1. Software Quality Assurance Lecture 4

2. Lecture Outline ISO ISO 9000 Series of Standards ISO 9001: 2000 Overview ISO 9001: 2008 ISO 9003: 2004 Overview

3. 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

4. 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.

5. 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

6. What is ISO 9001:2000? ISO 9001:2000 is an international standard for implementing a quality management system

7. 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?

8. 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

9. 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

10. 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

11. 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

12. 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

13. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Customers Requirements Product realization Customers Satisfaction Value adding activities Information flow Introduction to ISO 9000:2000

14. 1. Scope 1.1General 1.2 Application 2. Normative reference 3. Terms and definition e.g., Supplier Organization Customer ISO 9001:2000 Requirements

15. 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

16. To meet the requirements you must:  Document  Implement  Maintain  Continually improve effectiveness 4 Quality Management System

17. 4.1 General requirements Processes, interaction, improvement 4.2 Documentation requirements General Quality manual Control of document Control of records

18. 5 Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning Objectives Management system

19. 5.5 Responsibility, authority and communication Top management emphasis Management representative  Includes promotion of customer requirements throughout the organization Internal communication 5.6 Management review Lists of inputs and outputs Recommendation for improvement Action items expected Records 5 Management Responsibility

20. 6 Resource Management 6.1 Provision of resources to improve processes and enhance customer satisfaction 6.2Human 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

21. 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

22. 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

23. 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

24. 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

25. 8Measurement, 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 8.5Improvement Continually improve effectiveness of the system Corrective action Preventive action

26. ISO 90003:2004

27. 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