Manufacture Smarter Blog

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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.


Industry 4.0 and ISO 9001 Quality Management (Part 2)

1/29/2021 - BY: ANDY NICHOLS
In a recent blog post, we explored Industry 4.0 technologies from the perspective of Quality professionals, highlighting the importance of planning before implementing. This follow-up blog takes a closer look at the impact some of these technologies might have on the world of the typical Quality department and how they can be used to support Quality initiatives.


Industry 4.0 and ISO 9001 Quality Management (Part 1)

1/20/2021 - BY: ANDY NICHOLS
The concept of Industry 4.0 has been gradually introduced into manufacturing facilities in recent years, bringing with it operational improvements and countless other benefits. In a two-part blog series, we will explore how these exciting developments can support ISO 9001-based Quality Management Systems (QMS), as well as dive into their impact on the overall Quality department.


ISO 9001 – A Key to Cybersecurity? (Part 2)

11/6/2020 - BY: ANDY NICHOLS
A few weeks ago, we posted a blog dissecting the various requirements of ISO 9001:2015 related to the “control of documented information” and addressed how cyberattacks can affect customers, management, employees and even regulatory compliance. Now that the value of information security has been established, we’ll discuss how to incorporate safe cybersecurity practices to further support your organization’s controls of documented information.


ISO 9001 – A Key to Cybersecurity? (Part 1)

10/9/2020 - BY: ANDY NICHOLS
Between 40 and 60% of small businesses fail within a year of any type of disaster – including cyberattacks – unless some type of resiliency plan is put in place. So, what is needed to protect small and medium-sized businesses from such an attack? How can an organization become “cyber-resilient”?  ​While many might not realize it, if an organization already has an ISO 9001:2015-compliant QMS, that can be used as a platform on which to base an effective cybersecurity program.


Is Your Quality Policy “Motherhood” or “Apple Pie-in-the-Sky”?

8/21/2020 - BY: ANDY NICHOLS
Policies. Every day we are governed by them. They provide direction to us on a wide variety of issues, often expressed in simple terms for everyone to understand and implement. “No smoking.” “Mask required.” “No open-toed shoes.” Knowing this, why is it that things often go awry when trying to establish and maintain a Quality Policy?


Solving Problems in Your Business by Simply Asking, “Why?”

6/19/2020 - BY: DALE WICKER
Often when we are faced with a problem, we react quickly without thinking it through, ultimately treating the symptom and not the real cause. When situations like this occur in business, leaders need a proven, comprehensive method for solving problems that could arise. The 5-Why method is a simple, but powerful, analysis tool that can help teams identify the root cause of a problem.


10 Tips to Prepare for Your Virtual ISO Audit

5/15/2020 - BY: ANDY NICHOLS
If your organization is certified to ISO 9001, AS9100D or ISO 14001 and you have an audit scheduled to happen during the current COVID-19 restrictions, these tips are for you! ISO 9001 or 14001 certified organizations with an “ANAB” logo – or “IAF” logo – may be a candidate for conducting what’s known as an “ICT Audit,” which stands for “Information & Communication Technology.”


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Showing 21 - 30 of 85