7 Product Realization Requirements

7.1 Planning of product realization

Product realization is the term used to describe the work that the organization goes through to
develop, manufacture, and deliver the finished goods or services. An effective Quality
Management System (QMS) includes a comprehensive approach to getting from the product
concept to the finished product. This approach, sometimes called a quality plan, includes the
following:
product requirements and quality objectives,
creation of the processes, documents, and resources needed for product realization,
required verification, monitoring, inspection, and test activities,
the records to be kept.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product
The Standard requires the organization to determine product requirements. These requirements
can come from the customer, may be mandated by laws or regulations, and include generally
accepted standards within your industry or market. Requirements are established by standard
contracts or oral agreements that the sales department uses in discussions with customers, and
other sources.
7.2.2 Review of requirements related to the product
After gathering preliminary product requirements, these requirements need to be reviewed to be
sure that the customer understands them and that the organization is meeting these
requirements. This review must ensure:
The requirements are known and understood,
Any changes from the original contract or discussions is understood,
The organization has the ability to meet the requirements
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 Records are kept of this review.

Routine orders for items described in a catalog of products are considered reviewed when the
relevant product information is reviewed.
7.2.3 Customer communication
Put in place effective customer communications channels, to allow dialogue regarding:
product information,
questions about contracts, order handling, changes, and
receiving customer feedback, including complaints.
7.3.1 Design and development planning
To effectively plan the design and development process, the organization must:
Clearly define the stages involved in the design and development process.
Identify how the review and verification of the design will take place.
Describe clear responsibility and authority for the people doing this work.
See that design information flows effectively among the various groups having a role in
designing, selling, managing, manufacturing, and servicing the products.
Keep design and development plans up to date.
7.3.2 Design and development inputs
Determine the product requirements, including:
what it does and how well it must perform,
legal and regulatory requirements,
pertinent information from similar designs,
other pertinent requirements.
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7.3.3 Design and development outputs

The output of design and development must include sufficient information to verify that design
output meets design input requirements. In addition, it must:
include the information need to purchase component materials, manufacture the product,
and service the product.
specify how to determine if the product has acceptable performance,
highlight safety and usage considerations.
7.3.4 Design and development review
Review the design and development work products to:
determine if the design meets the design input requirements,
identify and problems with the design,
propose solutions to identified design problems,
Include representatives from each function concerned with the design and development stage
being reviewed. Keep records of the reviews.
7.3.5 Design and development verification
Verify, according to your plan, that the design output meets design input
requirements. Record the results of these verification activities.
7.3.6 Design and development validation
Validate the operation of the resulting product under actual operating conditions. If the product
has multiple uses, validate operation for each intended use. The methods for validation defined
in the design output should be followed. Whenever possible, the validation of a product or
service should be performed prior to delivery to the customer. Record the results of these
validation activities.
7.3.7 Control of design and development changes
Identify, document, review, and approve all design changes before carrying them out. Evaluate
the impact of the changes on the present design of the product. Keep records of the review.
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7.4 Purchasing
7.4.1 Purchasing process
The organization needs to ensure that purchased products and services meet purchasing
requirements. The purchasing group must establish criteria for how they evaluate and choose
suppliers. These criteria must be based on the suppliers ability to provide products and services
that meet order specifications, especially product and service quality requirements. The extent
of the controls depend on the importance of the purchased goods in the finished product.
Finally, records must be kept showing how purchased products and services were evaluated.
7.4.2 Purchasing information
Clearly describe on purchase orders the product or service being ordered. Consider including
the following specifications:
how products, procedures, processes, and equipment are approved for purchase,
required competencies for contracted personnel,
requirements for the supplier's quality management system.
Review and approve purchasing requirements before sending them out.
7.4.3 Verification of purchased product
Carry out a plan for verifying that purchased services and materials are adequate, i.e. meet
purchase specifications.

