8.

3 Design and development of

products and services

04/13/2021 1
 8.3 Design and development of products and
services ISO 9001:2015
8.3.1 General
The organization shall establish, implement and maintain a design
and development process that is appropriate to ensure the
subsequent provision of products and services. No change in
IATF 16949:2016 requirement
IATF 16949:2016
8.3.1.1 Design and development planning of products and
services- supplemental
The requirements of ISO 9001 section 8.3.1, shall apply to Product
and manufacturing process design and development and shall
focus on error prevention rather than detection

The organization shall document the design and development

process
04/13/2021 2
8.3.2 Design and development planning
ISO 9001:2015
In determining the stages and controls for design and development, the organization
shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development
process;
e) the internal and external resource needs for the design and development of
products and services
f) the need to control interfaces between persons involved in the design and
development process
g) the need for involvement of customers and users in the design and development
process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers
and other relevant interested parties
j) the documented information needed to demonstrate that design and development
requirements have been met.
04/13/2021 3
8.2.3.1 Design and development planning –
supplemental IATF 16949:2016
The organization shall ensure that design and development planning
includes all affected stakeholders with in the organisation and, as
appropriate, its supply chain. Examples of areas for using such a
multidisciplinary approach include but not limited to the following:
a) Project management ( for Example APQP or VDA-RGA)
b) product and manufacturing design activities ( Ex DFM, DFA), such as
consideration of the use of alternative designs and manufacturing
Multidisciplinary approach focus and
processes additional requirement
c) Development and review of product design risk analysis ( FMEAs),
including actions to reduce potential risks;
d) Development and review of manufacturing process risk analysis (for
ex FMEAs, process flows, control plans, and standard work instructions )
Note : A multidisciplinary approach typically includes the organization's
design, manufacturing, engineering, quality, production, purchasing,
supplier, maintenance and other appropriate functions.
04/13/2021 4
 8.3.2.2 Product design skills

IATF 16949:2016
The organisation shall ensure that personnel with product design
responsibility are competent to achieve design requirements and are
skilled in applicable product design tools and techniques. Applicable
tools and techniques shall be identified by the organisation
Note: An example of product design skills is the application of
digitized mathematically based data

No change in requirement

04/13/2021 5
8.3.2.3 Development of products with
embedded software
IATF 16949:2016
The organisation shall use a process for quality assurance for their
products with internally developed embedded software. A software
development assessment methodology shall be utilized to assess the
organization's software development process. Using prioritization
based on risk and potential impact to the customer, the organization
shall retain documented information of a software development
capability self assessment.
The organisation shall include software development with in the
scope of their internal audit programme ( see Sec 9.2.2.1)

New requirement added for Embedded

software development

04/13/2021 6
8.3.3 Design and development ISO 9001:2015
inputs
The organization shall determine the requirements essential for the
specific types of products and services to be designed and developed. The
organization shall consider:
a) functional and performance requirements; No changes
b) information derived from previous similar design and development
activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has committed to
implement;
e) potential consequences of failure due to the nature of the products and
services.
Inputs shall be adequate for design and development purposes, complete
and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and
development inputs.
04/13/2021 7
 8.3.3.1 Product design input
IATF 16949:2016
Identify, document and review product design input requirements As a result
of contract review.
Product design input requirements include but are not limited to the following
1. Product specifications including but not limited to special characteristics
( Sec 8.3.3.3)
2. Boundary and interface requirements Additional
3. Identification, traceability, and packaging requirements added
4. Consideration of design alternatives
5. Assessment of risks with the input requirements and the organisation’s
ability to mitigate / manage the risks, including from the feasibility analysis
6. Targets for conformity to product requirements including preservation,
reliability, durability, serviceability, health, safety, environmental,
development timing and cost;
7. Applicable statutory and regulatory requirements of the customer
identified country of destination, if provided
8. Embedded software requirements

04/13/2021 8
8.3.3.1 Product design input

IATF 16949:2016
Contd…
The organisation shall have a process to deploy information gained
from the previous design projects, competitive product analysis (bench
marking ), Supplier feed back, internal input, field data, and other
relevant sources for current and future projects of a similar nature
Note: One approach for considering design alternatives is the use of
trade off curves

Older requirement remains same

04/13/2021 9
8.3.3.2 manufacturing process design input
IATF 16949:2016
The organisation shall identify, document and review of manufacturing
process design input requirements including but not limited to the
following:
• product design output data including special characteristics
• targets for productivity, process capability and cost
• customer requirements ( if any)
• experience from previous developments
• New materials
• Product handing and ergonomic requirements
• Design for manufacturing and design for assembly
The manufacturing process design shall include the use of error
proofing methods to a degree appropriate to the magnitude of the
problems and commensurate with the risk encountered
04/13/2021 10
8.3.3.3 Special characteristics IATF 16949:2016
Shall use multi disciplinary approach to establish, document and
implement its processes to identify the special characteristics, including
those determined by the customer and risk analysis performed by the
organisation. And shall include the following:
a) Documentation of special characteristics - drawing, risk analysis,
control plans and standard work/ operator instructions. Identify with
special marking and cascade through each docs
b) Development of control and monitoring strategies for Special
characteristics – products and processes
c) Customer specified approval when required
d) Compliance to customer specific definitions and symbols or org
equivalent symbols and notations. Defined in a symbol conversation
table. Symbol conversation to be submitted to customer, if required
No change in the requirement
04/13/2021 11
8.3.4 Design and development controls

