Ch-4 ISO(Quality Management Systems)
Transcript of Ch-4 ISO(Quality Management Systems)
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Quality Circles
Is a small group employees in the same
work area or doing a similar type of work
who voluntarily meet regularly for about anhour every week to identify, analyze and
resolve work-related problems, leading to
improvement in their total performance
and enrichment of their work life.
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Features of QCSmall group of employees
Belong to same work area
Voluntary participation
Meet regularly every week
Identify analyze and resolve work related problems
They contribute to better performanceThey aim at enrichment of work life
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What QCs are not
Are not just for quality problems
Not substitute for task forces, product committees,
joint plant councils & quality assurance groups.
Do not change the existing structure of the
organization
Not means for the management to unload all their
problemsNot a forum for grievances
Are not a panacea for all ills of an organization
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QC BenefitsTeam sprit development
Change in the attitudeSelf development
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Chapter
4 QualityManagement Systems
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Introduction
A QMS can be defined as "A set of co-ordinated activities to direct and control
an organisation in order to continually improve the effectiveness and
efficiency of its performance."
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Cont.
The Benefits of a QMS
1. The customers' requirements confidence in the ability of the
organisation to deliver the desired product and service consistently
meeting their needs and expectations.
2. The organisation's requirements both internally and externally, and at
an optimum cost with efficient use of the available resources
materials, human, technology and information.
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Cont.
QMS
Organizations
Business
Progress
Time
QMS and Business Growth
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A good QMS will Set direction & meet customers expectation. Improve process control
Reduce wastage Lower costs
Increase market share
Facilitate training Involve staff
Raise morale
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Different ISO Standards
ISO 9001:2008 gives the requirements for quality
management systems.
Certification to the standard is used in global supply
chains to provide assurance about suppliers' ability tosatisfy quality requirements and to enhance customer
satisfaction in supplier-customer relationships.
ISO 14001:2004, which gives the requirements for
environmental management systems, retains its global
relevance for organizations wishing to operate in an
environmentally sustainable manner.
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Different ISO Standards
ISO/TS 16949:2009 gives the requirements for
the application of ISO 9001:2008 by suppliers
in the automotive sector.
ISO 13485:2003 gives quality management
requirements for the medical device sector for
regulatory purposes.
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Different ISO Standards
ISO/IEC 27001:2005 gives the requirements
for information security management systems.
ISO 22000:2005 gives the requirements for
food safety management systems.
ISO 50001:2011 gives the requirements for
energy management systems.
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What is ISO 9000?
The International Organization for Standardization (ISO) was founded
in 1946 in Geneva, Switzerland.
The objective of this organization is to promote the development of
international standards to facilitate free exchange of goods and
services across the globe.
ISO 9000 defines quality system standards.
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ISO 9000 objectives: Achieve, maintain & seek to continuously improveproduct quality & after sales services in relationship
to requirements.
Improve the quality of operations to continuously
meet customers stakeholders' stated & impliedneeds.
Provide confidence to internal & other stakeholders
that quality requirements are being achieved in thedelivered products.
Provide confidence that quality system
requirements are fulfilled.
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Benefits of ISO 9000 Certification
1. Achievement of international standard quality
2. Higher productivity
3. Increased customer satisfaction
4. Higher profitability
5. Higher employee morale
6. Reduction in customer complaints
7. Increased market share
8. Acceptability of the product in other countries, leading to increasedexport sales
9. Improved corporate image of the organization
10. Reduced need for inspection
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Cont.
ISO 9000: 2000 Series of Standards
ISO 9000: 2000 standards focus on developing, documenting and
implementing procedures to ensure consistency of operations and
performance in production and service delivery processes.
ISO 9000: 2000 consists of three series of standards:
1. ISO 9000: 2000Quality Management Systems (QMS): fundamental &
vocabulary discuss fundamental concepts to QMS & provides terminology
used in other standards.
2. ISO 9001: 2000Quality Management Systems (QMS): standard used
for registration by documenting conformity of the QMS to customer,
regulatory & organization requirements.