7.5 Production and service provision

7.5.1 Control of production and service provision
Plan production, installation, and service processes and provide an environment where work can
proceed in an orderly fashion. These controlled conditions may include:
information regarding product specifications,
written instructions for carrying out the work,
suitable equipment,
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 adequate tools for monitoring and measuring process and product characteristics,
activities for monitoring and measuring process and product characteristics,
criteria for product release,
delivery and post delivery servicing activities.
7.5.2 Validation of processes for production and service provision
Process validation demonstrates that operation of the processes achieves the planned results.
When it is not possible to verify the finished good or service through monitoring or
measurement the QMS must require validation. Validation is particularly important where
deficiencies are not identified until the product is in use, or the service is delivered. When
validation is required, the QMS must define the criteria for the following:
review and approval of the process,
approval of the equipment used,
competency of the people who operate the process,
specific methods and procedures used,
records to be kept,
ongoing assessment of the process validation
7.5.3 Identification and traceability
Where appropriate, establish procedures to identify a product and determine what specifications
pertain to it as it moves through manufacturing, delivery, and installation. Record the inspection
and measurement status of the product. Individual products or batches of products must have
unique serial identification recorded if assuring product product quality requires this.
7.5.4 Customer property
Special care must be taken when a customer provides their property for use or incorporation
into the product. Identify, verify, and protect customer property provided and
maintain records of lost, damaged or unsuitable customer property. This may include
intellectual property.
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7.5.5 Preservation of product

The standard requires the organization to preserve the product, including identification,
handling, storage, packaging, protection, and delivery of parts and products throughout all
processes.

7.6 Control of monitoring and measuring devices

Any measurement worth taking is worth taking correctly. The standard requires the organization
to identify the inspection, test and measurements taken, their required accuracy, and the
equipment used to make the measurements. Procedures must describe how measurements are
carried out.
Measuring equipment must be carefully cared for, including:
timely calibration to national standards,
identification with a calibration label,
preventing adjustments that would invalidate the calibration,
preserving the equipment accuracy during handling, storage and use.
Measurements taken with equipment later found to be inaccurate must be assessed and
corrected.

Planning Product Realization Processes (7.1)

Planning and developing product realization processes (7.1)
The standard requires the organization to plan and develop the processes required for
product realization.
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What does this mean?

The product realization processes are the processes needed to specify, develop, produce and
supply the product or service required, and in the context of the automotive industry would
include those needed to:

specify the products and services required by the organization s customers (the sales
process);

plan the provision of the identified products and services (the project-, contract- or
order-planning process);

design the identified products and services so as to meet customer requirements (the
design process);

procure the materials, components, services needed to accomplish the design and/or
generate or deliver the product or service (the procurement process);

generate the product (the production process);

supply the product or service (the distribution or service delivery processes);

provide support to customers (the after sales, technical support or customer-support

process).

These processes are all product or service specific and take the input from the customer
through a chain of related processes that deliver acceptable products or services to
customers. However, Section 7 of ISO/TS 16949 does not cover all of the product realization
processes some of them are placed in Section 8.
Product design may not have formed part of the organization s management system under
QS-9000 if the products were not designed for specific customers but were proprietary
designs (to the organization s own specifications). However,...
Customer-Related Processes (7.2)
Determination of requirements related to the product (7.2.1)
This heading implies there are other requirements that do not relate to the product that may
form part of the customer requirements. However, ISO 9000 defines a product as the result of
a process and includes services among these. It is therefore difficult to imagine any aspect of
customer requirements that would not relate to the product or service that is being provided.
Requirements related to the product or service could include:

Characteristics that the product is required to exhibit, i.e. the inherent characteristics.

Price and delivery requirements.

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Procurement requirements that constrain the source of certain components, materials

or the conditions under which personnel may work.

Management requirements related to the manner in which the project will be

managed, the product developed, produced and supplied.

Security requirements relating to the protection of information.

Financial arrangements for the deposit of bonds, payment conditions, invoicing, etc.

Commercial requirements such as intellectual property, proprietary rights, labelling,

warranty, resale, copyright, etc.

Personnel arrangements such as access to the organization s facilities by customer

personnel and vice versa.

