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Premium member Presentation Transcript SALIENT FEATURES OF ISO 9000 SERIES : SALIENT FEATURES OF ISO 9000 SERIES BY V.KEERTHANA CONTENTS : CONTENTS DEFINITION WHAT IS ISO NEED OBJECTIVE HISTORY WHO CREATES STANDARDS PRINCIPLE ADVANTAGES & DISAVANTAGES STRUCTURE OF SERIES ELEMENTS OF ISO9000 CERTIFICATION PROCEDURE VARIOUS LOGOS CONCLUSION REFERENCES DEFINITION : DEFINITION ISO 9000 is a series of standards , development and published by the ISO that define,establish and maintain an effective quality assurance system for manufacturing and service industries. WHAT IS ISO : WHAT IS ISO ISO is a name used for the International Organization for Standardization ISO is not an acronym It was formed in 1947 in geneva switzerland. It is a federation of national standard bodies of 143 countries. NEED : NEED 1)By implementing an organization can benefit many industries such as banking,health care,manufacturing etc 2)The goal of this implementation is to achieve customer satisfaction at its highest value 3)To compete in domestic markets 4)To improve quality system OBJECTIVE : OBJECTIVE 1. To promote development of standardization to facilitate international exchange of goods and services. 2. To promote cooperation in intellectual, scientific, technological, and economic activity HISTORY : HISTORY 1946 London - delegates from 25 countries to facilitate the international coordination and unification of industrial standards 1947 - ISO began to officially function 1951 - The first ISO standard was published In 1979 to meet growing awareness of quality in industry BS5750 std were developed ISO revised and issued BS5750 in 1987 as ISO 9000 series Revised in 1994 and 2000 ISO9001:2000 is valid till next year. WHO CREATES STANDARDS : WHO CREATES STANDARDS International Organization for Standardization - Geneva ISO tech committee - started in 1979 Standards created in 1987 To eliminate country to country differences To eliminate terminology confusion To increase quality awareness PRINCIPLE : PRINCIPLE PLAN, DO, CHECK & ACT ADVANTAGES : ADVANTAGES For the customer:- - Increase satisfaction and growth in confidence. for the company:- 1)Well defined organization and responsibilities, i.e., minimize grey areas and possible resources wastage. 2)Establishment of proper communication channel Slide 11: A greater degree of internal control. Greater productivity and cost reduction Evidence of compliance Recognition of standard achieved Greater productivity and cost reduction DISADVANTAGES : DISADVANTAGES Assessment and certification are costly Need to change and accept new working practices may strain management Unless carefully planned it become non-cost effective and burdensome Iso9001 only complements and supplements product quality standards STRUCTURE OF SERIES : STRUCTURE OF SERIES ISO 9001:2000 Requirements : ISO 9001:2000 Requirements 1.Scope 2. Normative reference 3.Terms and definitions 4.Quality management system 5.Management responsibility 6.Resource management 7.Product realisation 8.Measurement, analysis and improvement Slide 16: Scope: Thespecifiedrequirementsaregenericandapplicabletoallorganizations,regardlessoftheirtypeandsize. Normative Reference: ‘ Terms and vocabulary Supplier, Organization, Customer. Quality management system : Quality management system QUALITY Quality is the totality of charecteristics of an entity that bear on its ability to satisfy stated and implied needs Customer satisfaction,whole organisation involvement Quality Service DOCUMENTATION : DOCUMENTATION General Quality manual Control of documents Control of records Slide 20: DOCUMENTATION PYRAMID Management responsibility : Management responsibility Management commitment Customer focus Quality policy:vission,mission,commitment Planning Slide 22: Responsibility and authority Management representative Internal communication MANAGEMENT REVIEW Review input Review output Resource management : Resource management Provision of resources Human resources Infrastructure Work environment TRAINING : TRAINING Measurement,analysis,improvement : Measurement,analysis,improvement It is done To demonstrate conformity of product To ensure conformity of QMS AUDITING : AUDITING external audit: auditing by an external certification body internal audit: by internal staff trained for this process Improvement : Improvement Corrective action Preventive action Continual improvement THE CONTINUOUS IMPROVEMENT MECHANISM : THE CONTINUOUS IMPROVEMENT MECHANISM UNSATISFACTORY OUTCOME WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION REVIEW Steps to ISO Registration : Steps to ISO Registration 1) Educate application Internal audit Process diagram documentation Internal audit certifer Issue of certificate Slide 30: Award of the ISO 9000 certificate Slide 31: FROM INTERNET ISO 9000 – Selection and use (2001), available from http://www.iso.org/iso/en/isoonline.frontpage Explains what the ISO 9000 standards are and how they are used; and provides guidelines on how implement a quality management system. Guidance on the Documentation Requirements of ISO 9001:2000, (October 2000), Available on the Internet: http://www.bsi.org.uk/iso-tc176- Sc2 Publicizing your ISO 9000 or ISO 14000 certification, Available on the Internet: http://www.iso.org/iso/en/isoonline VARIOUS LOGOS OF ISO9001 : VARIOUS LOGOS OF ISO9001 Various logos used in p’industries : Various logos used in p’industries PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. high GMP conditions are mauntained Slide 34: High quality standards CONCLUSION : CONCLUSION It can be applied to any type of organization It help in maintaining an efficient quality system in an organization It creates confidence in customer on quality of product supplied It act as competitive barrier REFERENCE : REFERENCE http://www.iso.org/iso/en/isoonline.frontpage Quality Assurance and Quality Management in Pharmaceutical Industry by anjaneyulu,marayya www.pharmaworld.com Slide 37: Any Questions ? ? ? ? ? ? ? ? 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