Training Module
Training Module
Product Design & Development
Understand ISO 9001 product design and development controls, required evidence, and design change management
Understand
Implement
Manage
Audit
Training module overview
Many organisations “do design” effectively, but struggle to show consistent control: unclear inputs, informal design reviews, weak traceability from requirements to outputs, and change decisions that are hard to justify later. The result is rework, production surprises, and disputes about whether the design was actually verified or validated.
This module focuses on ISO 9001 product design and development expectations: planning, inputs/outputs, reviews, verification and validation, and controlled design changes. It explicitly separates product design controls from adjacent ISO 9001 specialisations: customer requirement capture is handled in Customer & Requirements Management, service design in Service Design & Development, and operational execution controls in Production Control and Service Provision & Control.
Many organisations “do design” effectively, but struggle to show consistent control: unclear inputs, informal design reviews, weak traceability from requirements to outputs, and change decisions that are hard to justify later. The result is rework, production surprises, and disputes about whether the design was actually verified or validated.
This module focuses on ISO 9001 product design and development expectations: planning, inputs/outputs, reviews, verification and validation, and controlled design changes. It explicitly separates product design controls from adjacent ISO 9001 specialisations: customer requirement capture is handled in Customer & Requirements Management, service design in Service Design & Development, and operational execution controls in Production Control and Service Provision & Control.
Target audience
Quality managers responsible for ISO 9001 implementation and system maintenance
Product development and engineering leads coordinating design activities
Process owners setting up or improving design governance and evidence
Operations / industrialisation leads interface-managing design handover to production
Management system coordinators supporting cross-functional control and documentation
Quality managers responsible for ISO 9001 implementation and system maintenance
Product development and engineering leads coordinating design activities
Process owners setting up or improving design governance and evidence
Operations / industrialisation leads interface-managing design handover to production
Management system coordinators supporting cross-functional control and documentation
Agenda
What ISO 9001 expects from product design and development control
When design and development controls apply (and when they don’t)
Typical evidence expectations and common gaps in practice
Planning design and development as a controlled process
Defining stages, responsibilities, interfaces, and decision points
Aligning design planning with project realities (without inventing parallel systems)
Design inputs and design outputs
Making inputs usable: requirements, constraints, standards, and prior lessons
Outputs that are “production-ready”: acceptance criteria, specifications, and instructions
Design reviews
What a review must achieve (beyond meetings and minutes)
Role clarity: reviewers, approvers, and cross-functional interfaces
Verification and validation
Practical distinction and how to demonstrate each in product contexts
Building a proportionate verification/validation record without overengineering
Design and development changes
Change triggers, impact evaluation expectations, and decision traceability
Protecting downstream stability: handover, re-verification, and controlled release
Workshop: build a product design control pack (case-based)
Map a design flow to required controls and evidence
Draft a minimal, complete set of records: plan, review points, V&V matrix, change log
What ISO 9001 expects from product design and development control
When design and development controls apply (and when they don’t)
Typical evidence expectations and common gaps in practice
Planning design and development as a controlled process
Defining stages, responsibilities, interfaces, and decision points
Aligning design planning with project realities (without inventing parallel systems)
Design inputs and design outputs
Making inputs usable: requirements, constraints, standards, and prior lessons
Outputs that are “production-ready”: acceptance criteria, specifications, and instructions
Design reviews
What a review must achieve (beyond meetings and minutes)
Role clarity: reviewers, approvers, and cross-functional interfaces
Verification and validation
Practical distinction and how to demonstrate each in product contexts
Building a proportionate verification/validation record without overengineering
Design and development changes
Change triggers, impact evaluation expectations, and decision traceability
Protecting downstream stability: handover, re-verification, and controlled release
Workshop: build a product design control pack (case-based)
Map a design flow to required controls and evidence
Draft a minimal, complete set of records: plan, review points, V&V matrix, change log
Course ID:
HAM-PDD-1
Audience:
Manager
Domain:
Quality
Available in:
English
Duration:
7 h
List price:
CHF 550
Excl. VAT. VAT may apply depending on customer location and status.
