Tag Archive: audit

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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Nov
03

World Quality Month is here… Spread the word!

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November is recognized internationally as World Quality Month.  Some interesting fun facts regarding its origin via ASQ include: Japan has celebrated World Quality Month in November since 1960. China originally recognized World Quality Month in September starting in 1978. North America started raising awareness in 1988 and originally celebrated in October. First promulgated by the …

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Apr
16

Top 3 Benefits of C-TPAT Audits

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Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is and how it benefits and adds organizational value. What is it? “The U.S. Customs-Trade Partnership Against Terrorism initiative (C-TPAT) is a voluntary U.S. Customs and Border Protection program designed to improve border security while also accelerating the …

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