Manufacture Smarter Blog

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Myth Busters: Common Misconceptions of ISO 9001

11/4/2022 - BY: ANDY NICHOLS
Since its first publication in 1987, the International Standard for Quality Management Systems known as “ISO 9000” has been plagued by many myths. As with all mythology, there are narratives and beliefs which have become almost foundational to the implementation of the ISO 9001 requirements. Like classical myths, those associated with ISO 9001 frequently become rituals which are implemented in the organization’s Quality Management System and become sacrosanct.


Don’t Be A Deer In The Headlights When it Comes to Your Quality Policy

10/21/2022 - BY: STEVE VAMPLEW
One of the many services we provide at the Michigan Manufacturing Technology Center (The Center) is conducting internal audits on our client’s Quality Management System (QMS) or Environmental Management System (EMS). In today’s manufacturing climate, where labor shortages abound, we are being called upon more than ever to perform these internal audits.


Variety is NOT the Spice of Manufacturing Life!

6/17/2022 - BY: ANDY NICHOLS
In manufacturing, we must measure or test the products we make because there is variation in the results and we don’t want to exceed the specification which would result in additional costs, time lost and possibly customer dissatisfaction.


The Problem with Problem Solving

4/15/2022 - BY: SHAUN LEAHEY
Nearly every Quality Manager or Plant Manager has had this situation come up: The phone is ringing and it’s the customer. You instantly get a sinking feeling in your stomach, thinking, here comes a complaint. On the rare occasion there isn’t a problem, you take advantage of strengthening your relationship with the person on the other end of the conversation. But often, you’ll begin the conversation listening to what problem the customer is experiencing and how you can help. Your new priority is to begin problem solving, starting with assembling a team. Wait, we’re supposed to use a problem-solving team? Who’s on the team?


How Often Do You Calibrate Your Internal Management System Auditors?

4/1/2022 - BY: ANDY NICHOLS
At first sight, this may seem to be a crazy question. I hear you say, “Seriously? Calibrate Internal Quality Auditors?” or “Where does the calibration sticker go?” Internal Management System Auditors can be “testing” the Quality Management System (QMS) and could be considered as items of testing equipment. Their brief, in the widest possible terms, is to inspect or evaluate the QMS for compliance and effectiveness.


Learning About Internal Audits from Dr. Joy

2/4/2022 - BY: ANDY NICHOLS
Dr. Joy Browne hosted the longest-running call-in therapy radio shows in America. Listening to her radio shows taught me a lot about why Quality Management Systems Internal Audit programs and Corrective Actions fail. It’s often about peoples’ relationships.


Why You Should Never Use “For Reference Only” In Your QMS

1/7/2022 - BY: ANDY NICHOLS
Since ISO 9001 appeared on the manufacturing scene in 1987, organizations have been vexed by the need to control two fundamental elements of the Quality Management System: Documentation Controls and Measuring Equipment Controls. 


Is Your Business Poised to Grow As a Medical Device Supplier?

10/29/2021 - BY: BOB JENKINS
When deciding whether to diversify into the medical device industry, there are many things to consider. Is my company, and the goods it produces, set up to easily pivot into medical devices? Could the transition be attained relatively quickly? How much work will this entail? 


Process Ownership? Yes!

10/22/2021 - BY: ANDY NICHOLS
For many in management, implementing a set of arcane requirements such as ISO 9001:2015 or its cousins, AS9100D or even IATF 16949, can seem like a daunting task! For starters, the title includes the word “Quality” and that’s a department, right? Aren’t they the people responsible?


Time to Upgrade Your Business? Consider MedAccred

4/23/2021 - BY: BOB JENKINS
In response to the drastic industry and economic changes faced during the COVID-19 pandemic, many manufacturers have had to pivot to provide completely different parts or services in order to keep their businesses operating. For those considering moving into medical device production, or those who already do some work in the space, a competitive advantage can be found with MedAccred.


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