February 2023 Webinar Now Available: Data Analysis - Ten Questions Auditors Should Ask - Rai Chowdhary (The KPI System)
The world relies on data and its analyses to make good decisions. ISO Standards have also followed suit by including clauses on the topic.
What should auditors look for? That is the million-dollar question. Why? Let us look at Section 8.4 Data Analysis from ISO 13485. The first paragraph requires documented procedures to determine, collect and analyze appropriate data…and determination of appropriate methods, including statistical techniques and the extent of their use.
How does one determine if the data, its analyses, and statistical techniques are appropriate? This means the auditor should know something about data, its collection, integrity, analysis, and reporting to ask meaningful questions. This session addresses just that.
Recording link: https://asq.webex.com/asq/ldr.php?RCID=cf85ab28c1cb8fc95289c89144979775
What should auditors look for? That is the million-dollar question. Why? Let us look at Section 8.4 Data Analysis from ISO 13485. The first paragraph requires documented procedures to determine, collect and analyze appropriate data…and determination of appropriate methods, including statistical techniques and the extent of their use.
How does one determine if the data, its analyses, and statistical techniques are appropriate? This means the auditor should know something about data, its collection, integrity, analysis, and reporting to ask meaningful questions. This session addresses just that.
Recording link: https://asq.webex.com/asq/ldr.php?RCID=cf85ab28c1cb8fc95289c89144979775
News Audit Division
03/07/2023 11:17am CST
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