audit

All articles tagged “audit”.

ISO 13485:201X Preparation (Medical Device Audits)

ISO 13485:201X Preparation (Medical Device Audits)

Factory Audits
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 […]
How well are your suppliers performing?

How well are your suppliers performing?

Supplier Management
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 […]
How do you know quality when you see it?

How do you know quality when you see it?

Quality Control
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 […]
World Quality Month is here… Spread the word!

World Quality Month is here… Spread the word!

News
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 was originally celebrated in October. First promulgated by […]
Top 3 Benefits of C-TPAT Audits

Top 3 Benefits of C-TPAT Audits

Factory Audits
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 […]
Best Practices For Minimizing Global Supplier Risk

Best Practices For Minimizing Global Supplier Risk

Supplier Management
We were just reading through an article posted by Supply Chain Management Review that discusses Four Best Practices for Minimizing Global Supplier Risk.  As a third-party quality engineering and consulting firm, we get questions about this often and have written a handful of articles related to the topic. We like the SCMR’s four best practices, […]
An introduction to ISO 9001:2008

An introduction to ISO 9001:2008

Quality Control
This video series is an excellent introduction to ISO 9001:2008 produced by QualityGurus.  The two-part series answers many of the questions we receive from clients. ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). […]
Preparing for an audit

Preparing for an audit

Factory Audits
A previous Quality Q & A newsletter article featured tips for audit preparation.   In the reprinted content below, Pro QC’s Supplier Development Manager discusses how each party can expedite the process.   Preparation for a factory audit can be broken down by responsibilities of the client, supplier (factory) and third party (Pro QC). Communication and […]