ISO 9000 & 14000

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ISO 9000 AND ISO 14000 M. ANITHA SRI, I/II M.PHARMACY, INDUSTRIAL PHARMACY, CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES, LAM.

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International Organization for Standardization – Geneva, Switzerland in 1947. “iso” = equal Network of many national standard bodies. World’s largest non-governmental, independent, voluntary developer. Covers almost all aspects. Published >19,000 international standards. 2

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ISO Founders 3

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ISO Organization 4

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ISO Organization 5 Dr. Elisabeth Stampfl-Blaha Chairman of the TMB Sophie Clivio Secretary of the TMB

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International Organization for Standardization (ISO) defines a standard as, "A document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context." “STANDARD” 6

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Identification of need. Collective Programming. Drawing up of the draft standard. Consensus. Validation Approval Review. - Fast – track procedure. LIFE CYCLE OF STANDARDS 7

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International coordination and unification. Harmonisation of processing, manufacturing and Quality Assurance standards. PURPOSE OF ISO 8

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Standard format for telephone and banking cards. Internationally standardized freight containers. What has ISO Accomplished? 9

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10 Standard sizes for bullets and rifles. Automobile control symbols. ISO international codes for country names, currencies and languages.

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11 Cameras and Film Sizes. Standardized paper sizes.

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ISO 9000 is for quality management. First published in 1987. Quality refers to all those features of a product (or service) which are required by the customer. Quality management means what the organization does to - ensure that its products or services satisfy the customer's quality requirements and comply with any regulations applicable to those products or services. Quality management 12

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Evolution of ISO 9000 series 14

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ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. ISO 9001:2000 combined the three standards—9001, 9002, and 9003—into one, called 9001. 15

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ISO 9000 PROCESS APPROACH 16

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QMS helps to- Make sure no bad product is produced, Determine what to do with a bad product, Deals with the root cause of problems, Keeps records to use as a tool to improve the system. MAINTAINING QMS BASED ON ISO 9000 17

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Global Adoption of ISO 9000 18 Source: ISO survey 2009

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ISO 14001 is for environmental management. - First published in 1996. This means what the organization does to: minimize harmful effects on the environment caused by its activities, to conform to applicable rules, to achieve continual improvement of its environmental performance. ISO 14000 19

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ISO14000 standards 20

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ISO 14000 21

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This standard is applicable to any organization that wishes to: implement, maintain and improve an environmental management system assure itself of its conformance with its own stated environmental policy (those policy commitments of course must be made) demonstrate conformance ensure compliance with environmental laws and regulations seek certification of its environmental management system by an external third party organization make a self-determination of conformance ISO 14001 Environmental Management 22

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Only standard that can be certified, upon- Minimising how business operations negatively impact the environment. Complying with the regulations and laws outlined in the EMS Continual improvement. ISO 14001 Standards 23

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ISO 14001 principles 24

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ISO 14000 Benefits 25 Cleaner, safer and healthier world. Reduced raw material use. Improved process efficiency. Reduced waste generation and disposal cost. Utilisation of recoverable resources.

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Cost saving-optimise operations. Enhanced customer satisfaction – road safety, toy safety. Access to new markets- prevent trade barriers. Increased market share- increase productivity. Environmental Benefits – air, water & soil quality. Benefits of ISO 27

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Amount of money- standards are not free. Time consuming. Paper work. Less flexibility. Difficult to use in smaller companies. Disadvantages of ISO 28

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29 What can i do if i think a standard is being misused? - complaint. 2. What's the difference between being certified/registered and being compliant? 3. What's the difference between being certified and being accredited? Award of the ISO 9000 certificate

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30 4. What's the difference between a Quality Manual and a Quality System? 5. Does this mean every widget made in the world will be the same? -NO, ISO standards are process standards. 6. Who can use ISO standards? -ISO standards are generic. 7. What resources are needed to implement these standards of QMS/EMS? a)leadership b)skills c)staff time d)support & information. 8. Should a pharmaceutical company already in tune with GMP be ISO 9000 certified? - YES.

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1. Cargill C.F. (1990)"Justifying the Need for A Standards Program". Standards Management a Handbook for Profits, ANSI, N.Y. 2. International Organization for Standardization (ISO). www.iso.ch 3. www.iso.org 4. ISO/TC 176: www.tc176.org, Quality management and quality assurance: Selection and use of the ISO 9000 family of standards. 5. ISO/TC 207 : www.tc207.org: Environmental management: The ISO 14000 family of International Standards. REFERENCES 31

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