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ISO 9000, Life Sciences, iso 13485

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

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

Medical device manufacturing companies need regulatory compliance software 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.

Alexa Sussman
By Alexa Sussman
on Tue, Sep 05, 2017
   
Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

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

Medical device manufacturing...

Alexa Sussman
By Alexa Sussman
on Tue, Sep 05, 2017
Is Quality Dying a Slow Death, or Evolving Beyond Definition?

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...

Tim Lozier
By Tim Lozier
on Mon, Nov 15, 2010
The Convergence of EH&S and Quality Management

ITTET (In These Tough Economic Times), Companies are always looking for a way to maximize their investments.  Whether it is...

Tim Lozier
By Tim Lozier
on Fri, May 21, 2010

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