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.
International Organization for Standardization

What is ISO is not an acronym

ISO? for International
Organization for
Standardization

The organization’s short name was

taken from the Greek word “isos”,
meaning “equal”.
8 MANAGEMENT PRINCIPLES

1. CUSTOMER FOCUS
2. LEADERSHIP

ISO 9001 3. INVOLVEMENT OF PEOPLE

4. PROCESS APPROACH

5. SYSTEM APPROACH

6. CONTINUAL IMPROVEMENT

7. FACTUAL APPROACH
8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
 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

Work
team

Output
Input
Customer Customer
Requirements Feedback
Elements of a Typical Quality
Management System Manual
Contents

1 Scope 1.1 General

1.2 Application

2 Normative Reference

3 Terms and Definitions

Quality Management
4 System
4.1 General Requirements
4.2 Documentation Requirements
Contents (cont.)

5 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

6 Resource Management 6.1 Provision of resources

6.2 Human resources
6.3 Infrastructure
6.4 Work environment
Contents (cont.)

7 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

8 Measurement, Analysis and 8.1 General

Improvement
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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
Section 2: Normative References

ISO 9001:2000 Elements

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

Definitions
Terms used by an organization:
Section 4: General requirements

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

LEVEL 1 - QUALITY MANUAL

1. Quality Policy
2. Quality Objectives
3. Requirement Standard
4. Other Statutory and Regulatory Requirements

2222
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

Quality Policy
The staff and management of ___ are
committed to consistent provision of quality
products and services 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 employee’s competence through periodic
evaluation and development of skills, knowledge and
abilities by providing appropriate training.
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

LEVEL 3 - QUALITY PLAN

1. Incoming Inspection Plan
2. In-Process Inspection Plan
3. Final Test Report/ Inspection Plan
4. Work Instruction

2727
Section 4: General requirements

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

2828
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

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

3030
Section 4: General requirements

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

3131
Section 4: General requirements

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

3232
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
Section 7: Product Realization

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 it’s 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 These correspond to:
• Get the facts before you
 customer communication decide
• Focus on customers
 product development • Use a process approach
• Work with your suppliers
 purchasing function
 operation
 monitoring
Section 8: Measurement, Analysis &
Improvement

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
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 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.
Reflection

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