The document discusses the history and principles of quality management systems. It describes the evolution of international standards like ISO 9000 beginning in the 1950s. The key principles of a quality management system are outlined, including customer focus, leadership and involvement of people. The structure of ISO 9001 is summarized, including the main elements like documentation, management responsibility, and monitoring and measurement. The roles and responsibilities in a quality system are defined. Finally, the concepts of mission, vision, policy and objectives are introduced in relation to quality management.

1. BY : MR. JASMIN SUTHAR
SR. ENGINEER – Q.A.
GALAXY SIVTEK PVT. LTD.

2.  The International Organization for Standardization (ISO)
brought out in 1987 a set of standards called ISO 9000 series of
standards on Quality Management System (QMS)
 This standard was brought in for the purpose of
establishing a customer oriented quality discipline in all
functions.
(Marketing, Design, Engineering, Production, Procurement, In
spection. Etc.)

3.  In 1950s, after the world war US defence dept. established the MIL-Q-
9858 standard as contractual specification for procurement.
 In 1979, UK published quality system standard
BS 5750 (3 parts) & BS 5781
 In 1987, ISO Geneva published a series of quality system
 First amendment was taken in 1994 (ISO 9000 : 1994)
 In Dec. 2000, the system was completely reviewed and new standard
ISO 9001 : 2000 series was released
 In 2008, ISO 9001 : 2008 series was released (Only introduced
clarifications to the existing requirements of ISO 9001 : 2000 and some
changes intended to improve consistency with ISO 14001 : 2004.

4.  Meet customer requirement
 Ger more revenue and business from new customers
 Improve Company and Product Quality
 Increase Customer Satisfaction with our Product.
 Develop a Professional Culture and Better Employee Morale
 Improve the Consistency of our Operations
 Improve Efficiency, Reduce Waste and Save Money

5. 5

6. QMS PRINCIPLES
1. Customer focus
 To identify and understand customer needs
 To satisfy customer requirements
 To meet customer expectations
2. Leadership
 Leaders establish unity of purpose, direction
of the organization
 Create and maintain the internal environment
in which people can becomes fully involved in
achieving the organization’s objective.
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7. QMS PRINCIPLES Continue
3. Involvement of People
 Full involvement of people at all level enables
their abilities to be used for the benefit of the
organization.
4. Process approach
Activities and related resources are managed as
a process to achieve desired goal
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8. QMS PRINCIPLES Continue
5. System approach to Management
 Identifying, understanding and managing a
system of interrelated processes as a
contribution to the organization’s effectiveness
and efficiency.
6. Continual Improvement
 Must become organization’s permanent
objective
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9. QMS PRINCIPLES Continue
7. Factual and documented approach to
decision making
 Effective decision are based on the analysis of
data & information.
8. Mutually beneficial relationship with the
suppliers
 Allows both the organization to create value
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10. Say What You Do
This means document your systems so you
will consistently do the job the same way every
time. We must make sure we have appropriate
documentation.
Do What You Say
This is what the auditors want to see.
Objective evidence that what you say you are
doing in your documentation is what you are
doing in practice.
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11. 4 Quality 5 Management 6 Resource 7 Product 8
Management Responsibility Management Realization Measurement
System Analysis &
improvement
Management
General Commitment Provision of Planning General
requirements resources
Customer focus Customer Monitoring &
Documentation Human related measurement
Requirements resources processes
Quality policy
Infrastructures Control of NCP
Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, a Improvements
uthority & Production &
communication service
provision
Management
Reviews Control of
monitoring &
measuring 11
equipment

12. 1. Determine the
5. Implement action, processes required
Continual For QMS
improvements
4.1 General
requirements
2. Criteria and
4. Monitoring and methods to ensure
Measuring of Operation & control
Processes,
Analysis the process
3. Availability of
information &
resources for
operation & control
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13. General
• Documented statement & Quality policy
• Quality Manual
• Documented Procedure & records
Quality Manual
4.2
Documentation Control of Documents
requirement • Approve doc. For adequacy
• Legible and identifiable
• Review and update
Control of records
• Identification, storage, protection, retrieval,
retention & disposition
• Provide evidence of conformity
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14. 5.1 5.2 5.3 5.4 5.5 5.6
Management Customer Quality Planning Responsibility Management
commitment focus policy authority & Review
communicate
Quality Responsibility General
objectives & authority
Review
QMS Management inputs
planning representative
Review
Internal outputs
communication
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15. Development, implementation and
Establishment of
continually improvement of QMS
•Quality Policy
•Quality Objectives (measurable &
consistent with Quality policy)
Ensuring the availability of resources
Top
Management’s Identification of Customer requirements &
commitment satisfaction
Communication of importance of
•Appointment of Management
Representative •Regulatory & statutory requirements
•Meeting customer requirements
•Conducting Management Reviews
•Quality Policy & Quality objectives
•Providing required resources •Responsibilities & authorities
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16. Processes needed for QMS are
established, implemented & maintained
Reporting to top management on the
MR Performance of QMS
(Responsibility
&
Authority)
Need for improvement for QMS
Liaison with external parties
16

