ISO 9001 Design and Development Process
ISO 9001:2015 · Clause 8.3 · 13485:2016
Build an Audit-Ready
Design & Development
Process — Without
a Full-Time Consultant
Diana Lynn, President of MSI, walks your engineering team through every ISO 9001 requirement for Design & Development using the exact same interview questions, templates, and process maps she uses with real clients. Built from 25 years and 70+ certifications.
100%
Client certification rate
70+
Companies certified
25yrs
ISO consulting experience
5-Video Training Series
Design & Development Process
ISO 9001:2015 · ISO 13485:2016 · Clauses 8.1, 8.3, 7.1, 7.3
1
Foundation, Branding & the Gap Assessment
ISO 9001 context, ISO 20671, D&D process flow
▶
2
Planning, Risk & Design Stages
Clause 8.3.2–8.3.3, V&V, product requirements matrix
▶
3
Design Reviews, Changes & Records
ECN process, audit questions, procedure development
▶
4
Improvement, Nonconformances & Audit Strategy
Section 10, corrective actions, continual improvement
▶
+
Bonus: D&D Plan Template Walkthrough
Live walkthrough of MSI's 20-page planning template
▶
$1,200
$497
Introductory offer · Lifetime access
30-Day
Money Back
Money Back
"
After 27 years of ISO consulting, one of my favorite topics to interview, draft procedures for, train on, and audit is the design process. This is not a process you just want to get by with — it's a proprietary process to be protected.
Diana Lynn, President — MSILead Auditor, ISO 9001 · ISO 13485 · ISO 14001
Your Instructor
25 years of live audits.
Distilled into 4 videos.
Distilled into 4 videos.
Diana founded MSI and has personally led hundreds of companies through ISO certification. This course is built from the same methodology — the same questions, templates, and process maps — she uses in actual client engagements.
Trained lead auditor: ISO 9001, ISO 13485, ISO 14001
100% certification success rate across all MSI clients
Present at client certification, surveillance, and recertification audits
Developed and formalized D&D processes for hundreds of companies
Also covers ISO 9004 — how to go above and beyond the requirements
Who This Is For
Built for the people who
own the design process
own the design process
Engineering Directors & VPs
Solve inconsistencies across engineering teams. Get a structured, repeatable D&D process that survives personnel changes and holds up under audit — without engaging a consultant for months.
Quality Managers & Directors
Prepare for certification or renewal audits with confidence. Understand exactly what ISO registrars look for in the D&D process — because Diana has been in those audit rooms for 25 years.
Companies Seeking First Certification
Stand up a compliant Design & Development process from scratch. The course includes MSI's 20-page D&D Plan template and a 36-question gap assessment to show you exactly where to start.
Companies Refreshing an Existing Process
If your D&D procedure hasn't been updated since your last certification cycle, the gap assessment will surface what's drifted. Diana specifically addresses what changed in the 2015 version that many companies still miss.
Medical Device Manufacturers
The gap assessment covers ISO 13485:2016 requirements. Diana offers an ISO 13485 add-on to the main training for companies that need the medical device standard covered in full.
Product & R&D Team Leads
Integrate ISO requirements into how your team actually works. A strong D&D process shortens innovation cycles, improves product launch speed, and builds brand value — it's a competitive advantage, not a compliance box.
This course is not for: Organizations that don't design or develop products or services — not all companies have this process, and ISO 9001 acknowledges that. It also isn't a substitute for a third-party registrar audit. ISO certification still requires an external registrar; this course prepares you to pass it.
The Insider Advantage
The same questions Diana asks
your competitors' engineering teams
When MSI builds a D&D procedure for a client from scratch, Diana runs a structured interview. Those exact interview questions — the ones that reveal where a D&D process is strong, weak, or missing entirely — are in Video 3 of this course.
Record OrganizationThe #1 weakness Diana sees across 25 years. Even the best companies mess up electronic file structure. Video 3 covers exactly how to organize design records so auditors can follow them cleanly.
2015 Standard UpdatesNature, duration, and complexity determination was added in the 2015 revision. Many certified companies still don't address it properly. Video 2 covers it directly.
Nonconforming OutputsNon-conformances now apply to process outputs — including electronic documents. If a drawing doesn't meet requirements, that file needs to be identified as nonconforming. Most companies don't know this.
Design Reviews as ControlsMSI uses design reviews as the primary means of controlling the D&D process. Diana explains exactly how to structure them, who attends, how to document them, and what auditors look for in the records.
