Process workshop

ISO 9001 IMPLEMENTATION METHODOLOGY

Process workshop

AGENDA

ISO 9001 Overview Approach Certification Requirements Critical Success Factor

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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ISO 9001:2008

Core Values from Excellence Models

Visionary Leadership Visionary Leadership Customer-Driven Excellence Customer-Driven Excellence Organizational & Personal Organizational & Personal Learning Learning Valuing Employees & Partners Valuing Employees & Partners Agility Agility Focus on the Future Focus on the Future Managing for Innovation Managing for Innovation Management by Fact Management by Fact Public Responsibility & Public Responsibility & Citizenship Citizenship Focus on Results & Creating Value Focus on Results & Creating Value Systems Perspective Systems Perspective

Principles from ISO 9001:2008

Customer Focus Customer Focus Leadership Leadership Involvement of People Involvement of People Process Approach Process Approach System Approach to Management System Approach to Management Continual Improvement Continual Improvement Factual Approach to Decision Factual Approach Making to Decision Making Mutually Beneficial Supplier Mutually Beneficial Supplier Relationships Relationships

ISO 9001:2008

Principles to Requirements The 8 principles are woven into 5 main elements of ISO 9001:2008
Documentation Management Resources Product/Service Improvement

Processes

ISO 9001 Focus?

demonstrate organizations ability to consistently provide product, meeting customer & applicable regulatory requirements enhance customers satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements

System Approach of ISO 9k

C U S T O M E R S

Continual Improvement of the Quality Management System Management responsibility

R e q u I r e m e n t s

Resource management

Measurement, analysis, improvement

S a t I s f a c t I o n

Input

Product

Product Output

C U S T O M E R S

Management responsibility 1 Management commitment 2 Customer focus 3 Quality Policy 4 Planning Quality objectives

z Quality management system planning

5 Responsibility, authority and communication

1. Responsibility and authority 2. management representative 3. Internal communication

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Management responsibility

6 Management review

1. General 2. Review input 3. Review output

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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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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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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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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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

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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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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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The Deming Cycle

The Deming Cycle for improvement is the cornerstone of all Management Systems

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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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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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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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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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AGENDA

ISO 9001 Overview Approach Certification Requirements Critical Success Factor

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Process workshop

Approach
Program Objectives

Phase 3
Certification

Improve Product Quality Improve Customer

Satisfaction

Phase 2
Implement Systems

Inculcate process Culture Provide support for

business growth

Phase 1
QMS Framework

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Approach
Steps CUSTOMER S.N. Bhobe engaged Techserv Project Initiation Proposal made Objectives were defined Contract drawn up Scope was discussed Schedule reviewed and accepted Contract Signed QMS Design QMS templates designed MR Appointed Discussed QMS Templates Quality coordinator Appointed Meetings with BU Heads Schedules were drawn QMS Implementation Identified scope for ISO 9001 QMS Templates approved TECHSERV CONSULTING

Certification

Outcome

Contract Signed Basic Understanding arrived at QMS Architecture finalized Project Kick-off

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Approach
Steps CUSTOMER TECHSERV CONSULTING

Project Initiation Arrange for process review meets Document Process for Design Document Process for Supervision Co-ordinate Meetings Co-ordinate & update of comments Document Quality Policy ISO 9001 Scope statement Establishing Quality Objectives Approve QMS Design QMS Advise on process design Participate in the Review meets Incorporate Review comments Maintain QMS artifacts Baseline the QMS ISO 9001 : 2008 Orientation

QMS Design

QMS Implementation

Certification

Outcome

Process Documents Quality Objectives Quality Policy Scope Statement

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Approach
Steps CUSTOMER Implement the processes Project Initiation Internal Audits Improve the process Corrective Actions QMS Design Preventive actions Management Review Establish Internal Audit team QMS Implementation Internal Auditors Training Advise on process improvements Internal Audit of QMS Advice on Certification Readiness TECHSERV CONSULTING

Certification

Outcome QMS Implemented Process Improved Certification Readiness verified

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Approach
Steps CUSTOMER TECHSERV CONSULTING

Project Initiation

Select a Certification Agency Identify Certification Agency Document Review Co-ordinate Audits Process Improvement

QMS Design

Advise on Audit Findings Closure Implementation Audit Advise on way forward Process Improvements Certification

QMS Implementation

Certification

Outcome ISO 9001 : 2008 Certification

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Process workshop

AGENDA

ISO 9001 : 2008 Approach Certification Requirements Critical Success Factor

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Process workshop

Certification Requirements
Quality Management System ISO Model Awareness Process Awareness Quality Policy awarenes Quality Objectives Certification Scope Process Improvement Culture Exclusions Customer Feedbacks Customer Complaint System Quality Planning Evidences Management Involvement Management Commitment Internal Audits Corrective / Preventive actions Management Reviews Calibration evidences Client Acceptance evidences Client Requirements evidence Control of Documents

Planning process evidences Quality Control Evidences Analysis of Data

Compliance to Regulations

Training evidences Identification & Traceablity

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Process workshop

AGENDA

ISO 9001 : 2008 Approach Certification Requirements Critical Success Factor

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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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Process workshop

Any Queries ?

Please Contact: ARUL NAMBI Director aruln@techservconsult.com +91 9892504538 www.techservconsult.com

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Process workshop

Thank you!

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