0
Process workshop




   ISO 9001

IMPLEMENTATION

 METHODOLOGY




                              1
Process workshop

AGENDA




         • ISO 9001 Overview
         • Approach
         • Certification Requirements
      ...
ISO 9001


     ISO 9001 is the internationally recognised standard
   for the quality management of businesses.

     It ...
ISO 9001:2008
                    Core Values from                     Principles from
                   Excellence Model...
ISO 9001:2008




                Principles to Requirements


                The 8 principles are woven into 5 main elem...
ISO 9001 Focus?


demonstrate organization’s ability to consistently provide
  product, meeting customer & applicable regu...
System Approach of ISO 9k


                  Continual Improvement of the
C                 Quality Management System    ...
Management responsibility

      1 Management commitment

      2 Customer focus

      3 Quality Policy

      4 Planning...
Management responsibility



          6 Management review

             1. General

             2. Review input

       ...
Resource management




           1 Provision of resources

           2 Human resources
              1. General
       ...
Product realization


     1 Planning of product realization

     2 Customer related processes

        1. Determination ...
Product realization



 3 Design and development (continued..)

    1. Design and development outputs
    2. Design and de...
Product realization


    5 Production and service provision

        1. Control of production and service provision
     ...
Measurement, analysis and improvement

1 General

2 Monitoring and measurement
   1. Customer satisfaction
   2. Internal ...
ISO 9001:2008

                  Why Do Organizations Lack
                Performance Improvement With
                  ...
ISO 9001:2008




     Effective Measurements = Effective Management

       – ISO 9001:2008 expects effective measurement...
The Deming Cycle
The Deming Cycle
for improvement is
the cornerstone of all
Management
Systems



                         18
1. PLAN: Design or revise business process
   components to improve results
2. DO: Implement the plan and measure its
   p...
What are the benefits 9001?

  Improve the ability to identify weaknesses in the system on
systematic basis

  Participati...
ISO 9001 – Certification Cycle


  Certification Audit

        Stage 1 – Documentation Review

        Stage 2 - Audit of...
External Audit Process


   Number of person days for audit will be determined

   Human Resources, Internal Audit process...
AGENDA




         • ISO 9001 Overview
         • Approach
         • Certification Requirements
         • Critical Succ...
Process workshop

Approach

Program Objectives
                                                                       Phas...
Approach

 Steps                               CUSTOMER                 TECHSERV CONSULTING

                         S.N....
Approach

 Steps                               CUSTOMER                 TECHSERV CONSULTING



    Project Initiation
    ...
Approach

 Steps                                CUSTOMER                TECHSERV CONSULTING


                         Imp...
Approach

 Steps                                   CUSTOMER           TECHSERV CONSULTING



    Project Initiation   Sele...
Process workshop

AGENDA




         • ISO 9001 : 2008
         • Approach
         • Certification Requirements
        ...
Process workshop

Certification Requirements

        Quality Management System     Quality Planning Evidences
        ISO...
Process workshop

AGENDA




         • ISO 9001 : 2008
         • Approach
         • Certification Requirements
        ...
Process workshop

Critical Success Factor



                          Perseverance
                          Management I...
Process workshop




Any Queries ?




                     Please Contact:

                     ARUL NAMBI
             ...
Process workshop




Thank you!




                        34
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ISO 9001 IMPLEMENTATION METHODOLOGY

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ISO 9001 IMPLEMENTATION METHODOLOGY

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  • Very systematic and simple presentation of the process.Thanks Arul!
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Transcript of "ISO 9001 IMPLEMENTATION METHODOLOGY"

  1. 1. Process workshop ISO 9001 IMPLEMENTATION METHODOLOGY 1
  2. 2. Process workshop AGENDA • ISO 9001 Overview • Approach • Certification Requirements • Critical Success Factor 2
  3. 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. 3
  4. 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 4
  5. 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 5
  6. 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 6
  7. 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 c O 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 7
  8. 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 8
  9. 9. Management responsibility 6 Management review 1. General 2. Review input 3. Review output 9
  10. 10. Resource management 1 Provision of resources 2 Human resources 1. General 2. Competence, awareness and training 3 Infrastructure 4 Work environment 10
  11. 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 11
  12. 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 12
  13. 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 13
  14. 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. 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 15
  16. 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 16
  17. 17. The Deming Cycle
  18. 18. The Deming Cycle for improvement is the cornerstone of all Management Systems 18
  19. 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 19
  20. 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 20
  21. 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 21
  22. 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 22
  23. 23. AGENDA • ISO 9001 Overview • Approach • Certification Requirements • Critical Success Factor 23
  24. 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 24
  25. 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 25
  26. 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 26
  27. 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 27
  28. 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 28
  29. 29. Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 29
  30. 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 30
  31. 31. Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 31
  32. 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 32
  33. 33. Process workshop Any Queries ? Please Contact: ARUL NAMBI Director aruln@techservconsult.com +91 9892504538 www.techservconsult.com 33
  34. 34. Process workshop Thank you! 34
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