QMS ISO9001 2008

Quality Management System

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

Qua

lity

Man

agem

ent S

yste

m Objectives of the Orientation

• To learn the benefits of implementing the requirements of the quality management system

• The effect of not following the requirements.

Qua

lity

Man

agem

ent S

yste

m Course Outline

• What is ISO and Quality Management System

• Clauses and Benefits of ISO 9001:2008

Qua

lity

Man

agem

ent S

yste

m ISO 9001:2008

So what about it?

ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM

Qua

lity

Man

agem

ent S

yste

m ISO 9001:2008

Quality Management Systems

- a web of interconnected processes that are used to manage a business.

Qua

lity

Man

agem

ent S

yste

m

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

Qua

lity

Man

agem

ent S

yste

m

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

Qua

lity

Man

agem

ent S

yste

m

• 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

Qua

lity

Man

agem

ent S

yste

m Model of Process Based QMS

Qua

lity

Man

agem

ent S

yste

m The Customer-Supplier Chain

CustomerFeedback

CustomerRequirements

OutputInput

Work team

Qua

lity

Man

agem

ent S

yste

m

Elements of a Typical Quality Management System Manual

Qua

lity

Man

agem

ent S

yste

m Contents

Scope 1.1 General

1.2 Application

1

Terms and Definitions3

Normative Reference2

Quality Management System 4.1 General Requirements

4.2 Documentation Requirements

4

Qua

lity

Man

agem

ent S

yste

m 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 Infrastructure

6.4 Work environment

6

Qua

lity

Man

agem

ent S

yste

m 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

Qua

lity

Man

agem

ent S

yste

m 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 …

Qua

lity

Man

agem

ent S

yste

m Section 2: Normative References

• ISO 9000:2005

• ISO 9001: 2008

• QMS ISO 9001:2000

• QMS ISO 9002:1994

Qua

lity

Man

agem

ent S

yste

m

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

Qua

lity

Man

agem

ent S

yste

m Section 3: Terms and Definition

Definitions

Terms used by an organization:

Qua

lity

Man

agem

ent S

yste

m

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

Qua

lity

Man

agem

ent S

yste

m

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.


Qua

lity

Man

agem

ent S

yste

m

22

LEVEL 1 - QUALITY MANUAL

1. Quality Policy

2. Quality Objectives

3. Requirement Standard

4. Other Statutory and Regulatory Requirements


Qua

lity

Man

agem

ent S

yste

m

Documentation requirements

Quality manual

The 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.


Qua

lity

Man

agem

ent S

yste

m

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 revisio

n


26

Qua

lity

Man

agem

ent S

yste

m

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


27

Qua

lity

Man

agem

ent S

yste

m

LEVEL 3 - QUALITY PLAN

1. Incoming Inspection Plan

2. In-Process Inspection Plan

3. Final Test Report/ Inspection Plan

4. Work Instruction


28

Qua

lity

Man

agem

ent S

yste

m

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


29

Qua

lity

Man

agem

ent S

yste

m

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


30

Qua

lity

Man

agem

ent S

yste

m

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


31

Qua

lity

Man

agem

ent S

yste

m

23 MANDATORY RECORDS (cont’n)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


32

Qua

lity

Man

agem

ent S

yste

m

23 MANDATORY RECORDS (cont’n)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


Qua

lity

Man

agem

ent S

yste

m Section 5: Management Responsibility

Management Responsibility

Qua

lity

Man

agem

ent S

yste

m Summary of Section 5

Management Responsibility• Commitment• Focus• Policy• Objectives• Planning

These correspond to the following principles:• Customer focus• Leadership

Qua

lity

Man

agem

ent S

yste

m Section 6: Resource Management

Resource Management

Qua

lity

Man

agem

ent S

yste


Resource Management

• Provide quality resources

• Provide quality personnel

• Provide quality infrastructure

• Provide quality environment

This corresponds to the following principle:• Involvement of People

Qua

lity

Man

agem

ent S

yste

m

Product /Service Realization

Section 7: Product Realization

Qua

lity

Man

agem

ent S

yste

m

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

Qua

lity

Man

agem

ent S

yste

m 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

Qua

lity

Man

agem

ent S

yste


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

Qua

lity

Man

agem

ent S

yste


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

Qua

lity

Man

agem

ent S

yste


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

Qua

lity

Man

agem

ent S

yste

m

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.


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


Qua

lity

Man

agem

ent S

yste


Measurement, Analysis and ImprovementPerform remedial processesMonitor and measure qualityControl nonconforming productsAnalyze quality informationMake quality improvements

This corresponds to:• Get the facts before you decide• Encourage continual improvement

Qua

lity

Man

agem

ent S

yste

m

End Of Presentation

Qua

lity

Man

agem

ent S

yste

m

A SHORT QUIZ

Qua

lity

Man

agem

ent S

yste

m 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?

Qua

lity

Man

agem

ent S

yste

m 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?

Qua

lity

Man

agem

ent S

yste

mAre 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.

Qua

lity

Man

agem

ent S

yste

mAre 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.

Qua

lity

Man

agem

ent S

yste

m

Now . . . TELL me what’s is going on !!!

Reflection

Qua

lity

Man

agem

ent S

yste

m

Prepared by: Sid Calayag

Presented by:

Sid Calayag – Lead Auditor ISO 9001:2008

Reference:

• Quality Management System

• ISO 9001:2008