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Showing posts tagged with: processes

Correct way to follow procedures and processes

Correct way to follow procedures and processes

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations. The procedure is correct, but are the follow-ups? But...
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Cup of Joe 36# - Scary word “Audit”

Cup of Joe 36# - Scary word “Audit”

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. A system audit also delivers objective evidence concerning the need for a reduction, elimination and most importantly, prevention of...
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Understanding Roles & Processes in ISO 13485:2016

Understanding Roles & Processes in ISO 13485:2016

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...
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