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ISO / CE / FDA SOP's and WI's and Design Dossier's
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Posted by Crispin (more from Crispin) on Wed, 5 Sep 2007 12:28:13 Share Post by Email
In Reply to: Any technical writers here?, 900Sman, Tue, 4 Sep 2007 18:55:30
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I'm a manufacturing engineer working in a medical device plant. We write all our own standard operating procedures (SOP's)and work instructions (WI's) for our quality system. The ISO quality systems that many plants use demand extensive documentation of every little thing from incoming receiving instructions, sampling with testing through all the assembly instructions for operators on the manufacturing floor and ending with traceability documentation so that all finished product can be traced back to the raw materials and procedures and people used to make the product through a lot number. I'm more at home with the actual machines and procedures that we use to make product but there are also design standards that must be followed when you are starting a new product or making a change to an existing product. This can all be found by researching ISO and FDA quality standards and systems. As much as we bitch about it, the whole system is pretty interesting and is now world wide and pertains to many products. If you notice the little CE mark on many products, it means that product was made in an ISO approved facility and conforms to the applicable standards for that type product and that a design dossier was submitted showing how the product conforms. The FDA is similar here in the US. Understanding this/these system(s) allows you to go anywhere and quickly adapt to any plant and/or any product. PM me if you like. C.

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