posted 23 March 2000 02:27 PM              

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What records from what departments must be retained and how long to meet element 4.5 of iso 9000. Would shipping retain picklists, bill of lading and packing slips and for how long? Where can I find specific answers /information like the above questions?

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From:West Chester, OH, USA
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posted 24 March 2000 05:32 AM               

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Are you talking about records in accordance with 4.16? If so - there is no requirement. Your company decides what is 'appropriate'. I have seen some companies which literally keep all records (one had close to 40 years worth) whilst others destroy them after a year.

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posted 24 March 2000 09:04 AM              

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Keep in mind to that some records may have retention periods for legal reasons. This may primarily be in employee files such as Training Records, Evaluations, etc..

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From:Calgary, Alberta,Canada
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posted 24 March 2000 09:25 AM               

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Dependant on the industry and customer requirements, some manufacturing standards will stipulate retention periods for records.

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posted 24 March 2000 09:51 AM               

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This is true, however ISO9001 does not specify any specify any retention times.

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From:Newberg, OR USA
Registered: Mar 2000

posted 24 March 2000 12:52 PM               

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I don't often see the phrase 'medical device' used in these postings. For those of us that have to deal with such things, both EN 46001 and ISO 13485 add the requirement to ISO 9001 that Quality Records must be kept for the life of the product (two year minimum). The good thing here is that the manufacturer defines what the lifetime is.

And what's a "Lurker" anyway?

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[This message has been edited by Tom Parsons (edited 24 March 2000).]

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