integrated management system
TRANSCRIPT
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
1St Party audit:
- Internal audit
(a) To assess own sys.
(b) Iden sys strengths & weaknesses.
(C) Powerful tool to aid continual
improvement.
2nd Party audit.
Customer auditing a supplier or
potential supplier.
- Aids selection & grading of suppliers.
- Foundation for supplier development.
3rd Party audit
Audit by a external body.
- For registration or certification
purpose.
- Reduces need for 2nd 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.