ISO 9001 clause 6.1 asks you to determine which risks and opportunities need addressing, analyse and evaluate them, plan suitable actions and how you will check their effectiveness, and build those actions into your processes. ISO 9001 itself requires neither a risk register nor FMEA, though customer or other applicable requirements still apply. The 2015 edition already required actions on both. ISO 9001:2026 separates them into distinct subclauses and explicitly requires analysis and evaluation of each. That does not mean two binders. This video walks one fictional 20-person CNC shop through its choices: a single 5-axis machine, one key programmer, new purchase order requirements, a cheaper bar stock supplier, a robot loading cell, and a repeat-part quote. These are the shop's choices, not an ISO checklist. **Takeaways** - Two practical risk questions: what could happen to good parts and delivery, and how likely is it. Then act, watch, or accept (teaching aids, not ISO terms) - Match risk actions to their potential impact on the quality system's results, using existing processes and their required records - Accepting a risk is an informed decision, not permission to ignore requirements - Treat opportunities as actions too: pilot, compare results with a target, check demand and capacity, and address the risks they bring - A practical evidence trail: did the action happen, did it work, and was effectiveness reviewed by management - This week: 30 minutes with the people who know the work, a response for each item, owner and date, when to reconsider, and effectiveness results into management review **Chapters** 0:00 Clause 6.1 in one shop example 0:17 What clause 6.1 asks you to do 0:37 No register or FMEA required, and what 2026 changed 1:01 The fictional 20-person CNC shop 1:13 Pick what matters 1:40 Act, watch or accept 1:58 Size the actions 2:57 Opportunities 3:27 A practical evidence trail 4:07 What to do this week 4:34 Wrap-up To connect actions, owners and follow-up evidence to the work, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #riskbasedthinking #machining #QMS #CNC
Watch ISO 9001 Risks and Opportunities: A Machine Shop Example (6.1) — 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.
Clause knowledge only pays off when it changes a record someone actually keeps. After this video, look at the register, form, or log in your own system that the topic touches, and decide whether an auditor could follow it end to end without a verbal explanation. That single check is usually the difference between a passing finding and an observation.
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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ISO 9001 clause 6.1 asks you to determine which risks and opportunities need addressing, analyse and evaluate them, plan suitable actions and how you will check their effectiveness, and build those actions into your processes. ISO 9001 itself requires neither a risk register nor FMEA, though customer or other applicable requirements still apply. The 2015 edition already required actions on both. ISO 9001:2026 separates them into distinct subclauses and explicitly requires analysis and evaluation of each. That does not mean two binders. This video walks one fictional 20-person CNC shop through its choices: a single 5-axis machine, one key programmer, new purchase order requirements, a cheaper bar stock supplier, a robot loading cell, and a repeat-part quote. These are the shop's choices, not an ISO checklist. **Takeaways** - Two practical risk questions: what could happen to good parts and delivery, and how likely is it. Then act, watch, or accept (teaching aids, not ISO terms) - Match risk actions to their potential impact on the quality system's results, using existing processes and their required records - Accepting a risk is an informed decision, not permission to ignore requirements - Treat opportunities as actions too: pilot, compare results with a target, check demand and capacity, and address the risks they bring - A practical evidence trail: did the action happen, did it work, and was effectiveness reviewed by management - This week: 30 minutes with the people who know the work, a response for each item, owner and date, when to reconsider, and effectiveness results into management review **Chapters** 0:00 Clause 6.1 in one shop example 0:17 What clause 6.1 asks you to do 0:37 No register or FMEA required, and what 2026 changed 1:01 The fictional 20-person CNC shop 1:13 Pick what matters 1:40 Act, watch or accept 1:58 Size the actions 2:57 Opportunities 3:27 A practical evidence trail 4:07 What to do this week 4:34 Wrap-up To connect actions, owners and follow-up evidence to the work, take a look at QMS2GO. https://qms2go.com #QMS2GO #ISO9001 #riskbasedthinking #machining #QMS #CNC