A process for determining product requirements should be designed so that it takes as its
input the identified need for a product and passes this through several stages where
requirements from various sources are determined, balanced and confirmed as the definitive
requirements that form the basis for product realization. The input can either be...
Design and Development (7.3)
Design and development control (7.3.1)
The standard requires the organization to control design and development of the product and
of manufacturing processes.
What does this mean?
With the addition of manufacturing processes, this requirement now has two dimensions:
product design and process design, and while both have many similarities, there are also
some differences. It is not intended that the word process replace the word product in Section
7.3. Those requirements of Section 7.3 that apply to process design are indicated separately,
so if it is not stated that the requirement refers to product design or process design, assume
it refers to product design.
Product design can be as simple as replacing the motor in an existing vehicle with one of a
different specification, or as complex as the design of a new automobile or any of its
subsystems. Product design can be of hardware, software (or a mixture of both) and can be of
new services or modified services. Before design commences there is either a requirement or
simply an idea. Product design is a creative process that creates something tangible out of an
idea or a requirement. The controls specified in the standard apply to the product and
process design process. There are no requirements that will inhibit creativity or innovation. In
order to succeed, the process of converting an idea into a design that can be put into
production or service has to be controlled. Product design is often a process which...
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Purchasing (7.4)
Purchasing process (7.4.1)
Ensuring purchased product conforms to specified requirements (7.4.1)
The standard requires the organization to ensure that purchased product conforms to
specified purchase requirements.
What does this mean?
ISO 9000 defines a supplier as an organization or person that provides a product and in
ISO/TS 16949 a product can be services, hardware, software or processed materials. A
supplier may therefore be a producer, distributor, retailer, vendor, contractor, subcontractor
or service provider. Purchased product is any product or service that is purchased rather than
freely given or otherwise acquired and applies to any product or service that affect
compliance with customer requirements. Specified purchase requirements are those
requirements that are specified by the customer, the organization or by statutes and
regulations that apply to purchased product. This would include any requirements limiting the
conditions or the source of supply.
Why is this necessary?
This requirement responds to the Factual Approach Principle.
All organizations have suppliers of one form or another in order to provide products and
service to their customers. Some of them directly or indirectly impact the product being
supplied to the organization s customers and others may have no impact at all such as office
supplies. From the scope of the standard we draw the conclusion that the requirement is not
intended to apply to products and service that have no impact on the customer but why
would you not want to manage such purchasing activities as effectively as other purchasing
activities? This is not...
Production and Service Provision (7.5)
Control of production and service provision (7.5.1)
Planning production and service provision (7.5.1)
The standard requires the organization to plan and carry out production and service provision
under controlled conditions.
What does this mean?
The process referred to in this section of the standard is the result-producing process, the
process of implementing or replicating the design. It is the process that is cycled repeatedly
to generate product or to deliver service. It differs from the design process in that it is
arranged to reproduce product or service to the same standard each and every time. The
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design process is a journey into the unknown whereas the production process is a journey
along a proven path with a predictable outcome. The design process requires control to keep
it on course towards an objective; the production process requires control to maintain a
prescribed standard.
There are two ways in which product quality can be controlled: by controlling the product that
emerges from the producing processes or by controlling the processes through which the
product passes. Process control relies on control of the elements that drive the process,
whereas product control relies on verification of the product as it emerges from the process.
In practice it is a combination of these that yields products of consistent quality. If you
concentrate on the process output to the exclusion of all else, you might find there is a high
level of rework of the end product. If you concentrate...
Control of Monitoring and Measuring Devices (7.6)
Determining monitoring and measurements to be undertaken (7.6)
The standard requires the organization to identify the monitoring and measurement to be
undertaken to provide evidence of conformity of product to determinedrequirements.
What does this mean?
This requirement should strictly be located in Section 8 but has been included in Section 7
because it is believed that there are some applications where it does not apply. Clearly there
are no applications where monitoring and measurement do not apply but there may be
applications where physical calibration of measuring devices may not be applicable in the
traditional sense of the word devices. The monitoring and measurements referred to are
those required to carry out product verification rather than the measurements to calibrate a
measuring device. The requirement is under product realization and not a subsection, and
therefore applies equally to product or service design, purchasing and production or service
delivery. It should not be interpreted as only applying to the characteristics of a product that
can be measured through examination. It applies equally to performance characteristics that
are inherent in the product design such as durability, safety and security, and to intangible
characteristics such as courtesy, respect and integrity in service design.
Measurement is the process of associating numbers with physical quantities and phenomena.
Measurements may be made by unaided human senses in which case they are often called
estimates or, more usually, by the use of instruments, which may...

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