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  Record retention element 4.5

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Author Topic:   Record retention element 4.5
metga
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posted 23 March 2000 02:27 PM           Edit/Delete Message   Reply w/Quote
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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Marc Smith
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From:West Chester, OH, USA
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posted 24 March 2000 05:32 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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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Karen
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posted 24 March 2000 09:04 AM           Edit/Delete Message   Reply w/Quote
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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gmac
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From:Calgary, Alberta,Canada
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posted 24 March 2000 09:25 AM     Click Here to See the Profile for gmac   Click Here to Email gmac     Edit/Delete Message   Reply w/Quote
Dependant on the industry and customer requirements, some manufacturing standards will stipulate retention periods for records.

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Marc Smith
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posted 24 March 2000 09:51 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
This is true, however ISO9001 does not specify any specify any retention times.

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Tom Parsons
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From:Newberg, OR USA
Registered: Mar 2000

posted 24 March 2000 12:52 PM     Click Here to See the Profile for Tom Parsons   Click Here to Email Tom Parsons     Edit/Delete Message   Reply w/Quote
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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