C
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3. I SO 9004: 2000Quality Management
Systems (QMS): guidelines for performanceimprovements provide guidelines that an
organization can use to establish a QMS
focused on improving performance.
Note: ISO 9000 standards revised in 2008,
known as ISO 9000:2008.
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Cont.
ISO 9000: 2000 Quality Management Principles
1. Principle of customer focus
2. Principle of Leadership
3. Principle of involvement of people
4. Principle of process approach
5. Principle of systems approach to management
6. Principle of continuous improvement
7. Principle of factual approach to decision-making
8. Principle of mutually beneficial supplier relationship
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Principle of customer focus: organization
should understand clear present & futurecustomer needs, & strive continuously for
exceeding the customer expectation.
Principle of leadership: most important part ofquality management. Create an internal
environment in which employees can perform
& involve fully in the process of achievingorganization quality goals.
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Principle of involvement of people: HR are key components of
the organization & success of an organization depends on its
employee involvement in quality management efforts.
Employees full involvement helps organization in achieving
its objective.
Principle of process approach: ISO 9000 calls for process
approach as good process automatically leads to good output.
Hence organization must focus on better and standard process
which can prevent defects rather than focusing corrective
actions.
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Principle of systems approach to management: organizations are
made of interrelated components in the form of various
functional groups & department with coordinated efforts.
Hence identifying understanding, & managing interrelated
process as s system contributes to the organizationseffectiveness & efficiency.
Principle of continuous improvement: organizations should focus
continuous improvement of existing products, services &
process. Continuous improvements of organizations overall
performance should be the permanent of the organization.
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Principle of realistic approach to decision-making: Data is the
most important for any decision-making. Hence collection of
reliable data is very important & effective decisions are made
on the analysis of accurate data.
Principle of mutually beneficial supplier relationship: Quality
products & services depends on quality of the inputs hence
suppliers are the key for getting best quality inputs. An
organization are interdependent and mutually beneficial
relationship enhances the ability of both to created value.
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Cont.
ISO 9001 Requirements
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management Systems (QMS)
5. Management Responsibilities
6. Resource Management
7. Product realization
8. Measurement, analysis and improvement
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1.Scope: the organization to demonstrate its ability to
provide a product that meets customer & regulatoryrequirements & achieve customer satisfaction.
2.Normative Reference: ISO 9000: 2000 QMS-
Fundamental & Vocabulary are normative reference
that provide applicable concepts & definition.
3.Terms & Definition: for the purposes of this
standard the terms & definitions given in ISO:2000
apply. In addition, the supply chain is defined as:Supplier-------Organization-------Customer
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4.Quality Management System (i) General Requirements: the organization shall establish,
document, implement & maintain QMS & continually improveits effectiveness.
(a) identify needed process such as management activities,
provision for resource, product realization & measurement.
(b) Determine their sequence & interaction.(c) Determine criteria & methods for effective operation &
control of these process.
(d) Ensure the availability of resources & information necessary
to support & monitor these processes.(e) Monitor, Measure, & analyze these process.
(f) Implement actions to achieve planned results & continuous
improvement of theses processes.
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4.Quality Management System (ii) Documentation: includes quality policy,
quality manual, documented procedures,operation & Control of processes etc.
Quality manual shall be established & maintained &
it must contain interactions among QMS processes. All the records must be established & maintained to
provide evidence of conformity.
Records must be legible, readily identifiable &
retrievable.
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5. Management Responsibilities
(i) Management Commitment
(ii) Customer focus
(iii) Quality Policy
(iv) Planning
(v) Responsibility, authority, & Communication
(vi) Management Review
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6. Resource Management
I. Provision of resources
II. Human Resources
III. Infrastructure
IV.Work environment
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7. Product realizationi. Planning of product realization
ii. Customer related processes
iii. Design & development
iv. Purchasing
v. Production & Service provision
vi. Control of monitoring & measuring devices
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Cont.
