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

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 organization’s short name was taken from the Greek word “isos”, meaning “equal”.

International Organization for Standardization

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

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

CustomerFeedback

CustomerRequirements

OutputInput

Work team

Elements of a Typical Quality Management System Manual

Contents

Scope 1.1 General

1.2 Application1

Terms and Definitions3

Normative Reference2

Quality Management System

4.1 General Requirements

4.2 Documentation Requirements4

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 resources6.2 Human resources6.3 Infrastructure6.4 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

4.1.1 Quality Policy

4.1.2 Organization

4.1.2.1 Responsibility and authority

4.1.2.2 Resources

4.1.2.3 Management representative

4.1.3 Management review

4.2 Quality System

4.2.1 general

4.2.2 quality system procedures

4.2.3 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 9002:1994ISO 9001:2000 Elements1. Scope2. Normative Reference3. Terms and Definitions4. Quality Management System5. Management Responsibility6. Resource Management7. Product Realization8. Measurement, Analysis and Improvement

Section 2: Normative References

Section 3: Terms and Definition

DefinitionsTerms 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.


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LEVEL 1 - QUALITY MANUAL

1. Quality Policy

2. Quality Objectives

3. Requirement Standard

4. Other Statutory and Regulatory Requirements


Documentation requirements

Quality manualThe quality manual describes our intent to establish a quality management

system with an emphasis on continual improvement.


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 customersby continual improvement of the QMS and conforming to local standards and prevailing codes of practice.


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


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

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LEVEL 3 - QUALITY PLAN

1. Incoming Inspection Plan

2. In-Process Inspection Plan

3. Final Test Report/ Inspection Plan

4. Work Instruction


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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


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

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23 MANDATORY RECORDS (cont’n)

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


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23 MANDATORY RECORDS (cont’n)11. Purchasing Process12. Availability of Monitoring and Measuring Equipment13. Preservation of Product14. Customer Property15. Control of Monitoring and Measuring Equipment16. Standards used for Calibrating Monitoring and Measuring

Equipment


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23 MANDATORY RECORDS (cont’n)17. Identify and Enable Calibration18. Result of Calibration and Verification19. Internal Audit20. Monitoring and Measurement of Product21. Control of Non-conforming Product22. Corrective Action23. Preventive Action


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


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



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


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


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


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

GeneralMeasurement and monitoring processes

To demonstrate product conformity, system conformity and

continually improve the Quality Management System.

Customer satisfaction Perception of fulfillment.


Monitoring and Measurement

Internal planned audit, etc. Process Auditors, independent of their own work will audit department

process.

Processes Demonstrate achievement of planned results.


Monitoring and Measurement

• Product Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions.

• Nonconforming process/product

• Elimination or correction of nonconforming processes.


Analysis of data Customer satisfaction Product and process requirements and trends

Suppliers


Improvement Continually improve effectiveness

of the system

Corrective action

Preventive action



Measurement, Analysis and ImprovementPerform 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 can’t 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, there’s 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 organization’s 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 what’s is going on !!!

Reflection