Training Module
Product Design & Development
Understand ISO 9001 product design and development controls, required evidence, and design change management
Training Module
Product Design & Development
Understand ISO 9001 product design and development controls, required evidence, and design change management
Training Module
Product Design & Development
Understand ISO 9001 product design and development controls, required evidence, and design change management
Does your product design process lack clarity and traceability, leading to repeated errors?
This training module teaches how to plan and control design and development activities to achieve a traceable system while maintaining pace.
Does your product design process lack clarity and traceability, leading to repeated errors?
This training module teaches how to plan and control design and development activities to achieve a traceable system while maintaining pace.
Does your product design process lack clarity and traceability, leading to repeated errors?
This training module teaches how to plan and control design and development activities to achieve a traceable system while maintaining pace.
Training module overview
Training module overview
Training module overview
Unclear inputs, inadequate reviews and weak traceability make product development inefficient and risk‑prone.
This training module explains how ISO 9001 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.
Unclear inputs, inadequate reviews and weak traceability make product development inefficient and risk‑prone.
This training module explains how ISO 9001 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
Target audience
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)
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?
It is a good fit if you…
implement or maintain ISO 9001 design and development controls.
support product or engineering teams with governance, evidence, and traceability.
struggle to show consistent control over design inputs, reviews, and changes.
need clearer separation between design work and production handover.
want design control that supports development speed rather than slowing it down.
implement or maintain ISO 9001 design and development controls.
support product or engineering teams with governance, evidence, and traceability.
struggle to show consistent control over design inputs, reviews, and changes.
need clearer separation between design work and production handover.
want design control that supports development speed rather than slowing it down.
If most of the points above apply, this module is likely a good fit.
It may not be the best fit if you…
already operate a clear, consistently applied ISO 9001 design control process.
are not involved in governing or evidencing design and development activities.
focus primarily on service design, customer experience, or service delivery models.
are looking for engineering methods, innovation techniques, or product strategy.
already operate a clear, consistently applied ISO 9001 design control process.
are not involved in governing or evidencing design and development activities.
focus primarily on service design, customer experience, or service delivery models.
are looking for engineering methods, innovation techniques, or product strategy.
Agenda
Agenda
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...
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...
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
Learning outcomes
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
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
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
Additional benefits
Additional benefits
Additional benefits
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
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
Module ID
HAM-QM-S-02
Domain
Audience
Manager
Auditor
Language
English
Delivery
Live virtual
Duration
7 h
List price
CHF 550
Excl. VAT. VAT may apply depending on customer location and status.
Delivery & learning format
Delivery & learning format
Delivery & learning format
Virtual live teaching
This module is delivered live, with a strong focus on discussion, practical application, and direct interaction with the instructor.
Sessions work through realistic examples, clarify concepts in context, and apply methods directly to participants’ organisational realities.
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.
Not sure if this module is right for you?
Not sure if this module is right for you?
Not sure if this module is right for you?
For an optimal learning experience
Preparation guidance
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.
For an optimal learning experience
Preparation guidance
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.
For an optimal learning experience
Preparation guidance
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
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.
Operational Control Foundations
Learn the fundamentals of designing and running controlled operational processes with clear roles, controls, records, and change handling
7 h
Operational Control Foundations
Learn the fundamentals of designing and running controlled operational processes with clear roles, controls, records, and change handling
7 h
Operational Control Foundations
Learn the fundamentals of designing and running controlled operational processes with clear roles, controls, records, and change handling
7 h
Supporting modules (optional)
Helpful if you want to deepen related skills, but not required to participate effectively.
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
7 h
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
7 h
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
7 h
Continuous learning
Follow-up modules
Continuous learning
Follow-up modules
Continuous learning
Follow-up modules
After completion of this module, the following modules are ideal to further deepen your competence. If you are looking for a structured learning path, modules can also be taken as part of a professional track.
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
Duration
7 h
List price
CHF 550
View module
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
Duration
7 h
List price
CHF 550
View module
Customer & Requirements Management
Understand how to determine, review, agree, and control customer requirements and related customer communications in ISO 9001
Duration
7 h
List price
CHF 550
View module
Production Control
Understand ISO 9001 requirements for controlled production conditions, identification and traceability, preservation, and control of production changes
Duration
7 h
List price
CHF 550
View module
Production Control
Understand ISO 9001 requirements for controlled production conditions, identification and traceability, preservation, and control of production changes
Duration
7 h
List price
CHF 550
View module
Production Control
Understand ISO 9001 requirements for controlled production conditions, identification and traceability, preservation, and control of production changes
Duration
7 h
List price
CHF 550
View module
Objectives & Performance Foundations
Learn the fundamentals of objective setting, KPI definition, and KPI governance for management systems
Duration
7 h
List price
CHF 550
View module
Objectives & Performance Foundations
Learn the fundamentals of objective setting, KPI definition, and KPI governance for management systems
Duration
7 h
List price
CHF 550
View module
Objectives & Performance Foundations
Learn the fundamentals of objective setting, KPI definition, and KPI governance for management systems
Duration
7 h
List price
CHF 550
View module
Improvement Management
Understand corrective actions, root cause analysis, action tracking, and effectiveness verification in management systems
Duration
7 h
List price
CHF 550
View module
Improvement Management
Understand corrective actions, root cause analysis, action tracking, and effectiveness verification in management systems
Duration
7 h
List price
CHF 550
View module
Improvement Management
Understand corrective actions, root cause analysis, action tracking, and effectiveness verification in management systems
Duration
7 h
List price
CHF 550
View module
Supplier Management Foundations
Learn the fundamentals of selecting, qualifying, and controlling suppliers and outsourced processes across their lifecycle
Duration
7 h
List price
CHF 550
View module
Supplier Management Foundations
Learn the fundamentals of selecting, qualifying, and controlling suppliers and outsourced processes across their lifecycle
Duration
7 h
List price
CHF 550
View module
Supplier Management Foundations
Learn the fundamentals of selecting, qualifying, and controlling suppliers and outsourced processes across their lifecycle
Duration
7 h
List price
CHF 550
View module
Process Design Foundations
Learn the fundamentals of defining process boundaries, mapping flows and handovers, and embedding controls and required evidence into usable process documentation
Duration
7 h
List price
CHF 550
View module
Process Design Foundations
Learn the fundamentals of defining process boundaries, mapping flows and handovers, and embedding controls and required evidence into usable process documentation
Duration
7 h
List price
CHF 550
View module
Process Design Foundations
Learn the fundamentals of defining process boundaries, mapping flows and handovers, and embedding controls and required evidence into usable process documentation
Duration
7 h
List price
CHF 550
View module
Ready to improve your management systems?
We support continuous improvement by embedding ISO requirements into everyday practice and daily operations.
Ready to improve your management systems?
We support continuous improvement by embedding ISO requirements into everyday practice and daily operations.
Ready to improve your management systems?
We support continuous improvement by embedding ISO requirements into everyday practice and daily operations.