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 !!!
