ISO-9001: 2000 Awareness Training

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ISO-9001 2000 Awareness Training

• Presentation By Shashikant Gupta

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ISO 90012000
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CONTENTS

• Course Objectives
• What is ISO?
• What is Quality?
• Terms and definitions
• Stake holders and their expectations
• Quality Management principles
• The software process
• ISO 90002000 Family of Standards
• ISO-90012000 Clauses
• Guidelines for Self Assessment

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COURSE OBJECTIVES

• To provide an overview of ISO 9001 2000
  standards
• To understand the elements that support the
  implementation of an ISO 90012000 Quality
  Management System

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What is ISO?

• The International Organization for
  Standardization (ISO) is a worldwide federation
  of national standards bodies from some 130
  countries, one from each country.
• ISO is a non-governmental organization
  established in 1947. The mission of ISO is to
  promote the development of standardization and
  related activities in the world with a view to
  facilitating the international exchange of goods
  and services, and to developing cooperation in
  the spheres of intellectual, scientific,
  technological and economic activity

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More about ISO

• Worldwide Federation of National Standards Bodies
  (ISO Member Countries)
• Preparation of International Standards carried
  out through
• - ISO Technical Committees (TCs)
• - Subcommittees (SCs)
• - Working Groups (WGs).

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More about ISO

• ISO Collaborates closely with the International
  Electro-technical Commission (IEC) on all matters
  of Electro-technical Standardisation.
• Committee Draft (CD) prepared by Technical
  Committees.
• Draft International Standards (DIS) adopted by
  the Technical Committees are circulated to the
  Member Bodies for voting.
• Publication as an International Standard requires
  approval by at least 75 of the Member Bodies
  casting a vote.
• ISO 9000 Standards prepared by Technical
  Committee ISO / TC 176, Quality Management and
  Quality Assurance.
• ISO 9001 prepared by Subcommittee SC2, Quality
  Systems.

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Objectives of ISO 9000

• A successful organisation should offer products
  that
• - Meet a well defined need, use or purpose.
• - Comply with applicable standards and
  specifications.
• - Comply with requirements of society.
• - Address environmental considerations.
• - Are available at competitive prices.
• - Satisfy customers expectations.
• - Are provided at a cost which will yield a
  profit.

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WHAT IS QUALITY?

• The formal definition of quality as stated in ISO
  9000 2000 is -
• Ability of a set of inherent characteristics of
  a product, system or process to fulfill
  requirements of customers and other interested
  parties.
• Note The term quality may be used with
  adjectives such as poor, good or excellent.

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TERMS AND DEFINITIONS

• ORGANIZATIONGroup of people and facilities with
  an arrangement of responsibilities, authorities
  and relationships.

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TERMS AND DEFINITIONS

• REQUIREMENT
• Need or expectation that is stated, generally
  implied or obligatory.
• Notes
• 1.Generally implied means it is custom or common
  practice for the organization, its customers, and
  other interested parties, that the need or
  expectation under consideration is implied.
• 2.A qualifier can be used to denote a specific
  type of requirement, e.g. product requirement,
  quality system requirement, customer requirement.
• 3.A specified requirement is one which is stated,
  for example, in a document.
• 4.Requirements can be generated by different
  interested parties.

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TERMS AND DEFINITIONS

• PROCESSSet of interrelated or interacting
  activities which transforms inputs into outputs.
• PRODUCTResult of activities or process.
• Notes
• A product may include service, hardware,
  processed materials, software or a combination
  thereof.
• A product can be tangible (e.g. assemblies or
  processed materials) or intangible (e.g.,
  knowledge or concepts) or a combination thereof.

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TERMS AND DEFINITIONS

• TRACEABILITYAbility to trace the history,
  application or location of that which is under
  consideration.
• Note When considering PRODUCT, traceability can
  relate to - origin of the material and parts-
  processing history- distribution and location of
  the product after delivery.

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TERMS AND DEFINITIONS

• PROCEDURESpecified way to carry out an activity
  or process.
• Note A procedure when documented, becomes a
  documented procedure.
• PROJECTUnique process, consisting of a set of
  coordinated and controlled activities with start
  and finish dates, undertaken to achieve an
  objective conforming to specific requirements,
  including the constraints of time, cost and
  resources.

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TERMS AND DEFINITIONS

• AUDITSystematic, independent and documented
  process for obtaining audit evidence and
  evaluating it objectively to determine the extent
  to which audit criteria are fulfilled.
• REVIEWActivity undertaken to determine the
  suitability, adequacy and effectiveness of the
  subject matter to achieve established objective.

