ISO 9001:2008


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Why Quality system is required? :

Why Quality system is required? Quality has been widely accepted as the most powerful and sustaining factor that would provide a supplier edge over competitors. Thus, activities to assure quality of products and or services to customers were initially organized by suppliers through third party certification of products or by providing facility for second party inspection by customers. Globalization of manufacture and marketing had by this time already impacted on the need to develop International Standards for products and services. Since the parallel development of Quality System standards by various national and multinational establishments proliferated, the International Organisation for Standardisation (ISO) recognized it as appropriate also to develop International Quality System Standard to harmonize efforts in this area by various national and multi-national bodies and thus to facilities international trade by providing globally accepted Quality System standards for third party certification under contractual requirements.


ISO 9000 FAMILY STANDARDS: INTRODUCTION: ISO, International Organization for Standadisation, was formed in 1947 with its headquarters at Geneva, Switzerland, at the initiative of United Nations Standards coordinating committee. ISO is a world-wide federation of standards bodies from more than 150 countries. Its mission is to promote the developments of standardization and related activities in the world with a view to facilitating the International exchange of goods and services, and to developing co-operation in the spheres of intellectual, scientific, technological and economic activity.

ISO 9001 Structure:

ISO 9001 Structure Quick History Original Standard in 1987 20 clauses Procedure-based Revision in 1994 A “tweak” Revision in 2000 Major overhaul 8 sections Focus on the Customer Focus on Business Results Revision in 2008 A “tweak”


ADVANTAGES OF ISO 9000 A passport to Global market Motivates exporters through marketing advantage Sets a base line for ultimate TQM Establishes ground for possible future Government mandate Reduces time consuming audits by customers and Regulating bodies commitment is assured Improves efficiency, reduces scrap and network. Hence, the profitability is higher Increased profitability is conducive to job security. Through its internal quality audits and management review requirements, it opens up beneficial horizontal and bottom up lines of communication Gives International recognition of ability Improves the Quality costs, removes uncertainty about quality and improves work culture Rightly ISO 9000 certification is termed as “GATEPASS FOR ENTRY TO GLOBAL MARKET”.

ISO clauses/ sections:

ISO clauses/ sections 1.0 Scope 2.0 Normative reference 3.0 Terms and definitions 4.0 Quality Management System (4.1-4.2) 5.0 Management Responsibility (5.1-5.6) 6.0 Resource Management (6.1-6.4) 7.0 Product Realization (7.1-7.6) 8.0 Measurement, analysis and improvement (8.1-8.5)



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CUSTOMERS CUSTOMERS 5.6 Management Review 5.3 Quality Policy 5.1 Management Commitment 6.4 Work Environment 6.3 Infrastructure 6.2 Human Resources (Training) 7.1 Planning 8.5 Corrective & Preventive Action 8.4 Analysis of Data (Suppliers, Process, Product, Customer) 8.3 Control of Nonconforming Product 8.2 Monitoring Customer Satisfaction 8.2 Internal Audits Bids, Quotations, Orders, and Contracts CUSTOMER REQUIREMENTS Shipping & Delivery Feedback 8.5 CONTINUAL IMPROVEMENT 5.0 MANAGEMENT RESPONSIBILITY 6.0 RESOURCE MANAGEMENT 7.0 PRODUCT REALIZATION 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT Covering the entire QMS is: 4.2.3 DOCUMENT CONTROL AND 4.2.4 RECORDS CONTROL Quality Management System 7.6 Monitoring & Measuring Devices 7.5 Production Control 7.4 Purchasing & Receiving 7.3 Design 5.4 Quality Objectives

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ISO CLAUSE 9001: 2008 1.Scope 1.1 General 1.2 Application 2. Normative reference 3. Terms and Definitions 4. Quality Management System (title only) 4.1 General requirements 4.2 Documentation requirements (title only) 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records

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5.0 Management Responsibility (title only) 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning (title only) 5.4.1 Quality objectives 5.4.2 Quality management system planning

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5.5 Responsibility, authority and communication (title only) 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review (title only) 5.6.1 General 5.6.2 Review input 5.6.3 Review output

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6.0 Resource Management (title only) 6.1 Provision of resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environment

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7.1 Planning of product realization 7.2 Customer-related processes (title only) 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication

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7.3 Design and development (title only) 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development output 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes

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7.4 Purchasing (title only) 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product

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8.1 General 8.2 Monitoring and measurement (title only) 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product

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8.3 Control of non-conforming product 8.4 Analysis of dataImprovement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

Eight Quality Management Principles:

Eight Quality Management Principles C ustomer Focus L eadership I nvolvement of People P rocess approach S ystems approach to management C ontinual Improvement F actual approach to decision making M utually beneficial supplier relationships


DETAILS OF 8 QUALITY MANAGEMENT PRINCIPLES: 1. Customer focus: Organizations depend on the customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations 2. Leadership: Leaders establish unit of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

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3. Involvement of people: People at all levels are essence of an organization and their full involvement enables and their abilities to be used for the organization’s benefit. 4. Process approach: A desired result is achieved more efficiently when activities and related resources are managed as a process. 5. System approach to Management: Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives

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6. Continual improvement: Continual improvement of the organization’s overall performance should be permanent objective of the organization. 7. Factual approach to decision making: Effective decisions are based the analysis of the data and information 8. Mutually beneficial supplier relationships An organization and its suppliers are inter-dependent and a mutually beneficial relationship enhances the ability: Of both to create value.

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Implementing a Quality Management System   Embrace the Eight Quality Management Principles Engage Top Managers Answer the question “Why do we need a formal Quality Management System?” Conduct a gap analysis Determine where you are compared to where you want to be Identify areas for improvement

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Review or create: Quality objectives that align with business objectives Quality Policy Quality Manual (Level I document) SOPs (Level II documents) Need to address a minimum of 6 areas Work Instructions (Level III documents) Forms (Level IV documents) Create QMS performance metrics Begin Management Review Meetings Conduct Internal Auditor training Perform internal audits Respond to internal audits and fill gaps Focus on document control, recordkeeping, continual improvement and management review Implementing a Quality Management System (cont)  

3rd Party Certification:

3 rd Party Certification Research and select a 3 rd party registrar Optional Pre-assessment meeting (you actually get some consulting) Will need at least two Management Review meetings Will need a full cycle of internal audits Practice certification Respond to gaps Formal certification

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Quality Management System Summary   Say what you do Write it down in standard format Do what you say Keep excellent records Audit to verify React to gaps Review at Top Management level Build in continual improvement

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