Definition Q - Definitions of all the Q's - QM, QMS, QP, QSR, etc.

D

Debbie Kerr

#1
Our start-up company made a bad decision in obtaining a Quality manual - which was very expensive and pretty useless! We are trying to make sure we are ISO 13485-based. This whole thing is new to me but I've found very helpful information on this site.

What I would like to know is a quick definition and differences for the following:
1. QSM (Quality System Manual)
2. QP (Quality Plan)
3. QMS
4. QSR
5. QM

Are any of these the same thing, just referred to with different letters?

Thanks for any help I can get!:confused:
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#2
Re: Definitions of all the Q's

Hello, Debbie!

It sure is good to have you drop by!:agree1:

Just inquisitive... I'm assuming in this quality manual, they use all these terms. You're wanting to find out what they mean. Correct?

Just felt the need to ask....:) would it be better in the end to "trash" the store-bought and write your own? It may take more time/effort fixing that than just starting new...

Now's the time to do it, before you get started.:D

Anyway, welcome! I don't think it will be a problem locating standard, most common used phrases for those letters.
 
D

Dean Frederickson

#3
Re: Definitions of all the Q's

Our start-up company made a bad decision in obtaining a Quality manual - which was very expensive and pretty useless! We are trying to make sure we are ISO 13485-based. This whole thing is new to me but I've found very helpful information on this site.

What I would like to know is a quick definition and differences for the following:
1. QSM (Quality System Manual)
2. QP (Quality Plan)
3. QMS
4. QSR
5. QM

Are any of these the same thing, just referred to with different letters?

Thanks for any help I can get!:confused:

#3 Quality Management System
#4 Quality System Regulations
#5 Quality Manual
No Debbie, none of the 5 mean the same thing.:cool:
 
#5
Re: Definitions of all the Q's

I've never heard of the term "Quality System Regulations" - In my world that would (more likely) be a Quality System RECORD.....;)
 

howste

Thaumaturge
Super Moderator
#8
Re: Definitions of all the Q's - QM, QMS, QP, QSR, etc.

What I would like to know is a quick definition and differences for the following:
1. QSM (Quality System Manual)
2. QP (Quality Plan)
3. QMS
4. QSR
5. QM

Are any of these the same thing, just referred to with different letters?

Thanks for any help I can get!:confused:
If they're in your manual, you get to define what they mean. If nobody knows what they mean though, you might just get rid of the acronyms. Here's what I've seen them defined as:

1. QSM - Quality System Manual
2. QP - Quality Policy (or Quality Plan)
3. QMS - Quality Management System
4. QSR - Quality System Regulations (FDA 21 CFR part 820)
5. QM - Quality Manager (or Quality Manual)
 
B

Bigfoot

#9
Re: Definitions of all the Q's - QM, QMS, QP, QSR, etc.

If they're in your manual, you get to define what they mean. If nobody knows what they mean though, you might just get rid of the acronyms. Here's what I've seen them defined as:

1. QSM - Quality System Manual
2. QP - Quality Policy (or Quality Plan)
3. QMS - Quality Management System
4. QSR - Quality System Regulations (FDA 21 CFR part 820)
5. QM - Quality Manager (or Quality Manual)
==========================:agree1:
If you are looking for definitions for these acronyms try these;

1. QSM - Quality System Manual - Level 1 Systems / Policy Manual
2. QP - Quality Policy (most likely) or Quality Plan - Policy statement from Leadership / Management of the organizations intent.
3. QMS - Quality Management System - Organized operating system of how you do business typically framed within the context of a related Standard or Regulatory Requirement.
4. Quality System Requirements - Requirements from Customers, Regulatory bodies, Standards, etc that define certain levels of expectation.
5. Quality Manager (most likely) - the person tasked with being stretched so thin that they may never see the light at the end of the tunnel, :lol: or Quality Manual - which is the approximate equal of item 1.
 
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