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TERMS AND DEFINITIONS

• CONFORMITY
• Fulfillment of a requirement
• NON-CONFORMITYNon-fulfillment of a requirement
• DEFECTNon-fulfillment of a requirement related
  to an intended or specified use
• CORRECTIONAction to eliminate a detected
  non-conformity.

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TERMS AND DEFINITIONS

• CORRECTIVE ACTIONAction to eliminate the cause
  of a detected non-conformity or other undesirable
  situation.
• PREVENTIVE ACTIONAction to eliminate the cause
  of a potential non-conformity or other
  undesirable potential situation.(Preventive
  action is taken to prevent occurrence whereas
  corrective action is taken to prevent
  recurrence.)

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TERMS AND DEFINITIONS

• CUSTOMER SATISFACTION
• Customers opinion of the degree to which a
  transaction has met the customers needs and
  expectations.
• QUALITY MANAGEMENT SYSTEM
• System to establish a quality policy and quality
  objectives and to achieve those objectives.

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TERMS AND DEFINITIONS

• QUALITY POLICY
• Overall intentions and direction of an
  organization related to quality as formally
  expressed by Top Management.
• Note 1 The quality policy should be consistent
  with the overall policy of the organization and
  should provide a framework for the settings of
  quality objectives.
• Note 2 Quality Management principles of this
  International Standard may form a basis for the
  establishment of a quality policy.

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TERMS AND DEFINITIONS

• QUALITY OBJECTIVE
• Something sought or aimed for, related to
  quality.
• Note 1 Quality objectives should be based on
  organizations quality policy.
• Note 2 Quality objectives are specified at
  different levels in the organization.
  At an operational level, quality
  objectives should be quantitative.
• Note 3 Different terms are sometimes used for
  quality objectives, such as quality
  targets, quality aims or quality goals.

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TERMS AND DEFINITIONS

• TOP MANAGEMENT
• Person or group of people who direct and control
  an organization at the highest level.

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TERMS AND DEFINITIONS

• QUALITY PLANNING
• Part of quality management focused on setting
  quality objectives and specifying necessary
  operational processes and related resources to
  fulfill the quality objectives.
• QUALITY IMPROVEMENT
• Part of quality management, focused on
  increasing effectiveness and efficiency .

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TERMS AND DEFINITIONS

• QUALITY CONTROLOperational techniques and
  activities that are used to fulfil requirements
  for quality.
• QUALITY ASSURANCEPlanned and systematic
  activities implemented within the quality system
  and demonstrated as needed to provide adequate
  confidence that an entity will fulfil given
  requirements for quality.

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TERMS AND DEFINITIONS

• EFFECTIVENESS
• Measure of the extent to which planned
  activities are realized and planned results
  achieved.
• EFFICIENCY
• Relationship between the result achieved and the
  resources used.

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TERMS AND DEFINITIONS

• SUPPLIER Organisation that provides a product to
  the customer.
• CUSTOMERRecipient of a product provided by the
  supplier.
• Notes
• Example Consumer, client, end-user, retailer,
  beneficiary or purchaser.
• The customer can be either external or internal
  to the organisation.

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TERMS AND DEFINITIONS

• SUPPLIER CHAIN AS PER ISO 90012000
• SUPPLIER
• ORGANIZATION
  
• 
  CUSTOMER

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STAKE HOLDERS AND THEIR EXPECTATIONS
Organizations stakeholder Typical expectations
Customers (Interested Parties) Product Quality
Employees Career / work satisfaction
Owners Return on Investment
Suppliers Continuing Business opportunity
Society Responsible stewardship
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QUALITY MANAGEMENT PRINCIPLES

• Customer Focus
• Leadership
• Involvement of people
• Process Approach
• System Approach to Management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

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QUALITY MANAGEMENT PRINCIPLES

• Customer Focus
• -Understand current and future customer needs
• -Meet customer requirements and strive to
  exceed customer expectations

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QUALITY MANAGEMENT PRINCIPLES

• Leadership
• -Establish unity of purpose, direction, and the
  internal environment of the organization.
• -Create the environment in which people can
  become fully involved in achieving the
  organizations objectives.

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QUALITY MANAGEMENT PRINCIPLES

• Involvement of people
• -People at all levels are the essence of an
  organization and their full involvement enables
  their abilities to be used for the
  organizations benefit.

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QUALITY MANAGEMENT PRINCIPLES

• Process approach
• -A desired result is achieved more
  efficiently when related resources and
  activities are managed as a process.
• System approach to management
• -Identifying, understanding and managing a
  system of interrelated processes for a given
  objective contributes to the effectiveness
  and efficiency of the organization.

