ISO 9001 IMPLEMENTATION METHODOLOGY

1. Process workshop
ISO 9001
IMPLEMENTATION
METHODOLOGY
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2. Process workshop
AGENDA
• ISO 9001 Overview
• Approach
• Certification Requirements
• Critical Success Factor
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3. ISO 9001
ISO 9001 is the internationally recognised standard
for the quality management of businesses.
It applies to the business processes that create and
control the products and services an organisation
supplies.
It prescribes systematic control of activities to ensure
that the needs and expectations of customers are met.
It is designed and intended to apply to virtually any
product or service, made by any process anywhere in
the world.
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4. ISO 9001:2008
Core Values from Principles from
Excellence Models ISO 9001:2008
Visionary Leadership
Visionary Leadership
Customer-Driven Excellence
Customer-Driven Excellence Customer Focus
Customer Focus
Organizational & Personal
Organizational & Personal
Learning Leadership
Learning Leadership
Valuing Employees & Partners Involvement of People
Valuing Employees & Partners Involvement of People
Agility Process Approach
Agility Process Approach
Focus on the Future System Approach to Management
Focus on the Future System Approach to Management
Managing for Innovation Continual Improvement
Managing for Innovation Continual Improvement
Management by Fact Factual Approach to Decision
Management by Fact Factual Approach to Decision
Making
Making
Public Responsibility &
Public Responsibility &
Citizenship Mutually Beneficial Supplier
Citizenship Mutually Beneficial Supplier
Relationships
Relationships
Focus on Results & Creating Value
Focus on Results & Creating Value
Systems Perspective
Systems Perspective
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5. ISO 9001:2008
Principles to Requirements
The 8 principles are woven into 5 main elements
of ISO 9001:2008
– Documentation
– Management
– Resources
– Product/Service Processes
– Improvement
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6. ISO 9001 Focus?
demonstrate organization’s ability to consistently provide
product, meeting customer & applicable regulatory
requirements
enhance customer’s satisfaction through effective
application of the system including processes for its
continual improvement and assurance of conformity to
customer and applicable regulatory requirements
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7. System Approach of ISO 9k
Continual Improvement of the
C Quality Management System S C
a
U Management t U
S R responsibility I
s
S
e
T q
f T
a
O u
I
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Resource Measurement, analysis, t
M r
I M
e management improvement
E m
o
n
E
e
R n
R
S t
Product Product S
s
Input
Output
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8. Management responsibility
1 Management commitment
2 Customer focus
3 Quality Policy
4 Planning
Quality objectives
Quality management system planning
5 Responsibility, authority and communication
1. Responsibility and authority
2. management representative
3. Internal communication
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9. Management responsibility
6 Management review
1. General
2. Review input
3. Review output
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10. Resource management
1 Provision of resources
2 Human resources
1. General
2. Competence, awareness and training
3 Infrastructure
4 Work environment
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11. Product realization
1 Planning of product realization
2 Customer related processes
1. Determination of requirements related to the
product
2. Review of requirements related to the
product
3. Customer communication
3 Design and development
1. Design and development planning
2. Design and development of inputs
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12. Product realization
3 Design and development (continued..)
1. Design and development outputs
2. Design and development review
3. Design and development verification
4. Design and development validation
4 Purchasing
1. Purchasing process
2. Purchasing information
3. Verification of purchased product
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13. Product realization
5 Production and service provision
1. Control of production and service provision
2. Validation of processes for production and service
provision
3. Independent and traceability
4. Customer property
5. Preservation of product
6 Control of monitoring and measuring devices
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14. Measurement, analysis and improvement
1 General
2 Monitoring and measurement
1. Customer satisfaction
2. Internal audit
3. Monitoring and measurement of processes
4. Monitoring and measurement of product
3 Control of non-confirming product
4 Analysis of data
5 Improvement
1. Continual improvement
2. Corrective action
3. Preventive action 14

15. ISO 9001:2008
Why Do Organizations Lack
Performance Improvement With
ISO 9001:2008?
– Leadership is not committed
– Leadership is not involved
– Executive management does not function as a
team
– Poor implementation strategy
– Poor internal or external consulting advice
– Focus on certificate / not on effectiveness
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16. ISO 9001:2008
Effective Measurements = Effective Management
– ISO 9001:2008 expects effective measurements
system for management control and action
– Based on effective measurements, products and
processes are improved to directly impact customer
satisfaction
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17. The Deming Cycle

