1. ISO-9001: 2000 Awareness Training
Presentation By : Shashikant Gupta

2. ISO – 9001:2000

3. CONTENTS… Course Objectives What is ISO? What is Quality?
Terms and definitions
Stake holders and their expectations
Quality Management principles
The software process
ISO 9000:2000 Family of Standards
ISO-9001:2000 Clauses
Guidelines for Self Assessment

4. COURSE OBJECTIVES
To provide an overview of ISO 9001: 2000 standards
To understand the elements that support the implementation of an ISO 9001:2000 Quality Management System

5. 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 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

6. 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).

7. 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.

8. 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.

9. 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.

10. TERMS AND DEFINITIONS
ORGANIZATION Group of people and facilities with an arrangement of responsibilities, authorities and relationships.

11. 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.

12. TERMS AND DEFINITIONS
PROCESS Set of interrelated or interacting activities which transforms inputs into outputs.
PRODUCT Result 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.

13. TERMS AND DEFINITIONS
TRACEABILITY Ability 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.

14. PROCEDURE Specified way to carry out an activity or process.
TERMS AND DEFINITIONS
PROCEDURE Specified way to carry out an activity or process.
Note: A procedure when documented, becomes a ‘documented procedure’.
PROJECT Unique 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.

15. TERMS AND DEFINITIONS
AUDIT Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
REVIEW Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objective.

16. TERMS AND DEFINITIONS CONFORMITY Fulfillment of a requirement
NON-CONFORMITY Non-fulfillment of a requirement
DEFECT Non-fulfillment of a requirement related to an intended or specified use
CORRECTION Action to eliminate a detected non-conformity.

17. TERMS AND DEFINITIONS
CORRECTIVE ACTION Action to eliminate the cause of a detected non-conformity or other undesirable situation.
PREVENTIVE ACTION Action 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.)

18. TERMS AND DEFINITIONS CUSTOMER SATISFACTION
Customer’s opinion of the degree to which a transaction has met the customer’s needs and expectations.
QUALITY MANAGEMENT SYSTEM
System to establish a quality policy and quality objectives and to achieve those objectives.

19. 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.

20. TERMS AND DEFINITIONS QUALITY OBJECTIVE
Something sought or aimed for, related to quality.
Note 1: Quality objectives should be based on organization’s 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.

21. TERMS AND DEFINITIONS
TOP MANAGEMENT
Person or group of people who direct and control an organization at the highest level.

22. 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 .

23. TERMS AND DEFINITIONS
QUALITY CONTROL Operational techniques and activities that are used to fulfil requirements for quality.
QUALITY ASSURANCE Planned 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.

24. 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.

25. TERMS AND DEFINITIONS
SUPPLIER Organisation that provides a product to the customer.
CUSTOMER Recipient 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.

26. SUPPLIER CHAIN AS PER ISO 9001:2000
TERMS AND DEFINITIONS
SUPPLIER CHAIN AS PER ISO 9001:2000
SUPPLIER
ORGANIZATION
CUSTOMER

27. STAKE HOLDERS AND THEIR EXPECTATIONS
Organization’s stakeholder
Typical expectations
Customers (Interested Parties)
Product Quality
Employees
Career / work satisfaction
Owners
Return on Investment
Suppliers
Continuing Business opportunity
Society
Responsible stewardship

28. 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

29. QUALITY MANAGEMENT PRINCIPLES
Customer Focus
-Understand current and future customer needs
-Meet customer requirements and strive to exceed customer expectations

30. 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 organization’s objectives.

31. 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 organization’s benefit.

32. 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.

33. 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.

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

35. THE SOFTWARE PROCESS REQUESTS SOFTWARE PROCESS CONTROL
SOFTWARE PRODUCTS
OR SERVICES
RESOURCES
PEOPLE
HARDWARE
SOFTWARE
TIME
EFFORT
MONEY
QUALITY
VALUES
FEEDBACK
CONTROL
Version 2.0 Date: 01/03/2003

36. TO ACHIEVE PROCESS CONTROL
Measurement is effected.
Comparison against a pre-set goal is made.
Any deviations are corrected by a feedback mechanism.

37. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
SAT I S FACT ION
MANAGEMENT
RESPONSIBILITY R E Q U I M N T S
RESOURCE
MANAGEMENT
MEASUREMENT,
ANALYSIS,
IMPROVEMENT
PRODUCT
REALISATION
INPUT
OUTPUT
PRODUCT
MODEL OF THE PROCESS APPROACH

38. ISO 9000:2000 FAMILY OF STANDARDS
SUBJECT
STANDARD
1. QUALITY MANAGEMENT SYSTEMS – FUNDAMENTALS AND VOCABULARY
ISO : 2000
2. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO : 2000
3. QUALITY MANAGEMENT SYSTEMS – GUIDELINES FOR PERFORMANCE IMPROVEMENTS
ISO : 2000

39. MODEL FOR QUALITY ISO 9001 : 2000 QUALITY MANAGEMENT SYSTEMS –
REQUIREMENTS

40. STANDARDS / GUIDELINES FOR CERTIFICATION
ISO 9000 : QMS Fundamentals & Vocabulary
ISO 9001 : QMS Requirements
ISO 9004 : QMS Guidelines for Performance Improvement
ISO : Guidelines for application of ISO to the development, supply, installation and maintenance of Computer Software
ISO : 1995 QM – Guidelines for Quality Plans
ISO : 1997 QM – Guidelines for Quality in Project Management

41. STANDARDS / GUIDELINES FOR CERTIFICATION
ISO : 1995 QM – Guidelines for Configuration Management
ISO : 1995 – Guidelines for developing Quality Manuals / Documentation
ISO / IEC : 1995 – Information Technology – Software life cycle process
ISO / IEC : 2001 – Software Engineering Product Quality (non-functional attributes)
ISO : 2000 Guidelines for Quality Systems Auditing

42. ISO 9001 : 2000 QUALITY MANAGEMENT SYSTEMS - CLAUSES
4.1 General Requirements (For Software Development and Services)
4.2 Documentation Requirements
General
Quality Manual
Control Of Documents
Control Of Records

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

44. 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

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

46. 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

47. 7. Product Realization
7.3 Design And Development
7.3.1 Design And Development planning
7.3.2 Design And Development inputs Design 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

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

49. 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

50. 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
Monitoring and measurement of product

51. 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

52. 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

53. 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

54. 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

55. PERFORMANCE MATURITY LEVELS
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.

56. PERFORMANCE MATURITY LEVELS
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.

57. PROCESS METHODOLOGY 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.

58. PROCESS METHODOLOGY 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.

59. 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 project’s effectiveness and plan solutions to remaining problems and objectives for further improvement.

60. 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)

61. DEMING’S PDCA CYCLE WHERE YOU ARE Plan Revise Approach Improve Plan
WHERE YOU WANT TO BE
Benchmark
- Plan
Initial
Approach
Plan
Revise
Approach
Deployment
- Impediments
- Short Term
- Long Term
Improve Plan
Act Do
Results
Version 2.0 Date: 01/03/2003
Check

62. Outcome of this awareness training…
An overview of ISO-9001:2000 standards
Understanding Quality and it’s importance
Definitions of certain frequently used ISO terminologies
Knowledge about Quality Management Principles
How a Software Process works?
PDCA life cycle
Meaning of ISO-9001:2000 clauses and it’s application