What is Quality ? Degree to which a set of inherent
characteristics fulfill requirements Characteristics include
Distinguishing features Inherent & or Assigned requirements
Qualitative or Quantitative Stated implied or Obligatory
requirements What is Quality ? Degree to which a set of inherent
characteristics fulfill requirements Characteristics include
Distinguishing features Inherent & or Assigned requirements
Qualitative or Quantitative Stated implied or Obligatory
requirements
Slide 3
Many Facets of Quality Quality of Work Quality of services
Quality of information Quality of process Quality of system Quality
of People Quality of Objective Quality of Company Many Facets of
Quality Quality of Work Quality of services Quality of information
Quality of process Quality of system Quality of People Quality of
Objective Quality of Company
Slide 4
Quality Management Principles Customer Focus (5,7,8)
Leadership(5,8) Involvement of People(5,6) Process Approach (4,7)
System Approach to management (4,5,8) Continual Improvement (5,8)
Factual Approach to decision making (8) Mutually beneficial
supplier relationship (7.4) Quality Management Principles Customer
Focus (5,7,8) Leadership(5,8) Involvement of People(5,6) Process
Approach (4,7) System Approach to management (4,5,8) Continual
Improvement (5,8) Factual Approach to decision making (8) Mutually
beneficial supplier relationship (7.4)
Slide 5
Evolution of QA Standards As a measure to standardize in 1972
November came BS 4891 A (A guide to QA) In 1975 BS 5750 was
published in three parts This led to formation of technical
committee in QA which drafted ISO 9000 series Members from 81
countries formed this technical committee India is one of the
member of this technical committee Evolution of QA Standards As a
measure to standardize in 1972 November came BS 4891 A (A guide to
QA) In 1975 BS 5750 was published in three parts This led to
formation of technical committee in QA which drafted ISO 9000
series Members from 81 countries formed this technical committee
India is one of the member of this technical committee
Slide 6
Evolution of QA Standards 1.It started consequent to lessons
learnt during the world War II This led to a revolutionary approach
to quality. During war though the products were meeting the
standard specifications but were failing in the functionality
consistency from product to product was missing This led to Quality
Ordinance was formulated in USA In Europe as NATO AQAP republished
as DEFSTANS Evolution of QA Standards 1.It started consequent to
lessons learnt during the world War II This led to a revolutionary
approach to quality. During war though the products were meeting
the standard specifications but were failing in the functionality
consistency from product to product was missing This led to Quality
Ordinance was formulated in USA In Europe as NATO AQAP republished
as DEFSTANS
Slide 7
Evolution of QA Standards Systematic way of managing an
organizations QMS Based on Plan-Do-Check-Act Model (PDCA) Focused
on Improvement of QMS Systematic way of managing an organizations
QMS Based on Plan-Do-Check-Act Model (PDCA) Focused on Improvement
of QMS
Slide 8
Process Approach A quality system is based on processes Any
activity or group of activities that takes inputs add value to it
and provides an out put to an internal or external customer
Processes use organizations resources to provide definitive results
( Purchasing, Marketing, Training, Manufacturing, QA, QC Storage
Designing r processes) A process approach treats QMS as a set of
interrelated processes covering not only the manufacture of a
product or provision of a service, but also management processes
and support processes. A "process" is something that transforms a
collection of inputs into outputs. Process Approach A quality
system is based on processes Any activity or group of activities
that takes inputs add value to it and provides an out put to an
internal or external customer Processes use organizations resources
to provide definitive results ( Purchasing, Marketing, Training,
Manufacturing, QA, QC Storage Designing r processes) A process
approach treats QMS as a set of interrelated processes covering not
only the manufacture of a product or provision of a service, but
also management processes and support processes. A "process" is
something that transforms a collection of inputs into outputs.
Slide 9
EMS documentation 4.4.4 Model of Process
Slide 10
Policy Planning Implementation Checking Corrective Action
Management Review QMS Model is Based on the P-D-C-A Model,
Plan-Do-Check-Act which is an iterative four-step management method
used in business for the control and continuous improvement of
processes and products. It is also known as Deming Cycle
Slide 11
What is a Process ? Any activity or group of activities that
takes an input add value to it and provides an out put to internal
or external customer is called a process. Processes use resources
& blend or transform them to produce desired results. A
business consist of following processes: Purchasing, Marketing,
Training, Manufacturing, QA,QC,Storage,Designing What is a Process
? Any activity or group of activities that takes an input add value
to it and provides an out put to internal or external customer is
called a process. Processes use resources & blend or transform
them to produce desired results. A business consist of following
processes: Purchasing, Marketing, Training, Manufacturing,
QA,QC,Storage,Designing
Slide 12
PLAN - objectives and processes necessary to deliver results in
accordance with expected output ie the target or goals &
customer requirements DO - Implement the plan, execute the process,
make the product. CHECK - Monitor & Measure processes against
objectives/policiesCollect data for charting and analysis Study the
actual results & compare against the expected results ACT -
Carry out corrective actions on significant differences between
actual and planned results. Analyze the differences to determine
their root causes. Take action for continual improvement
Slide 13
Why Implement QMS? Struggling to stay in compliance and keep
track of regulations/laws QMS is just one of many responsibilities
Establish a framework to move beyond compliance Vehicle for
positive change; improved employee morale, enhanced public image
Employee turnover Last but not least To check whether the
product/services meet the customer requirements Why Implement QMS?
