Software Quality Assurance

Lecture 4

Lecture Outline

• ISO• ISO 9000 Series of Standards• ISO 9001: 2000 Overview• ISO 9001: 2008• ISO 9003: 2004 Overview

What is ISO?

• Greek word “ISOS”• International Organization for Standardization• Worldwide network of the national standards institutes

157 Member Nations• Promotes international standards in various fields to

facilitate the worldwide exchange of goods & services• Non-governmental organization: members are not, as is

the case in the UN, delegations of national governments • Published three documents which outline requirements

for a Quality Management System ISO 9000 Quality System Standards

Quality Management System

• QMS approach encourages organizations to analyze customer requirements, define processes that contribute to the achievement of a product that is acceptable to customer, and keep these processes under control.

• It provides the confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.

Quality Management Principle

• “A Quality Management Principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all stakeholders.”

ISO/TS 176/SC 2/N 376

What is ISO 9001:2000?

ISO 9001:2000 is an international

standard for implementing a quality management system

ISO 9001:2000 sets out how a company can

establish an effective quality management system to meet its

stakeholders’ needs

ISO 9001:2000 sets out how a company can

establish an effective quality management system to meet its

stakeholders’ needs

Why Use ISO 9001:2000?

ISO 9000:2000 - Fundamentals and Vocabulary

Provides an introduction to Quality Management Systems (QMS) and vocabulary

ISO 9001:2000 - Requirements Specifies requirements for a QMS where

capability to provide product that meets customer and regulatory requirements needs to be demonstrated

ISO 9004:2000 - Guidelines for Performance Improvement

Provides guidance on using an established QMS to further enhance customer satisfaction and product/service quality

IS0 9000:2000 Series of Standards

ISO 9001 Requirements

• Model for Use in Design, Development, Production, Installation & Servicing

• Use: Where a Supplier’s Capability to Design & Supply

Conforming Product Needs to be Demonstrated• Applicable When:

Design is Required & Products Reqts are Stated in Performance Terms, or they Need to be Established

• Aimed at Achieving Customer Satisfaction by Preventing Nonconformity at all Stages from Design to Servicing

ISO 9002 Requirements

• Model for QA in Production, Installation & Servicing• Use:

Where a Supplier’s Capability to Supply Conforming Product to an Established Design Needs to be Demonstrated

• Applicable When: Specified Requirements are Stated in Terms of an

Established Design or Specification• Aimed at Achieving Customer Satisfaction by

Preventing Non-conformity at All Stages from Production to Servicing

ISO 9003 Requirements

• Model for QA in Final Inspection & Test• Use:

Where a Supplier’s Capability to Detect & Control the Disposition of Any Product Nonconformity During Final Inspection & Test Needs to Be Demonstrated

• Applicable When: Conformance to Specified Requirements is to

be Assured by the Supplier Solely at Final Inspection & Test

1. Customer focus

2. Leadership

3. Involvement of people

4. Process approach

5. System approach to management

6. Continual improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationship

Eight Quality Management Principles

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Measurement, analysis and improvement

Measurement, analysis and improvement

ProductProductInput Output

Management responsibility

Resource management

Resource management

Clause 5

Clause 6 Clause 8

Clause 7

Customers

Requirements

Product

realization

Customers

Satisfaction

Value adding activitiesInformation flow

Introduction to ISO 9000:2000

1. Scope

1.1 General

1.2 Application

2. Normative reference

3. Terms and definitione.g., Supplier Organization Customer

ISO 9001:2000 Requirements

Possibility to reduce scope

No 9002 or 9003

Can reduce the scope of requirements related to “product realization”

May not exclude any requirement that affects ability to provide product and/or service that meets customer and regulatory requirements

Permissible Exclusions

• To meet the requirements you must: Document Implement Maintain Continually improve effectiveness

4 Quality Management System

4 Quality Management System

4.1 General requirements Processes, interaction, improvement

4.2 Documentation requirements General Quality manual Control of document Control of records

5 Management Responsibility

5.1 Management commitment

5.2 Customer focus5.3 Quality policy5.4 Planning

Objectives Management system

5.5 Responsibility, authority and communication

Top management emphasis Management representative

Includes promotion of customer requirements throughout the organization

Internal communication5.6 Management review

Lists of inputs and outputs Recommendation for improvement Action items expected Records

5 Management Responsibility

6 Resource Management

6.1 Provision of resources to improve processes and enhance customer satisfaction

6.2 Human resource Determine competence Provide training or other action Evaluate effectiveness of action

6.3 Infrastructure Buildings, workspace, utilities Process equipment Support services

6.4 Work environment Manage conditions of environment to

achieve product requirement conformance

7 Product Realization

7.1 Plan and develop the processes Include product objectives, relevant

processes and resource, appropriate test and validation

7.2 Customer related processes Customer requirement - stated and

implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers

7.3 Design and development Planning, inputs, outputs, systematic

reviews, verification and validation, control of changes

7 Product Realization

7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product

7.5 Production and service provision Controlled conditions including product

characteristics, work instructions, suitable equipment, measuring devices, and system

Release, delivery and post delivery activities

Validation of processes when no other method

Identification and traceability of product and it’s status

Care of customer property Preservation of product

Includes constituent parts

7 Product Realization

7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration

8 Measurement, Analysis, and Improvement

8.1 General Plan and implement Measurement and monitoring processes

To demonstrate product conformity, system conformity and continually improve the QMS

8.2 Monitoring and measurement Customer satisfaction

Perception of fulfillment Internal planned audit, etc.

Auditors independent of their own work Processes

Demonstrate achievement of planned results Product

Monitor and measure characteristics Conformity with acceptance criteria Waivers / concessions

8 Measurement, Analysis, and Improvement

8.3 Control of nonconforming product Elimination, concession, preclude

intended use

8.4 Analysis of data Customer satisfaction Product and process requirements and

trends Suppliers

8.5 Improvement Continually improve effectiveness

of the system Corrective action Preventive action

ISO 90003:2004

The ISO 90003 Standard

• Key Highlights: Systemic Requirements and Guidelines Management Requirements and Guidelines Resource Requirements and Guidelines Realization Requirements and Guidelines Remedial Requirements and Guidelines