A build-to-print shop can determine that ISO 9001 clause 8.3 (design and development) is not applicable, but only when its actual work supports that decision and the justification is documented in its QMS scope. Since the 2015 edition ISO 9001 no longer uses "exclusions"; it uses applicability, and the 2026 edition keeps that approach. The requirement must genuinely not apply to your activities, and leaving it out must not affect your ability or responsibility to deliver conforming products and enhance customer satisfaction. This video follows one fictional 12-person CNC shop whose one-line "design, not applicable" statement fell apart when an auditor asked to see the last three jobs. It shows what can pull design responsibility back in (deciding a missing tolerance or changing a feature yourself, reverse engineering a sample, designing tooling you sell to the customer, outsourcing design you are still responsible for), what usually does not (planning your setups and machining sequence), and the three questions that settle your own answer. The shop and its choices are examples, not an ISO checklist, and no certification body is guaranteed to read your justification the same way. Takeaways - ISO 9001:2008 allowed "exclusions"; since 2015 the standard uses "not applicable" with a justification in your documented scope - Two tests: the requirement genuinely does not apply to your activities, and leaving it out cannot affect your ability or responsibility to deliver conforming products and enhance customer satisfaction - Deciding a missing tolerance or changing a feature yourself may mean taking on design responsibility; design changes, where applicable, need review, control, authorization and records - Reverse engineering a sample, designing tooling you sell to the customer, or outsourcing design you are responsible for can bring clause 8.3 into play - Ask the customer, document the answer, and get the required approval before changing anything; the customer keeps design authority where the contract assigns it - If your shop regularly designs or changes product features, reassess whether 8.3 applies and keep the process proportionate - Three-question check: who owns the design and approves changes; do you ever fill gaps, change, reverse engineer or design deliverable tooling; do your last three jobs prove it - Document your scope and justification, and discuss any uncertainty with your certification body before Stage 1 Chapters 0:00 Can a build-to-print shop skip design? 0:24 The short answer 1:13 The one-line exclusion 1:33 Where it breaks 2:33 The fix 3:13 Your 3-question check 3:37 Wrap up To keep drawing questions, approvals and revisions tied to the job, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #buildtoprint #machining #QMS #CNC
Watch Build-to-Print and ISO 9001: Can You Skip Design (Clause 8.3)? — a free video from the QMS2GO Learning Hub for quality managers, internal auditors, and manufacturing leaders working with ISO 9001 quality management systems. Every video in the hub is produced by the QMS2GO quality team and is free to view without signup.
Certification and surveillance audits sample records, not intentions. This video is most useful when you map what it describes onto the documented information you already produce — procedures, approvals, corrective actions, calibration and training records — and close whichever of those is thin before the next audit cycle.
Most quality teams get the most value by treating each video as a working session rather than passive background. Note the ISO 9001 clauses referenced, compare what is described against how your own organization currently handles that requirement, and write down the gap. Where the gap is a missing record, a missing owner, or a process that lives only in someone's head, that is exactly what a certification or surveillance auditor will find first. Share the video with process owners and supervisors so quality ownership is not concentrated in one person.
Quality managers building or inheriting an ISO 9001 quality management system, internal auditors preparing an audit program to ISO 19011, consultants supporting multiple client sites, production and operations leaders who own corrective actions, and executives who need a plain-language view of how quality performance connects to on-time delivery, scrap, rework, and customer complaints. No prior auditor training is assumed, and every video in the hub is free to view without signup or a credit card.
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A build-to-print shop can determine that ISO 9001 clause 8.3 (design and development) is not applicable, but only when its actual work supports that decision and the justification is documented in its QMS scope. Since the 2015 edition ISO 9001 no longer uses "exclusions"; it uses applicability, and the 2026 edition keeps that approach. The requirement must genuinely not apply to your activities, and leaving it out must not affect your ability or responsibility to deliver conforming products and enhance customer satisfaction. This video follows one fictional 12-person CNC shop whose one-line "design, not applicable" statement fell apart when an auditor asked to see the last three jobs. It shows what can pull design responsibility back in (deciding a missing tolerance or changing a feature yourself, reverse engineering a sample, designing tooling you sell to the customer, outsourcing design you are still responsible for), what usually does not (planning your setups and machining sequence), and the three questions that settle your own answer. The shop and its choices are examples, not an ISO checklist, and no certification body is guaranteed to read your justification the same way. Takeaways - ISO 9001:2008 allowed "exclusions"; since 2015 the standard uses "not applicable" with a justification in your documented scope - Two tests: the requirement genuinely does not apply to your activities, and leaving it out cannot affect your ability or responsibility to deliver conforming products and enhance customer satisfaction - Deciding a missing tolerance or changing a feature yourself may mean taking on design responsibility; design changes, where applicable, need review, control, authorization and records - Reverse engineering a sample, designing tooling you sell to the customer, or outsourcing design you are responsible for can bring clause 8.3 into play - Ask the customer, document the answer, and get the required approval before changing anything; the customer keeps design authority where the contract assigns it - If your shop regularly designs or changes product features, reassess whether 8.3 applies and keep the process proportionate - Three-question check: who owns the design and approves changes; do you ever fill gaps, change, reverse engineer or design deliverable tooling; do your last three jobs prove it - Document your scope and justification, and discuss any uncertainty with your certification body before Stage 1 Chapters 0:00 Can a build-to-print shop skip design? 0:24 The short answer 1:13 The one-line exclusion 1:33 Where it breaks 2:33 The fix 3:13 Your 3-question check 3:37 Wrap up To keep drawing questions, approvals and revisions tied to the job, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #buildtoprint #machining #QMS #CNC