clause 8.3

Clause 8.3 most commonly refers to the design and development requirements in ISO 9001:2015, the international standard for quality management systems. It defines how an organization plans, controls, and documents design and development activities when creating new products, services, or significant process changes.

What clause 8.3 covers in ISO 9001:2015

Within ISO 9001:2015, clause 8.3 “Design and development of products and services” addresses the full lifecycle of design and development work. It typically includes requirements around:

• Planning design and development: Defining responsibilities, stages, reviews, verifications, validations, and interfaces between functions such as engineering, quality, and production.
• Design and development inputs: Capturing and controlling requirements such as customer needs, statutory and regulatory requirements, functional and performance criteria, and lessons learned.
• Design and development controls: Applying reviews, verification, and validation to ensure that the design meets input requirements before release to manufacturing or service delivery.
• Design and development outputs: Generating outputs like specifications, drawings, work instructions, and acceptance criteria that are suitable for production and downstream processes.
• Design and development changes: Managing and documenting design changes, assessing their impact on form, fit, function, risk, and compliance, and ensuring controlled release into production systems (e.g., MES, ERP, PLM).

In industrial and regulated manufacturing environments, clause 8.3 typically shows up in:

• Product and process design procedures within the QMS
• Engineering change control workflows linking PLM, ERP, and MES
• Design reviews that include production, quality, and supply chain stakeholders
• Records that demonstrate verification, validation, and approval of new or modified designs

Applicability and exclusions

Not every organization performs design and development. In ISO 9001, clause 8.3 can be declared not applicable if the organization does not design products or services and this is clearly justified in the scope of the quality management system. For example, a contract manufacturer that builds strictly to customer-controlled specifications may exclude clause 8.3, while still needing robust control of manufacturing processes and changes.

Even when clause 8.3 is excluded, related activities such as process validation, document control, and change management are usually still required under other ISO 9001 clauses and sector-specific standards (for example in aerospace or medical device manufacturing).

Common confusion

• Clause 8.3 vs. general process control: Clause 8.3 focuses on design and development activities. Routine manufacturing process control, work instruction use, and inspection are addressed in other parts of ISO 9001 (for example clause 8.5).
• Clause 8.3 vs. sector-specific design requirements: Industry standards such as AS9100 or ISO 13485 include additional or modified design requirements. Clause numbers may align but the detailed expectations can differ.

Context from ISO 9001 certification discussions

In certification discussions, clause 8.3 is often mentioned as the clause most commonly and narrowly excluded. When excluded, certification bodies typically expect clear scope definition and evidence that the organization truly does not perform design or development of products or services, even indirectly through process or configuration design.