Typical Quality Management system Based on ISO 9001-2008

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Presentation Transcript

Quality Management System : 

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

Objectives of the Orientation : 

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 : 

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

ISO 9001:2008 : 

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

ISO 9001:2008 : 

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

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”. International Organization for Standardization

8 MANAGEMENT PRINCIPLES : 

ISO 9001 1. 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

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. 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. THE Process Based Approach

Model of Process Based QMS : 

Model of Process Based QMS

The Customer-Supplier Chain : 

The Customer-Supplier Chain Customer Feedback

Elements of a Typical Quality Management System Manual : 

Elements of a Typical Quality Management System Manual

Contents : 

Contents

Contents (cont.) : 

Contents (cont.)

Contents (cont.) : 

Contents (cont.) 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8

Quality Manual(ISO 9001:2008) : 

Quality Manual(ISO 9001:2008)

Section 1: Scope : 

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 : 

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

Slide 18: 

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 : 

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

Slide 20: 

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

Slide 21: 

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

Slide 22: 

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

Slide 23: 

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

Quality Policy : 

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

Slide 25: 

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 employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training. For revision Section 4: General requirements

Slide 26: 

LEVEL 2 - QUALITY PROCEDURES Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products Corrective Action Preventive Action 26 Section 4: General requirements

Slide 27: 

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

Slide 28: 

28 LEVEL 4 - FORMS / FORMATS/RECORDS Testing Report forms Commissioning Report Forms Inspection forms Check Sheets/Check List Miscellaneous Documentation Forms Section 4: General requirements

Slide 29: 

23 MANDATORY RECORDS Management Review Competence, Training and Awareness Planning and Production Review of Requirement Related to Product Design and Development Input 29 Section 4: General requirements

Slide 30: 

30 23 MANDATORY RECORDS (cont’n) Design and Development Output Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes Section 4: General requirements

Slide 31: 

31 23 MANDATORY RECORDS (cont’n) Purchasing Process Availability of Monitoring and Measuring Equipment Preservation of Product Customer Property Control of Monitoring and Measuring Equipment Standards used for Calibrating Monitoring and Measuring Equipment Section 4: General requirements

Slide 32: 

32 23 MANDATORY RECORDS (cont’n) Identify and Enable Calibration Result of Calibration and Verification Internal Audit Monitoring and Measurement of Product Control of Non-conforming Product Corrective Action Preventive Action Section 4: General requirements

Section 5: Management Responsibility : 

Section 5: Management Responsibility

Summary of Section 5 : 

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

Section 6: Resource Management : 

Section 6: Resource Management

Summary of Section 6 : 

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

Section 7: Product Realization : 

Section 7: Product 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

Section 7: Product Realization : 

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 : 

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 it’s status Care of customer property Preservation of product Includes constituent parts

Section 7: Product Realization : 

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 : 

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

Section 8: Measurement, Analysis & Improvement : 

Section 8: Measurement, Analysis & Improvement

Slide 44: 

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

Slide 45: 

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

Slide 46: 

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

Slide 47: 

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

Slide 48: 

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

Summary of Section 8 : 

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

Slide 50: 

End Of Presentation

A SHORT QUIZ : 

A SHORT QUIZ

What do you do when accepting a task?(Answerable by Yes or No) : 

What do you do when accepting a task?(Answerable by Yes or No) Before accepting an assignment, do you make sure you understand completely what you are supposed to do? Are the deadlines clear? Is it clear how much responsibility and authority you have in the project? Do you know which tasks you can perform on your own. Without reporting back to your boss? 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) : 

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

Are You Quality-Conscious?(Answerable by True or False) : 

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

Are You Quality-Conscious? (Continuation) : 

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

Reflection : 

Reflection

Slide 57: 

Prepared by: Sid Calayag Presented by: Sid Calayag – Lead Auditor ISO 9001:2008 Reference: Quality Management System ISO 9001:2008

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