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QUALITY MANAGEMENT PRINCIPLES

• Continual improvement
• -A permanent objective of the organization is
  continual improvement.
• Factual approach to decision making
• -Effective decisions are based on the
  logical or intuitive analysis of data and
  information.

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QUALITY MANAGEMENT PRINCIPLES

• Mutually beneficial supplier relationships
• -The ability of the organization and its
  suppliers to create value enhanced by mutually
  beneficial relationships.

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THE SOFTWARE PROCESS

• REQUESTS

SOFTWARE PROCESS
SOFTWARE PRODUCTS OR SERVICES
RESOURCES
PEOPLE HARDWARE SOFTWARE TIME EFFORT MONEY
QUALITY VALUES
FEEDBACK
CONTROL
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TO ACHIEVE PROCESS CONTROL

• Measurement is effected.
• Comparison against a pre-set goal is made.
• Any deviations are corrected by a feedback
  mechanism.

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C U S T O M E R
C U S T O M E R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT
SYSTEM
SAT I S FACT ION
MANAGEMENT RESPONSIBILITY
R E Q U I R E M E N T S
MEASUREMENT, ANALYSIS, IMPROVEMENT
RESOURCE MANAGEMENT
PRODUCT REALISATION
OUTPUT
INPUT
PRODUCT
MODEL OF THE PROCESS APPROACH
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ISO 90002000 FAMILY OF STANDARDS
SUBJECT STANDARD
1. QUALITY MANAGEMENT SYSTEMS FUNDAMENTALS AND VOCABULARY ISO 9000 2000
2. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS ISO 9001 2000
3. QUALITY MANAGEMENT SYSTEMS GUIDELINES FOR PERFORMANCE IMPROVEMENTS ISO 9004 2000
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MODEL FOR QUALITY

• ISO 9001 2000
• QUALITY MANAGEMENT SYSTEMS
• REQUIREMENTS

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STANDARDS / GUIDELINES FORCERTIFICATION

1. ISO 9000 2000 - QMS Fundamentals Vocabulary
2. ISO 9001 2000 - QMS Requirements
3. ISO 9004 2000 - QMS Guidelines for
   PerformanceImprovement
4. ISO 9000 - 3 1997 - Guidelines for application
   of ISO to the development, supply, installation
   and maintenance of Computer Software
5. ISO 10005 1995 QM Guidelines for Quality
   Plans
6. ISO 10006 1997 QM Guidelines for Quality in
   Project Management

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STANDARDS / GUIDELINES FORCERTIFICATION

• ISO 10007 1995 QM Guidelines for
  Configuration Management
• ISO 10013 1995 Guidelines for developing
  Quality Manuals / Documentation
• ISO / IEC 12207 1995 Information Technology
  Software life cycle process
• ISO / IEC 9126-1 2001 Software Engineering
  Product Quality
  (non-functional attributes)
• ISO 19011 2000 Guidelines for Quality Systems
  Auditing

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ISO 9001 2000QUALITY MANAGEMENT SYSTEMS -
CLAUSES

• 4. Quality Management System
• 4.1 General Requirements (For Software
  Development and Services)
• 4.2 Documentation Requirements
• 4.2.1 General
• 4.2.2 Quality Manual
• 4.2.3 Control Of Documents
• 4.2.4 Control Of Records

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• 5. Management Responsibility
• 5.1 Management Commitment
• 5.2 Customer Focus
• 5.3 Quality Policy
• 5.4 Planning
• 5.4.1 Quality objectives
• 5.4.2 Quality management system

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• 5. Management Responsibility
• 5.5 Responsibility, Authority and
  Communication
• 5.5.1 Responsibility and Authority
• 5.5.2 Management Representative
• 5.5.3 Internal Communication
• 5.6 Management Review
• 5.6.1 General
• 5.6.2 Review Input
• 5.6.3 Review Output

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• 6.Resource Management
• 6.1 Provision Of Resources
• 6.2 Human Resources
• 6.2.1 General
• 6.2.2 Competence, Awareness and training
• 6.3 Infrastructure
• 6.4 Work Environment

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• 7. Product Realization
• 7.1 Planning the Product Realization
• 7.2 Customer Related Process
• 7.2.1 Determination of Requirements
  related to the Product
• 7.2.2 Review of Requirements related to the
  product
• 7.2.3 Customer Communication

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• 7. Product Realization
• 7.3 Design And Development
• 7.3.1 Design And Development planning
• 7.3.2 Design And Development inputs 7.3.3 Desig
  n And Development outputs
• 7.3.4 Design And Development review
• 7.3.5 Design And Development verification
• 7.3.6 Design And Development validation
• 7.3.7 Control of Design And Development
• changes

