Which quality standard does your shop need: ISO 9001, AS9100 or ISO 13485? The one your products, customers and applicable requirements call for, and your shop can demonstrate. ISO 9001 is the general quality management standard; AS9100D includes the ISO 9001:2015 requirements and adds aviation, space and defense requirements; ISO 13485:2016 is a separate medical device standard written for regulatory purposes, and it does not automatically cover all ISO 9001:2015 requirements. This video follows three fictional shops: a general job shop that almost chased AS9100 with no aerospace customers, an aerospace bracket supplier whose PO requires AS9100, and a medical device contract manufacturer asked for ISO 13485. The shops are examples, not a certification guarantee. **Takeaways** - Let customer requirements and your product decide, not the logo - ISO 9001 fits general industrial work; traceability under 8.5.2 applies when it is a requirement - AS9100D adds, for example, operational risk (8.1.1), configuration management (8.1.2), controls for suspect or non-authentic parts (8.1.4), production process verification, commonly demonstrated through first article inspection (8.5.1.3), on-time delivery as a management review input (9.3) and human factors in corrective action (10.2) - ISO 13485:2016 adds, for example, records kept for the device lifetime or as regulations require, never less than two years from release (4.2.5), cleanliness requirements (7.5.2), validation of processes whose results cannot be fully verified afterward (7.5.6) and documented traceability with extent based on applicable regulations (7.5.9) - FDA's QMSR (effective February 2, 2026) incorporates ISO 13485; it generally does not apply to ordinary component suppliers, but finished devices and accessories are different - Ask: which standard do our POs and supplier agreements name, where do our parts end up, and what changes on our floor? **Chapters** 0:00 Which standard does your shop need? 0:28 The short answer 1:20 The general shop 2:10 The aerospace supplier 3:10 The medical contract manufacturer 4:39 Where is it written? 5:22 Your 3-question check 5:51 Wrap up To keep customer requirements, revisions and evidence tied to each job, whichever standard you run, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #AS9100 #ISO13485 #machining #QMS
Watch ISO 9001 vs AS9100 vs ISO 13485: Which Does Your Shop Actually Need? — 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.
Most ISO 9001 nonconformances trace back to the same root: a requirement understood by one person and recorded nowhere. Use this video to name the owner, the evidence, and the review cadence for the process it describes, then write those three things down where the rest of the team can see them.
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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Which quality standard does your shop need: ISO 9001, AS9100 or ISO 13485? The one your products, customers and applicable requirements call for, and your shop can demonstrate. ISO 9001 is the general quality management standard; AS9100D includes the ISO 9001:2015 requirements and adds aviation, space and defense requirements; ISO 13485:2016 is a separate medical device standard written for regulatory purposes, and it does not automatically cover all ISO 9001:2015 requirements. This video follows three fictional shops: a general job shop that almost chased AS9100 with no aerospace customers, an aerospace bracket supplier whose PO requires AS9100, and a medical device contract manufacturer asked for ISO 13485. The shops are examples, not a certification guarantee. **Takeaways** - Let customer requirements and your product decide, not the logo - ISO 9001 fits general industrial work; traceability under 8.5.2 applies when it is a requirement - AS9100D adds, for example, operational risk (8.1.1), configuration management (8.1.2), controls for suspect or non-authentic parts (8.1.4), production process verification, commonly demonstrated through first article inspection (8.5.1.3), on-time delivery as a management review input (9.3) and human factors in corrective action (10.2) - ISO 13485:2016 adds, for example, records kept for the device lifetime or as regulations require, never less than two years from release (4.2.5), cleanliness requirements (7.5.2), validation of processes whose results cannot be fully verified afterward (7.5.6) and documented traceability with extent based on applicable regulations (7.5.9) - FDA's QMSR (effective February 2, 2026) incorporates ISO 13485; it generally does not apply to ordinary component suppliers, but finished devices and accessories are different - Ask: which standard do our POs and supplier agreements name, where do our parts end up, and what changes on our floor? **Chapters** 0:00 Which standard does your shop need? 0:28 The short answer 1:20 The general shop 2:10 The aerospace supplier 3:10 The medical contract manufacturer 4:39 Where is it written? 5:22 Your 3-question check 5:51 Wrap up To keep customer requirements, revisions and evidence tied to each job, whichever standard you run, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #AS9100 #ISO13485 #machining #QMS