Integrated Management System

HEMARUS INDUSTRIES LIMITED

IMS FOR BEGINERS


By: Vijay Singh
Manager -QC
INTERNATIONAL ORG FOR
STANDARDISATION (IS0)


 World wide federation of National
bodies.
 ISO tech committees prepare
standards.
 Draft International standards must
be approved by at least 75% of
the member bodies casting the
vote.


GENERAL
 Adoption of QMS sys is a Strategic
decision of the Org.
 Standards do not imply uniformity in
the structure of QMS or
documentation.
 Design & implementation of QMS is
influenced by needs, objectives,
products, processes, size & structure
of the Org.
NEED FOR ISO
 To address the ever changing market
scenario.
 To meet the customer requirements.
 To create customer focused organization.
 To imbibe process approach across the
organization.
 To meet all regulatory requirements for our
products.
NEED FOR ISO
 To institutionalize “QMS” involving all
employees & stakeholders.
 For continual improvement of all
processes.
USE OF STANDARDS
 Can be used by internal & external
bodies.
 By certification bodies for assessment.
 By regulatory bodies.
 Organization's own requirement

INTEGRATED MANGAEMENT SYSTEM
STANDARDS
 ISO 9001:2008 “QMS”.
 ISO 14001:2004 “EMS”.
 OHSMS 18001:2007 “Occupational
health & safety management system

Benefits of ISO IMS
ISO Management Systems insure that the company has :

 Identify Plans: processes, activities, risks, legal & other requirements,
associated tasks.
 • Insure implementation: plans are documented, implemented,
maintained, providing resources, communications, training, emergency
preparedness, and systems to monitor/measure performance,
accident/incidents.
 • Improve management system: objectives, targets, programs, data
analysis, monitoring of operations, tracking of non- conformances,
corrective/preventive actions. Internal & third party audits with
management reviews.
= Performance, Productivity and Profits
Why Integrate?
A. Identify your Whole Management System
 Formalize your systems
 Reduce duplication and improve costs - profits
 Reduce risks and impacts - compliance
 Focus on business goals-objectives, improve, measure, balance conflicting
objectives
B. Insure that you-
 Eliminate conflicting procedures, responsibilities and relationships
 Create consistency
 Harmonize and optimize practices
 Improve communication
 Facilitate training and development
• Improve what you do
 Financial Returns
 Customer Satisfaction
 Monitoring what you Measure
PLAN – DO – CHECK – ACT CYCLE
PROCESS APPROACH
 PLAN: Establish objectives &
processes.
 DO: Implement & operate.
 CHECK: Monitor & measure
 ACT: Take actions to
continually improve.


Management
Responsibility
Resource
Management
Product
Realization
Continual improvement of “QMS”
Customers







Requirements



Customers
Satisfaction
Measurement,
Analysis &
improvement
Product
Output
Input
MODEL: PROCESS BASED “QMS
PDCA MODEL: ISO 14001: 2004 (E)
OH & S MGMT SYS MODEL
OHSAS 18001:2007

STEP ONE- IDENTITY
 Commitment - need for Integrated Management System If yes, Are you going to self-
declare or register
 Define Scope of Management System
 Person(s) responsible for system - IMS Representative (s), Team Leaders
 Training:
E-learning, on-site
Standard requirements (Core Training)
Internal or Lead Auditor training, skills training identified
 Gap Analysis – (optional)
 Preliminary Review: Processes, Site Corporate and ISO Requirements
Risks: Quality, Environment, Health & safety, Financial.
Legal & Other Requirements:
 Planning: Policy, Objectives, Targets & Program
 Control Plan: Control of operations for customer quality satisfaction, continuous
improvement, prevention of pollution, reduction of accidents/incidents tied to the bottom
line. Change Management

STEP ONE- IDENTITY

STEP TWO- INSURE
 Implementation and operations of plans
 Documentation, Data Control & Analysis Manual (4.4.4)
 Procedures Manual (4.2 – 4.6)
 Records (4.5.4)
 do not duplicate written documentation, make reference to other systems where
applicable. i.e. ISO 90010 – Quality
 Resources Roles, Responsibility & Authority defined, documented,
Communications/Consultation – internal, external
 Operational Control – Use of Control Plan, Purchasing, Production
 Plan for Emergency Response
 Competence , Training & Awareness – Orientation, operations – SOP’s, emergency
response, contractor/supplier, internal auditing

STEP TWO- INSURE

 Monitoring & Performance Measurement
o Performance (accidents, incidents, pollution prevention)Operations
o Work place inspections – pre-starts
o Objectives & Targets

 Evaluation of Compliance
 Nonconformity, Corrective/Preventive Action, Accidents, Incidents
 Control of Non-conforming Product

STEP THREE- IMPROVE

 Internal Audits (4.5.5) to established IMS and Standard
 Audit Program – types of audits, schedules
 Auditor Selection, training, competence, evaluation
 Audit Procedure
 Conduct Audits - based on importance of activity concerned and previous audits.
Findings, Reports

 Management Review – assess opportunities for improvement and need for changes
(continuing suitability, adequacy, effectiveness)
 Inputs & Outputs
 IMS Representative(s) report to top management on performance and
recommendations for improvement


Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
1 Scope 1 Scope 1 Scope
2 Normative
references
2 Normative
references
2 Normative
references
3 Terms &
definitions
3 Terms &
definitions
3 Terms &
definitions
4 OH&S Mgmt
Sys
elements
EMS
requirements
“Q” sys
requirement
s
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.1 Gen req 4.1 Gen req 4.1 Gen req
5.5


Responsibili
ty, authority
& commn
5.5.1 Responsibili
ty &
authority
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.2 OH&S policy 4.2 Environ
policy
5.1

Management
Commitment
5.3 “Q” policy
8.5.1 Continual
improvement
4.3 Planning 4.3 Planning 5. Planning
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.3.1 Hazard
Iden, risk
Assessment &
determining ctrl
4.3.1 Environmental
aspects
5.2

Customer focus

7.2.1


Determination of
requirements
related to the
product.

7.2.2
Review of
requirements
related to the
product.
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.3.2 Legal &
other
requireme
nts
4.3.
2
Legal &
other
requiremen
ts
- -
4.3.3 Objective
s
&
programm
es
4.3.
3
Objectives,
targets &
programme
s
5.4.1

“Q”objecti
ves.
5.4.2
8.5.1
QMS
Continual
improvem
ent
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.1 Resources,
roles,
responsibility
,
accountabilit
y & authority
4.4.1 Resources,
roles,
responsibilit
y & authority
5.1

Mgmt
commitment.

5.5.1
Responsibilit
y & auth.

5.5.2


Mgmt Reps.

6.1



Provision of
resources.
6.3
Infrastructure
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.2 Competen
ce
Trg &
awarenes
s
4.4.2 Competen
ce
Trg &
awareness

6.2.1 Human
Resource
s
Compete
nce,
awarene
ss & Trg
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.3 Communi
cations,
participati
on &
Consultati
on
4.4.3 Communic
ations
5.5.3


7.2.3
Internal
commu
nication
.
Custom
er
commu
nication
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.4 Document
ation
4.4.4

“EMS”
Document
ation

4.2.1 General
Docu
requireme
nts
4.4.5 Control of
document
4.4.5

Control of
document
4.2.3

Control of
document
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.6 Operational
control
4.4.6 Operational
control
7.1


Planning &
product
realization.
7.2


Customer
related
processes.
7.2.1




Determination
of
requirements
related to the
product.
7.2.2 Review of
requirements
related to the
product
Cl ISO 9001
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.5
Design & development planning.
Design & development inputs.
Design & development outputs.
Design & development review.
Design & development verification.
Design & development validation.
Control of design & development changes.
Purchasing process.
Purchasing information.
Verification of purchased product.
Production & service provision.
Control of production & service provision.
Validation of processes for production & service provision.
Preservation of product.
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.4.7 ERP 4.4.7 ERP 8.3 Control of
non
conformi
ng
product.
4.5 Checking 4.5 Checking 8 Measure
ment,
analysis
&
improve
ments.
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.5.1 Performance
Measurement
& monitoring
4.5.1 Monitoring
&
measureme
nt
7.6


Control of
monitoring &
measuring
devices.

8.1
General


8.2.3

Monitoring &
measurement
of process.
8.2.4


Monitoring &
measurement
of product.
8.4 Analysis of
data.
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.5.2 Evaluatio
n of
complian
ces
4.5.2 Evaluatio
n of
complian
ces
- -
4.5.3 Incident
investigat
ion, NC,
CAPA
- - - -
4.5.3.1 Incident
investigat
ion
- - - -
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.5.3.2 NC,
CAPA
4.5.3 NC,
CAPA
8.3




Control of
non
conformi
ng
product.
8.4

Analysis
of data.
8.5.2 CA
8.5.3 PA
Comparison of standards
Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.5.4 Control of
records
4.5.4 Control of
records
4.2.4 Control of
records

4.5.5 Internal
audit
4.5.5 Internal
audit
8.2.2 Internal
audit

Cl OHSAS
18001
Cl

ISO
14001
Cl

ISO
9001
4.6 Managem
ent review
4.6 Managem
ent
review
5.1


Management
commitment.

5.6

Management
review.
5.6.1

General

5.6.2

Review input.
5.6.3

Review output.
8.5.1 Continual
improvement.
TYPES OF AUDIT
 1
St
Party audit:
- Internal audit
(a) To assess own sys.
(b) Iden sys strengths & weaknesses.
(C) Powerful tool to aid continual
improvement.

2
nd
Party audit.
 Customer auditing a supplier or
potential supplier.
- Aids selection & grading of suppliers.
- Foundation for supplier development.

3
rd
Party audit
 Audit by a external body.
- For registration or certification
purpose.
- Reduces need for 2
nd
party audit.
- International recognition & market
competitiveness.



In nut shell.
 Establish a system.
 Plan
 Implement.
 Document.
 Review.
 CAPA.
 Follow up & review.
IMS

 Integrated three standards into one system
to suit our needs.
 Integrated Management System.
 Easy to understand.
 Easy to implement.
 Saves time.
 Avoids repetition of work.
 Efficient, non taxing & user friendly.

THANK YOU.