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qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality

4 steps how to carry out RCA

4 steps how to carry out RCA

Why? Where? How? When? What? Most problems don’t have obvious solutions. That’s why they remain problems, and that’s why, it’s necessary to be aware of underlying causes, especially when planning to carry out a root cause analysis. Root cause analysis is basically a process with a systematic approach for identifying a problem. It provides companies a way to prevent...
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.
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ISO 9001 – 2015 Checklist

ISO 9001 – 2015 Checklist

If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.
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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 Checklist

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager, the following checklist will guide you.
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