understanding iso 9001 2008
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Understanding ISO 9001:2008 Quality Management System
A presentationfor
ATOSCO
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NiMble ServicesInnovative and Value adding solutions
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Strategic management consulting
Operational improvement and cost effectiveness
New initiative:
Project management
Quality Management Systems Consulting
Business Process Reengineering
IT services: Design – RFP – Vendor selection – Contract Award
HR management
Educational 3M tool
eLearning C of E: Varsity – Institutional – Continuous Education
Knowledge management
Training and learning organization
Feasibility study Business plan Implementation plan
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Before We Start…
Your participation is KEY to success…..
If in doubt, stop & clarify any time….Share your thoughts any time….
Get involved….Participate, and
Contribute to make this program successful
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Presentation Goals
To introduce ISO 9001 : 2008 QMS & its benefits. To outline ISO9000 implementation plan. Roles
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Expectations Yesterday
SERVICE
SYSTEM
Quality
TIMELINES
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Expectations Today
Any time ready to Change
Good Ambience
Good Quality
PriceGood
Consistency
Customer Needs &
Requirement
One Stop Solution
Excellent Service
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What is Change?
Change is Improvement
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What to Change???
Attitude Vision/Goals
Technology
Culture
Approach Strategy
Procedure Values Speed Perception
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Our Vision
“…Businesses must have a vision aboutwhat they exist for, which is shared by
everyone in the company.”Moon and Bonny in the
Introduction of Business Ethics: facing up to the issues.
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There is no risk in changing, but thereis risk if we are not changing…
If we don’t risk anything, we riskeverything…
System should be adopted for changing
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Quality Management SystemQuality
• Fitness for purpose• Excellence• Meeting Customer Expectations not just needs
Management
• Planning, Organizing, Directing, Controlling, Structuring
System
• Work culture• Framework• Policies & procedures
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Cost of Poor Quality Service
Hidden Costs of Poor Quality©All Rights Reserved - NiMble Business Solutions
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Introducing ISO 9001:2008
Getting Started…….
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What is ISO?
ISO is the International Organization for Standardization based in Geneva, Switzerland. On 23 Feb 1947, ISO began operations.
ISO member organizations: National standards institutes from countries large & small from all regions of the world
ISO develops technical standards to contribute in making the manufacturing & supply of goods & services more efficient, safer and cleaner.
Since 1947, ISO has published more than 15,000 standards
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About ISO 9001
It’s a Quality Management System Standard
Initially published in 1987
First revision in 1994, Second revision in 2000
ISO 9001:2008 is the latest version released in 14 Nov 2008
Strong emphasis on Customer Satisfaction and Continual Improvement
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Continuous v/s Continual Improvement
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Continuous Improvement
Initial Level of Performance
Point of Failure
Continual Improvement
Point of Failure
Last Improved Level
Improvement PhaseConsolidation Phase
Initial Level of Performance
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The ISO9000 Environment
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Develops International
Standards
ISOInternational
Organization for Standardization
•Non-governmental Organisation
158 member countries•2830 groups, 30000 experts
•ISO 9000 represents QMS family
Grants License to Certification
agencies
Accreditation bodies
•UK – UKAS•Holland - RvA
•USA - RAB•Germany - DAR
Assesses management
system compliance with
ISO standards
Certification Agencies
Third Party Certification
Agencies
Assists organizationin getting ready for
certificationConsulta
ntsNiMble
Business Solutions
Entity implements andContinuously improves
the QMSOrganiza
tionsClient
Company
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Key Benefits of ISO 9000 for ATOSCO
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A QMS Improves How?Management control System based approach. Regular performance reviews.
Process efficiency & productivity Introduction of measurable objectives and process level keyperformance indicators.
Quality consistency Non conforming process and products are identified, rootcause investigated, corrective & preventive actionimplemented and effectiveness measured.
Staff morale & motivation Documented policy & objectives provide direction &purpose. Documented processes and procedures promoteclarity & understanding. Performance expectations aredefined. Training needs regularly assessed.
Supplier & contractor performance Defined system of evaluation for selection and performancemonitoring.
International recognition &reputation
Third party certification to a globally recognized standard.
Internal inter‐department service Monitoring levels Monitoring& measurements of inputs & outputs. Proactivefeedback. Defined procedures for complaint handling.
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ISO 9000 QMS & its Elements
Getting Started…….
