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Showing posts with the label QMS procedures

A Nonconforming Output Was Found. What Happens Next?

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A part fails inspection. A service does not meet the agreed requirements. Or a customer reports a problem after delivery. The first instinct may be to fix it and move on. But before anything is used, delivered, or released again, someone needs to control the affected output and decide what happens to it. Here is the process at a glance: 1. Detect the nonconformity A nonconforming output can be found during incoming inspection, while work is underway, at final release, or after delivery. Everyone should know how to report one—and feel comfortable doing so promptly. 2. Contain the affected output Remove it from the normal flow so it cannot be used or delivered by mistake. A physical item might go on a designated hold shelf with a HOLD tag. A service that cannot be set aside may need to be suspended or contained. 3. Decide what happens to it An authorized person determines the appropriate action. Depending on the situation, that could mean correction, continued segregation, r...

ISO 9001:2026 Risks and Opportunities—What Has Changed?

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What is Changing in Clause 6.1? Clause 6.1.1 & 6.1.2 (Risks): Protect what you have. Identifies and evaluates uncertainties that could undesirably affect your ability to deliver conforming products and services. Clause 6.1.1 & 6.1.3 (Opportunities): Pursue what creates value. Requires structured planning, integration, and evaluation for favorable circumstances that could desirably improve QMS performance. Context & Climate Change: Clarifies how Clause 4 context inputs flow into risk planning, addressing the 2024 climate amendment without forcing an artificial climate risk into every QMS. ISO 9001:2015 vs. ISO 9001:2026 Direction Topic ISO 9001:2015 ISO 9001:2026 Direction Clause Structure Combined in 6.1.1 & 6.1.2 Determination together (6.1.1); Action planning split into 6.1.2 (Risks) & 6.1.3 (Opportunities) Opportunities Required, but easily buried in ri...