The document discusses the basics of quality management systems including definitions of quality, total quality management, ISO standards, quality management principles, benefits of certification, and key aspects of establishing a quality management system such as developing processes, auditing performance, and continually reviewing and improving the system. It provides an overview of quality management concepts, standards, and implementation.

1. Quality Management
System
• Mr. Namdeo G. Shinde
• Assistant Professor
• Department of Pharmaceutics,
• Satara College of Pharmacy, Degaon, Satara
• under
• Dr. Babasaheb Ambedkar Technological University,
Lonere Raigad, (MS) INDIA.

2. Basics of quality management system
Quality word oriented from Latin word ‘Qualitus’ it means General
excellence OR distinctive feature.
The customer or user is at focus.
If customer or user is happy and satisfied with our product or
service than product or service is called good quality.
Simply quality is ‘fitness for use’

3. It must be remember that the quality is not the job of only a single
person or single department but, it is responsibility of whole
organization.
Quality of Product and service is measurable, managerial,
technological and statistical feature of organization.

4. Total Quality: The term total quality was used for first time in 1969
in Tokyo by Feigenbaum at first international conference of Quality
Control.
Total Quality Management (1980s-1990s): A new phrase of Quality
Control & Management coined in Japan as Total Quality Management.
In 1987, International Organization for Standardization take lead and
launched ISO 9000 is a series of quality management systems (QMS)
standards based on BS 5750 series of standard of BSI.

5. Dr. Joseph Juran:
Quality there are no shortcut of quality, it is neither an accidental
not it happens overnight. Quality must be planned.
Quality planning, Quality control, Quality improvement
Dr. W. Edward Deming:
Adopt a new policy a transformation of the style of management.
Create a structure of organization which allows every one to work
towards transformation.
Philip B. Crosby:
Quality is to conformation requirements.
The performance standard is zero defect.

6. Total Quality Management (TQM)
Total Made up of the whole(or) Complete.
Quality Degree of Excellence a product or service provides to the
customer in present and future.
Management Act/art/manner of handling , controlling, directing, etc.
TQM is the art of managing the whole to achieve
excellence

7. “TQM is a management approach for an organization, centered on
quality, based on the participation of all its members and aiming at
long-term success through customer satisfaction, and benefits to all
members of the organization and to society.”
TQM requires that the company maintain this quality standard in all
aspects of its business. This requires ensuring that things are done
right the first time and that defects and waste are eliminated from
operations.
Definition:
Total Quality Management(TQM) is a management strategy aimed
at embedding awareness of quality in all organizational processes.

8. Six basic concepts of TQM
1. A committed and involved management to provide long term
top to bottom organization support.
2. An unwavering focus on the customer, both internally and
externally.
3. Effective involvement and utilization of the entire work force.
4. Continuous improvement of the business and production
5. Treating suppliers of the business and production process.
6. Establishing the performance measures

9. 6 Cs in TQM
1. Commitment
2. Culture
3. Control
4. Customer focus
5. Co-operation
6. Continuous improvements

10. Business success may simply be the extent to which your organization
can produce a higher-quality product or service than your
competitors are able to do at a competitive price.
When quality is the key to a company’s success, quality management
systems allow organizations to keep up with and meet current quality
levels, meet the consumer’s requirement for quality, retain
employees through competitive compensation programs, and keep
up with the latest technology.
WHY QUALITY IS IMPORTANT

11. Management systems are needed in all areas of activity, whether
large or small businesses, manufacturing, service or public sector.
A good QMS will:
• Set direction and meet customers’ expectations
• Improve process control
• Reduce wastage
• Lower costs
• Increase market share/ values
• Facilitate training
• Involve staff
• Raise morale

12. Quality Cost
Prevention Cost : Planning, Document, Control, Training Appraisal
cost- inspection test installation Calibration, M/c Depreciation,
Reports & Rejects.
Internal Failure Cost: Scraps, Repair Rework, Design Changes, Defect
Failure Analysis, Retests & Re-Inspection, Downgrading, Down Time.
External Failure Cost: Complaints, Goodwill, Failures, Services &
Replacement, Guarantee & Warranty, Compensation, Recall, Loss of
Sales, Seconds Sales.

13. Benefits of quality:
Improved quality
Employee participation
Less migration of employee
Team work
Internal external customer satisfaction
Productivity with connectivity
Profitability & increase market share

14. Continuous Quality Improvement (CQI)
It focus on the process of quality improvement
CQI implementation attempts to develop a quality system that is
never satisfied; it It strives for constant innovation to improve work
processes and systems by reducing time-consuming, low value-
added activities.

15. Find a process to improve.
Organize to improve a process.
Clarify what is known.
Understand variation.
Select a process improvement.
Then move through the process improvement plan:
Plan-Create a time line, including all resources, activities, dates, and
personnel training.
Do- Implement the plan and collect data.
Check—analyze the results of the plan.
Act—act on what was learned and determine the next steps.

