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Process workshop

ISO 9001 IMPLEMENTATION METHODOLOGY

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Process workshop

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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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 4 .

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 5 .

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 .

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 7 . analysis.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.

management representative 3. authority and communication 1. Responsibility and authority 2. Internal communication 8 .Management responsibility 1 Management commitment 2 Customer focus 3 Quality Policy 4 Planning Quality objectives z Quality management system planning 5 Responsibility.

Review input 3. General 2. Review output 9 .Management responsibility 6 Management review 1.

General 2. awareness and training 3 Infrastructure 4 Work environment 10 . Competence.Resource management 1 Provision of resources 2 Human resources 1.

Design and development planning 2. Customer communication 3 Design and development 1. Determination of requirements related to the product 2. Design and development of inputs 11 .Product realization 1 Planning of product realization 2 Customer related processes 1. Review of requirements related to the product 3.

Design and development validation 4 Purchasing 1. Purchasing information 3. Purchasing process 2. Design and development verification 4. Verification of purchased product 12 .Product realization 3 Design and development (continued. Design and development outputs 2..) 1. Design and development review 3.

Preservation of product 6 Control of monitoring and measuring devices 13 .Product realization 5 Production and service provision 1. Control of production and service provision 2. Customer property 5. Independent and traceability 4. Validation of processes for production and service provision 3.

Monitoring and measurement of product 3 Control of non-confirming product 4 Analysis of data 5 Improvement 1. Monitoring and measurement of processes 4. Continual improvement 2. analysis and improvement 1 General 2 Monitoring and measurement 1.Measurement. Preventive action 14 . Internal audit 3. Corrective action 3. Customer satisfaction 2.

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 .

products and processes are improved to directly impact customer satisfaction 16 .ISO 9001:2008 Effective Measurements = Effective Management – ISO 9001:2008 expects effective measurements system for management control and action – Based on effective measurements.

The Deming Cycle .

The Deming Cycle for improvement is the cornerstone of all Management Systems 18 .

CHECK / STUDY: Assess the measurements and report the results to decision makers 4. DO: Implement the plan and measure its performance 3.1. ACT: Decide on changes needed to improve the process 19 . PLAN: Design or revise business process components to improve results 2.

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 .

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 .ISO 9001 – Certification Cycle Certification Audit ™ Stage 1 – Documentation Review ™ Stage 2 .

discussions ™ Non-Conformance – Major / Minor ™ Observations ™ Good Practices ™ Opportunity for improvements ™ Findings to be closed maximum of three months and provide evidence 22 . 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.External Audit Process ™ Number of person days for audit will be determined ™ Human Resources. records. interviews. Internal Audit process.

AGENDA • ISO 9001 Overview • Approach • Certification Requirements • Critical Success Factor 23 .

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 24 .

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 25 .

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 26 .

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 27 .

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 28 .

Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 29 .

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 30 .

Process workshop AGENDA • ISO 9001 : 2008 • Approach • Certification Requirements • Critical Success Factor 31 .

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 .

techservconsult.com +91 9892504538 www.com 33 .Process workshop Any Queries ? Please Contact: ARUL NAMBI Director aruln@techservconsult.

Process workshop Thank you! 34 .