What You'll Walk Away With
Tangible outputs from
every module
every module
MSI's 20-page D&D Plan Template
The same template Diana uses with every client — with a live walkthrough in the bonus video. Includes all fields required by the standard so you know what you can't delete before your audit.
Product Requirements Matrix
A structured matrix for tracking design features, user needs, inputs, outputs, validation steps, and results — keeping your design inputs and outputs traceable and audit-ready throughout the lifecycle.
36-Question Gap Assessment Score
Start by benchmarking your current process before Video 1. The assessment covers ISO 9001:2015 and ISO 13485:2016 requirements, and identifies your "golden nuggets" — specific, actionable improvements to make.
Procedure Development Framework
The interview questions from Video 3 are the same ones MSI uses to draft D&D procedures for clients from scratch. Use them to audit your existing procedure or build a new one against the standard.
Process Map / Turtle Diagram
A one-page document that establishes D&D as a key process, shows inputs/outputs/records, and demonstrates it's controlled. MSI's editable software version is available on their website to adapt for hardware or other designs.
Risk-Based Thinking Embedded in Design
Learn how to set up a risk and opportunities assessment specific to the D&D process, identify high-rated risks that need mitigation, and cross-reference corrective actions back to the risk matrix — the way auditors expect to see it.
ISO 20671 Brand Value Framework
A bonus topic Diana covers in Video 1 — the international standard for brand valuation. Learn how a well-run design process contributes to brand strength, market share, and company value beyond mere compliance.
Certificate of Completion
Every enrollee receives a certificate for LinkedIn, professional development records, or auditor documentation — suitable for demonstrating ongoing training commitment to your registrar.
Course Curriculum
Five videos.
Every requirement
and every record.
Every requirement
and every record.
Each module builds on the last — from benchmarking your current process against ISO requirements, through the standard's specific requirements, into the exact audit questions registrars ask, and finally into improvement and corrective action.
What's Included
5 video modules (4 training + 1 bonus template walkthrough)
36-question Design & Development Gap Assessment
MSI's 20-page D&D Plan Template
Product Requirements Matrix
Process map / turtle diagram template
Engineering Change Notice (ECN) template
Certificate of completion
Instructor Q&A support (24hr response)
Lifetime access + all future updates
30-Day Money-Back Guarantee
If you don't find the course valuable within 30 days, contact MSI for a full refund — no questions asked.
1
▼
Diana opens by walking through the 36-question gap assessment — the same one used in this course — so you can benchmark your process before diving into requirements. Then she introduces the full ISO 9001 structure and the design decision flow from customer agreement to go/no-go.
- The Design & Development Gap Assessment: how to complete it and what your answers reveal about your current process
- ISO 20671 — the international branding standard, and how a formalized D&D process builds brand strength, market share, and company valuation
- ISO 9001:2015 structure overview: where D&D lives in Clause 8.3 and how it connects to Section 4 (process requirements) and 8.1 (operational planning)
- ISO 9004 — going above and beyond the requirements: shorter innovation cycles, reliable KPIs, and what world-class design processes look like
- Sources that trigger a design project: customer requirements, regulatory changes, new technology (including AI), supplier changes, and internal innovation
- The design decision flow: from customer agreement through feasibility, business analysis, go/no-go, and design project initiation
2
▼
The planning and risk requirements are where most companies have gaps — especially those certified before 2015. Diana covers the six planning criteria, the design input must-haves, and how to structure your design stages so every review, verification, and validation activity is accounted for.
- Nature, duration, and complexity of design activities — a 2015 addition that many certified companies still don't address properly
- How to define your formal design stages (3–8 stages typical) and what has to happen at the conclusion of each one
- Design input must-haves: functional requirements, performance requirements, similar previous designs, applicable regulatory requirements (UL, CE, IEEE, FDA), and potential consequences of failure
- Risk and opportunity management for design projects: ISO 31000 definition of risk, how to rate and mitigate risks, and how to show this in a risk matrix
- Verification vs. validation — a commonly confused distinction: what each means, when each is required, and how to document them at each design stage
- The Product Requirements Matrix: how to track design features from user needs through inputs, outputs, and validation results
- How to structure your electronic and hard-copy filing system so any design engineer — including new hires — can navigate design records during an audit
- MSI's 20-page D&D Plan Template: what's in it, what you cannot delete, and how to adapt it for your first design project
3
▼
This is the most practically dense module. Diana shares the exact questions MSI asks in client interviews when developing a D&D procedure from scratch — the same questions ISO registrars use to evaluate your process. She also covers how to run design reviews, manage Engineering Change Notices, and organize records so they hold up under audit scrutiny.
