Quality Management System

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

Qu al it y Ma na ge me nt Sy st em

Objectives of the Orientation

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

Qu al it y Ma na ge me nt Sy st em

Course Outline

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

Qu al it y Ma na ge me nt Sy st em

ISO 9001 : 2008

So what about it?

ISO 9001 is a standard for

QUALITY MANAGEMENT SYSTEM

Qu al it y Ma na ge me nt Sy st em

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

Qu al it y Ma na ge me nt Sy st em International Organization for Standardization What is ISO? ISO is not an acronym for International Organization for Standardization The organization ’ s short name was taken from the Greek word “ isos ”. . meaning “ equal ”.

FACTUAL APPROACH 8. PROCESS APPROACH 5.Qu al it y Ma na ge me nt Sy st em 8 MANAGEMENT PRINCIPLES 1. CUSTOMER FOCUS 2. CONTINUAL IMPROVEMENT 7. LEADERSHIP 3. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS . INVOLVEMENT OF PEOPLE ISO 9001 4. SYSTEM APPROACH 6.

This means that in everything we do there are inputs and outputs. and means to get the work done. suppliers and customers. • All work is a process.Qu al it y Ma na ge me nt Sy st em THE Process Based Approach • 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. .

Qu al it y Ma na ge me nt Sy st em Model of Process Based QMS .

Qu al it y Ma na ge me nt Sy st em The Customer-Supplier Chain Work team Output Customer Input Customer Feedback Requirements .

Qu al it y Ma na ge me nt Sy st em Elements of a Typical Quality Management System Manual .

2 Documentation Requirements . 2 Application Normative Reference Terms and Definitions Quality Management System 4 .Qu al it y Ma na ge me nt Sy st em Contents 1 2 3 4 Scope 1 . 1 General Requirements 4 . 1 General 1 .

2 Human resources 6 .) 5 Management Responsibility 5 .Qu al it y Ma na ge me nt Sy st em Contents (cont. 4 Planning 5 . 4 Work environment . authority and communication 5 . 1 Management Commitment 5 . 3 Infrastructure 6 . 3 Quality Policy 5 . 5 Responsibility . 1 Provision of resources 6 . 2 Customer focus 5 . 6 Management Review 6 Resource Management 6 .

1 Planning of product realization 7 .2 8. 2 Customer .4 8. 4 Purchasing 7 . 6 Control of monitoring and measuring devices 8 Measurement .) 7 Product Realization 7 .5 General Monitoring and measurement Control of nonconforming product Analysis of data Improvement . Analysis and Improvement 8.related processes 7 . 5 Production and service provision 7 .Qu al it y Ma na ge me nt Sy st em Contents (cont.1 8. 3 Design and development 7 .3 8.

Qu al it y Ma na ge me nt Sy st em Quality Manual (ISO 9001:2008) .

metal finishing system.  • Exclusion . environmental control system for automotive and other industrial or commercial applications. ventilation and air conditioning system.Qu al it y Ma na ge me nt Sy st em Section 1: Scope Includes the design and construction of cleanroom.Design and development validation …  .

Qu al it y Ma na ge me nt Sy st em Section 2: Normative References • • • •  ISO 9000:2005 ISO 9001: 2008 QMS ISO 9001:2000 QMS ISO 9002:1994 .

1 Management 4.3 Management representative 4.3 quality planning 7. Terms and Definitions 4.14 Corrective and preventive action ISO 9002:1994 4.2 Organization 4.1.1 general and 2.11 Control of inspection.1. Management Responsibility 4.17 Internal quality audits 4.2.3 Management review 4.2. Quality Management System 4.2 Quality System 4.2.20 Statistical techniques . Analysis and Improvement 8. storage. Resource Managementprocedures 3.5 document and data control 4.18 Training 4.responsibility Realization Product 4.10 inspection and testing 4.19 Servicing 4.4 design control 4.15 Handling. packaging. 4.2 quality system 6.16 Control of quality records 4. Scope 5.1 Quality Policy Measurement.2 Resources 4. Scope 2.1.13 Control of nonconforming product 4.9 process control 4.6 purchasing 4.1. Normative Reference 3. preservation and delivery 4. Normative Reference test equipment 4.1. Definitions 4.2.1 Responsibility and authority 4.3 contract review 4.7 control of customer-supplied product 4.8 product identification and traceability 4.2.1. measuring 1.Qu al it y Ma na ge me nt Sy st em Section 2: Normative References ISO 9001:2000 Elements 1.12 Inspection and test status 4.2.

