Training Module
Product Design & Development Control
Control product design and development, produce the required evidence, and manage design changes effectively
Overview
Unclear inputs, inadequate reviews and weak traceability make product development inefficient and risk???prone.
This training module explains how design controls help teams plan design activities, define and validate inputs and outputs, and distinguish verification from validation. Participants see how to keep the development process agile while creating the evidence needed for conformity and market confidence. The module does not cover detailed technical methods; it concentrates on governance and control.
Applicable environments
This module applies to organisations implementing or operating a Quality Management System (QMS) in line with ISO 9001. It focuses on how the standard’s requirements are interpreted and applied in practice within real organisational contexts.
The content is relevant for organisations seeking certification as well as for those using ISO 9001 as a reference framework to structure responsibilities, processes, and controls in the quality management domain.
Target audience
People involved in designing, building, operating, or improving a QMS aligned with ISO 9001
Executives and department heads accountable for the effectiveness and performance of a QMS
Those responsible for processes, policies, IT systems, risks, and controls related to quality management
Auditors of ISO 9001 who want to deepen their understanding of management-side best practices (not audit technique)
Decision support
Is this module for you?
Agenda
What ISO 9001 expects from product design and development control
Planning design and development as a controlled process
Design inputs and design outputs
Design reviews
Verification and validation
Design and development changes
Case-based workshop
Show detailed agenda...
Learning outcomes
Key outcomes
Apply design and development controls to plan activities with clear inputs and outputs
Run design reviews that gather the right stakeholders and evidence decisions
Differentiate verification from validation and integrate both into the development cycle
Additional capabilities
Produce design outputs that support manufacturing, service and support teams
Control design changes through structured evaluation and approval
Link design and development controls to other quality processes without creating bureaucracy
Materials
Learning materials
Slide deck
Participant workbook
Templates & tools
Practical, reusable artefacts to apply the module directly to your organisation.
Extendable design and development process template
Design input and output checklist
Design review record template
Verification & validation matrix template
Design change request and impact evaluation template
Confirmation
Certificate of completion
Delivery
Live virtual delivery
This module is delivered live online and combines conceptual framing, discussion, case work and direct interaction with the instructor.
A public cohort is currently not scheduled. If you register your interest, we will notify you when a new public cohort is scheduled or suitable delivery options become available.
Custom delivery options
For organisations with specific constraints or learning objectives, the module can be adapted in format or scope, including in-house delivery and contextualised case material.
For an optimal learning experience
Prerequisites & preparation
This module is designed as part of a modular training approach. Topics are deliberately distributed across modules and are not repeated in full, in order to avoid unnecessary redundancy. Each module is self-contained and can be taken on its own. Where prior knowledge or experience is helpful, this is indicated below so you can decide whether any preparation is useful for you.
Assumed background
Participants should be comfortable discussing elements of operational control at a practical level. Helpful background includes basic understanding of:
Process thinking including the importance of clearly defined roles and responsibilities
The importance of documented information
Operational objectives and controls
Controlled change handling
Preparatory modules
Foundational modules (depending on background)
Useful if you are new to the underlying concepts or want a shared baseline before attending this module.
Supporting modules (optional)
Helpful if you want to deepen related skills, but not required to participate effectively.
