design and development

Design and development refers to the structured activities an organization uses to define, create, and validate new or changed products, services, or processes before they are released for use or production.

Core meaning in industrial and regulated environments

In manufacturing and other regulated operations, design and development commonly includes:

• Translating customer, regulatory, and internal requirements into defined specifications
• Creating and refining product definitions (such as drawings, models, bills of material, specifications)
• Designing associated processes, equipment, tooling, software, and work instructions needed to produce or deliver the product or service
• Reviewing, verifying, and validating designs to confirm they meet requirements and intended use
• Controlling changes to product and process design and ensuring changes are evaluated and approved before implementation

Design and development activities may apply to physical products, manufacturing processes, production software, inspection methods, service offerings, or combinations of these.

Operational context

Operationally, design and development appears in:

• Product lifecycle systems such as PLM, CAD, and PDM where product definitions and revisions are created and controlled
• Manufacturing engineering activities such as defining routings, work instructions, inspection plans, fixtures, and NC programs
• Quality management through formal design reviews, risk analyses, verification and validation testing, and documented approvals
• System integrations where released designs flow from engineering tools into ERP, MES, and QMS for execution and control

In many organizations, design and development is governed by documented procedures that set expectations for inputs, reviews, outputs, records, and change control.

Relation to ISO 9001 and other quality standards

In ISO 9001 and related quality management standards, design and development is a defined process that covers:

• Design and development planning
• Design and development inputs and outputs
• Design and development review, verification, and validation
• Control of design and development changes

Organizations that do not design their own products or services, or that work strictly to customer-controlled designs, may justify limited applicability of design and development requirements in their quality management system. Where design and development is in scope, standards typically expect objective evidence that the process is defined, followed, and controlled.

What it includes and excludes

Design and development includes:

• Defining what a product, process, or service will be and how it will function
• Engineering and technical decision making that affects form, fit, function, performance, or safety
• Planned iterations such as prototypes, trials, and pilot runs used to confirm the design

Design and development typically does not include:

• Routine production or service delivery performed to an already released design
• Minor adjustments within pre-approved limits that do not change defined requirements
• Purely administrative changes that do not affect product or process performance

Common confusion

Design and development vs. production: Design and development focuses on defining and proving the product or process before general release. Production focuses on repeatedly executing that defined process under control.

Design and development vs. R&D: Research and development often covers exploratory or experimental work that may or may not lead to a product. Design and development, in a quality management context, refers to controlled activities that generate a defined, releasable product or process configuration.

Link to the source context

In the context of ISO 9001 clause 8.3, design and development refers to the organization’s formal process for planning, controlling, and documenting how products and services are designed and developed, including reviews, verification, validation, and design change control.