Qu al it y Ma na ge me nt Sy st em Section 3: Terms and Definition  Definitions  Terms used by an organization: .

§Improving how we provide service. . improvement The focus is on looking at: §What we do. §Who we are doing it for.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements Processes. interaction.

ØControl of records Each record must be controlled in order to ensure uniform quality. in order to ensure use of the most recent information. . adoption and revision dates.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements Documentation requirements Ø Control of document Documents must show a control number.

QUALITY MANUAL Quality Policy Quality Objectives Requirement Standard Other Statutory and Regulatory Requirements 1.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  LEVEL 1 . 3. 2. 22 . 4.

.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements Documentation requirements Ø Quality manual The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement.

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

Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  Current Objectives Maintain good business relationship with the clients. knowledge r o F n io is v e r and abilities by providing appropriate training. . Deliver quality products and services to the satisfaction of the clients Effect efficiency in operations by continual improvement of the Quality Management System. Improve employee’s competence through periodic evaluation and development of skills.

26 .QUALITY PROCEDURES Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products Corrective Action Preventive Action 1.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  LEVEL 2 . 4. 5. 6. 3. 2.

3. 4. 27 .Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  LEVEL 3 . 2.QUALITY PLAN Incoming Inspection Plan In-Process Inspection Plan Final Test Report/ Inspection Plan Work Instruction 1.

Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  LEVEL 4 . 28 .FORMS / FORMATS / RECORDS Testing Report forms Commissioning Report Forms Inspection forms Check Sheets/Check List Miscellaneous Documentation Forms 1. 2. 4. 3. 5.

Training and Awareness Planning and Production Review of Requirement Related to Product 1. 4. 3. 2.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  23 MANDATORY RECORDS Management Review Competence. 5. Design and Development Input 29 .

9. 7. 10.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  23 MANDATORY RECORDS ( cont ’ n ) Design Design Design Design and and and and Development Development Development Development Output Review Verification Validation 6.Control of Design and Development Changes 30 . 8.

Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  11.Control of Monitoring and Measuring Equipment 16.Preservation of Product 14.Standards used for Calibrating Monitoring and Measuring Equipment 23 MANDATORY RECORDS ( cont ’ n ) 31 .Purchasing Process 12.Availability of Monitoring and Measuring Equipment 13.Customer Property 15.

Preventive Action 23 MANDATORY RECORDS ( cont ’ n ) 32 .Corrective Action 23.Identify and Enable Calibration 18.Result of Calibration and Verification 19.Control of Non-conforming Product 22.Qu al it y Ma na ge me nt Sy st em Section 4: General requirements  17.Monitoring and Measurement of Product 21.Internal Audit 20.

Qu al it y Ma na ge me nt Sy st em Section 5: Management Responsibility Management Responsibility .

Qu al it y Ma na ge me nt Sy st em Summary of Section 5  Management Responsibility Commitment Focus Policy Objectives Planning These correspond to the following principles: Customer focus Leadership • • • • • .

Qu al it y Ma na ge me nt Sy st em Section 6: Resource Management Resource Management .

Qu al it y Ma na ge me nt Sy st em Summary of Section 6 Resource • Provide • Provide • Provide • Provide  Management quality resources quality personnel quality infrastructure quality environment This corresponds to the following principle: Involvement of People .

Qu al it y Ma na ge me nt Sy st em Section 7: Product Realization Product /Service Realization .

