Quality System Essentials
CLSI subscribes to a quality management system (QMS) approach in the development of standards and guidelines that facilitates project management, defines a document structure using a template, and provides a process to identify needed documents. The QMS approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide.
To view each QSE, click "Filter Off" and select from the dropdown options.
Primary
|
OR
|
CS
|
FS
|
PE
|
SI
|
EQ
|
PM
|
DR
|
IM
|
NC
|
AS
|
CI
|
N/A
|
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AUTO01-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO02-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO03-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO04-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO05-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO07-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO08-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO09-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO10-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO11-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO12-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO13-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO15-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO16-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUTO17-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIS01-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIS02-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C24-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C29-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C31-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C34-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C37-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C38-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C39-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C40-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C42-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C43-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C45-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C46-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C48-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C49-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C50-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C52-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C56-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C57-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C58-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C61-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C62-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C63-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C64-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP05-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP06-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP07-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP09c-Ed3
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
EP10-A3-AMD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP12-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP14-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP15-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP17-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP18-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP19-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP21-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP23-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP24-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP25-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP26-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP27-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP28-A3c
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP29-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP30-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP31-A-IR
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP32-R
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP33-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP34-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP35-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP36-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP37-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP39-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EP43-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP05-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP15-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP16-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP17-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP20-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP23-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP33-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP34-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP36-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP39-A6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP40-A4-AMD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP41-Ed7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP42-Ed7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP44-A4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP45-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP47-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP48-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GP49-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H02-A5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H07-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H15-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H20-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H21-A5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H26-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H30-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H42-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H43-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H44-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H47-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H48-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H52-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H54-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H56-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H57-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H58-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H59-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H60-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H62-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA02-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA20-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA21-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA23-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA25-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA26-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA28-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA30-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA33-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA34-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I/LA37-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M02-Ed13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M02QG-Ed1
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
M07-Ed11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M100-Ed33
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M11-Ed9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M15-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M22-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5-S-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed5-S2-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M23-Ed6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M24-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M24S-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M26-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M27-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M27-M44-S-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M28-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M29-A4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M34-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M35-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M36-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M38-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M38-M51-S-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M39-Ed5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M40-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M41-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M43-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M44-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M45-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M47-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M48-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M50-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M51-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M52-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M53-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M54-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M56-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M57-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M57-S-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M58-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M59-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M60-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M61-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M62-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM01-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM03-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM05-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM06-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM07-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM09-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM11-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM12-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM13-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM14-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM17-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM18-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM19-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM20-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM21-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM22-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM23-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MM24-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS01-Ed7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS03-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS04-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS05-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS06-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS07-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS08-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NBS09-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT01-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT02-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT04-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT05-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT06-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT07-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT08-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT09-A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT10-A2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT12-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT13c-Ed3
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
#INVALID VALUE
|
POCT14-Ed2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT15-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POCT17-Ed1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS01-Ed5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS02-A6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS03-Ed4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS04-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS05-Ed3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS06-A3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
QMS11-Ed2
|
|
|
|
|
|