- Design reviews as controls: how to use them as the primary control mechanism for the D&D process, who must participate by title, and how to handle formal vs. informal reviews
- What to cover in every design review: confirming inputs are being met, verification and validation status, actions assigned, and approval to proceed to the next stage
- Record organization — the #1 weakness Diana sees: how to structure folders by ISO heading so auditors can follow the sequence of events from plan through release to manufacturing
- Managing documents in progress: how to name and mark electronic files as work-in-progress, on-hold, or obsolete so no one uses an outdated version
- Engineering Change Notice (ECN) process: what triggers a design change, how to review and authorize it, how to assess impact on inventory, downstream documents, and existing products
- The audit interview questions MSI uses with every client — covering how designs are currently controlled, how stages are named, how V&V is done, and how interfaces between departments are managed
- The turtle diagram / process map: how to create a one-page document that establishes D&D as a key process, with inputs, outputs, risks, performance indicators, and supporting records all visible at a glance
- Minimum records required by the standard, and how to identify what additional records your specific process needs to demonstrate conformity
4
▼
The final training module covers what the 2015 standard means by "improvement" and how to demonstrate it to auditors. Diana also addresses nonconforming outputs — a requirement many companies still apply only to physical product — and how the corrective action process applies directly to the design process.
- Nonconforming outputs: the standard now applies this to any output including electronic documents, drawings, and bill of materials — not just physical product — and how to identify and control them electronically
- How to notify customers when a shared drawing or released document is found to be nonconforming after delivery
- The corrective action process applied to design: identifying root causes (not just describing what happened), immediate vs. subsequent actions, and cross-referencing CARs back to the risk matrix
- NCR vs. corrective action form: when each is appropriate and MSI's recommendation for most companies
- How to demonstrate continual improvement to auditors: quality objectives related to the design process, on-time delivery through design stages as a KPI, audit results as evidence
- Internal and external audit strategy for the design process: what leadership commitment looks like, how to show your process is meeting requirements, and what registrars focus on
- Golden nuggets: Diana's framework for identifying one meaningful improvement to implement after completing the course — the approach MSI uses in its membership program
- ISO 13485 preventive action requirement: why it still applies if you're 13485-certified even though ISO 9001 dropped it
+
▼
Diana walks through MSI's actual D&D Plan Template section by section — the same document she provides to every client when starting a design project. This is a practical guide to using the template, not just owning it.
- How to set up the template as a controlled form with version control at both template and project level
- The fields you cannot delete — they're direct standard requirements — and how to mark inapplicable sections instead of removing them
- Responsibilities and authorities section: how to break out the president, design project lead, marketing, purchasing, and other engineers across mid-size companies
- How to address customer involvement: contracted design, company-investment design, and proprietary design each look different in the planning document
- Interface control, methods and tools, milestone timelines, and Gantt chart cross-referencing
- Design phases in the template: concept/definition review → engineering phase review → prototype phase review → final design review → design changes (ECN)
- How to use TBD entries during early planning when information isn't yet available, and what date-based commitments to include
- Approval to proceed sections: who signs off to move from each phase to the next, and how to document that approval as a formal record
Free Gap Assessment
Not sure where
your process stands?
your process stands?
Start with the same 36-question Design & Development Gap Assessment that opens Video 1. Diana reviews responses personally and an MSI consultant follows up with specific findings — completely free, no commitment required.
Take the Free Assessment →
Takes ~15–17 minutes · Covers ISO 9001:2015 & ISO 13485:2016 · MSI follows up personally
Free · Included with Course
Design & Development Gap Assessment
Does your organization have a documented Design & Development procedure?
✅ Yes, fully documented
📝 Partially — some docs exist
❌ No formal documentation
36 questions across 7 areas
Planning & process stages
Risk & opportunities
Design reviews & controls
Verification & validation
Records & documentation
Change management (ECN)
Roles & responsibilities
Statutory & regulatory
What Clients Say
From companies MSI
has taken through certification
has taken through certification
★★★★★
"MSI assessed our strengths and weaknesses and provided the leadership needed to make us ready for the ISO 9001 certification audit. The tools and guidance were vital to making our goals a success."
★★★★★
"I recommend MSI with complete confidence. We have worked closely with their staff over two years. They attend to detail and help us grow as a company. I have very high regard for their company."
