ISO-9001: 2000 Awareness Training

Presentation By : Shashikant Gupta

ISO 9001:2000

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

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

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

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).

More about ISO

ISO Collaborates closely with the International Electrotechnical Commission (IEC) on all matters of Electrotechnical 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.

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.

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.

TERMS AND DEFINITIONS

ORGANIZATION
Group of people and facilities with an arrangement of responsibilities, authorities and relationships.

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.

TERMS AND DEFINITIONS

PROCESS Set of interrelated or interacting activities which transforms inputs into outputs. PRODUCT
Result of activities or process.

Notes : 1 A product may include service, hardware, processed materials, software or a combination thereof. 2 A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g., knowledge or concepts) or a combination thereof.

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.

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.

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.

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.

TERMS AND DEFINITIONS CORRECTIVE ACTION

Action to eliminate the cause of a detected nonconformity or other undesirable situation.

PREVENTIVE ACTION
Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. (Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.)

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.

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.

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.

TERMS AND DEFINITIONS

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

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 .

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.

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.

TERMS AND DEFINITIONS

SUPPLIER Organisation that provides a product to the customer. CUSTOMER Recipient of a product provided by the supplier.
Notes: 1 Example: Consumer, client, end-user, retailer, beneficiary or purchaser. 2 The customer can be either external or internal to the organisation.

TERMS AND DEFINITIONS

SUPPLIER CHAIN AS PER ISO 9001:2000

SUPPLIER ORGANIZATION CUSTOMER

STAKE HOLDERS AND THEIR EXPECTATIONS

Organizations stakeholder
Customers (Interested Parties) Employees Owners Suppliers Society

Typical expectations
Product Quality Career / work satisfaction Return on Investment Continuing Business opportunity Responsible stewardship

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

QUALITY MANAGEMENT PRINCIPLES

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

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.

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.

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.

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.

QUALITY MANAGEMENT PRINCIPLES

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

THE SOFTWARE PROCESS

REQUESTS

RESOURCES

SOFTWARE PRODUCTS OR SERVICES

SOFTWARE PROCESS
PEOPLE HARDWARE SOFTWARE TIME EFFORT MONEY

QUALITY VALUES
FEEDBACK

CONTROL Version 2.0 Date: 01/03/2003

TO ACHIEVE PROCESS CONTROL

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

C U S
R E T Q U O I R E M M E E N T S

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

MANAGEMENT RESPONSIBILITY

RESOURCE MANAGEMENT

MEASUREMENT, ANALYSIS, IMPROVEMENT

S A T I S F A C T I O N
PRODUCT

C U S T

O
M E R

INPUT

PRODUCT REALISATION

OUTPUT

MODEL OF THE PROCESS APPROACH

ISO 9000:2000 FAMILY OF STANDARDS

SUBJECT
1. QUALITY MANAGEMENT SYSTEMS FUNDAMENTALS AND VOCABULARY 2. QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

STANDARD
ISO 9000 : 2000

ISO 9001 : 2000

3. QUALITY MANAGEMENT ISO 9004 : 2000 SYSTEMS GUIDELINES FOR PERFORMANCE IMPROVEMENTS

MODEL FOR QUALITY

ISO 9001 : 2000

QUALITY MANAGEMENT SYSTEMS REQUIREMENTS

STANDARDS / GUIDELINES FOR CERTIFICATION

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

5. 6.

STANDARDS / GUIDELINES FOR CERTIFICATION

ISO 10007 : 1995 QM Guidelines for Configuration Management 8. ISO 10013 : 1995 Guidelines for developing Quality Manuals / Documentation 9. ISO / IEC 12207 : 1995 Information Technology Software life cycle process 10. ISO / IEC 9126-1 : 2001 Software Engineering Product Quality (non-functional attributes) 11. ISO 19011 : 2000 Guidelines for Quality Systems Auditing 7.

ISO 9001 : 2000 QUALITY 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

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

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

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

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

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 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

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

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

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

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

GUIDELINES FOR SELF - ASSESSMENT

Specific features of the ISO 9004 selfassessment 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

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

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

PERFORMANCE MATURITY LEVELS

Maturity Level 1 Performance Level Guidance

No formal approach

No systematic approach evident, no results, poor results or unpredictable results. Problem - or prevention-based systematic approach minimum data on improvement results available. Systematic process-based approach, early stage of systematic improvements; data available on conformance to objectives and existence of improvements trends.

Reactive approach

Stable formal system approach

PERFORMANCE MATURITY LEVELS

Maturity Level 4 Performance Level Continual improvement emphasized Guidance Improvement process in use; good results and sustained improvement trends.

Best-in-class performance

Strongly Integrated Improvement process; best-in-class benchmarked results demonstrated.

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.

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.

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.

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.

QUALITY MANUAL (LEVEL I)

QUALITY PROCEDURES (LEVEL II)

OTHER QUALITY DOCUMENTS (WORK INSTRUCTIONS, STANDARDS, GUIDELINES, TEMPLATES, FORMS) (LEVEL III)

Consists detailed work documents

DEMINGS PDCA CYCLE

WHERE YOU ARE
WHERE YOU WANT TO BE
Benchmark - Plan

Plan

Initial Approach

Revise Approach

Improve Plan

Deployment - Impediments

Act

- Short Term - Long Term

Do VersionResultsDate: 2.0 Check 01/03/2003

Outcome of this awareness training

An overview of ISO-9001:2000 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-9001:2000 clauses and its application