QPS 8.3-01 Design and Development

ISO 9001:2026 Design and Development Procedure Specification

Updated for 2026 This procedure has been refreshed for the ISO 9001:2026 revision — design and development now also orients toward resource-saving technologies, environmentally friendly materials, and minimizing the environmental impact of what's being designed.

  • Covers the full cycle: development request, requirements, verification, and validation
  • Defines the Technical Director's responsibility and authority as Process Owner
  • Integrates environmental-impact minimization and climate-change reporting into every design, per the new edition
  • Change control process for managing design and development changes
  • User-friendly format and professional layout — reviewed and approved by experienced auditors
QPS 8.3-01 Design and Development

Description

Procedure for planning, executing, and controlling the design and development of products and services under ISO 9001:2026 — including the new requirement to minimize the environmental impact of what's being designed and to monitor the organization's impact on climate change. Our Templates were reviewed and approved by experienced ISO 9001 quality auditors.

The specification covers design inputs, requirements development, verification and validation, change control, and documented information — with the process owner now also responsible for orienting design toward resource-saving technologies and environmentally friendly materials.

Who Needs This Procedure

This procedure is for organizations implementing ISO 9001:2026 that need a documented design and development process — from the initial development request through requirements definition, verification, validation, and change control.

Design decisions made here feed the environmental-impact framework used across the 2026 procedures — see QPS 10.1-01 Environmental Impact Monitoring. Climate-change impact from new designs is then reviewed by Top Management in QPS 9.3-01 Management Review.

Included in the Package

Quality Procedure Specification

25 pages MS Word document covering the full design and development cycle — development request, requirements, verification, validation, and change control — including environmental-impact minimization and sustainability requirements. Includes:

  • QSF 8.3-01-01 Excerpt from Coordinating Council Protocol — Development Request
  • QSF 8.3-01-02 Excerpt from Coordinating Council Protocol — Requirements Approval
  • QSF 8.3-01-03 Excerpt from Coordinating Council Protocol — Project Approval
  • QSF 8.3-01-04 Protocol of Expert Evaluation
  • QSF 8.3-01-05 Product (Service Provision) Specification Requirements
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$34.00

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FAQ

What's new in the ISO 9001:2026 version of this procedure?
The design and development process now explicitly requires orientation toward resource-saving technologies and environmentally friendly materials, minimization of environmental impact for what's being designed, and reporting of climate-change-impact-minimization information for use in marketing. Adverse environmental impact is also now tracked as a process risk.
What forms are included?
Five: three Coordinating Council Protocol excerpts (QSF 8.3-01-01/02/03) for development requests, requirements approval, and project approval; a Protocol of Expert Evaluation (QSF 8.3-01-04); and a Product (Service Provision) Specification Requirements form (QSF 8.3-01-05).
Can I customize it?
Yes — it's delivered as an editable MS Word document, same as every other QPS on the site.

Related Products

QPS 10.1-01 Environmental Impact Monitoring New for 2026

Monitoring and minimizing the environmental and climate-change impact of QMS process operations — the same framework design decisions here feed into.

$49.00

View Environmental Impact Procedure →

QPS 9.3-01 Management Review Updated for 2026

Procedure for planning and conducting management reviews of the QMS, including the dedicated climate-change impact review.

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View Management Review Procedure →

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