★★★★★
"MSI is reliable, knowledgeable, experienced, adaptable and committed to helping us keep to our schedule. Their systematic approach made a genuinely complex process manageable."
How It Compares
The smart alternative
to costly consulting
to costly consulting
| MSI Video Series Best Value | Hire a Consultant | Generic ISO Training | |
|---|---|---|---|
| Built from real audit experience, not just the standard | ✓ | ✓ | ✗ |
| Covers full D&D process end-to-end | ✓ | ✓ | ~ |
| MSI's D&D Plan Template (20-page) included | ✓ | Extra cost | ✗ |
| 36-question Gap Assessment included | ✓ | Extra cost | ✗ |
| Actual audit interview questions revealed | ✓ | ✗ | ✗ |
| Learn at your own pace, rewatch anytime | ✓ | ✗ | ✓ |
| Lifetime access | ✓ | ✗ | ✗ |
| Typical cost | $497 | $5,000–$25,000+ | $500–$1,500 |
Common Questions
Everything you need
to decide
to decide
Does this course replace a third-party ISO audit? +
No — ISO 9001 certification still requires a third-party registrar audit. What this course does is prepare your Design & Development process to pass that audit. Think of it as the preparation, not the certification itself. Diana is present at MSI clients' actual certification audits — this course gives you the same preparation.
Is this applicable to ISO 13485 (medical devices)? +
The 36-question gap assessment in this course already covers ISO 13485:2016 requirements alongside ISO 9001. The main training videos focus on ISO 9001. If you need a full 13485 training add-on, contact MSI directly — Diana mentions this is available as an addition to the course.
We already have ISO certification. Is this still useful? +
Absolutely. This course is specifically designed for companies refreshing an existing process. Diana covers what changed in the 2015 version of the standard that many certified companies still haven't addressed — particularly the nature/duration/complexity requirement and the expanded definition of nonconforming outputs. The gap assessment alone will surface what's drifted since your last audit cycle.
How is this different from free YouTube videos on ISO? +
Most ISO content explains what the standard says. This course reveals what actually happens inside a client engagement — including the interview questions MSI uses to develop procedures from scratch, the record organization approach that prevents audit findings, and the specific ways auditors evaluate the D&D process. That's built from 25 years of live consulting and being present in audit rooms, not reading the clause.
Can I expense this through my company? +
Yes. MSI provides a detailed invoice, course outline, and certificate of completion — all standard documentation for professional development reimbursement. Many participants expense this under quality management or engineering training budgets. The certificate is also suitable for LinkedIn and professional development records.
What if I want MSI to consult directly with my team? +
MSI offers consulting engagements at a day rate — including drafting the full D&D procedure for you and providing all forms and record formats. They also conduct internal audits onsite or virtually, and can review your existing procedures and manual. Complete the free gap assessment and an MSI consultant will follow up to discuss your options.
Enrollment
One investment.
Lifetime access.
Lifetime access.
Introductory Offer
Design & Development Process Series
Everything your team needs to build an audit-ready D&D process — taught by the consultant who's done it 70+ times
$1,200
$497
One-time payment · Lifetime access · All future updates included
5 video modules (4 training + 1 bonus template walkthrough)
36-question D&D Gap Assessment (ISO 9001 & 13485)
MSI's 20-page D&D Plan Template
Product Requirements Matrix
Process map / turtle diagram template
Engineering Change Notice (ECN) template
Certificate of completion
Instructor Q&A support (response within 24 hours)
Free MSI gap assessment review with consultant follow-up
🛡️ 30-day money-back guarantee — full refund, no questions asked
Free Ebook
ISO 9001 Design &
Development Process
Tips & Best Practices
Development Process
Tips & Best Practices
Diana's ebook starts with a story most ISO consultants can't tell: standing on an Air Force base in Germany at twenty, repairing runways, driving forklifts — and how that shift from reactive maintenance to proactive design thinking became the foundation of everything she teaches.
The practical sections cover the ISO 9001 design and development requirements in plain language — inputs, controls, outputs, and change management — along with the gap assessment framework, process management basics, strategic planning, and the ISO 20671 brand value standard.
From the ebook
"The biggest weakness I have observed throughout my years is the lack of organization in records and a lack of consistency across engineering departments."
Diana Lynn — 25 years of ISO audits
No signup required · Available at msi-international.com
Your next audit starts with
today's decisions
Start with the free gap assessment to see exactly where your process stands — or enroll and get everything at once.
