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Quality Plan - Do we really need a quality plan?

S

sardonyx

#11
enlightened

:thanx:

Thanks all for the enlightenment :agree1: I'll take your ideas and implement in our company.
 
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Al Rosen

Staff member
Super Moderator
#12
RCBeyette said:
Can anyone tell us if there is a requirement for a Quality Plan in ISO 13485?
ISO 13485:2003, 7.1 is the same as ISO 9001:2000, 7.1. with an additional requirement for Risk Management. If your of the opinion that there is no "Quality Plan" required for ISO 9001:2000, then ISO 13485:2003 does not require a "Quality Plan". I believe that the sum of the documents to satisfy the requirements in 7.1 is a "Quality Plan". You say t
-m
t
, I say t
-mä
t
.
 
S

sardonyx

#13
Sounds better and no headache to me! Whatever we have documents under 7.1 is considered a quality plan. :agree1:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#14
ISO 10005 Quality management -- Guidelines for quality plans. Last published revision was 1995, but the document is presently being revised.
 
J

Jim Howe

#17
In the aerospace industry during the 1980's we had QAP's (quality assurance plans) and QAIP's (quality assurance inspection plans). They were mandated by the SOW (statement of work) and composed by the PPAP (program product assurance engineer). Once composed they were routed out to all of management and supervision for approvals (a task that usually took several months and as many as 20+ signatures.) This of course could only happen with some sort of Initial Quality Planning in order to have the documents ready prior to production startup.
Does any of this sound familiar to anyone? As cumbersome as it sounds the system worked quite well as part of Mil-Q-9858A. When production started everyone new what to do and when to do it and why! If not they simply referred to the QAIP and found out. Gray areas were referred to the PPAP assigned to the program who had full access to the all mighty! On some occassions a revision to the document was warranted. Obviously then the documents were a controlled document.
Sometimes a climpse into the past can be quite revealing. Who needs ISO? ;) Hope this helps!
 
B

Bridget

#18
Quality Plans are required for some of us

The FDA requires a quality plan, Section 820.20d. Just wanted to add my :2cents: .
Bridget
 

Al Rosen

Staff member
Super Moderator
#19
Bridget said:
The FDA requires a quality plan, Section 820.20d. Just wanted to add my :2cents: .
Bridget
Yes, that is true but doe it have to be one document? I don't believe so.

21CFR820.20

d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
 
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