1 Quality Management Standards

2 THE ISO 9000 FAMILY ISO 9000: 2005 Identifies the fundamentals and vocabulary for Quality Management Systems (QMS) ISO 9001:2008 Specifies requirements for a QMS where capability to provide product that meets customer and regulatory requirements needs to be demonstrated ISO 9004:2009 Provides guidance on QMS that contributes to the satisfaction of customers and other interested parties

3 ISO 9000 : 2008 Eight quality management principles 1.Customer focus 2.Leadership 3.Involvement of people 4.Process approach 5.System approach to management 6.Continual improvement 7.Factual approach to decision making 8.Mutually beneficial supplier relationships

ISO 9001:2008 CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Requirements Product realization Satisfaction Value adding activities Information flow Customers

5 Inputs With What? (Materials / Equipment) How Many? (Measurement / Controls) How? (Methods/Procedures) WHO? Special Skills? / Competence? Outputs Process Linkages Objectives and Targets Business Process Source: AIAG ISO/TS 16949:2002 Implementation Guide PROCESS REQUIREMENTS

6 SCOPE OF STANDARD 1.Scope +General +Application 2.Normative reference 3.Terms and definition e.g., Supplier Organization Customer

7 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4.1General requirements +Document, implement, maintain and continually improve +Identify and determine sequence and interaction of processes +Determine criteria and methods needed +Ensure availability of resources +Monitor, measure and analyze processes +Implement actions to achieve planned results

8 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 4.2 Documentation requirements +Management system documentation +Quality Manual +Control of documents +Control of records

9 MANAGEMENT RESPONSIBILITY 5.1Management commitment 5.2Customer focus 5.3Quality policy +Must be documented +Must be used for setting objectives 5.4Planning +Document objectives- Must be Measurable +Quality management system planning

10 MANAGEMENT RESPONSIBILITY 5.5Responsibility, authority and communication +Responsibility and authority +Management representative +Internal communication

11 MANAGEMENT RESPONSIBILITY 5.6Management Review +General +Review input +Review output

12 RESOURCE MANAGEMENT 6.1Provision of resources 6.2Human resources +General +Competence, awareness and training 6.3Infrastructure 6.4Work environment

13 PRODUCT REALIZATION 7.1 Planning of product realization 7.2 Customer-related processes + Determination of requirements related to the product + Review of requirements related to the product + Customer communication

14 PRODUCT REALIZATION 7.3 Design and development +Planning, inputs, outputs, systematic reviews, verification and validation, control of changes 7.4 Purchasing +Supplier evaluation and selection +Relevant purchasing information +Verification of purchased product - receiving, source

15 PRODUCT REALIZATION 7.5 Production and service provision + Controlled conditions including product characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activities + Validation of processes when no other method + Identification and traceability of product and it’s status + Care of customer property + Preservation of product 6 Includes constituent parts

16 PRODUCT REALIZATION 7.6 Control of monitoring and measuring devices + Calibrated or verified where necessary + Adjusted and re-adjusted as necessary + Identified to enable calibration status + Safeguarded from invalid adjustment + Protected from damage and deterioration

17 MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.1General 8.2Monitoring and measurement +Customer satisfaction +Internal audit +Monitoring and measurement of processes +Monitoring and measurement of product

18 MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.3Control of nonconforming product 8.4Analysis of data 8.5Improvement +Continual improvement +Corrective action +Preventive action

19 ISO 9001:2008 A Structured Approach to Quality Management

20 Documented Systems

Diaco Inc QUALITY SYSTEM DOCUMENTATION STRUCTURE 1st Level Quality Manual 2nd Level Procedures 3rd Level Work Instructions  Machine instructions  Computer inputs  Detailed work instructions 4th Level Technical Data  International standards  Computer operating manuals  Detailed product specifications Policy and Objectives What the company wishes to achieve How the company implements its policy Structured to reflect process flow of events Detailed instructions How to complete a job or task

TQM TOTAL QUALITY MANAGEMENT

T otal quality management is a systemic approach to productivity improvement using qualitative and quantitative methods and involving all stakeholders to continuously improve the quality of all products and services. TQM

IS THE SET OF MANAGEMENT PROCESSES AND SYSTEMS THAT CREATE DELIGHTED CUSTOMERS THROUGH EMPOWERED EMPLOYEES, LEADING TO HIGHER REVENUES & LOWER COST THE JURAN INSTITUTE, Inc.

TQM It is the process of individual & organizational development the purpose of which is to increase the level of satisfaction of all the stakeholders PIKE, R J BARNES

WHY TQM?

B/C IT IS FOR BENEFIT OF ALL STAKEHOLDERS INTERNAL SATKEHOLDER EXTERNAL STAKEHOLDER

COMPONENTS OF TQM 1.PRICE REDUCTION 2.CUSTOMER SATISFACTION 3.INVOLVEMENT OF EVERYONE 4.CONTINUOUS QUALITY IMPROVEMENT 5.LEADERSHIP

PRICE REDUCTION COST AN ESSENTIAL ELEMENT OF TQM CROSBY PHILOSPHY QUALITY IS FREE QLTY IS THE RIGHT OF CUSTOMER

Who determines quality ? THE CUSTOMER If the customer does not perceive you as offering quality service you are not.

INVOLVEMENT OF EVERYONE

CONTINUOUS IMPROVEMENT Improve each and everyday - Do not focus on problems, focus on improvements. IF YOU’RE NOT PART OF THE SOLUTION, YOU’RE PART OF THE PROBLEM.

CONTINUOUS IMPROVEMENT Customers are not interested in excuses, they’re interested in results. Be proactive - because if you don’t someone else will. Ishikawa Says The organization which does not make a change in the 06 months is a dead organizations

LEADERSHIP NO EFFORT FOR QUALITY IMPROVEMENT CAN SUCCEED WITHOUT COMMITMENT OF TOP MANAGEMENT

LEADERSHIP A NATION WITHOUT LEADERSHIP IS THE HERD OF SWINE EINSTEIN