ISO 9001 Quality

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

The organization shall establish, document,

implement, maintain and continually improve the
effectiveness of quality management system
according to the requirements of ISO 9001.
Documented quality policy
(Appropriate and provide framework for QMS)

Documented quality objectives.

4.2.1 (b)
&
4.2.2

General

Quality manual.

Quality
Manageme
nt System

4.2.4

Control
of
records

Establish a documented procedure to define the

Manageme
nt
Responsibi
lity

5.1
&
5.6.1

Manage
ment
Commit
ment

Manageme
nt
Responsibi
lity
Responsibi
lity,
authority

5.2

Customer
Focus

Customer requirements are defined and met

5.5.1

Responsi
bility and
authority

Responsibilities, and authorities are defined and

control needed for the identification, storage,

(Intra web policy

documents)

protection, retrieval, retention and disposition of

records.
Periodic Management reviews of QMS.
Records of management review shall be
maintained.

communicated

Organogram an
JDs

ISO 9001 Quality

Management
System
and
communica
tion
6

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

Appropriate communication processes are

Human
Resource
sCompete
nce,
training
and
awarenes
s
Human
Resource
sCompete
nce,
training
and
awarenes
s
Human
Resource
sCompete
nce,
training
and
awarenes
s

Competency of personnel performing work

established within organization.

Circular control
form

Job specifications

affecting conformity to products requirements.

Provide training or take other actions to achieve

necessary competence

Maintain appropriate records of education,

training, skills and experience of persons
performing any tasks within QMS

HR training
policy

ISO 9001 Quality

Management
System
10

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

Quality objectives and requirements for the

product

The need to establish processes and documents,

and resources specific to the product
c) required verification, validation, monitoring,
measurement, inspection and test activities
specific to the product and its acceptance
required verification, validation, monitoring,
measurement, inspection and test activities
specific to the product and its acceptance
Documentation of customer specifications

Documentation of protocols of delivery and post

delivery activities.

Documentation of statutory and regulatory

requirements applicable to products.

Statutory and regulatory requirements applicable

to the product.

PSQCA licsne,
PFA licsnce,
Patent and Copy
rights

ISO 9001 Quality

Management
System
Products

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

Prior to commitment of supply, product

requirements are defined,

CSD, iMT
agreements and
PIA agreement

The organization shall determine and implement

effective arrangements for communicating with
customers in relation to product information,
enquiries, contracts or order handling, including
amendments, and customer feedback including

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.

Inputs relating to product requirements shall be

determined and records maintained.

Patent and trade

marks
registration

Legal
requirements
such as PFA
Product
registration

ISO 9001 Quality

Management
System
19

Product
Realization

7.4.1

Purchasi
ng
Process

Suppliers conform to specified purchase

requirements, Suppliers are evaluated after

Supplier
evaluation

evaluation. Criteria for selection, evaluation and

re-evaluation shall be established.
Records of the results of evaluations and any
necessary actions arising from the 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

The organization shall establish and implement

Control
of
Productio
n&
service
provision
Control
of
Productio
n&
service
provision
Control
of
productio
n

the availability of information that describes the

Control
of
Productio

the inspection or other activities necessary for

ensuring that purchased product meets specified
purchase requirements.

characteristics of the product,

the availability of necessary work instruction,

Production work
instructions

Use of suitable equipment.

Approval of production equipment

Machinery
approval and user
procedures

Availability and use of moniotoring and

Scale calibration
QA and Scales
equipments

measuring equipments

ISO 9001 Quality

Management
System
n
22

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

the implementation of monitoring and

Control
of
monitori
ng and
measurin
g
equipme
nt
General

Measuring equipment shall be calibrated or

measurement

Product should be uniquely identified and

traceable

verified at specified intervals. Records of

calibration results shall be maintained.

The organization shall plan and implement the

monitoring, measurement, analysis and
improvement processes needed to demonstrate
conformity to product requirements,

Customer
Satisfacti
on

The organization shall monitor information

relating to customer perception as to whether the
organization has met customer requirements.
The methods for obtaining and using this

Internal
Audit

information shall be determined.

The organization shall conduct internal audits at
planned intervals to determine whether the
quality management system conforms to the
requirements of ISO 9001 and quality
management system established by the

Production
control sheets

Batch number
marking
procedure
Calibration
reports
+
Calibration
testing results

ISO 9001 Quality

Management
System
organization, and is effectively implemented and
maintained.

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

Evidence of conformity with the acceptance

criteria of products shall be maintained

The release of product to customer shall not

proceed until the planned arrangements have
been satisfactorily completed.
A documented procedure shall be established to
define the controls and related responsibilities
and authorities for dealing with nonconforming
product.

QA/QC
checklists

Warehousing and
transportation
agreements