16.  General elements of QMS includes:
 The organization’s quality policy and quality objectives
 Quality manual
 Procedures, instructions, and records
 Data management
 Internal processes
 Customer satisfaction from product quality
 Improvement opportunities
 Quality analysis
ELEMENTS AND REQUIREMENTS OF A QUALITY
MANAGEMENT SYSTEM

17. ESTABLISHING AND IMPLEMENTING QMS
Establishing a quality management system helps organizations run
effectively.
Before establishing a quality management system, the organization
must identify and manage various connected, multifunctional
processes to ensure customer satisfaction is always the target
achieved.

18. The basic steps to implementing a quality management
system are as follows:
Design
Build
Deploy
Control
Measure
Review
Improve

19. The design and build portions serve to develop the structure of a
QMS, its processes, and plans for implementation.
Senior management must oversee this portion to ensure the needs
of the organization and the needs of its customers are a driving force
behind the systems development.
Deploy:
Deployment is best served in a granular fashion i.e. breaking each
process down into sub processes, and educating staff on
documentation, education, training tools, and metrics.

20. Control and measurement are two areas of establishing a QMS that
are largely accomplished through routine, systematic audits of the
quality management system.
The specifics vary greatly from organization to organization
depending on size, potential risk, and environmental impact.
CONTROL AND MEASURE

21. Review and improvement deal with how the results of an audit are
handled.
The goals are to determine the effectiveness and efficiency of each
process toward its objectives, to communicate these findings to the
employees, and to develop new best practices and processes based
on the data collected during the audit.
REVIEW AND IMPROVE

22. ISO 9001:2008
Quality Management
Systems

23. ISO 9000:2005 – Quality Management Systems, Fundamentals
and Vocabulary
ISO 9001:2008 – QMS – Requirements (required for certification)
Management Responsibility:
Resource Management
Product/Service realization
Measurement, analysis, improvement
ISO 9004-2009 – QMS – Guidelines for performance improvement
ISO FAMILY

24. ISO 9001:2008
ISO 9001 is for Quality Management.
Quality refers to all those features of a product (or service)
which are required by the customer.
Quality management means what the organization does to ensure
that its products or services satisfy the customer's quality
requirements, and Comply with any regulations applicable to those
products or services.

25. Quality management also means what the organization does to
enhance customer satisfaction, and
achieve continual improvement of its performance
ISO 9001 is an generic standards.
Generic means that the same standards can be applied:
to any organization, large or small, whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department

26. Management system means what the organization does to manage its
processes, or activities in order that its products or services meet the
organization’s objectives, such as,
satisfying the customer's quality requirements,
complying to regulations, or
meeting environmental objectives
Everyone is clear about who is responsible for doing
what, when, how, why and where.
MANAGEMENT SYSTEMS

27. Management system standards provide the organization with an
international, state-of-the-art model to follow.
ISO 9001 concerns the way an organization goes about its work.
They are not product /service standards.
They are process standards.
They Can be used by Product manufacturer and service providers.
ISO 9001 gives the requirements for what the organization
must do to manage processes affecting quality of its products
and services.

28. CERTIFICATION AND REGISTRATION
Certification is known as Registration in some countries.
An Independent, external body has audited an organizations
management system and verified that it conforms to the
requirements specified in the standard (ISO 9001).

29. The major reason why many companies want ISO 9001 certification is
that they want to portray themselves as a worthy company to do
business with, many of them do not really realize the benefits.
Direct Benefits:
• Improved customer satisfaction;
• Improved quality of products and services;
• Employees satisfaction and more commitment to the organization;
• Better management and a more effective organization;
• Improve relations with suppliers;
• Improved promotion of corporate image.
BENEFITS OF ISO CERTIFICATION

30. Indirect Benefits:
• Review business goals, and assess how well the organization is
meeting those goals;
• Identify processes that are unnecessary or inefficient, and then
remove or improve them;
• Review the organizational structure, clarifying managerial
responsibilities;
• Improve internal communication, and business and process
interfaces;
• Improve staff morale by identifying the importance of their output
to the business, and by involving them in the review and improvement
of their work.

31. QMS PRINCIPLES
Any organization can benefit from implementing ISO 9001 as its
requirements are underpinned by 8 management principles:
A customer focused organization
Leadership
The involvement of people
Ensuring a process approach
A systematic approach to management
A factual approach to decision making
Mutually beneficial supplier relations
Continuous improvement.

32. QUALITY MANUAL
Quality Manual is the main, top-level document which establishes
the quality policies and objectives of an organization.
It provides evidence of what specific controls are implemented to
ensure product/service quality.
Benefits to
• Customers
• Suppliers
• Employees
• The Company