Training Module
Auditing Product & Service Development
Assess controls, validation and effectiveness in product and service design and development against ISO 9001 requirements
Overview
Design and development activities determine whether products and services can reliably meet requirements before delivery begins. In ISO 9001, design and development controls are intended to ensure that requirements are translated into workable solutions through structured planning, review, verification, and validation.
In practice, design controls often appear complete in documentation while weaknesses surface later in delivery: unclear inputs, informal design decisions, ineffective reviews, or insufficient validation under real operating conditions.
This module develops the capability to audit whether design and development activities are sufficiently controlled and produce reliable outcomes. Participants first review how design and development functions within ISO 9001 for both products and services, then learn how auditors test planning discipline, review effectiveness, verification and validation evidence, and design change control.
Applicable environments
This module focuses on auditing clauses and controls that are specific to ISO 9001. It is intended for auditors working with organisations operating a quality management system (QMS) according to this standard.
Target audience
Aspiring auditors who want to audit quality management systems against ISO 9001 following best practices
Practising ISO 9001 auditors who want to strengthen their audit knowledge, judgement, and effectiveness
Decision support
Is this module for you?
Agenda
Design and development in ISO 9001
Effective auditing of design and development
Design inputs and planning
Design reviews as control points
Verification and validation evidence
Design changes across the lifecycle
Design-to-delivery traceability
Case-based audit simulation
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Learning outcomes
Key outcomes
Assess whether design and development activities are planned and controlled within the management system
Test whether design inputs, reviews, verification, and validation provide credible assurance of performance
Trace design decisions and outputs to delivery outcomes using defensible audit evidence
Additional capabilities
Evaluate whether design changes are controlled across the lifecycle
Detect common design failure patterns such as incomplete inputs or ineffective reviews
Select meaningful sampling targets when auditing design and development activities
Formulate defensible audit conclusions on design and development effectiveness
Materials
Learning materials
Slide deck
Participant workbook
Templates & tools
Practical, reusable artefacts to apply the module directly to your organisation.
Audit interview planning tool
Documented information checklist
Sampling tool
Audit analysis worksheets
Failure pattern library
Supporting AI prompt set
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
This module assumes participants can perform basic audit activities and apply evidence-based judgement.
Helpful background includes:
General understanding of ISO 9001 terminology and management system structures
Ability to follow audit trails across design documentation, technical records, and operational evidence
Basic familiarity with product or service development activities
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.