Implementation
The process of im plement in g ISO 9000 depends on :
Step 1:Top Management Commitment
Step 2:Establish Implementation Team
Step 3:Start ISO 9000 Awareness Programmes
Step 4:Provide Training
Step 5:Conduct Initial Status Survey
Step 6:Create a Documented Implementation Plan
Step 7:Develop Quality Management System Documentation
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Step 8:Document Control
Step 9:Implementation
Step 10:Internal Quality Audit
Step 11:Management Review
Step 12:Pre-assessment Audit
Step 13:Certification and Registration
Step 14:Continual Improvement
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Step 1:Top Management Commitment
Communicating the importance of customer as well as statutory &
regulatory requirements. Defining quality policy & making this known to every employees.
Ensuring that quality objectives are established at all levels and functions
Ensuring the availability of resources required for the development &
implementation of the QMS.
Appointing a management representative (MR) to coordinate QMS
activities
Conducting management review.
The management should also consider action such as1. Leading the organization by example,
2. Participating in improvement projects.
3. Creating an environment that encourages the involvement of people.
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Step 2:Establish Implementation Team
Establish team & appoint a management
representative (MR).
MR is coordinator to plan and oversee
implementation. Team should contain, all functional
department: Marketing, design &
development, planning, production,quality control etc.,
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Step 3:Start ISO 9000 Awareness Programmes
Arrange the awareness programme about, the QMS , the advantage it offers to
employees, customers & the organization.
The awareness programme should emphasize the benefits that organization expects
to realize through its ISO 9000 quality management system.
The programme should also stress the higher levels of participation & self-direction
that quality management system renders to employees.
The programme could be conducted by implementation team or by experts hired toeducate all levels of employees.
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Step 4:Provide Training
The training should cover the basic concepts of QMS &
standards & overall impact on the strategic goals of
the organization, the changed processes, likely work
culture implication s of the system.
Training is also necessary for writing the quality
manual, procedures, work instruction, auditingprinciples, techniques of laboratory management,
calibration, testing procedures, etc,
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Step 5:Conduct Initial Status Survey
Ascertain and establish the following
What is the present operation/process? What already exists?
Analyze the relevant sections of the quality standards-ISO
9001:2000:
What is actually required?
If necessary, supplement and change operational arrangement
in accordance with the standard, develop documents and
records and describe operations/processes.
What is desired operation/process?
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Step 6:Create a Documented Implementation Plan
The implementation plan should through & specific
1. Quality documentation to be developed
2. Objective of the system
3. Pertinent ISO 9001: 20000 section
4. Person or team responsible
5. Approval required
6. Training required
7. Resources required
8. Estimated completion date
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Step 7:Develop Quality Management System Documentation
Documentation of the QMS includes
1. Documented statements of a quality policy & quality objectives.
2. A quality manual
3. Documented procedures & records required by the standard ISO 90001:
2000,
4. Documents needed by the organization to ensure the effective planning,
operation and control of its processes.
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Step 8:Document Control
Should include
1. approval for adequacy by authorized person before issue,
2. Review, updating & re-approval of documents by authorized person
3. Identification of changes and of the revision status of documents
4. Availability of relevant versions of documents at points of use
5. Identification and control of documents of external origin
6. Assurance of legibility and identifability of documents, and prevention of
unintended use obsolete documents.
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Step 9:Implementation
QMS being documented as documentation is developed.
In smaller companies the QMS can be implemented all at once throughout.
The implementation progress should be monitored to ensure that the QMS
is effective & conforms the to the quality.
The activities include internal quality audit, formal corrective action and
management review.
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Step 10:Internal Quality Audit
Check regularly internal quality audits to verify the installed QMS.
1. Conforms to the planned arrangements, to the requirements of the
ISO:2000 & to the QMS requirements established by theorganization.
2. Is effectively implemented & maintained.
3. Internal audits should be planned and performed as part of an
ongoing strategy.
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Step 11:Management ReviewThe management review include information on:
1. Results of audits
2. Customer feedback
3. Process performance and product conformity
4. Status of preventive and corrective actions
5. Follow-up actions from previous management reviews
6. Changes that could affect the QMS and
7. Recommendations for improvements.
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Step 12:Pre-assessment Audit If no nonconformance exists normally time to apply for the
certification
A pre-assessment audit should be arranged with an
independent and qualified auditors.
