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All documentation need to be refenced to Quality System?

L

l_dominguez

#1
#1
In test stations were found some documents that are not reference to job instructions, i.e: rework flow, stamp criteria, etc.
Those has been using but are not reference to Job instructions, the control plan only made reference to job instructions not to rework flow and stamp criteria. Those looks as island and no links were found.
Is required and/or defined in ISO or QS9000 that all documentation need to be refenced to Quality System (Job instructions, procedures and/or Quality Manual?
Where?
 
QMS for Medical Device Companies
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Marc

Marc

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#2
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I'd have to know more specifics. The question becomes how does one know what the interactions are - so references are assumed.
... In test stations were found some documents that are not reference to job instructions...
Click to expand...
Job instructions often call out (reference) test procedures. Control plans are supposed to reference (call out or specify) every specific inspection and/or test.
Is required and/or defined in ISO or QS9000 that all documentation need to be refenced to Quality System...
Click to expand...
Not all documentation. The auditors are looking at the 'flow' from one system or procedure to another - how you get there from here. Some companies use 'On The Job Training' to address some of these issues.

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