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ISO 9000 Introduction. Imran Hussain. Why have a Quality Standard?. Customer. contract. Supplier. subcontract. Vendor. Subcontractor. Motivation for ISO 9000. Helps in selection of suppliers and vendors Places onus of proving quality on supplier Controls Processes Procedures
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ISO 9000Introduction Imran Hussain
Customer contract Supplier subcontract Vendor Subcontractor
Motivation for ISO 9000 • Helps in selection of suppliers and vendors • Places onus of proving quality on supplier • Controls • Processes • Procedures • Quality records
Benefits of ISO 9000 • Customers and users will benefit by receiving the products that are: • Conforming to the requirements • Dependable and reliable • Available when needed • Maintainable
Benefits of ISO 9000 • People in the organization will benefit by: • Better working conditions • Increased job satisfaction • Improved health and safety • Improved morale • Improved stability of employment
Benefits of ISO 9000 • Owners and investors will benefit by: • Increased return on investment • Improved operational results • Increased market share • Increased profits
Benefits of ISO 9000 • Suppliers and partners will benefit by: • Stability • Growth • Partnership and mutual understanding
Benefits of ISO 9000 • Society will benefit by: • Fulfillment of legal and regulatory requirements • Improved health and safety • Reduced environmental impact • Increased security
ISO 9000 and Quality Management (QM) • ISO standards based on the following QM principles: • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships
ISO 9000 and SQA Group • Responsibility lies with management • SQA group • implements standards • Monitors effectiveness in organization
Responsibilities of SQA Group • Perform audits • Promote awareness • Communicate Quality System to staff • Support implementation of ISO 9000 • Perform customer satisfaction surveys • Facilitate improvement following customer feedback • Review project quality at milestones • Act as partner in quality project
Responsibilities of SQA Group • Facilitate improvement and defect prevention activities • Monitor and verify process compliance • Monitor effectiveness of processes • Monitor institutionalisation of processes • Chair organization quality reviews • Facilitate external audits • Test planning, execution, reporting and recommendation • Test lab management • Support a metrics culture
ISO 9000 History and Background • BS 5750 (forerunner to ISO 9000) • ISO 9000: 1987 • ISO 9000: 1994 • ISO 9000: 2000
ISO 9000: 1994 • Family of standards • Applicable to manufacturing organizations, servicing organizations and software organizations • Different flavours • ISO 9001 (full product lifecycle) - superset • ISO 9002 (production, installation, servicing) • ISO 9004 (inspection and testing)
Quality Management System Documentation Quality Manual Quality System Procedures Work Instructions Forms
Quality Manual • Quality Policy • Objectives • Overview • Organisation • Responsibilities • Requirements Policy/Responsibility/Procedure Reference
Quality System Procedures • A set of procedures which detail how the requirements of the quality manual are to be implemented • Detailed procedures which define how the processes are to be performed and controlled • Specifying who is responsible for what
Work Instructions • Detailed instructions for the performance of specific tasks • Such instructions may cover • Materials • Processes • Verification
Forms • Records that provide proof that specified activities were carried out • A.k.a. quality records
Quality Management System Standard ISO 9000 Quality Manual Policy Statement, Commitment, Organisation, Responsibilities LEVEL 1 Quality System Procedures Company Practices, Interfaces LEVEL 2 Work Instructions Written Instructions to Control Tasks LEVEL 3 Forms Quality Records LEVEL 4 Sales Design Purchasing Manufacturing Accounts Personnel After Sales
Documenting Procedures Say what you do Do what you say And where necessary Show what you did
ISO 9000: 1994 Clauses • Management Responsibility • Quality System • Contract Review • Design Control • Document Control • Purchasing • Purchaser Supplied Product • Product Identification and Traceability • Process Control • Inspection and Testing
ISO 9000: 1994 Clauses • Inspection Measuring and Test Equipment • Inspection and Test Status • Control of Non-Conforming Product • Corrective Action • Handling, Storage, Packaging and Delivery • Quality Records • Internal Quality Audits • Training • Servicing • Statistical Techniques
References • Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2 • A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3