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• 7. Product Realization
• 7.4 Purchasing
• 7.4.1 Purchasing Process
• 7.4.2 Purchasing Information
• 7.4.3 Verification of Purchased Product

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• 7. Product Realization
• 7.5 Product and Service Provision
• 7.5.1 Control of Service Provision
• 7.5.2 Validation of Processes for
  production and service provision
• 7.5.3 Identification and traceability
• 7.5.4 Customer Property
• 7.5.5 Preservation of Product
• 7.6 Control of monitoring and measuring devices

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• 8. Measurement, analysis and improvement
• 8.1 General
• 8.2 Monitoring and measurement
• 8.2.1 Customer Satisfaction
• 8.2.2 Internal Audit
• 8.2.3 Monitoring and measurement of process
• 8.2.4 Monitoring and measurement of product

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• 8. Measurement, analysis and improvement
• 8.3 Control of non conforming product
• 8.4 Analysis of data
• 8.5 Improvement
• 8.5.1 Continual Improvement
• 8.5.2 Corrective Action
• 8.5.3 Preventive Action

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GUIDELINES FOR SELF - ASSESSMENT

• Specific features of the ISO 9004
  self-assessment methodology are that it can
• Be applied to the entire Quality Management
  System or to a part of the Quality Management
  System
• Be applied to the entire organization or a part
  of the organization
• Be completed in a short period of time with
  internal resources

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GUIDELINES FOR SELF - ASSESSMENT

• Be completed by a cross-section team or by one
  person in the organization, when supported by Top
  Management
• Form the input to a more comprehensive Quality
  Management System self-assessment process
• Identify and facilitate the prioritization of
  opportunities for improvement

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GUIDELINES FOR SELF - ASSESSMENT

• Facilitate the maturity of the Quality Management
  System towards world - class performance levels
• Another advantage to the use of this methodology
  is that is can be regularly used to appraise the
  progress of improvement efforts

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PERFORMANCE MATURITY LEVELS
Maturity Level Performance Level Guidance
1 No formal approach No systematic approach evident, no results, poor results or unpredictable results.
2 Reactive approach Problem - or prevention-based systematic approach minimum data on improvement results available.
3 Stable formal system approach Systematic process-based approach, early stage of systematic improvements data available on conformance to objectives and existence of improvements trends.
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PERFORMANCE MATURITY LEVELS
Maturity Level Performance Level Guidance
4 Continual improvement emphasized Improvement process in use good results and sustained improvement trends.
5 Best-in-class performance Strongly Integrated Improvement process best-in-class benchmarked results demonstrated.
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PROCESSMETHODOLOGY FOR IMPROVEMENT

• Actions for continual improvement should consist
  of the following steps
• Reason for improvement select an area for
  improvement and the reason for working on it.
• Current situation Evaluate existing process
  efficiency. Collect and analyse data to discover
  what types of problems occur most often. Select a
  problem and set a target for improvement.

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PROCESSMETHODOLOGY FOR IMPROVEMENT

• Analysis Identify and verify the root causes of
  the problem.
• Identification of possible solutions Explore
  alternatives and implement solutions that will
  eliminate the root causes of the problem and
  prevent them from recurring.

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PROCESS METHODOLOGY FOR IMPROVEMENT

• Evaluation of effects Confirm that the problem
  and its root causes have been decreased, the
  solution worked, and the target for improvement
  has been met.
• Evaluation of efficiency of the process and
  effectiveness of the improvement action Review
  the improvement projects effectiveness and plan
  solutions to remaining problems and objectives
  for further improvement.

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QUALITY SYSTEM DOCUMENT HIERARCHY
Describes the quality system in accordance with
the stated Quality Policy and objectives and the
applicable standard Describes the activities of
individual functional units needed to implement
the quality system elements in the
organization. Consists detailed
work documents
QUALITY MANUAL (LEVEL I)
QUALITY PROCEDURES (LEVEL II)
OTHER QUALITY DOCUMENTS (WORK INSTRUCTIONS,
STANDARDS, GUIDELINES, TEMPLATES, FORMS)
(LEVEL III)
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DEMINGS PDCA CYCLE

• WHERE YOU ARE
• WHERE YOU WANT TO BE

Benchmark - Plan
Initial Approach
Plan
Revise Approach
Deployment - Impediments - Short Term -
Long Term
Improve Plan
Act
Do
Results
Check
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Outcome of this awareness training

• An overview of ISO-90012000 standards
• Understanding Quality and its importance
• Definitions of certain frequently used ISO
  terminologies
• Knowledge about Quality Management Principles
• How a Software Process works?
• PDCA life cycle
• Meaning of ISO-90012000 clauses and its
  application