The pre-assessment audit would provide a degree of
confidence for formally going ahead with an application forcertification.
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Step 13:Certification and Registration Once QMS has been operation for few months & stabilized.
The formal application for certification could be made to
selected certification agency.
If the documents conform to the requirements of the quality
standard , then on-site audit is carried out.
If certification bodies find the system to be working
satisfactory, it awards the organization a certificates for period
of 3-years.
During this 3-year period, it will carry out surveillance audits
to ensure that the system is continuing to operate satisfactorily.
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Step 14:Continual Improvement
organization should continually seek to improve the
effectiveness & suitability of the QMS through the
use of:
1. Quality policy
2. Quality objective3. Audit results
4. Analysis of data
5. Corrective & preventive actions
6. Management review
ISO 9004:2000 provides a methodology for continual
improvement.
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Q y g y
ISO 9001:2008 Standard
The ISO 9000 standard contains requirements
affecting virtually all aspects of any company.
Because ISO 9000 is designed for any
company of any size and in any industry, the
requirements are rather broad and hard to read.
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ISO 9001:2008 Standard
The ISO 9001:2008 requirements fal l into th e fol low ing sect ions :
Section 1: Quality Management System
Section 2: Management Responsibility
Section 3:Resource Management
Section 4: Product Realization
Section 5:Measurement, Analysis and Improvement
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Section 1: Quality Management SystemISO 9001: 2008 standards outlines the necessary steps to
implement the ISO 9001 QMS:
1. Identify the process needed for the QMS.
2. Determine the sequence & interaction of these processes.
3. Determine how these process are effectively operated and
controlled.
4. Ensure all information is available to support the operation &
monitoring of these processes.
5. Measure, monitor & analyze these processes, & implement
action necessary to correct the process and achieve continual
improvement.
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Section 2: Management Responsibility
Top management commitment to quality is important.
Requires a quality policy, objective, reinforces the
involvement of top management with customer requirement.
Top management has to establish responsibilities & authorities
within the company, including Management Representative.
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Section 3:Resource Management
Determine the requirements, provide in timely
manner, resources needed to implement and
improve the processes of QMS and address
customer satisfaction.
Including employee training as well as for the
physical facilities and work enviornment
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Section 4: Product Realization
Defined as that sequence of processes and sub-processesrequired to achieve the product.
This section also contains various requirements for the design of
products and for the planning of processes, projects and
services.
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Section 5:Measurement, Analysis and ImprovementMeasurement & monitoring activities include
internal audits and monitoring of customerperception as to whether the company has
fulfilled customer requirements.
All these activities must be defined, planned andimplemented. Measuring and monitoring
allows the company to manage by fact, not by
guess.
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What is ISO 9001 Certification?
ISO 9001 certification is also known as ISO 9001 registration, ISO 9000
registration, ISO 9001:2008 certification or ISO 9001:2008 registration.
All of these refer to an independent certification body attesting that a
company's ISO 9001 quality management system meets all
requirements of the ISO 9001 2008 standard.
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What are the changes in ISO 9000:2008
ISO 9000: 2008 only introduces clarifications to the existing
requirements of ISO 9000:2000.
Reasons for limited changes are A key factor in the
development of ISO 9001:2008 was to limit the impact of
changes on users.
Changes & Benefits are:
Easier to use
Clearer language
Easier to translate into the other languages Better compatibility with the environmental
management standard ISO 14001:2004.
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Problems Related to ISO 9000
Problem 1:Management Attitude and Purpose
Problem 2:Implementation by Consultants
Problem 3:ISO 9000 Management Representative without Power
Problem 4: Insufficient Resources
Problem 5: Lack of Improvement
Problem 6: Making it Complicated
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Problem 1:Management Attitude and Purpose
Goal should be clear defined
Not for customer requirement
Not for attracting the business
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Problem 2:Implementation by Consultants
Consultants promise to write quality manual, qualityprocedures and other documents & provide training.
Consultant is unfamiliar with the business, the company & its
culture resulting system does not fit the company.
For fees tires to set an overly complicated & complicated
quality system.
Consultant is not flexible.
