Quality Management System Understanding our QMS for the achievement of organization and business success.

Objectives of the Orientation To learn the benefits of implementing the requirements of the quality management system The effect of not following the requirements.

Course Outline What is ISO and Quality Management System Clauses and Benefits of ISO 9001:2008

ISO 9001:2008 So what about it? ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM

ISO 9001:2008 Quality Management Systems - a web of interconnected processes that are used to manage a business.

What is ISO? ISO is not an acronym for International Organization for Standardization The organizations short name was taken from the Greek word isos, meaning equal. International Organization for Standardization

ISO CUSTOMER FOCUS 2. LEADERSHIP 3. INVOLVEMENT OF PEOPLE 4. PROCESS APPROACH 5. SYSTEM APPROACH 6. CONTINUAL IMPROVEMENT 7. FACTUAL APPROACH 8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS 8 MANAGEMENT PRINCIPLES

When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach. All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done. When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach. All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.

Model of Process Based QMS

The Customer-Supplier Chain Customer Feedback Customer Requirements Output Input Work team

Elements of a Typical Quality Management System Manual

Contents Scope 1.1 General 1.2 Application 1 Terms and Definitions 3 Normative Reference 2 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 4

Contents (cont.) Management Responsibility 5.1 Management Commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review 5 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 6

Contents (cont.) Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices 7

Quality Manual (ISO 9001:2008)

Section 1: Scope Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications. Exclusion - Design and development validation …

Section 2: Normative References ISO 9000:2005 ISO 9001: 2008 QMS ISO 9001:2000 QMS ISO 9002:1994

1. Scope 2. Normative Reference 3. Definitions 4.1 Management responsibility Quality Policy Organization Responsibility and authority Resources Management representative Management review 4.2 Quality System general quality system procedures quality planning 4.3 contract review 4.4 design control 4.5 document and data control 4.6 purchasing 4.7 control of customer-supplied product 4.8 product identification and traceability 4.9 process control 4.10 inspection and testing 4.11 Control of inspection, measuring and test equipment 4.12 Inspection and test status 4.13 Control of nonconforming product 4.14 Corrective and preventive action 4.15 Handling, storage, packaging, preservation and delivery 4.16 Control of quality records 4.17 Internal quality audits 4.18 Training 4.19 Servicing 4.20 Statistical techniques ISO 9002:1994 ISO 9001:2000 Elements 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement Section 2: Normative References

Section 3: Terms and Definition Definitions Terms used by an organization:

Processes, interaction, improvement The focus is on looking at: What we do. Who we are doing it for. Improving how we provide service. Section 4: General requirements

Documentation requirements Control of document Documents must show a control number, adoption and revision dates, in order to ensure use of the most recent information. Control of records Each record must be controlled in order to ensure uniform quality. Section 4: General requirements

2222 LEVEL 1 - QUALITY MANUAL 1. Quality Policy 2. Quality Objectives 3. Requirement Standard 4. Other Statutory and Regulatory Requirements Section 4: General requirements

Documentation requirements Quality manual The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement. Section 4: General requirements

The staff and management of ___ are committed to consistent provision of quality products and services Quality Policy that will satisfy the demands and expectations of customers by continual improvement of the QMS and conforming to local standards and prevailing codes of practice. Section 4: General requirements

Current Objectives Maintain good business relationship with the clients. Deliver quality products and services to the satisfaction of the clients Effect efficiency in operations by continual improvement of the Quality Management System. Improve employees competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training. For revision Section 4: General requirements

LEVEL 2 - QUALITY PROCEDURES 1. Control of Documents 2. Control of Records 3. Internal Quality Audits 4. Control of Non-conforming Products 5. Corrective Action 6. Preventive Action 2626 Section 4: General requirements

2727 LEVEL 3 - QUALITY PLAN 1. Incoming Inspection Plan 2. In-Process Inspection Plan 3. Final Test Report/ Inspection Plan 4. Work Instruction Section 4: General requirements

2828 LEVEL 4 - FORMS / FORMATS/RECORDS 1. Testing Report forms 2. Commissioning Report Forms 3. Inspection forms 4. Check Sheets/Check List 5. Miscellaneous Documentation Forms Section 4: General requirements

23 MANDATORY RECORDS 1. Management Review 2. Competence, Training and Awareness 3. Planning and Production 4. Review of Requirement Related to Product 5. Design and Development Input 2929 Section 4: General requirements

