ISO 9001:2008 an Overview

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ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM Presentation by Virendra Sahdev:

ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM Presentation by Virendra Sahdev

ABOUT ISO 9001:

ABOUT ISO 9001 It’s a Quality Management System Standard Initially published in 1987 First revision in 1994, Second revision in 2000 ISO 9001:2008 is the latest version released in 14 Nov 2008 Strong emphasis on Customer Satisfaction and Continual Improvement

INTRODUCTION:

INTRODUCTION Quality Fitness for purpose Excellence Meeting Customer Expectations not just needs Management Planning, Organizing, Directing, Controlling, Structuring System Work culture Framework Policies & procedures

GENERIC STANDARD:

GENERIC STANDARD ISO 9001 :2008 is a generic standard. Generic means that the same standards can be applied: to any organization , large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department

PROCESS APPROACH:

PROCESS APPROACH Understanding and meeting requirements The need to consider processes in terms of added value Obtaining results of process performance and effectiveness Continual improvement of processes based on objective measurement PLAN ACT DO CHECK

WHAT IS A PROCESS:

WHAT IS A PROCESS Sequence of interdependent and linked PROCEDURES which, at every STAGE , consume one or more RESOURCES (employees, time, energy, machines, money) to CONVERT inputs (data, material, parts, etc.) into OUTPUTS . These outputs then serve as inputs for the next stage until a known GOAL or END RESULT is reached.

PROCESS APPROACH MODEL :

© 2002 Systex Services 7 PROCESS APPROACH MODEL CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Customer Customer Requirements Satisfaction Product realisation Input Product Output Measurement analysis improvement Resource management Management responsibility

Continuous v/s Continual Improvement:

Continuous v/s Continual Improvement A comparision Continuous Improvement Initial Level of Performance Point of Failure Continual Improvement Point of Failure Last Improved Level Improvement Phase Consolidation Phase Initial Level of Performance

ISO 9001:2008 Main Clauses:

ISO 9001:2008 Main Clauses Quality Management System Management Responsibility Resources Management Product Realization Measurement, Analysis and Improvement …

4 Quality Management System:

4 Quality Management System 4.1 General Requirements 4.2 Documentation requirements 4.2.1 General Requirements 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records vs

5 MANAGEMENT RESPONSIBILITY:

5 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment Establish policy and objectives (SMART) Communicate importance of meeting customer and regulatory Requirements Conducting Management Reviews Ensuring availability of resources 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives 5.4.2 QMS Planning 5.5 Responsibility, authority & communication 5.5.1 Responsibility & authority 5.5.2 Management Representative 5.5.3 Internal Communication Contd …

5 MANAGEMENT RESPONSIBILITY:

5 MANAGEMENT RESPONSIBILITY 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output …Contd..

6 RESOURCE MANAGEMENT:

6 RESOURCE MANAGEMENT 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, training & awareness 6.3 Infrastructure 6.4 Work Environment …

7 PRODUCT REALIZATION:

7 PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer Related processes 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 … Contd …

7 PRODUCT REALIZATION:

7 PRODUCT REALIZATION 7.3 Design & Development 7.3.1 Design & Development Planning 7.3.2 Design & Development Inputs 7.3.3 Design & Development Outputs 7.3.4 Design & Development Review 7.3.5 Design & Development Verification 7.3.6 Design & Development Validation 7.3.7 Control of Design & development Changes 7.4 Purchasing 7.4.1 Purchasing process Vendor Selection & evaluation 7.4.2 Purchasing Information 7.4.3 Verification of Purchased product … Contd …

7 PRODUCT REALIZATION:

7 PRODUCT REALIZATION 7.5 Production & Service Provision 7.5.1 Control of Production & Service Provision 7.5.2 Validation of Production & Service Provision 7.5.3 Identification & Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring & Measuring Equipment Calibration … Contd

8 MEASUREMENT, ANALYSIS & IMPROVEMENT:

8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8.1 General 8.2 Monitoring & Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & Measurement of Processes 8.2.4 Monitoring & Measurement of Product 8.3 Control of Non-conforming Product 8.4 Analysis of Data Customer Satisfaction Conformity to product requirements 8.5 Improvement 8.5.1 Continual Improvement through policy, objectives, audit results, analysis 8.5.2 Corrective Action 8.5.3 Preventive Action …

Benefits of ISO 9001:2008:

Benefits of ISO 9001:2008 Clarity in definition of authorities and responsibilities Enhanced corporate image and market positioning Better records and documentation in case of litigation Use of recognized mark (of certifying agency) on stationary and advertisement Reduction in the need for multiple second party assessments Better traceability to root causes of quality problems Rectification of errors at the earliest stage No repetition of  errors …

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