Struggling to stay in compliance and keep track of regulations/laws
QMS is just one of many responsibilities Establish a framework to
move beyond compliance Vehicle for positive change; improved
employee morale, enhanced public image Employee turnover Last but
not least To check whether the product/services meet the customer
requirements
Slide 14
Quality Management Principles QMS is based on System approach
to management Improvement Factual approach to decision making
Mutually beneficial supplier relationships Customer focused
organization Leadership Involvement of people Process approach
Quality Management Principles QMS is based on System approach to
management Improvement Factual approach to decision making Mutually
beneficial supplier relationships Customer focused organization
Leadership Involvement of people Process approach
Slide 15
To Whom Do these Standards Apply? Standard is Voluntary Large
and Small Business & Industry Service Sectors (hospitals,
hotels, etc.) City and County Government Applicable to all types of
organizations, of all sizes anywhere in the world To Whom Do these
Standards Apply? Standard is Voluntary Large and Small Business
& Industry Service Sectors (hospitals, hotels, etc.) City and
County Government Applicable to all types of organizations, of all
sizes anywhere in the world
Slide 16
Expected changes during 2015 from previous standards 1 ISO
9001:2015 QMS standard shall align with high-level organizational
structure 2 Greater emphasis on risk-based thinking 3 Focus on
achieving value for the company and its customers 4 Increased
flexibility regarding use of documentation Expected changes during
2015 from previous standards 1 ISO 9001:2015 QMS standard shall
align with high-level organizational structure 2 Greater emphasis
on risk-based thinking 3 Focus on achieving value for the company
and its customers 4 Increased flexibility regarding use of
documentation
Slide 17
Quality Management Principles These 8 principles manifest
themselves through four main clauses of management responsibility
Resource management Product realization Measurement Analysis and
improvement Documentation of processes All these clauses are
structured around PDCA cycle Quality Management Principles These 8
principles manifest themselves through four main clauses of
management responsibility Resource management Product realization
Measurement Analysis and improvement Documentation of processes All
these clauses are structured around PDCA cycle
Slide 18
Introduction A good QMS, if integrated into goals, provides a
way to reduce variation which may provide financial benefits such
as reduced scrap and general process efficiencies. A
well-functioning QMS makes good sense from a business and financial
perspectives. Introduction A good QMS, if integrated into goals,
provides a way to reduce variation which may provide financial
benefits such as reduced scrap and general process efficiencies. A
well-functioning QMS makes good sense from a business and financial
perspectives.
Slide 19
ISO is an acronym It is a greek word meaning equal consistency
ISO International organization for standardization ISO initially
traces its evolution from US military quality MIL-Q.9058A The
NATO-AQAPI & BS 5750 Created by the International Organization
of Standardization, a non- governmental organization (NGO)
established in 1947 ISO is a worldwide federation of national
standards bodies from over 100 countries; American National
Standards Institute (ANSI) is US representative. They have created
many standards ISO is an acronym It is a greek word meaning equal
consistency ISO International organization for standardization ISO
initially traces its evolution from US military quality MIL-Q.9058A
The NATO-AQAPI & BS 5750 Created by the International
Organization of Standardization, a non- governmental organization
(NGO) established in 1947 ISO is a worldwide federation of national
standards bodies from over 100 countries; American National
Standards Institute (ANSI) is US representative. They have created
many standards
Slide 20
QMS Requirements ISO 9001:2008 QMS standard specifies the
requirements where in an organization need to demonstrate its
ability to provide a product that meets customers & applicable
statutory & regulatory requirements & must aim to enhance
customer satisfaction through effective application of the system
All requirements are generic in nature & applicable to all
types of organizations. Any requirement which can not be applied to
any organization due nature of an organization may be considered
for exclusion. QMS Requirements ISO 9001:2008 QMS standard
specifies the requirements where in an organization need to
demonstrate its ability to provide a product that meets customers
& applicable statutory & regulatory requirements & must
aim to enhance customer satisfaction through effective application
of the system All requirements are generic in nature &
applicable to all types of organizations. Any requirement which can
not be applied to any organization due nature of an organization
may be considered for exclusion.