17. 6.1 6.2 6.3 6.4
Provision of Human Infrastructures Work
resources Resources Environment
General
Competence,
awareness &
training
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18. Resources required to
Implementing, monitoring & continual
improvements
Enhance Customer satisfaction by meeting
customer requirements
Human Resources
Resource
Management Infrastructures
Infrastructures needed to achieve product
conformity
Work environment
Work environment needed to achieve product
conformity
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19. Competent on the basis of appropriate
education, skill and experience
Define competencies for people performing
work affecting product quality
6.2
Human Provide training or actions
Resources
Evaluate effectiveness of the training / actions
Employees should aware importance of the
activity being performed
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20. 7.1 7.2 7.3 7.4 7.5 7.6
Planning Customer Design and Purchasing Production Control of
of product related development & service monitoring &
processes provision measuring
realization equipment
Determination D&D planning Purchasing Control
of requirement process
related to the
D&D inputs Validation of
product
Purchasing processes
D&D outputs information
Review of Identification &
requirement D&D review Verification of traceability
related to the purchased
product products
D&D verification Customer
property
Customer
communication D&D validation
Preservation of
product
Control of D&D
Changes
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21. Quality objectives & requirement of
Products
Processes, procedures, resources to
realize product
7.1
Planning of Product
realization Verification, validation, monitoring, inspe
ction and testing of product
Record to demonstrate conformance
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22. Identification of Customer / Market
requirements
• Specified by customer
• Requirements taken for granted
• Statutory and regulatory requirements
7.2
Customer related
processes – (Sales) Review of requirements related
product prior to acceptance /
commitment to customers - ability to
meet customer requirements
Effective communication with customer in relation to
• Product information
•Enquiries, contracts or order handling, including
amendments
• Customer feedback, including Customer complaints
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23. Planning (Determine)
• stages
• review, verification, validation (each
stage)
•Responsibility and authority
7.3
Design and
Development
Design inputs and outputs
Review and verification, validation and control of changes
•Accuracy
•Potential hazards & faults
•Corrections
•Evaluations against lessons learned
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24. Degree of control depends on effects of
subsequent processes and effect on final
product
7.4
Purchasing
Purchasing is done
in controlled manner
to ensure that Supplier evaluation
purchased products
conforms to specific
requirements
Verification of purchased product –
Inspection and testing
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25. Product characteristics
(Specs) Procedures and work instructions
Suitable equipments to manufacture.
7.5 Monitoring and inspection & testing
Production and
service provision
Manufacturing / Product release, delivery and post delivery
service provision
under controlled
condition to ensure Process validation
conformity of product
Identification and traceability
•Customers property (Identify, verify, protect and safeguard)
•Preservation of product (during
processing, storage, Handling, delivery)
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26. • Calibrate and validate at specific interval
• traceable to international measurement
standard
7.6
Control of monitoring • Adjusted or re-adjusted as necessary
and measuring • Protect from damage and deterioration
equipment during handling, maintenance and storage
Identification in order to determine its
calibration status
26

27. 8.1 8.2 8.3 8.4 8.5
General Monitoring & Control of Analysis of Improvement
measurement non data
conforming
product
Customer Continual
satisfaction improvements
Internal audits Corrective
action
Monitoring &
Measurement of Preventive
processes action
Monitoring &
Measurement of
product
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28. To demonstrate
8.1 - To demonstrate
•Conformity of the product
•Plan & carried out inspection, testing, measurement, analysis & improvement
•Conformity to QMS requirements
processes.
•Continually improvements and the effectiveness of the system
•Demonstrate that products & services meet defined requirements.
•Continually improve the effectiveness of the QMS
8.2 - Monitoring and Measurements
•Measure Customer satisfaction / perception
•Conduct Internal audits
•Monitoring and measurements of processes – to demonstrate ability to meet
planned results
•Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP (Non Conforming Products)
•To assure that NCP products are identified and controlled to prevent
unintended use / delivery
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29. 8.4 - Analysis of data
Collection and analysis of data generated through QMS
activities to verify suitability, effectiveness and continual
improvement of the system
Analysis shall provide information related to
•Customer satisfaction / perception
•Conformity to specs, requirements
•Process data & product trends
• Opportunities for preventive actions
•Suppliers data
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30. 8.5 - Improvements
Continual Improvements
•QMS needed to be continually improved
Corrective action
•Resolve complaints and nonconformities.
•Investigate causes of nonconformities
•Record results of investigation.
•Corrective action is determined, carried out, effective &
reviewed.
Preventive action
•Use information from many sources to detect, analyze &
eliminate potential causes.
•Identify steps needed to prevent problems
•Ensure preventive action is effective
•Action taken are recorded and reviewed.
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31. Mission Purpose for which we are working?
What we would like to be? Vision
Policy Which path we need to adopt?
What we should achieve? Objectives
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32. • Does NOT define quality
• Is NOT a one-time process
• Is NOT easy
• Requires commitment
• Requires resources
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33. BY : MR. JASMIN SUTHAR
SR. ENGINEER – Q.A.
GALAXY SIVTEK PVT. LTD.
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