18. The Deming Cycle
for improvement is
the cornerstone of all
Management
Systems
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19. 1. PLAN: Design or revise business process
components to improve results
2. DO: Implement the plan and measure its
performance
3. CHECK / STUDY: Assess the measurements
and report the results to decision makers
4. ACT: Decide on changes needed to improve
the process
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20. What are the benefits 9001?
Improve the ability to identify weaknesses in the system on
systematic basis
Participation of employees would help to enhance the
systems capability
Improved communication between among employees
Improved consistency in quality and deliveries
Continual improvement culture
Improved customer trust
Establish the expectations of employees
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21. ISO 9001 – Certification Cycle
Certification Audit
Stage 1 – Documentation Review
Stage 2 - Audit of Implementation based on Standards and QMS
Surveillance Audits 1 (Before one year from Certification Audit)
Audit of Implementation based on Standards and QMS
Surveillance Audits 2 (Before one year from Surveillance Audit 1)
Audit of Implementation based on Standards and QMS
Re-certification Audit (Before one year from Surveillance Audit 2)
Audit of Implementation based on Standards and QMS
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22. External Audit Process
Number of person days for audit will be determined
Human Resources, Internal Audit process, Management Representative processes reviewed
In addition to the above sample projects will be selected for audits
They may visit sites where the project is executed
Audit will be conducted by way of evaluating the documents, records, interviews, discussions
Non-Conformance – Major / Minor
Observations
Good Practices
Opportunity for improvements
Findings to be closed maximum of three months and provide evidence
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23. AGENDA
• ISO 9001 Overview
• Approach
• Certification Requirements
• Critical Success Factor
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24. Process workshop
Approach
Program Objectives
Phase 3
• Improve Product Quality Certification
• Improve Customer
Satisfaction Phase 2
• Inculcate process Culture Implement Systems
• Provide support for
business growth Phase 1
QMS Framework
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25. Approach
Steps CUSTOMER TECHSERV CONSULTING
S.N. Bhobe engaged Techserv
Proposal made
Project Initiation
Objectives were defined
Contract drawn up
Scope was discussed
Schedule reviewed and accepted
Contract Signed
QMS templates designed
QMS Design
MR Appointed
Discussed QMS Templates
Quality coordinator Appointed
Meetings with BU Heads
Schedules were drawn
Identified scope for ISO 9001
QMS Implementation
QMS Templates approved
Certification
Outcome Contract Signed
Basic Understanding arrived at
QMS Architecture finalized
Project Kick-off
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26. Approach
Steps CUSTOMER TECHSERV CONSULTING
Project Initiation
Arrange for process review meets Design QMS
Document Process for Design Advise on process design
Document Process for Supervision Participate in the Review meets
Co-ordinate Meetings Incorporate Review comments
Co-ordinate & update of comments Maintain QMS artifacts
QMS Design Document Quality Policy Baseline the QMS
ISO 9001 Scope statement ISO 9001 : 2008 Orientation
Establishing Quality Objectives
Approve QMS
QMS Implementation
Certification
Outcome Process Documents
Quality Objectives
Quality Policy
Scope Statement
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27. Approach
Steps CUSTOMER TECHSERV CONSULTING
Implement the processes
Project Initiation
Internal Audits Advise on process improvements
Improve the process Internal Audit of QMS
Corrective Actions Advice on Certification Readiness
QMS Design
Preventive actions Internal Auditors Training
Management Review
Establish Internal Audit team
QMS Implementation
Certification
Outcome
QMS Implemented
Process Improved
Certification Readiness verified
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28. Approach
Steps CUSTOMER TECHSERV CONSULTING
Project Initiation Select a Certification Agency
Identify Certification Agency
Document Review
Co-ordinate Audits
Process Improvement
Advise on Audit Findings Closure
QMS Design Implementation Audit
Advise on way forward
Process Improvements
Certification
QMS Implementation
Certification
Outcome
ISO 9001 : 2008 Certification
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29. Process workshop
AGENDA
• ISO 9001 : 2008
• Approach
• Certification Requirements
• Critical Success Factor
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30. Process workshop
Certification Requirements
Quality Management System Quality Planning Evidences
ISO Model Awareness Management Involvement
Process Awareness Management Commitment
Quality Policy awarenes Internal Audits
Quality Objectives Corrective / Preventive actions
Certification Scope Management Reviews
Process Improvement Culture Calibration evidences
Exclusions Client Acceptance evidences
Customer Feedbacks Client Requirements evidence
Customer Complaint System Control of Documents
Planning process evidences Compliance to Regulations
Quality Control Evidences Training evidences
Analysis of Data Identification & Traceablity
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31. Process workshop
AGENDA
• ISO 9001 : 2008
• Approach
• Certification Requirements
• Critical Success Factor
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32. Process workshop
Critical Success Factor
Perseverance
Management Involvement
Management Commitment
Implementation rigour
Internal Audit effectiveness
Quality of Management Reviews
Quality of Corrective / Preventive actions
Employee participation
Measurement systems
Never prepare for audits
Process Improvements culture
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33. Process workshop
Any Queries ?
Please Contact:
ARUL NAMBI
Director
aruln@techservconsult.com
+91 9892504538
www.techservconsult.com
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34. Process workshop
Thank you!
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