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Management
System
Documentation Requirement Summary
Serial
No.
Sectio
n No.
Section
Name
Quality
Manageme
nt System
5.5
Sub
Section
No.
Sub
Section
Name
4.1
General
Require
ments
Quality
Manageme
nt System
4.2.1 (a)
&
5.3
Quality
Manageme
nt System
Quality
Manageme
nt System
4.2.1 (a)
General
&
Quality
Policy
General
Description
Compliance
with relevant
Intraweb
Document
4.2.1 (b)
&
4.2.2
General
Quality manual.
Quality
Manageme
nt System
4.2.4
Control
of
records
Manageme
nt
Responsibi
lity
5.1
&
5.6.1
Manage
ment
Commit
ment
Manageme
nt
Responsibi
lity
Responsibi
lity,
authority
5.2
Customer
Focus
5.5.1
Responsi
bility and
authority
communicated
Organogram an
JDs
Manageme
nt
Responsibi
lity
Resource
Manageme
nt
5.5.3
6.2.2 (a)
Resource
Manageme
nt
6.2.2 (b)
Resource
Manageme
nt
6.2.2 (e)
Internal
Commun
ication
Human
Resource
sCompete
nce,
training
and
awarenes
s
Human
Resource
sCompete
nce,
training
and
awarenes
s
Human
Resource
sCompete
nce,
training
and
awarenes
s
Circular control
form
Job specifications
HR training
policy
10
10
Product
Realization
7.1 (a)
Product
Realization
7.1 (b)
Product
Realization
7.1 (c)
7.2.1 (a)
7.2.1 (a)
7.2.1 (b)
7.2.1 (c)
Planning
of
Product
Realizati
on
Planning
of
Product
Realizati
on
Planning
of
Product
Realizati
on
Determin
ation of
requirem
ents
related to
Products
Determin
ation of
requirem
ents
related to
Products
Determin
ation of
requirem
ents
related to
Products
Determin
ation of
requirem
ents
related to
PSQCA licsne,
PFA licsnce,
Patent and Copy
rights
11
12
Product
Realization
7.2.2 (a
and b)
Product
Realization
7.2.3
Review
of
Require
ments
related to
product
Customer
Commun
ication
CSD, iMT
agreements and
PIA agreement
13
14
Product
Realization
7.3.1
Product
Realization
7.3.2
Design
and
Develop
ment
Planning
Design
and
Develop
ment
Inputs
customer complaints
The organization shall plan and control the
design and development of product.
Legal
requirements
such as PFA
Product
registration
Product
Realization
7.4.1
Purchasi
ng
Process
Supplier
evaluation
20
21
22
Product
Realization
Product
Realization
7.4.2
7.4.3
Product
Realization
7.5.1 (a)
22
Product
Realization
7.5.1 (b)
22
Product
Realization
7.5.1 (c )
7.5.2 (b)
22
Product
Realization
7.5.1 (d)
Purchasi
ng
Informati
on
shall be maintained.
The organization shall ensure the adequacy of
specified purchase requirements prior to their
communication to the supplier.
Verificati
on of
Purchase
d Product
Control
of
Productio
n&
service
provision
Control
of
Productio
n&
service
provision
Control
of
productio
n
Control
of
Productio
Production work
instructions
Machinery
approval and user
procedures
Scale calibration
QA and Scales
equipments
measuring equipments
Product
Realization
24
25
26
27
7.5.1 (e)
7.5.3
Product
Realization
7.6
Measureme
nt, analysis
and
improveme
nt
8.1
Measureme
nt, analysis
and
improveme
nt
8.2.1
Measureme
nt, analysis
and
improveme
nt
8.2.2
Control
of
Productio
n&
service
provision
Identifica
iton and
Traceabil
ity
Control
of
monitori
ng and
measurin
g
equipme
nt
General
measurement
Customer
Satisfacti
on
Internal
Audit
Production
control sheets
Batch number
marking
procedure
Calibration
reports
+
Calibration
testing results
29
29
30
Measureme
nt, analysis
and
improveme
nt
Measureme
nt, analysis
and
improveme
nt
Measureme
nt, analysis
and
improveme
nt
8.2.4
8.2.4
8.3
Monitori
ng &
Measure
ment of
Products
Monitori
ng &
Measure
ment of
Products
Control
of Non
conformi
ng
product
QA/QC
checklists
Warehousing and
transportation
agreements