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ISO 9001 IMPLEMENTATION METHODOLOGY
The document provides an overview of the ISO 9001 quality management standard and certification process. It discusses the key principles and requirements of ISO 9001, including customer focus, leadership, engagement of people, process approach, and continual improvement. It also outlines the certification requirements and critical success factors for organizations going through the ISO 9001 implementation and certification process.
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ISO 9001 IMPLEMENTATION METHODOLOGY
- 1. Process workshop ISO 9001 IMPLEMENTATION METHODOLOGY 1
- 2. Process workshop AGENDA • ISO 9001 Overview • Approach • Certification Requirements • Critical Success Factor 2
- 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. 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. 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. ISO 9001 Focus? demonstrateorganization’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. System Approach ofISO 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. 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. Management responsibility 6 Management review 1. General 2. Review input 3. Review output 9
- 10. Resource management 1 Provision of resources 2 Human resources 1. General 2. Competence, awareness and training 3 Infrastructure 4 Work environment 10
- 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. Product realization 3Design 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. 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. Measurement, analysis andimprovement 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 15
- 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.
- 18. The Deming Cycle forimprovement is the cornerstone of all Management Systems 18
- 19. 1. PLAN: Designor 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. What are thebenefits 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. 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. 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. AGENDA • ISO 9001 Overview • Approach • Certification Requirements • Critical Success Factor 23
- 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. 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. 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. 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. 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. Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 29
- 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. Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 31
- 32. Process workshop Critical SuccessFactor 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. Process workshop Any Queries? Please Contact: ARUL NAMBI Director aruln@techservconsult.com +91 9892504538 www.techservconsult.com 33
- 34.