Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

[fa icon="calendar'] Tue, Sep 05, 2017 / by Alexa Sussman

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing companies need to comply with a regulatory standard to maintain compliance and be sure that products are safe and effective. But there are multiple options that complicate the process of deciding which standard to comply with. Some make the decision to comply with more than one for the sake of covering all bases.

Here’s a breakdown of what Life Science organizations should consider about the two most common standards for medical device companies: ISO 9001:2015 and ISO 13485: 2016.

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ISO 9000 Life Sciences iso 13485

We the People: A Trained Employee-centric approach to QMS & EHS – by EtQ

[fa icon="calendar'] Mon, Feb 28, 2011 / by Tim Lozier

Last week I spoke a lot about the concept of integration and consolidation (and a little about my Spring cleaning habits).  In the post, I mentioned how in an effort to consolidate and/or integrate business systems, many software solutions would need to serve a dual purpose, or converge.  Specifically, Quality Management Systems and Environmental Health and Safety Systems share enough commonalities that they can easily be converged into a single system.

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Environmental Health and Safety Management EHS Management qms Integration quality management software ISO 9000 ISO 14001 OHSAS 18001 Aviation Safety Management

Is Quality Dying a Slow Death, or Evolving Beyond Definition?

[fa icon="calendar'] Mon, Nov 15, 2010 / by Tim Lozier

So after a brief break from my blog, I'm refreshed and back for more. So I thought I would start the ball rolling with a little thought-provoking (and perhaps controversial) topic:

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Quality Management ISO 9000

The Convergence of EH&S and Quality Management

[fa icon="calendar'] Fri, May 21, 2010 / by Tim Lozier

ITTET (In These Tough Economic Times), Companies are always looking for a way to maximize their investments.  Whether it is streamlining operations, reducing...(ahem)overhead, or consolidating systems, these measures help to not only keep a company going, but also help to improve in the long-run. 

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EHS Management Quality Management ISO 9000 ISO 14001 OHSAS 18001

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