Quality management system

1. QUALITY MANAGEMENT SYSTEM
(QMS)
By:
Hanu Dadhwal

2. QUALITY MANAGEMENT SYSTEM
(QMS)
 A quality management system (QMS) is a formalized
system that documents processes, procedures, and
responsibilities for achieving quality policies and
objectives.
 A QMS helps to coordinate and direct an
organization’s activities to meet customer and regulatory
requirements and improve its effectiveness and
efficiency on a continuous basis.

3. PURPOSE OF QMS
Quality management systems serve many purposes,
including:
 Improving processes
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction

4. BENEFITS OF QUALITY MANAGEMENT
SYSTEMS
 Implementing a quality management system affects every aspect of an
organization's performance.
 Two overarching benefits of quality management systems include:
 Meeting the customer’s requirements, which helps to install confidence
in the organization, in turn leading to more customers, more sales, and
more repeat business.
 Meeting the organization's requirements, which ensures compliance
with regulations and provision of products and services in the most cost-
and resource-efficient manner, creating room for expansion, growth, and
profit.

5. ELEMENTS AND REQUIREMENTS OF A
QUALITY MANAGEMENT SYSTEM
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
Each element of a quality management system serves a purpose toward the
overall goals of meeting the customers’ and organization’s requirements.
Ensuring each of the elements of a QMS is present ensures proper execution
and function of the QMS.

6. 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, multi-
functional processes to ensure customer satisfaction is always the target
achieved.
The basic steps to implementing a quality management system are as
follows:
 Design
 Build
 Deploy
 Control
 Measure
 Review
 Improve

7. DESIGN AND BUILD
 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.

8. 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. Company intranets are increasingly
being used to assist in the deployment of quality
management systems.

9. CONTROL AND MEASURE
 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.

10. REVIEW AND IMPROVE
 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.

11. ISO 9001:2008
Quality Management
Systems

12. ISO FAMILY
 ISO 9000:2005 Consists of 3 areas
 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

13. 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.

14. ISO 9001:2008(CONT…..)
 Quality management also means what the organization
does to
 enhance customer satisfaction, and
 achieve continual improvement of its performance.

15. ISO 9001:2008(CONT…..)
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

16. ISO 9001:2008(CONT…..)
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

17. MANAGEMENT SYSTEMS
 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

18. MANAGEMENT SYSTEMS (CONT….)
 To be really efficient and effective, the organization can
manage its way of doing things by systemizing it.
 Nothing important is left out.
 Everyone is clear about who is responsible for doing
what, when, how, why and where.
 Management system standards provide the organization
with an international, state-of-the-art model to follow.

19. MANAGEMENT SYSTEMS (CONT….)
 ISO 9001 concerns the way an organization goes about its
work.
 They are not product standards.
 They are not 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.

20. 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).

21. BENEFITS
 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 (some
direct and others indirect):
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.

22. BENEFITS
 Indirect Benefits: It helps companies to
• 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.

23. 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.

24. 4 LEVELS OF DOCUMENTS

25. QUALITY MANUAL?
A Quality Manual is the main, top-level
document which establishes the quality
policies and objectives of an organization.

26. WHAT WILL A QUALITY MANUAL
PROVIDE TO A COMPANY?
 Overall it provides evidence of what
specific controls are implemented to
ensure product/service quality.
 Who will benefit ?
• Customers
• Suppliers
• Employees
• The Company

27. A QUALITY MANUAL SHOULD….
1. Address all Quality System elements
2. Contain or refer to quality procedures
“Documentation”

28. THE IMPORTANCE OF DOCUMENTATION

29. BENEFITS OF DOCUMENTATION:
QUALITY MANUAL
 The Key is to move towards:
 Consistently repeating the best practices
and
 Improving those processes which are lacking

30. BASIC QUALITY MANUAL OUTLINE
 Introduction
 Policy and Objectives
 Definitions
 Quality System
 Organization
 Authority and Responsibilities
 Compliance
 Internal Review and Audit
 Documentation and Change
 Purchasing
 Inspection and Testing
 Training

31. ADVANTAGES OF QUALITY
MANUAL
1. To prevent risks
2. To detect deviations
3. To correct errors
4. To improve efficiency
5. To reduce costs
6. To meet customer needs
7. To market company

32. PROCEDURES
 Procedure is defined as-an established or official
way of doing something.
 In this case we will follow the standard operating
procedures .

33. WORK INSTRUCTIONS
 A work instruction is a tool provided to help someone
to do a job correctly. This simple statement implies that
the purpose of the work instruction is quality and that
the target user is the worker.

34. DOCUMENTS , FORMS , RECORDS….
 It includes data sheets, lab results sheets ,
customer feed back forms, evaluation forms of
employees etc.

35. WHAT IS OUR QUALITY POLICY?
 CPTL EIA division strives to become a leading
consultants with highest standards in the active field of
EIA/EMP for carrying out environmental
monitoring/analysis & audits in a professional ,
systematic & accurate manner.
 These objectives will be achieved through customer
satisfaction with an attitude of dedicated professional
expert in the organization
 All these objectives will be in accordance to ISO 9001:
2008 Quality Management System.

36. WHAT IS OUR QUALITY OBJECTIVE?
 The C.E.O ensures that this quality policy laid for CPTL-
EIA division is available to all its personnel which is
duly understood and meritoriously followed by all the
staff.