1 Plan and develop the processes nInclude product objectives.stated and 7. relevant processes and resource. appropriate test and validation requirement .Qu al it y Ma na ge me nt Sy st em Section 7: Product Realization 7 .2 Customer related processes nCustomer implied nStatutory and regulatory nProduct requirements and changes nOrganization ability nCommunication with customers .

systematic reviews. control of changes evaluation and selection nRelevant purchasing information nVerification of purchased product .3 7. Purchasing nSupplier inputs.Qu al it y Ma na ge me nt Sy st em Section 7: Product Realization 7. outputs.4 Design and development nPlanning. verification and validation.

Qu al it y Ma na ge me nt Sy st em Section 7: Product Realization 7 . work instructions. measuring devices. suitable equipment. and system nRelease. 5 Production and service provision nControlled conditions including product characteristics. delivery and post delivery activities nValidation of processes when no other method nIdentification and traceability of product and it’s status nCare of customer property nPreservation of product uIncludes constituent parts .

Qu al it y Ma na ge me nt Sy st em Section 7: Product Realization 7.6 Control of monitoring and measuring devices nCalibrated where necessary nAdjusted and readjusted nIdentifies status nSafeguarded from invalid adjustment nProtected from damage or deterioration .

Qu al it y Ma na ge me nt Sy st em Summary of Section 7 Control process  of the following These correspond to: Get the facts before you decide Focus on customers Use a process approach Work with your suppliers • • • • • • realization planning customer communication product development purchasing function operation monitoring .

Analysis & Improvement CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM .Qu al it y Ma na ge me nt Sy st em Section 8: Measurement.

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

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

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

Section 8: Measurement. Analysis & Improvement Analysis of data ØCustomer ØProduct satisfaction and process requirements and trends ØSuppliers .

Analysis & Improvement Improvement ØContinually improve effectiveness action action of the system ØCorrective ØPreventive .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 .Qu al it y Ma na ge me nt Sy st em Summary of Section 8  Measurement.

Qu al it y Ma na ge me nt Sy st em  End Of Presentation .

Qu al it y Ma na ge me nt Sy st em A SHORT QUIZ .

do you make sure you understand completely what you are supposed to do? 3.Qu al it y Ma na ge me nt Sy st em What do you do when accepting a task? (Answerable by Yes or No) 1.Is it clear how much responsibility and authority you have in the project? 6. Without reporting back to your boss? 7.Are the deadlines clear? 5.Do you let your boss know if a new assignment makes it difficult for you to do your other jobs? .Do you know which tasks you can perform on your own.Before accepting an assignment.

Is it clear who makes decisions when your boss is not available? 10.Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly? 9. do you talk to your boss about the situation? 11.If a problem arises that you can’t handle.Do you get the information and background material you need to do the job properly? 8. .Do you make suggestions to make priorities on how much time you will allow the project? 7.Qu al it y Ma na ge me nt Sy st em What do you do when accepting a task (Continuation) 6.

there’s always room for improvement. Customers pay little attention to quality. A quality program must mesh with the organization’s goals and profit plans. 2.Qu al it y Ma na ge me nt Sy st em Are You Quality-Conscious? (Answerable by True or False) 1. 4. Quality means conformance to standards. When it comes to quality. . 5. 3. Nobody can be aware of quality needs all the time.

Quality should operate in all parts of a business 7. 8. 9. 10.Qu al it y Ma na ge me nt Sy st em Are You Quality-Conscious? (Continuation) 6.People who talk about quality are mostly idealists. Quality relates to the process as much as to the goal. Quality requires commitment. Personal quality standards and business quality standards have little in common. .

TELL me what’s is going on !!! . . .Qu al it y Ma na ge me nt Sy st em Reflection Now .

Qu al it y Ma na ge me nt Sy st em Prepared by: Sid Calayag Presented by:   Sid Calayag – Lead Auditor ISO 9001:2008  Reference: • Quality Management System • ISO 9001:2008 .

Sign up to vote on this title
UsefulNot useful