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How Will ISO 13485:2016 Impact Your Relationship With Suppliers & Why You Should Be Using ISO 13485:2016 CERTIFIED Suppliers From Now On

The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. Speaking as the Quality Systems Director of CrossWind Machining (component manufacturer for the medical device industry) and just completing our ISO 13485:2016 Certification, the new 2016 revision (from 2003) is all about mitigating risk from every aspect of the medical device manufacturing process. And with ISO 13485:2003 no longer being valid after 2019, suppliers are having to decide how much time & money they are willing to put into separating themselves.


What the new Standard Says About RiskOne particularlynotable change with ISO 13485:2016is the addition of more explicit risk management requirements. Companies will be required to consider the risk associated with a device from conception through its use. Device makers must plan and imple…

Why You Should Consider Trade School Instead of College

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For a lot of people, going to a four-year college seems like an automatic choice when they graduate from high school. The reason is obvious – higher income. According to the National Center for Educational Statistics, a bachelor’s degree accounted for an average of $16,900 in additional income per year compared to a high school diploma ($30,000 versus $46,900).
Over a 30-year career in the workforce, that’s more than a $500,000 difference in earnings. These numbers may not paint the whole picture, however. Due to the increasingly high costs associated with a college education, as well as other drawbacks, more and more people have been considering trade school as an education alternative.Skilled labor is needs just as much as an educated work force! Trade School vs. College: Drawbacks to College Education Length: Four (or More) Years vs. Two Years For starters, a bachelor’s degree typically takes four years of study, which means that people who enter the workforce after receiving their bac…

Wanted: Women to Fill Well Paying Jobs in Manufacturing

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Here at CrossWind Machining we know hard difficult it can be to find skilled workers to run our machines.  We are in a niche here, making small diameter parts for the medical device industry.  Not to mention that the machines we use are swiss screw machines, which are even harder to find machining talent for than your standard mill or lathe machine.  CrossWind is situated in the Sierra Foothills of CA.  The scenery is amazing, it is cheaper here than many areas in the state, we have a low crime rate, great schools, etc., but it is still very difficult to find the talent that we need to help our company to grow.  One of the biggest reasons for this is that women are not being drawn to this field.
“Women constitute manufacturing’s largest pool of untapped talent in the United States. They comprise just over one-fourth (27 percent) of manufacturing employees even though women make up nearly half (47 percent) of the total U.S. labor force.”  Overall, there is a shortage in skilled worker…

Is Going Automated Worth the Investment?

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With new technology comes change in the way we do everyday things.  For instance I spend about 5 minutes, before I even get out of bed, checking the weather for the week, reading through my emails and texts, checking my Facebook updates, and maybe even playing a word or 2 on Words With Friends.  Sometimes I’ll text my husband or one of my sons about something that needs to be taken care of or to ask co-workers if they need anything for the shop on my way in and then update my shopping list.  I haven’t even left my bed yet and I’ve already done so many things that I couldn’t have done, from the comfort of my bed, without my smartphone.  Now I did have to spend a few hundred dollars on this phone so that I would be able to do these things, but it saves me a lot of time searching the internet or reading a newspaper (which hardly anyone does anymore anyways) for the exact same information.  Not to mention, when I show up at work I won’t have to turn around and head back to town to get su…
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Do Our High Schools Teach Students the Real Basics of Life?
A couple of months ago my 18 year old son had to mail a letter off to request his high school transcripts.  Before it went into the mailbox I took a look at it and realized that he had the “to” and “from” labels backwards.  It never occurred to me that my son wouldn’t know how to mail off a letter properly.  When I was younger, in elementary school and even higher, we had to send off letters to pen pals, government officials, and even some companies seeking correspondence.  Everything is done digitally now so my son had never had to learn.  At the same time, I’m seeing credit card offers coming for him in the mail.  He’s almost 19, so legally he can get one if he wanted to, but what a huge mistake that would be for him at this point in his life.  He’d have $10,000 racked up in debt in no time.  We’ve sat down together and discussed how credit cards and other loans work so I know he has some basic knowledge, but I would really …
5 Ways to Keep Your Employees Happy Without Breaking the Bank
I’m sure most of us have had a “lousy” employer or two in their life.  You know, the boss that expects everything and gives nothing.  You’ve probably also worked for companies that you really enjoyed.  What made you like where you worked?  Was it financial incentives?  Maybe you had good benefits or was it just the atmosphere of the place?  What keeps employees showing up day to day, being productive, and not looking for employment elsewhere?
About 15 years ago I worked for a company that published a magazine for the higher education market.  They also put on a tradeshow annually.  When I started the job the pay wasn’t great, but I saw potential in what my job could eventually become and I really liked some of the people working there.  I got along very well with almost everyone and the benefits were decent too.  I quit after 6 months.  Why?  My boss was a jerk.  He lied to me repeatedly about introducing me to customers so t…

3D Printing vs. CNC Machining

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Recently I have been looking into 3D printing for Crosswind Machining.  There is so much buzz all over the news and internet about it and I wondered if we could benefit from adding it to our shop floor. I think companies need to always be open to change.  Not only so that we make quality products with the machines that we already have, but also looking for ways to improve our capabilities to serve our customers with new ideas and new technology. As a matter of fact our Quality Policy states ”…to consistently surpass customers’ expectations in both quality and delivery scheduling.  We make every effort to continually maintain and improve our system.” That includes looking at newer technologies like 3d printing.  After doing quite a bit of research I have no doubt in my mind that this technology will play a large part of the manufacturing industry in the next 10 years.  Additive manufacturing is being utilized in multiple fields already such as medical, manufacturing, art, automotive i…