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INTEGRATED MANAGEMENT
SYSTEM
MANUAL ISO 9001:2008, ISO
14001:2004
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INTEGRATED MANAGEMENT
SYSTEM MANUAL
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38
TABLE OF CONTENTS
Section
1
2
3
4
--
--4.1
Company Profile
Scope
Exclusion
Structure of Quality, Health & Safety &
Environmental Management System
Manual
Definitions & Abbreviations
Integrated Management System
General Requirements
4.2
-5.1
5.2
Management Responsibility
Management Commitment
Customer Focus
5.3
5.4
---5.5
--
--5.6
-6.1
6.2
-6.3
6.4
-7.1
7.2
7.4
-7.4
----7.5
Section Title
-8.1
Page No
QMS
1.0
---
EMS
----
5
7
7
7
3.0
4.0
4.1
4.2.3
4.2.4
5.0
5.1
5.2
9
13
13
5.3
5.4
-5.4.1
5.4.2
-4.0
-4.4.5
4.5.4
-4.4.1
4.3.1
4.3.2
4.2
4.3
4.3.1
4.3.3
4.3.3
5.5
4.4.1
19
5.5.2
5.5.3
5.6
6.0
6.1
6.2
6.2.2
6.3
6.4
7.0
7.1
7.2
7.4
7.4.3
7.5
7.5.1
7.5.2
4.4.1
4.4.3
4.6
-4.4.1
-4.4.2
4.4.1
-4.4
4.4.6
--4.4.6
-4.4.6
4.4.6
20
20
21
23
23
23
23
24
24
26
26
26
26
27
27
27
27
7.5.3
7.5.4
7.6
--4.5.1
27
28
28
4.5
30
8.1
--
30
13
16
16
16
16
18
18
18
19
Section
8.2
----8.3
8.4
8.5
----
Section Title
Page No
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
--4.5.5
4.5.1
4.5.2
4.5.1
4.5.2
4.4.7
4.5.3
4.5.1
--4.5.3
4.5.3
30
30
30
31
31
32
33
33
33
33
34
SECTION 1
COMPANY PROFILE
COMPANY PROFILE
SECTION 2
SCOPE
2.
SCOPE
The scope of this Integrated Management System manual is to
demonstrate the companys commitment to provide consistently products
that meet customer and regulatory requirements. It applies to all the
activities and functions of company related to Storages, Inspection, and
Packing etc. This manual establishes compliance with the requirements of
Quality and Environmental Management System as well as regulations.
2.1
2.2
Structure
Manual
of
Integrated
Management
System
This integrated system manual follows the integrated format of ISO 9001:
2008 & ISO 14001:2004. It provides direction for the implementation and
maintenance of the Quality, and Environmental Management Systems to
ensure products are of the highest quality and customer satisfaction is
obtained through an environment of continual improvement while
following all the applicable rules and regulations of health, safety and
environment.
This Manual provides an orientation of an effective Quality and
Environmental
Management
System
implemented
at
Harrison
Pharmaceuticals. It aims to enhance customer (internal and external)
satisfaction through the effective implementation of integrated
management system including processes for continual improvement,
assurance of conformity to customer and complying with legal
requirements.
SECTION 3
DEFINITIONS &
ABBREVIATIONS
3.
CPA
Quality
-
QMS
EMS
OHSAS
IMS
EPM
SMD
NEQS
Accident/Incident
Auditor
Continual Improvement
Corrective Actions
Document
Environment
Hazards
Interested Party
Internal Audits
Nonconformance
Preventive Actions
IMS
QHSE Objective
Risk Assessment
Safety
Tolerable Risk
SECTION 4
INTEGRATED MANAGEMENT SYSTEM
(ISO: 9001, ISO: 14001)
4.
General Requirements
4.2.1 General
The following controlled documents ensure the effective operation
and control of our processes:
Levels
I
II
III
IV
Documentation Types
Integrated System Policy, Integrated system
Manual, Job Descriptions, Organizational Chart
Integrated System Procedures
Process Flows / Work Instructions/SOPs / Safety
Signs
Forms and Formats / Records
d)
e)
f)
g)
SECTION 5
MANAGEMENT
RESPONSIBILITY
5.
MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management of Harrison Pharmaceuticals has defined the overall
strategy and objectives for the Integrated Management System in the
form of the Integrated System (IMS) Policy.
Top management is committed to continue improvement of the
integrated management system is shown through active participation in
the Management Review Meetings & by endorsement and review of the
Integrated System Policy.
5.1.1 Top management identifies and provides adequate resources
to achieve the Integrated System Policy objectives. The need
for required resources is discussed at Management Review
Meetings and documented in the Minutes of Management
Review Meetings.