The organization shall apply controls to the design and development process
to ensure that:
a) the results to be achieved are defined; ISO 9001:2015
b) reviews are conducted to evaluate the ability of the results of design and
development to meet requirements; No changes
c) verification activities are conducted to ensure that the design and
development outputs meet the input requirements;
d) validation activities are conducted to ensure that the resulting products
and services meet the requirements for the specified application or intended
use;
e) any necessary actions are taken on problems determined during the
reviews, or verification and validation activities;
f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation have

distinct purposes. They can be conducted separately or in any combination, as
is suitable for the products and services of the organization.
04/13/2021 12
8.3.4.1 Monitoring IATF 16949:2016

Measurements at specified stages of design and

development shall be defined, analysed and reported with
summary results as input to management review.

When required by the customer, Measurements of the

product and process development activity shall report to
customer at stages specified or agreed to by the customer
Note: These measurements include quality risks, costs, lead-times, critical paths
and others as appropriate.

No change in requirement

13
8.3.4.2 Design and development validation

Design and development validation IATF 16949:2016

- Performed in accordance with customer requirements, any
applicable industry and government agency –issued regulatory
standards
- Timing shall planned in alignment with customer specific
timing, as applicable.
Where contractually agreed with the customer – include
evaluation of the interaction of the organisation product.,
embedded software, within the system of the final customer’s
product.

New requirements are

added

04/13/2021 14
 8.3.4.3 prototype programme

IATF 16949:2016
• Organisation to have a prototype programme and
control plan, when required by the customer.
• Use of same suppliers, tooling, and manufacturing
processes, wherever possible.
• All performance testing activities to be monitored for
timely completion.
• any outsourced services, the organisation shall include
type and extent of control in the scope of QMS, to
ensure conform the requirements (ISO 9001 Sec 8.4 )
No change in the requirement

04/13/2021 15
8.3.4.4 Product approval process

IATF 16949:2016
 Conform to product and mfg process approval procedure recognised
by customer
 This product and manufacturing process approval procedure shall
also be applied to externally provided products and services See ISO
9001 sec 8.4.3. prior to submission of their part approval to the
customer
 Shall obtain documented product approval prior to shipment, if
required by the customer. Records shall be retained

Note: Product approval should be subsequent to verification of

manufacturing process.

No changes in the requirement

04/13/2021 16
8.3.5 Design and development outputs

ISO 9001:2015
The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of
products and services;
c) include or reference monitoring and measuring requirements, as
appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are
essential for their intended purpose and their safe and proper
provision.

The organization shall retain documented information on design and

development outputs.
No changes in the requirement

04/13/2021 17
8.3.5.1 Design and development outputs -
supplemental
Product design output to be expressed in terms that can be verified and validated
against design input requirements.
Product design output to include:
IATF 16949:2016
• Design risk analysis ( FMEA)
• reliability study results New outputs added in
• product special characteristics the requirement
• product error-proofing such as DFSS, DFMA, FTA
• product definition including 3D models, technical data packages, product
manufacturing information, geometric dimensioning and tolerancing (GD&T)
• product design review results
• Service diagnostic guidelines and repair and serviceability instructions
• Service part requirements
• Packaging and labelling requirements for shipping
Note : interim design outputs should include any engineering problems being
resolved through a trade off process
04/13/2021 18
8.3.5.2 manufacturing process design outputs
Manufacturing process design output in a manner that enables
verification against mfg process design input requirements. Shall
verify outputs against mfg process design input requirements
Manufacturing process design output to include: IATF 16949:2016
specifications and drawings
Special characteristics for product and mfg. process
Identification of process input variables that impact characteristics
Tooling and equipment for production and control, including capability
studies of equipment and processes
manufacturing process flow chart / layout including linkages of product
and process and tooling
Capacity analysis
manufacturing process FMEA’s New outputs added in
the requirement
Maintenance plan and instructions
04/13/2021 19
8.3.5.2 manufacturing process design outputs

Contd… IATF 16949:2016

control plan
Standard work and Work instructions
Process approval acceptance criteria
Data for quality, reliability, maintainability and measurability.
Results of error proofing activities, as appropriate
Methods of rapid detection and feed back of Product/
manufacturing process non conformities.

04/13/2021 20
8.3.6 Design and development changes

IATF 16949:2016

The organization shall identify, review and control changes made

during, or subsequent to, the design and development of products
and services, to the extent necessary to ensure that there is no
adverse impact on conformity to requirements.

The organization shall retain documented information on:

a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.

No changes in the requirement

04/13/2021 21
8.3.6.1 Design and development changes
supplemental
IATF 16949:2016
Shall evaluate all design changes after initial product approval,
including those proposed by the organisation or its suppliers, for
potential impact on fit, form, function, Requirement
performance, andfor
added /orthe
durability supplemental clause

These changes shall be validated against customer requirements and

approved internally, prior to production implementation
If required by the customer,
Shall obtain documented approval or documented wavier from
the customer prior to production implementation

For product with embedded software,

Shall document revision level of software and hardware as part of
the change record
04/13/2021 22
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