Quality Management System

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.
◼ 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.
 Purpose of QMS

◼ Quality management systems serve many purposes,

including:
 Improving processes
 Facilitating and identifying training opportunities

 Engaging staff

 Setting organization-wide direction

 Benefits of QMS
◼ 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.
 Elements & Requirements of QMS
◼ 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.
 Establishing & 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 *Deploy *Measure *Improve
*Build *Control *Review
 Design & 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.
 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.
 Control & 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.
 Review & 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.
 ISO 9001:2008

Quality Management System

 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

 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.
 ISO 9001:2008 (Cont…)

◼ Quality management also means what the organization does to:

 Enhance customer satisfaction, and

 Achieve continual improvement of its performance.
 ISO 9001:2008 (Cont…)

◼ ISO 9001 is a generic standard. 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
 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

 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.
 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.
 Certification & 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).
 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.
 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.
 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.
4 Levels of Documents
 Quality Manual

◼ A Quality Manual is the main, top-level document which

establishes the quality policies and objectives of an
organization.
 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
 A Quality Manual Should…

1. Address all Quality System elements

2. Contain or refer to quality procedures

“Documentation”
The Importance of Documentation
 Benefits of Documentation

◼ Quality Manual
 The key is to move towards:

◼ Consistently repeating the best practices

and

◼ Improving those processes that are lacking

 Basic Quality Manual Outline
* Introduction * Compliance
* Policy and Objectives * Internal Review and Audit
* Definitions * Documentation and Change
* Quality System * Purchasing
* Inspection and Testing
* Organization
* Training
* Authority and Responsibilities
Advantages of Quality Manual

◼ To prevent risks
◼ To detect deviations
◼ To correct errors
◼ To improve efficiency
◼ To reduce costs
◼ To meet customer needs
◼ To market company
 Procedures

◼ Procedure is defined as-an established or official way of

doing something.

◼ In this case we will follow the standard operating

procedures.
 Work Instructions

◼ 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.
 Documents, Forms, Records…

◼ It includes the following:

 Data sheets
 Lab results sheets

 Customer feed back forms

 Evaluation forms of employees

 Etc.
Six Sigma
 Six Sigma

◼ According to the Quick Guide to Six Sigma Statistics, Six

Sigma basically means a measure of quality that endeavors
for near perfection. Six Sigma is a disciplined, data-driven
approach and methodology for eliminating defects (driving
toward six standard deviations between the mean and the
nearest specification limit) in any process – from
manufacturing to transactional and from product to service.
◼ The statistical representation of Six Sigma illustrates
quantitatively how a process is performing. To accomplish
Six Sigma, a process must not produce more than 3.4
defects per million opportunities. A Six Sigma defect is
defined as anything outside of customer specifications. A
Six Sigma opportunity is then the total quantity of chances
for a defect.
◼ The primary intention of the Six Sigma methodology is the
execution of a measurement-based strategy that centers on
process improvement and variation reduction through the
application of Six Sigma improvement projects.
Why 6 Sigma?
Quality Improvement
 6 Sigma is about…

◼ 6σ is about Customers
 Customer satisfaction and customer value.
◼ 6σ is about Variation
 Special and Common Cause of Variation,
 Process Capability.

◼ 6σ is about Process and Scientific Investigation,

 Business Processes the Reality,
 Scientific Investigation.

◼ 6σ is about People and Learning Not Cost

 Goals of 6 Sigma
 Quality control,
 Identify, analyze, and remove causes of errors and defects in the
organization,
 Total Quality Management,

 Ultimate goal: Zero defects,

 Reducing variability in business and manufacturing processes,

 Expand a company’s top line performance.

 Methodologies

◼ Six sigma projects follow 2 methodologies

DMAIC DMADV
- used for projects aimed at improving - used for projects aimed at creating
an existing business process. new product or process designs.

Five phases: Five phases:

1. Define 1. Define
2. Measure 2. Measure
3. Analyze 3. Analyze
4. Improve 4. Design
5. Control 5. Verify
Benchmarking
 Benchmarking

◼ The process of improving performance by continuously

identifying, understanding, and adapting outstanding
practices found inside and outside the organization.

◼ At its simplest, benchmarking means…

“Improving ourselves by learning from others.”

Benchmarking…

◼ Benchmarking is the process of comparing ones business

processes and performance metrics to industry bests and/or
best practices from other industries.
 Why are others better?
 How are others better?

 What can we learn?

 How can we catch up?

 How can we become the best in our industry?

Benchmarking…

…is the practice of being humble enough to admit that

someone else is better at something and wise enough to try
and learn how to match and even surpass them at it.”
Benchmarking Features
Commonly Benchmarked Performance Measures

◼ Financial Ratios
◼ Productivity Ratios
◼ Customer-Related Results
◼ Operating Results
◼ Human Resource Measures
◼ Quality Measures
◼ Market Share Data
◼ Structural Measures
 Why Benchmarking?

◼ Benchmarking gives us the chance of gaining:

 Better awareness of ourselves (US)
◼ What are we doing?
◼ How are we doing it?

◼ How well we are doing it?

 Better awareness of the best (THEM)

◼ What are they doing?
◼ How they are doing it?

◼ How well they are doing it?

 Advantages of Benchmarking

◼ Product and Process Improvement

◼ Time and Cost Reduction
◼ Competitive Strategy
 Disadvantages of Benchmarking

◼ What is best for someone else may not suit you

◼ Poorly defined benchmarks may lead to wasted effort and
meaningless results
◼ Incorrect comparisons
◼ Reluctance to share information
Types of Benchmarking