Tag Archive: audit

Mar
05

Are ISO 13485 and FDA 21 CFR Part 820 audits the same?

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Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug Administration regulates current good manufacturing …

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Feb
12

Supply Chain Management – Webinar Review

Our Tampa office worked with the local ASQ section and Hillsborough Community College’s Institute for Corporate and Continuing Education and coordinated and instructed a series of webinars that will run through this month.  The webinar scheduled for today discusses Supply Chain Management, which many in our industry recognize is a broad topic. As a brief …

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Jan
26

ISO 13485:201X Preparation (Medical Device Audits)

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ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and …

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Dec
10

How well are your suppliers performing?

In a recent post, we discussed several New Year’s goals that we frequently hear from clients and prospects around this time of year.  One of the most common is evaluating and improving supplier performance. We know that suppliers may appear qualified at first and then fail to deliver the required quality after time and money have been invested in …

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Nov
17

How do you know quality when you see it?

After describing what it is that Pro QC does the other day, an individual paused and asked how we know what quality is when we see it. And, that’s a very interesting question that many conclude is just too subjective to answer. Likely the most popular general definition is Deming’s idea of whether something is meeting or exceeding …

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