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ISO 9001:2008 Quality Management System
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Management
Responsibility
Measurement,
Analysis, Improve
ment
Resource
Management
C
U
S
T
O
M
E
R
REQU I REMENT
S
AT I S FAC T I ON
PRODUCT
C
U
S
T
O
M
E
R
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ISO 9001:2008 Main Clauses
Quality Management System
Management Responsibility
Resources Management
Product Realization
Measurement, Analysis and Improvement©All Rights Reserved - NiMble Business Solutions
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Management Responsibilities
Management Commitment
Establish policy and objectives (SMART) Communicate importance of meeting customer and regulatory Requirements Conducting Management Reviews Ensuring availability of resources
Customer FocusResponsibility, Authority and communication
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Resource Management
Provision of Resources (in a timely manner)
Human Resources
CompetenceAwarenessTraining
Infrastructure
Work Environment
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Product Realization
Customer-related processes
Determination of requirementsReview of requirementsCustomer communication
Design and Development
Purchasing
Vendor Selection & evaluationPurchasing informationVerification of purchased product
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Measurement Analysis
Control of Monitoring and Measuring Devices (Calibration)Monitoring and Measurement
Customer SatisfactionInternal Audit
Analysis of DataCustomer SatisfactionConformity to product requirements
SuppliersImprovementContinual improvement through policy, objectives, audit results, analysisof data, corrective/preventive actions and management reviews
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ISO 9001:2008 QMS Implementation
Overview of QMS implementation project……
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Overview of the QMS implementation project
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2.1 Process analysis
2.2Preparation of QMS documentation
2.3Delivery of ISO9001 awareness training
MobilizationPhase 1
3.1 Internal auditor training
3.2 Commencement of internal quality auditing of the QMS
3.3 Verification of corrective & preventive action
3.4 Management review meeting
3.5 Selection of a certification body
Phase 2 Phase 3
The project is segmented in three phases:
QMS Documentation & Initial
Training
QMS Implementation1.1 Gap Analysis
1.2Definition of QMS scope, quality policy & objectives
1.3 QMS design and documentation architecture
Phase 4
Support During
4.1 Document review
4.2 Assessment audit
ISO 9001:2008
Certificatio
nAudit(to be carried
out by anindependen
t3rd party)
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ISO 9001:2008 QMS Implementation – Key Steps
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Process Review & Preparation of QMS documentation
Document review & signoff
Implementation of the QMS
Customer Feedback
Product & Process measurement
Internal Audit
Management Review
Agree Corrective /Preventive action for system improvement
Certification & Surveillance Audit
Follow up Verification
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Roles
Top Management Role
Management Representative Role
Function Head Role
QMS Coordinator Role©All Rights Reserved - NiMble Business Solutions
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Top Management Role“Leadership, commitment and active involvement “
Define structure, roles, responsibilities, Authorities
Communicate the importance of quality to staff
Provide necessary resources in a timely manner
Sponsor big/small improvement activities
Actively seek customer feedback and enhance customer satisfaction
Review the performance of the quality system objectives and competition
Create an environment for continual improvement in everything we do
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Management Representative Role
Ensuring the system is understood & followed
Ensuring appropriate control of documentation
Coordination of internal audits of QMS
Providing inputs for management review on status of QMS implementation
Promoting active involvement of everyone and ensure customer focus
Coordinate with consultants, certification body
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Function Head RoleUnderstand the quality policy and objectives
Understand the role, responsibilities, authorities
Ensure alignment to quality policy and objectives
Train all supervisory and support staff on quality
Measure and monitor key process/product indicators
Analyze and identify areas of improvement
Drive improvement projects
Know what customer thinks about our services and communicate it down the line.
Review performance and progress
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QMS Coordinator Role
Understand the QMS requirements & role of the respective functions, support in drafting necessary procedures / process maps
Conduct awareness session for the department staff on a selected topic / procedure / process
Agree / decide an action plan for QMS effective implementation
Coordinate Internal audits, closure of NCs related to respective functions
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Achieving ISO 9001 is only the beginning…..
“Remember”
Quality Management Systems take time to mature…‘Rome wasn’t built in a day’
Management commitment is absolutely essential (& a requirement of the standard)
Staff involvement is critical ….develop a quality Culture
Customer feedback and process measurement should help drive continual improvement
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Remember the Goal!
Customer Satisfaction
Process EfficiencyProfitability
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THANK YOU
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