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Problem 3:ISO 9000 Management Representative without Power
MR who is desperately trying to improve
company while top management pays mere lip
service to ISO 9001.
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Problem 4: Insufficient Resources
MR should be trained
Management allocation enough time
Financial resources
Availability of documents
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Problem 5: Lack of Improvement
Common misconception that an QMS needs to
be implemented, certified & thats it.
System must constantly evolve as the company
changes, as the market conditions change & as
technologies improve.
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Problem 6: Making it Complicated
Processes System
Unfair practices
Overly bureaucratic
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ISO 14000
ISO 14000 is environmental management system, to
protect environment and to prevent pollution while
taking into account the economic needs of thesociety.
The standard based on the principles of continuous
improvement in environmental performance of a
company.
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Benefits of EMS
1. Assuring customers about environmental commitment of the organization
2. Maintaining good public image and relations
3. Increased brand image and market share
4. Competitive advantage
5. Conservation of scarce resources
6. More exports
7. No legal harassments
8. Increased compliance to statutory requirements
9. Protection to human health
10. Cost effectiveness.
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Cont.
Requirements of ISO 14001
In order to effectively implement and benefit from an ISO 14001 EMS, it is
important to have an understanding of the standard's requirements.
Policies
ISO 14001 requires that the organization have a policy statement to drive theEMS.
Planning
Environmental Aspects
Legal and Other Requirements
Objectives and Targets
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Policies
A policy statement to drive the EMS.
May be short, one page or less documents &
simply affirm the commitments.
for example: we are committed to prevention
of pollution.
The policy must be clearly endorsed by top
management and be available to the public &
employees.
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Cont.
Implementation and Operation
Environmental Management Programmes (EMP)
Structure and Responsibility
Training Awareness and Competence
Communications
EMS Documentation
Document Control
Operations Control
Emergency Planning and Response
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Checking and Corrective Action
Monitoring and Measurement
Non-conformance, Corrective, and Preventive Action
Records
EMS Audit
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Cont.
Integrating ISO 14000 and ISO 9000
Implementing ISO 14000 requires huge efforts and it can consume a lot
of time an organization.
But organizations which have successfully implemented ISO 9000
previously may find it easy and this is due to the fact that manyrequirements for ISO 14000 would have already in place.
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Relationship with Health and Safety
ISO 14000 is an environmental management system which aims at
improving environmental management system and it results in improved
work environment.
Improved work environment will always result increased health and
safety to the employees.
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The Capability Maturity Model (CMM) The original Capability Maturity Model (CMM) was developed at
the Software Engineering Institute (SEI) at Carnegie MellonUniversity to support improvements in the reliability of software
development organizations, i.e., their ability to develop quality
software on time and within budget.
It was designed to help developers to select process-improvement
strategies by determining their current process maturity andidentifying the most critical issues to improving their software
quality and process.
The CMM includes a number of key concepts: maturity levels, key
process areas, key practices and common features.
CMM is a software process maturity model. This model attempts to
quantify a software organisations capability to consistently and
predictably produce high-quality software products.
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The Capability Maturity Model (CMM)
CMM is a development model created after study of data
collected from organizations that contracted with the U.S.
Department of Defense, who funded the research. The term
"maturity" relates to the degree of formality and optimization
of processes, from ad hoc practices, to formally defined steps,to managed result metrics, to active optimization of the
processes.
The model's aim is to improve existing
software-development processes, but it canalso be applied to other processes.
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There are five levels defined along the continuum of the model
and, according to the SEI: "Predictability, effectiveness, and
control of an organization's software processes are believed toimprove as the organization moves up these five levels.
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1. Initial (disorganized, ad hoc, individual heroics) - the starting
point for use of a new or undocumented repeat process.
2. Repeatable - the process is at least documented sufficiently
such that repeating the same steps may be attempted.
3. Defined - the process is defined/confirmed as a standard
business process, and decomposed to levels 0, 1 and 2 (the lastbeing Work Instructions).
4. Managed - the process is quantitatively managed in
accordance with agreed-upon metrics.
5. Optimizing - process management includes deliberate processoptimization/improvement.
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