ISO 9000 AND ISO 14000

-M. ANITHA SRI. M.Pharmacy.

 International Organization for Standardization Geneva, Switzerland in 1947. iso = equal Network of many national standard bodies. Worlds largest non-governmental, independent, voluntary developer. Covers almost all aspects. Published >19,000 international standards.
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ISO Founders

ISO Organization
General Assembly
Policy Development Committees

Council

Technical Management Board Technical Advisory Groups

Technical Committees Technical Committees Technical Committees Technical Committees
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ISO Organization

Dr. Elisabeth Stampfl-Blaha Chairman of the TMB

Sophie Clivio Secretary of the TMB

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STANDARD
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."

LIFE CYCLE OF STANDARDS

1. 2. 3. 4. 5. 6. 7. Identification of need. Collective Programming. Drawing up of the draft standard. Consensus. Validation Approval Review. - Fast track procedure.
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PURPOSE OF ISO
International coordination and unification. Harmonisation of processing, manufacturing and Quality Assurance standards.

What has ISO Accomplished?

Standard format for telephone and banking cards. Internationally standardized freight containers.

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

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Cameras and Film Sizes. Standardized paper sizes.

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Quality management
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.
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STANDARD

CONTENT Provides definition and concepts. Explains how to select other standards for a given business Quality assurance in design, development, production, installation and servicing Quality management and quality system elements

APPLICATION

ISO 9000

All industries including software development

ISO 9001

Engineering and construction firms, manufacturers that design, develop, install and service products All industries
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ISO 9004

Evolution of ISO 9000 series

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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 standards9001, 9002, and 9003 into one, called 9001.
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ISO 9000 PROCESS APPROACH

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MAINTAINING QMS BASED ON ISO 9000

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.

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Global Adoption of ISO 9000

Rank 1 Country China No. of certificates 257,076 130,066 68,484 59,576 53,152 47,156 41,193 37,493 28,935 23,400
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2
3 4 5

Italy
Japan Spain Russia

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7 8 9

Germany
UK India USA

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Korea

Source: ISO survey 2009

ISO 14000
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.
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ISO14000 standards
STANDARD 14000 14001 14010 CONTENT Guide to Environmental Management Principles, Systems and Supporting Techniques Environmental Management Systems - Specification with Guidance for Use Guidelines for Environmental Auditing - General Principles of Environmental Auditing Guidelines for Environmental Auditing - Audit Procedures-Part 1: Auditing of Environmental Management Systems Guidelines for Environmental Auditing - Qualification Criteria for Environmental Auditors

14011
14012 14013/15

Guidelines for Environmental Auditing - Audit Programmes, Reviews & Assessments

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ISO 14000
STANDARD 14013/15 14020/23 14024 14031/32 14040/43 14050 14060 CONTENT Guidelines for Environmental Auditing - Audit Programmes, Reviews & Assessments Environmental Labeling

Environmental Labeling - Practitioner Programs - Guiding Principles, Practices and Certification Procedures of Multiple Criteria Programs
Guidelines on Environmental Performance Evaluation Life Cycle Assessment General Principles and Practices Glossary Guide for the Inclusion of Environmental Aspects in Product Standards

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ISO 14001 Environmental Management

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

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ISO 14001 Standards

Only standard that can be certified, upona) Minimising how business operations negatively impact the environment. b) Complying with the regulations and laws outlined in the EMS c) Continual improvement.

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ISO 14001 principles

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ISO 14000 Benefits

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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Benefits of ISO
Cost saving-optimise operations. Enhanced customer satisfaction road safety, toy safety. Access to new marketsprevent trade barriers. Increased market shareincrease productivity. Environmental Benefits air, water & soil quality.
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Disadvantages of ISO
Amount of moneystandards are not free. Time consuming. Paper work. Less flexibility. Difficult to use in smaller companies.

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1. 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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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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REFERENCES
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.
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