Process workshop

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ISO 9001

IMPLEMENTATION

METHODOLOGY

Process workshop

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AGENDA

• ISO 9001 Overview

• Approach

• Certification Requirements

• Critical Success Factor

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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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Visionary Leadership

Customer-Driven Excellence

Organizational & PersonalLearning

Valuing Employees & Partners

Agility

Focus on the Future

Managing for Innovation

Management by Fact

Public Responsibility &Citizenship

Focus on Results & Creating Value

Systems Perspective

Visionary Leadership

Customer-Driven Excellence

Organizational & PersonalLearning

Valuing Employees & Partners

Agility

Focus on the Future

Managing for Innovation

Management by Fact

Public Responsibility &Citizenship

Focus on Results & Creating Value

Systems Perspective

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to DecisionMaking

Mutually Beneficial SupplierRelationships

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to DecisionMaking

Mutually Beneficial SupplierRelationships

ISO 9001:2008ISO 9001:2008 Core Values fromExcellence Models

Principles fromISO 9001:2008

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Principles to Requirements

The 8 principles are woven into 5 main elements of ISO 9001:2008

–Documentation –Management–Resources–Product/Service Processes– Improvement

ISO 9001:2008ISO 9001:2008

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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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System Approach of ISO 9k

CUSTOMERS

CUSTOMERS

Management responsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProduct

Continual Improvement of theQuality Management System

RequIrements

SatIsfactIon

InputOutput

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Management responsibility

1 Management commitment

2 Customer focus

3 Quality Policy

4 PlanningQuality objectives

Quality management system planning

5 Responsibility, authority and communication

1. Responsibility and authority2. management representative3. Internal communication

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Management responsibility

6 Management review

1. General

2. Review input

3. Review output

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Resource management

1 Provision of resources

2 Human resources1. General2. 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 planning2. Design and development of inputs

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Product realization

3 Design and development (continued..)

1. Design and development outputs2. Design and development review 3. Design and development verification4. Design and development validation

4 Purchasing

1. Purchasing process2. Purchasing information3. Verification of purchased product

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Product realization

5 Production and service provision

1. Control of production and service provision2. Validation of processes for production and service

provision3. Independent and traceability4. Customer property5. Preservation of product

6 Control of monitoring and measuring devices

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Measurement, analysis and improvement

1 General

2 Monitoring and measurement1. Customer satisfaction2. Internal audit3. Monitoring and measurement of processes4. Monitoring and measurement of product

3 Control of non-confirming product

4 Analysis of data

5 Improvement1. Continual improvement2. Corrective action3. Preventive action

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– 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

ISO 9001:2008ISO 9001:2008

Why Do Organizations Lack Performance Improvement With

ISO 9001:2008?

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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

ISO 9001:2008ISO 9001:2008

The Deming Cycle

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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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Approach

•• Improve Product QualityImprove Product Quality

•• Improve Customer Improve Customer SatisfactionSatisfaction

•• Inculcate process CultureInculcate process Culture

•• Provide support for Provide support for business growthbusiness growth

Program Objectives

QMS Framework

Implement Systems

Certification

Phase 1

Phase 2

Phase 3

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Approach

Steps

S.N. Bhobe engaged Techserv

Objectives were defined

Scope was discussed

Contract Signed

MR Appointed

Quality coordinator Appointed

Schedules were drawn

QMS Templates approved

TECHSERV CONSULTING

Outcome Contract SignedBasic Understanding arrived at

QMS Architecture finalizedProject Kick-off

Certification

QMS Implementation

Project Initiation

QMS Design

Proposal made

Contract drawn up

Schedule reviewed and accepted

QMS templates designed

Discussed QMS Templates

Meetings with BU Heads

Identified scope for ISO 9001

CUSTOMER

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Approach

Steps

Arrange for process review meetsDocument Process for DesignDocument Process for SupervisionCo-ordinate MeetingsCo-ordinate & update of commentsDocument Quality PolicyISO 9001 Scope statementEstablishing Quality ObjectivesApprove QMS

TECHSERV CONSULTING

Outcome Process DocumentsQuality Objectives

Quality PolicyScope Statement

Certification

QMS Implementation

Project Initiation

QMS Design

Design QMSAdvise on process designParticipate in the Review meetsIncorporate Review commentsMaintain QMS artifactsBaseline the QMSISO 9001 : 2008 Orientation

CUSTOMER

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Approach

Steps

Implement the processes

Internal Audits

Improve the process

Corrective Actions

Preventive actions

Management Review

Establish Internal Audit team

TECHSERV CONSULTING

OutcomeQMS ImplementedProcess Improved

Certification Readiness verified

Certification

QMS Implementation

Project Initiation

QMS Design

Advise on process improvements

Internal Audit of QMS

Advice on Certification Readiness

Internal Auditors Training

CUSTOMER

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Approach

Steps

Select a Certification Agency

Document Review

Process Improvement

Implementation Audit

Process Improvements

Certification

TECHSERV CONSULTING

OutcomeISO 9001 : 2008 Certification

Certification

QMS Implementation

Project Initiation

QMS Design

Identify Certification Agency

Co-ordinate Audits

Advise on Audit Findings Closure

Advise on way forward

CUSTOMER

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AGENDA

• ISO 9001 : 2008

• Approach

• Certification Requirements

• Critical Success Factor

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Certification Requirements

Quality Management SystemQuality Management System

ISO Model AwarenessISO Model Awareness

Process AwarenessProcess Awareness

Quality Policy Quality Policy awarenesawarenes

Quality ObjectivesQuality Objectives

Certification ScopeCertification Scope

Process Improvement CultureProcess Improvement Culture

ExclusionsExclusions

Customer FeedbacksCustomer Feedbacks

Customer Complaint SystemCustomer Complaint System

Planning process evidencesPlanning process evidences

Quality Control EvidencesQuality Control Evidences

Analysis of DataAnalysis of Data

Quality Planning EvidencesQuality Planning Evidences

Management Involvement Management Involvement

Management CommitmentManagement Commitment

Internal AuditsInternal Audits

Corrective / Preventive actionsCorrective / Preventive actions

Management ReviewsManagement Reviews

Calibration evidencesCalibration evidences

Client Acceptance evidencesClient Acceptance evidences

Client Requirements evidenceClient Requirements evidence

Control of DocumentsControl of Documents

Compliance to RegulationsCompliance to Regulations

Training evidencesTraining evidences

Identification & Identification & TraceablityTraceablity

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AGENDA

• ISO 9001 : 2008

• Approach

• Certification Requirements

• Critical Success Factor

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Critical Success Factor

PerseverancePerseverance

Management InvolvementManagement Involvement

Management CommitmentManagement Commitment

Implementation rigourImplementation rigour

Internal Audit effectivenessInternal Audit effectiveness

Quality of Management ReviewsQuality of Management Reviews

Quality of Corrective / Preventive actionsQuality of Corrective / Preventive actions

Employee participationEmployee participation

Measurement systemsMeasurement systems

Never prepare for auditsNever prepare for audits

Process Improvements cultureProcess Improvements culture

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Any Queries ?

Please Contact:

ARUL NAMBIDirector

aruln@techservconsult.com+91 9892504538

www.techservconsult.com

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Thank you!