MANDATORY RECORDS (contn) 6. Design and Development Output 7. Design and Development Review 8. Design and Development Verification 9. Design and Development Validation 10. Control of Design and Development Changes Section 4: General requirements

MANDATORY RECORDS (contn) 11. Purchasing Process 12. Availability of Monitoring and Measuring Equipment 13. Preservation of Product 14. Customer Property 15. Control of Monitoring and Measuring Equipment 16. Standards used for Calibrating Monitoring and Measuring Equipment Section 4: General requirements

MANDATORY RECORDS (contn) 17. Identify and Enable Calibration 18. Result of Calibration and Verification 19. Internal Audit 20. Monitoring and Measurement of Product 21. Control of Non-conforming Product 22. Corrective Action 23. Preventive Action Section 4: General requirements

Section 5: Management Responsibility Management Responsibility

Summary of Section 5 Management Responsibility Commitment Focus Policy Objectives Planning These correspond to the following principles: Customer focus Leadership

Section 6: Resource Management Resource Management

Summary of Section 6 Resource Management Provide quality resources Provide quality personnel Provide quality infrastructure Provide quality environment This corresponds to the following principle: Involvement of People

Product /Service Realization Section 7: Product Realization

7.1 Plan and develop the processes Include product objectives, relevant processes and resource, appropriate test and validation 7.2 Customer related processes Customer requirement - stated and implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers Section 7: 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

Section 7: Product Realization 7.5 Production and service provision Controlled conditions including product characteristics, work instructions, suitable equipment, measuring devices, and system Release, delivery and post delivery activities Validation of processes when no other method Identification and traceability of product and its status Care of customer property Preservation of product Includes constituent parts

Section 7: Product Realization 7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration

Summary of Section 7 Control of the following process realization planning customer communication product development purchasing function operation monitoring These correspond to: Get the facts before you decide Focus on customers Use a process approach Work with your suppliers

CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM Section 8: Measurement, Analysis & Improvement

General Measurement and monitoring processes To demonstrate product conformity, system conformity and continually improve the Quality Management System. Customer satisfaction Perception of fulfillment. Section 8: Measurement, Analysis & Improvement

Monitoring and Measurement Internal planned audit, etc. Process Auditors, independent of their own work will audit department process. Processes Demonstrate achievement of planned results. Section 8: Measurement, Analysis & Improvement

Monitoring and Measurement Product Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions. Nonconforming process/product Elimination or correction of nonconforming processes. Section 8: Measurement, Analysis & Improvement

Analysis of data Customer satisfaction Product and process requirements and trends Suppliers Section 8: Measurement, Analysis & Improvement

Improvement Continually improve effectiveness of the system Corrective action Preventive action Section 8: Measurement, Analysis & Improvement

Summary of Section 8 Measurement, Analysis and Improvement Perform remedial processes Monitor and measure quality Control nonconforming products Analyze quality information Make quality improvements This corresponds to: Get the facts before you decide Encourage continual improvement

End of Presentation

A SHORT QUIZ

What do you do when accepting a task? (Answerable by Yes or No) 1. Before accepting an assignment, do you make sure you understand completely what you are supposed to do? 2. Are the deadlines clear? 3. Is it clear how much responsibility and authority you have in the project? 4. Do you know which tasks you can perform on your own. Without reporting back to your boss? 5. Do you let your boss know if a new assignment makes it difficult for you to do your other jobs?

What do you do when accepting a task (Continuation) 6. Do you make suggestions to make priorities on how much time you will allow the project? 7. Do you get the information and background material you need to do the job properly? 8. Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly? 9. Is it clear who makes decisions when your boss is not available? 10. If a problem arises that you cant handle, do you talk to your boss about the situation?

Are You Quality-Conscious? (Answerable by True or False) 1. When it comes to quality, theres always room for improvement. 2. Nobody can be aware of quality needs all the time. 3. Customers pay little attention to quality. 4. A quality program must mesh with the organizations goals and profit plans. 5. Quality means conformance to standards.

Are You Quality-Conscious? (Continuation) 6. Quality should operate in all parts of a business 7. Personal quality standards and business quality standards have little in common. 8. Quality requires commitment. 9. Quality relates to the process as much as to the goal. 10. People who talk about quality are mostly idealists.

Now... TELL me whats is going on !!! Reflection