Training module
Product Design & Development Control
Control product design and development, produce the required evidence, and manage design changes effectively
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.
Overview
What this module is about
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.
Audience
Who it is for
Management system implementers and coordinators
Executives and department heads accountable for management system performance
Those responsible for processes, policies, assets, risks and controls
Auditors seeking insight into management-side practice, not audit technique
Consultants working on management system design, governance or improvement
Decision supportIs this module for you?
It is a good fit if you…
implement or maintain 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.
It may not be the best fit if you…
already operate a clear, consistently applied 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.
What to bring
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
Agenda
What is taught
6 parts01What ISO 9001 expects from product design and development control
How ISO 9001 defines when design and development controls apply, when they do not, and what auditors typically expect to see as evidence, including common gaps observed in real implementations
02Planning design and development as a controlled process
How to structure design and development as a controlled process by defining stages, responsibilities, interfaces, and decision points, while aligning planning with real project execution rather than creating parallel management systems
03Design inputs and design outputs
How to define usable design inputs, including requirements, constraints, standards, and prior lessons learned, and produce design outputs that are production-ready through clear acceptance criteria, specifications, and instructions
04Design reviews
How to design effective design reviews that go beyond meetings and minutes, clarify the roles of reviewers and approvers, and ensure cross-functional interfaces are explicitly addressed
05Verification and validation
How to distinguish verification from validation in practical product contexts and demonstrate each proportionately, using records that provide sufficient assurance without overengineering
06Design and development changes
How to manage design and development changes through defined triggers, impact evaluation, and decision traceability, while protecting downstream stability through controlled handover, re-verification, and release
Outcomes
Learning outcomes
01
Apply design and development controls to plan activities with clear inputs and outputs
02
Run design reviews that gather the right stakeholders and evidence decisions
03
Differentiate verification from validation and integrate both into the development cycle
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
The content and the assessment
Written module
The full content in writing, complete in itself. Videos are recorded for parts of it as an alternative way through, and the written module always carries everything.
Exercises
Graded work on the case organisation's own registers: structured answers checked against the encoded case, written answers scored against a rubric traced to it, with a trainer holding the final word on every assessed item.
On completion
The assessed exercises must be passed before the certificate is issued.
Scheduling
No public run of Product Design & Development Control is scheduled at the moment. Tell us you are interested and we will let you know when the next one opens, or discuss running it in-house.
Module facts
- Module ID
- HAM-QM-S-02
- Discipline
- Quality Management
- Part of tracks
- Management System Manager
Case organisation
All modules share one company
Each module enters the company at a particular point in its history and finds it as that history has left it.
Northstar Integrated Services AG is a group headquartered in Zurich, operating in six European countries, with about 1,350 employees at the end of 2025. It provides digital operations platforms and managed operational services to regulated organisations in healthcare, the public sector and industrial services. Founded in 2008 as a field-operations firm serving business customers, it had about twenty-five employees when its first regulated customer, a hospital group, required documented decisions, named accountability and evidence on request. It moved into the platform business in 2016 and in 2024 acquired an operating business in Poland and the Czech Republic, whose legal entity continues inside the group.
Linked registers
Organisation and people, roles, risks, objectives, policies, documents and records, communications, findings, audits and reviews, interested parties, processes
Records, not summaries
The evidence sits in the registers and documents where a real organisation would keep it.
A history
The company has a timeline from 2008, so a structure can be examined before and after it changed.
More than one legal entity
A Swiss parent company and an acquired subsidiary in Poland and the Czech Republic, with customers in several jurisdictions
Why it matters
Judgement develops on material that is incomplete and partly contradictory, as it is in practice. Northstar is built that way on purpose. Because modules enter its history at different points, a governance structure can be seen while it is built, when it is outgrown and when it is rebuilt.
Delivery & dates
How this module reaches you
Delivered live online, combining conceptual framing, discussion, case work and direct interaction with the trainer. In-house and contextualised delivery is available on request.
No public run is scheduled at the moment. Most modules run on request as well as on the public calendar, so tell us the timing you need.
Want this module scheduled?
We will tell you when the next run is scheduled, or run this module in-house with your own case material.
Not sure it is the right module?
Describe your context in a short message and we will tell you honestly.