5.1.2 Top management regularly communicates to the organization
the importance of meeting IMS requirements, customer and
regulatory requirements.
5.1.3 Top management is also committed to minimize pollution and
ensure health & safety rules are followed while ensuring
environmental friendly conditions in all the sites and the
working premises.
5.2
Customer Focus
5.3
Related Documents:
i. Integrated System Policy
Environment
IMS POLICY
While
activities, the impact
aim of Combined
Fabric
is product
to ensure
health
carrying
Minimizeout
theitsenvironmental
of operations
and
through
andsafety
its employees,
contractors,
customers
and local improvement
communities, in
to
the of
adaptions
of sustainable
practices
and continuous
protectenvironmental
theenvironment
and ensure public safety on the basis of the following
performance
guiding principles:
Ensure regular monitoring of Effluent discharge, Air Emissions and other
parameters
associated
with various
processes
andwith
activities
at work
all
activities must
be managed
in strict
compliance
regulations
and
place
buyers terms of engagements;
Managing
wastes
proper
segregation
disposalthat constitute
the
adoption
of through
principles,
standards
andand
solutions
international bestpractices in business for the protection of health, safety,
the environment and public safety;
OUR COMMITMENTS
Quality
5.4
Planning
Related Documents:
i. Procedure for Environmental Aspects Analysis
5.4.2 IMS Objectives & Targets
IMS objectives & targets are set keeping in view the following
parameters:
a) Integrated System Policy
b) Significant environmental aspects and identified health and
safety risks
c) Applicable legal and other requirements
d) View of interested parties
e) Financial, Operational and other requirements
5.5
Related Documents:
i.
ii.
5.6
Management Review
SECTION 6
RESOURCSE MANAGEMENT
6.
RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management of Harrison Pharmaceuticals identifies and provides the
resources, including equipment, raw materials, work areas, and trained
personnel for implementing and continually improving the effectiveness
of the integrated management system.
The justification and acquisition of the required resources is discussed at
the Management Review Meeting and documented in Management
Review minutes. Roles and responsibilities to maintain and improve the
integrated management systems are defined in concerned job
descriptions.
i.
6.3
Infrastructure
ii.
Good Maintenance
iii.
Supporting Services
iv.
SECTION 7
PRODUCT REALIZATION
7.
7.1
PRODUCT REALIZATION
Planning of Product Realization
The organization plans and develops the processes needed for product
realization. Planning of product realization is ensured to be consistent
with the requirements of the other processes of the integrated
management system and should meet the customer requirements.
Records of planning are maintained.
This is achieved through effective development, implementation and
monitoring the planned activities. has developed a comprehensive
system for the monitoring of control measures throughout the
processing and in the events of nonconformities.
7.2
Customer-Related Processes
7.2.1 Determination & Review of Requirements Related to
the Product and Intended Use
Requirements for service are identified and documented. These
requirements include:
a) Requirements specified by the customer / users
b) Requirements not stated by the customer / users but
necessary for specified or intended use, when known
c) Any additional requirements determined by the Combine
Fabric Limited.
7.2.2 Related Documents:
I.
7.3
7.4
PurchasingProcess
7.4.1 Purchasing Process
It is the responsibility of purchasingdepartment to ensure that
materials used in a product are procured from approved suppliers
who can comply with the purchase order and regulatory
requirements as specified. An Approved Supplier List is maintained.
Suppliers are selected on the basis of their ability to meet purchase
order requirements, and / or the results of a quality system review,
where applicable. Assessment of suppliers is conducted before any
purchase. Supplier assessment records are maintained.
7.5
7.5.2
Validation of Processes for Production and Service
Provision
Excluded from the management system because product
requirements can be validated through production monitoring and
product testing
7.5.3
7.5.4
Customer Property
The customer provides drawings/pictures and specification
according to which the products are to be made. All these
specifications and drawings/pictures are properly identified and
stored.
7.6
from
damage
during
handling
SECTION 8
MEASUREMENT, ANALYSIS
AND
IMPROVEMENT
8.
MEASUREMENT,
IMPROVEMENT
ANALYSIS
AND
8.1 General
Measurement and monitoring activities needed to assure conformity
and continually improve the effectiveness of the Integrated
Management System as defined, planned, and implemented.
This includes the determination of the need for, and use of,
applicable methodologies including statistical techniques.
Health, Safety
Electricity consumption
Water consumption
Waste generation /disposal
Paper Waste / Usage
Fuel Consumption
f) Employee Injuries
g) Customer complaints
h) Supplier evaluation
Related Document
i.
Control of
Incidents
8.3
Non-conformances,Accidents
and
Procedure
for
Non-Conformities,
Preventive Action
Procedure for Incident Investigation
Corrective
and