ISO 9001 Clause 8.3
This clause requires the organisation to plan and ensure that controls are in place for any design and development that takes place.
What Does ISO 9001 Clause 8.3 Require?
Clause 8.3 of ISO 9001:2015 requires organisations that design or develop products or services to establish, implement and maintain a design and development process. The clause covers planning, inputs, controls, outputs, changes and the overall management of the design process.
As noted in the article on Clause 4.3, this is also the clause most commonly claimed as not applicable. Whether that exclusion is accepted by your certification body is a separate matter - see the FAQ below.
Clause 8.3.2 - Design and Development Planning
When planning design and development, the organisation must consider the nature and complexity of the activities, the process stages required including design reviews, verification and validation activities, responsibilities and authorities, internal and external resource requirements, how interfaces between people involved are controlled, customer and user involvement, requirements for subsequent products and services, and the level of control expected by customers and other interested parties.
Clause 8.3.3 - Design and Development Inputs
Before designing, the organisation must determine the requirements essential to the product or service. These include functional and performance requirements, information from previous similar activities, applicable legal and regulatory requirements, standards and codes the organisation has committed to, and the consequences of failure. Inputs must be adequate, complete and unambiguous - contradictory requirements must be resolved.
Clause 8.3.4 - Design and Development Controls
Controls must be applied to the design process to ensure that: results to be achieved are defined, design reviews are conducted, verification is carried out to confirm outputs meet input requirements, and validation is conducted to confirm the resulting product or service meets the requirements for its intended use.
Clause 8.3.5 and 8.3.6 - Outputs and Changes
Design outputs must be adequate for the subsequent provision of products and services, include or reference monitoring and acceptance criteria, and specify characteristics essential to safe and proper use. Design changes must be identified, reviewed, controlled and approved - with consideration of any adverse effects on conformity.
Where Clause 8.3 applies, I'll look for a documented design process with defined stages - planning, inputs, controls, outputs and change management. I'll check that design reviews are being conducted, that verification and validation activities are recorded, and that design changes go through an approval process rather than being made informally. The depth of documentation needed depends on the complexity of the design activity - a simple bespoke service design needs less than a complex engineered product. Where an organisation has claimed Clause 8.3 as not applicable, I'll assess whether that exclusion is genuinely justified based on what I observe during the audit.
For organisations that do undertake design, a design planning form that covers the key inputs and stages provides a practical framework that addresses most of what Clause 8.3 requires. The important thing is that the design process has defined stages with review and approval points, that inputs are captured before design begins, and that outputs are documented and linked back to the original requirements. For organisations that design services rather than products, the same principles apply - the terminology is different but the process discipline is the same.
Clause 8.3 is the most contentious clause in ISO 9001 - and has been for years. If you genuinely design products or services, you need a documented design process with proper controls. That's fair enough. The problem is that certification bodies interpret what counts as design very differently. Some will accept that manufacturing to customer drawings means no design activity and therefore the clause is not applicable. Others will argue that any decisions about how to configure a service or product constitute design, so the clause always applies. The standard itself supports the first interpretation, but auditors don't always follow the standard.
If you're claiming the exclusion, check your CB's position before certification - not at the Stage 1 audit. If your CB won't accept the exclusion, the least painful route is often to implement a minimal design process and procedure that shows you've addressed the requirements, even if the design activity itself is simple. It saves the argument.
Practical Compliance Guidance
To comply with Clause 8.3, organisations that undertake design need a documented design and development process covering planning, inputs, controls, outputs and change management. For organisations claiming the exclusion, the justification must be documented in the QMS scope under Clause 4.3.
The alphaZ documents below support compliance with Clause 8.3.
| alphaZ document | How it supports Clause 8.3 |
|---|---|
| ISO 9001 Management System Toolkit | The complete toolkit including design and development documentation and all supporting documents. |
| F-Q1 Design Review and Planning Form | A structured checklist for planning and reviewing design and development activities, covering all the required elements of Clause 8.3.2 through to outputs and validation. |
| F-Q13 Design Change Request Form | Provides a controlled record for managing design changes, directly supporting the Clause 8.3.6 requirement to review, control and approve changes to design outputs. |
Note - all the above files can be downloaded with an alphaZ subscription