What you get
Learning outcomes
Determine when ISO 9001 design and development controls apply to a product scope and lifecycle
Set up a design and development plan that clarifies stages, responsibilities, interfaces, and decision points
Define and structure design inputs so they are complete, usable, and traceable
Specify design outputs that are adequate for downstream use (including production handover)
Implement design reviews with clear purpose, participation, and documented outcomes
Distinguish verification from validation in product contexts and build proportionate evidence
Establish a controlled approach to design changes, including impact evaluation and traceable decisions
Determine when ISO 9001 design and development controls apply to a product scope and lifecycle
Set up a design and development plan that clarifies stages, responsibilities, interfaces, and decision points
Define and structure design inputs so they are complete, usable, and traceable
Specify design outputs that are adequate for downstream use (including production handover)
Implement design reviews with clear purpose, participation, and documented outcomes
Distinguish verification from validation in product contexts and build proportionate evidence
Establish a controlled approach to design changes, including impact evaluation and traceable decisions
Learning materials
Slide deck
Participant workbook
Certificate of completion
Slide deck
Participant workbook
Certificate of completion
Templates & tools
Product design & development planning template (stages, roles, interfaces, records)
Design input checklist (requirements, constraints, obligations, lessons learned)
Design output adequacy checklist (handover readiness)
Design review record template (purpose, issues, actions, decisions)
Verification & validation matrix template (methods, criteria, evidence)
Design change request and impact evaluation template
Design change log (release, communication, downstream actions)
Optional AI prompt set for summarising review outcomes and change impacts (supporting professional judgement)
Product design & development planning template (stages, roles, interfaces, records)
Design input checklist (requirements, constraints, obligations, lessons learned)
Design output adequacy checklist (handover readiness)
Design review record template (purpose, issues, actions, decisions)
Verification & validation matrix template (methods, criteria, evidence)
Design change request and impact evaluation template
Design change log (release, communication, downstream actions)
Optional AI prompt set for summarising review outcomes and change impacts (supporting professional judgement)
Prerequisites
This module assumes familiarity with general management system concepts and the difference between process control and project execution. It also assumes participants understand the generic foundations that ISO 9001 design controls depend on (these are referenced here and are not re-taught in this module).
Helpful background includes:
Basic understanding of process ownership, documented information, and role clarity
Familiarity with risk-and-opportunity thinking at a concept level (no risk methodology is taught here)
Experience participating in product development, engineering change, or industrialisation workflows
This module assumes familiarity with general management system concepts and the difference between process control and project execution. It also assumes participants understand the generic foundations that ISO 9001 design controls depend on (these are referenced here and are not re-taught in this module).
Helpful background includes:
Basic understanding of process ownership, documented information, and role clarity
Familiarity with risk-and-opportunity thinking at a concept level (no risk methodology is taught here)
Experience participating in product development, engineering change, or industrialisation workflows
Strongly recommended preparatory modules
Risk Management Foundations: Consistent Risk and Opportunity Logic Across Management Systems
Learn the fundamentals of identifying, evaluating, treating, and monitoring risks and opportunities across management systems.
7 h
Risk Management Foundations: Consistent Risk and Opportunity Logic Across Management Systems
Learn the fundamentals of identifying, evaluating, treating, and monitoring risks and opportunities across management systems.
7 h
Risk Management Foundations: Consistent Risk and Opportunity Logic Across Management Systems
Learn the fundamentals of identifying, evaluating, treating, and monitoring risks and opportunities across management systems.
7 h
Helpful preparatory modules
The modules below prepare for an optimal learning experience – but are not strictly necessary for participants to follow.
System Foundations: Context, Stakeholders, and System Boundaries
Understand organisational context, stakeholders, and system boundaries
7 h
System Foundations: Context, Stakeholders, and System Boundaries
Understand organisational context, stakeholders, and system boundaries
7 h
System Foundations: Context, Stakeholders, and System Boundaries
Understand organisational context, stakeholders, and system boundaries
7 h
Documentation & Knowledge Foundations: Documented Information, Records, and Organisational Knowledge
Fundamentals of documented information control, records, and knowledge capture for management systems
7 h
Documentation & Knowledge Foundations: Documented Information, Records, and Organisational Knowledge
Fundamentals of documented information control, records, and knowledge capture for management systems
7 h
Documentation & Knowledge Foundations: Documented Information, Records, and Organisational Knowledge
Fundamentals of documented information control, records, and knowledge capture for management systems
7 h
Continuous learning
Follow-up modules
Follow-up modules
After completion of this module, the following modules are ideal to further deepen the participant's competence.
After completion of this module, the following modules are ideal to further deepen the participant's competence.
Ready to achieve mastery?
Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.
Ready to achieve mastery?
Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.
Ready to achieve mastery?
Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.