ISO 9001 Clause 8.3 Design and development of products and services
- wilkshireconsulting
- Mar 17
- 6 min read
In ISO 9001 8.3 Design and development of products and services focuses on organizations that engage in product or service design. What 8.3 does is it establishes a structured approach to ensure that design outputs meet customer requirements, regulatory standards, and internal quality objectives. This clause only applies when organizations create new products/ services, or they modify existing ones. This clause may not apply to your organization.
In this blog post we will be discussing the following:
8.3 consists of 6 sections –
· 8.3.1 General
· 8.3.2 Design and Development Planning
· 8.3.3 Design and Development Inputs
· 8.3.4 Design and Development Controls
· 8.3.5 Design and Development Outputs
· 8.2.6 Design and Development Changes
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:
8.3 Design and development of products and services
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.
8.3.2 Design and development planning
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.
8.3.3 Design and development 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;
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.
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;
b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
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.
8.3.5 Design and development outputs
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.
8.3.6 Design and development changes
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.
8.3.1 General
In this first section of 8.3 organizations must establish, implement, and maintain design and development process that ensures products and services meet specified requirements.
· Applicability:
· If an organization designs its own products or services, this clause applies.
· If an organization only follows pre-existing specifications such as contract manufacturing, this clause may not apply
8.3.2 Design and Development Planning
As for planning the organization must plan the design and development process by considering:
1. Potential risks associated with the design process.
2. Roles and responsibilities of involved personnel.
3. Controls and reviews to ensure requirements are met.
4. Resources needed, including personnel, tools, and technology.
5. Required inputs and expected outputs.
6. Process stages required for structured development.
7. Nature, duration and complexity of the design process
An example of this would be if you are a car manufacturer and your developing a new vehicle model, you must plan engineering stages, prototype development, and safety testing procedures.
8.3.3 Design and Development Inputs
Organizations must determine and document inputs necessary for effective design and development. These include:
· Customer requirements: such as functional and performance expectations.
· Regulatory and legal requirements: such as industry standards and compliance regulations.
· Previous design lessons: to prevent repeating past mistakes.
· Economic and operational constraints: such as budget and available materials.
These inputs should be:
· Clear, complete and unambiguous
· Reviewed and approved for adequacy
An example of this would be if you are a medical device company and you must ensure compliance with FDA guidelines when developing a new product.
8.3.4 Design and Development Controls
Organizations must apply controls at different design stages to ensure conformity and effectiveness. These include:
· Reviews – Periodic assessment to verify progress and compliance.
· Verification – Ensuring design outputs meet input requirements.
· Validation – Confirming that the final product preforms as intended.
· Problem resolution – Addressing issues before moving to the next phase.
An example of this would be if you are a software development company and you might use beta testing to validate that a new application meets user needs before final release.
8.3.5 Design and Development Outputs
The outputs must:
1. Meet input requirements such as customer needs and legal standards.
2. Be suitable for production and service provision such as practicality of implementation.
3. Include necessary specifications and acceptance criteria.
4. Ensuring that products can be safely used and maintained.
5. Maintain traceability to design inputs.
An example of this would be if you are a civil engineering firm must produce blueprints and material specifications before construction begins.
8.2.6 Design and Development Changes
Organizations must:
1. Identify, review, and control any changes in the design process.
2. Evaluate the impact of changes on performance, cost, and compliance.
3. Document modifications and ensure proper approval.
An example of this would be if you are a smartphone company alters battery capacity, it must verify safety, update manuals, and inform suppliers.
In conclusion, implementing Clause 8.3 Design and development of products and services ensures that organizations can achieve innovation while maintaining quality and regulatory compliance. In the next blog post we will be diving deeper into Clause 8.4 Control of externally provided processes, products and services.
Related blog posts –
ISO 9001 Clause 8.2 Requirements for Products and Services
ISO 9001 8.1 Operational planning and control
ISO 9001 - 8 Operation Clause 8: 8.1 – 8.7
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
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Phone: (248) 890-9283
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