16949.
Documented process for continual improvement. The process for continual improvement needs to be
documented. It should include identification of the methodology used, objectives, measurement
effectiveness and required documented information. The aim is to ensure continual improvement of the
QMS as one of its key features. The process can be documented in the Procedure for continual
improvement.
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Conclusion
IATF 16949 implementation can turn into a problematic project if you don’t set it up correctly from the
very beginning. Documentation that is required by the standard, extended by non-mandatory documents,
forms a significant part of the QMS implementation. Knowing what the standard requires as mandatory
documentation helps the organization to be well-prepared for the certification audit. On the other hand,
decisions on adding non-mandatory documents should represent a balance between competence of
employees and administrative controls that can help an organization avoid nonconformities.
Implementing both mandatory and non-mandatory documents in an optimal scope increases the
efficiency of the QMS and creates benefits for both the organization itself and its customers.
Sample documentation templates
Download a free preview of the IATF 16949 Documentation Toolkit – in this free preview you will be able
to see the Table of Contents of each of the mentioned policies and procedures, as well as a few sections
from each document.
References
16949Academy
International Organization for Standardization
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