ISO 9000 Introduction
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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
ISO 9000 Introduction
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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