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WHAT IS ISO ?
ISO International Organization for Standardization Established in 1947 to develop common international quality standards. ISO is a worldwide federation of national standard bodies of 140 countries. Bureau of Indian Standards (BIS) is the Indian representative to ISO Located in Switzerland
ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the requirements outlined in standards 9001, 9002 or 9003.
Organizations choose the standards to which they want to become registered, based on their structure, their products, services and their specific function.
ISO 9001
Comprehensive
assurance. It has 20 elements covering design, development, production, installation and servicing. Suitable for organizations which develop their own designs of the products manufacture them & supply to the customers.
ISO 9002
Model for quality assurance having 18 elements covering production and installation of manufacturing systems. Suitable for those organization who receive full design & detailed specifications from the customers.
ISO 9003
Model for quality assurance having 12 elements covering final inspection and testing. Suitable for those organizations that perform final inspection &testing of products purchased from external suppliers. who do not have any design or manufacturing activity of their own ,but simply procure goods from other producers, carry out inspection& testing & then supply to the customer.
Design/ Development
Procurement
Production
Installation
Servicing
Define and document commitment, policy and objectives, responsibility and authority, verification resources and personnel. Appoint a management representative and conduct regular reviews of the system 2 Quality system Establish and maintain a documented quality system ensuring that products conform to specified requirements 3 Contract Review Ensure that customer's contractual requirements are evaluated and met 4 Design Control Requires procedures for controlling & verifying product design to ensure that specified requirements are being met. 5 Document control System for control and identification of all documents regarding quality, e.g. procedures, instructions, and specifications 6 Purchasing Ensure that purchased products conform to specified requirements 7 Product Identif ica- System to identify and control traceability of product at all stages from raw tion & traceability materials through production to the final product as delivered to the customer 8 Process control Ensure and plan the control of production which directly effects quality by documented work instructions, monitoring and control of processes 9 Inspection and Inspect and test incoming products, intermediate and final product; establish testing product conformance to specified requirements and identify non-conforming products; maintain inspection and test records 10 Inspection, Selection and control of equipment to ensure reliability and accuracy in measuring and test measuring data equipment
11 Inspection and test status For the whole process the products shall be identified and clearly marked concerning test status, including indication of conformance or nonconformance 12 Control of non-confor- Identification, documentation, evaluation, isolation (if possible) and ming products disposition of non-conforming products 13 Corrective actions Prevention of reoccurrence of failures (non-conforman- ce)
14 Handling, storage Protection of the quality of the product during hand- ling, storage, packaging and delivery packaging and delivery 15 Quality records 16 Internal Quality Audits 17 Training 18 Purchaser Supplied Product 19 Servicing Records, including those which demonstrate that the specified requirements have been met, shall be control- led and maintained Regular, planned internal audits shall be carried out, documented and recorded to verify the effectiveness of the quality system Training requirements at all levels shall be identified and the training planned, conducted and recorded Requires procedures for verification, storage, & maintenance of purchased product Requires procedures for performing servicing to be carried out by competent personnel
20 Statistical Techniques Requires procedures for identifying the use of ST in process, product & service.
Accreditation Bodies:
Registrars all over the world are required to obtain the authority to audit and recommend registration of a firm from the Accrediting Bodies. Some famous International registrars include : 1. ABS Quality Evaluations. Inc. 2. American Association for Laboratory Accreditation. 3. AT & T Quality Registrar. 4. British Standards Institution (BSI) Quality Assurance. 5. Bureau Veritas Quality International (BVQI). 6. Canadian General Standards Board. 7. Det Norske Veritas Industry (DNV) etc.
DISADVANTAGES
Expensive & time consuming System can be burdensome Management capability can be strained Increases workload & employee dissatisfaction
HISTORY
US Military & NATO Standards International Standards Organisation MIL AQAP (ISO) Committee Std
CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others ISO 9000: 2000 ISO 9000: 1994 ISO 9000: 1987
BS 5750
National Standards
International Standard
Certification Milestones
1. Brief management team 2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records
Quality Policy
4. Implement procedures 5. Train internal auditors 6. Conduct internal audits Proced -ures 7. Conduct management review 8. Preliminary assessment 9. External assessment 10. Certification
Work Instructs
Quality Records
FEEDBACK
The Implementation Of ISO9000 In Vietnam: Case Studies From The Footwear Industry
Two Vietnamese footwear companies- Nu-An Shoe Company and the Me-An Shoe Company, bring out important role that management attitude plays in determining the process and impact of ISO implementation.
IMPACT
Physical plant is well maintained Procedures are well defined & systematized Professional working environment Less wastage due to decline in defective rate More summer holidays Jump in profits- salary levels increased & investment increased .
CONCLUSION
Implementation of ISO 9000 was great success Full commitment & support from the management board Drive staffs attitude in a positive direction
Impact
Minor changes were made in the working procedures Pessimistic attitude of the employees Profits did not improve ,employees did not get benefits Could not continue with ISO certification
CONCLUSION
Managements perspective on quality and commitment to ISO is the key to its successful implementation. Management must initiate and take responsibility for the necessary changes, employ policies that encourage innovation and recognize employees motivation and competencies to make ISO a real success
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