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WHAT IS ISO? A process for assuring consistent material and product quality via contractual arrangements.

What is ISO? :

What is ISO? ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. International Standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade.


Objective.. Increases customer confidence in the quality of supplied materials, products, or services. It focuses primarily on the product ( which may be service, material or product) and its development and production. Especially important for trade between different countries with different languages and cultures.

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Identify and understand user needs in the field of quality management. D evelop standards that respond effectively to the expectations of users. S upport implementation of these standards; and F acilitate meaningful evaluation of the resulting implementations using the ISO process to achieve international marketing and compatibility with other ISO management standards.


MEMBERS "P" members(PARTICIPANT) : Represent countries who wish to vote, participate actively in discussions and have access to all relevant documentation . "O" members(OBSERVER) : Members represent countries not wishing to vote, but rather only to participate in discussions and receive all relevant information . "L" organizations(LIASION) : Are international or broadly based regional organizations who are invited to take part in discussions and are permitted to receive all information from the TC but are not granted voting status.

ISO Story:

ISO Story The ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’. In February 1947 the new organisation , ISO, officially began operations.


Since then, ISO has published over 19000 International Standards covering almost all aspects of technology and manufacturing. Today ISO has members from 164 countries and 3335 technical bodies to take care of standard development. More than 150 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.


Standards A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. ISO has published over 19000 International Standards that can be purchased from ISO or its members.

Popular standards:

Popular standards ISO 31000 Risk management ISO 9000 Quality management ISO 26000 Social responsibility ISO 14000 Environmental management ISO 50001 Energy management ISO 22000 Food safety management ISO 3166 Country codes ISO 4217 Currency codes ISO 639 Language codes

ISO 31000 Risk management :

ISO 31000 Risk management ISO 31000:2009 ISO 31000:2009, Risk management – Principles and guidelines , provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment

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However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes . Organizations using it can compare their risk management practices with an internationally recognised benchmark, providing sound principles for effective management and corporate governance.

Related Standards :

Related Standards A number of other standards also relate to risk management. ISO Guide 73:2009, Risk management - Vocabulary complements ISO 31000 by providing a collection of terms and definitions relating to the management of risk.

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ISO/IEC 31010:2009, Risk management – Risk assessment techniques focuses on risk assessment. Risk assessment helps decision makers understand the risks that could affect the achievement of objectives as well as the adequacy of the controls already in place. ISO/IEC 31010:2009 focuses on risk assessment concepts, processes and the selection of risk assessment techniques.

ISO 9000 - Quality management:

ISO 9000 - Quality management The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

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There are many standards in the ISO 9000 family, including: ISO 9001:2008 - sets out the requirements of a quality management system ISO 9000:2005 - covers the basic concepts and language ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

ISO 26000 - Social responsibility:

ISO 26000 - Social responsibility ISO 26000 provides guidance on how businesses and organizations can operate in a socially responsible way. This means acting in an ethical and transparent way that contributes to the health and welfare of society.

ISO 14000 - Environmental management :

ISO 14000 - Environmental management The ISO 14000 family addresses various aspects of environmental management. It provides practical tools for companies and organizations looking to identify and control their environmental impact and constantly improve their environmental performance. ISO 14001:2004 and ISO 14004:2004 focus on environmental management systems. The other standards in the family focus on specific environmental aspects such as life cycle analysis, communication and auditing.

ISO 50001 - Energy management:

ISO 50001 - Energy management This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management. Develop a policy for more efficient use of energy Fix targets and objectives to meet the policy Use data to better understand and make decisions about energy use Measure the results Review how well the policy works, and Continually improve energy management.

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How does ISO develop standards?

Standards catalogue:

Standards catalogue ISO has developed over 19 000 International Standards and all are included in the ISO Standards catalogue. You can browse by ICS (International Classification for Standards) . ICS is a way of classifying standards into fields such as electrical engineering or paper technology.

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You can browse by TC (technical committees) . ISO standards are developed by experts from TCs focusing on all kinds of different subjects from screw threads to shipping technology. By clicking on the TC you can see all the standards published by this group of experts. You can search the standards catalogue using a key word or the number of the standard (all ISO standards are numbered) for example ‘quality management’ or ‘9001’ to find ISO 9001.


ISO, GMP and TQM ISO Describes a system approach. GMP Has required national standards. But lacks a system approach. TQM Is a management approach. to long term success centered on “quality” through customer satisfaction TQM is based on the participation of all members of an organization in continually improving processes, products and services

Comparison: GMP and ISO:

Comparison: GMP and ISO ISO GMP Objectives customer satisfaction customer protection binding nature Voluntary legally binding Supervision neutral institution health authority degree of detail General Detailed type of business all businesses pharma specific main emphasis system related product related standards own standards legally set standards


ISO FAMILY ISO 9001 Quality Management Systems Requirements ISO 9004 Quality Management Systems-Guidelines For Performance Improvements ISO 14000 Series on Environmental Management ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing ISO 17799 security

ISO 10000 family:

ISO 10000 family ISO 10006 project management ISO 10007 configuration management ISO 10012 measurement systems ISO 10013 quality documentation ISO 10014 managing economics of quality ISO 10015 training


CONTROL OF DOCUMENTS To approve document for adequacy prior to issue. To review and update as necessary and reapproved document. To ensure the changes and the current revision status of document are identified. To ensure that relevant version of applicable documents are available at points of use. To ensure that document remain legible and readily identifiable. To ensure that documents of external origin are identified and that distribution controlled. To prevent the unintended use of obsolete documents & to apply suitable identification to them if they are retained for any purpose.


CONTROL OF RECORDS Records should be legible Bear unique identification Storage location & protection Storage period Accessibility status Disposal mechanism Easy retrieval as & when required


INTERNAL AUDIT It aims at determination of performance of QMS. (a)Audit schedule (b)Audit scope and criteria (c)Selection of auditors (d)Recording of observation (e)Verification of corrective action (f)Reporting of critical non-conformities (g)Review of effectiveness of implementation


CONTROL OF MANUFACTURING RECORDS (a)Product or process criteria (b)Monitoring criteria (c)Recording mechanism of non conformities (d)Action to be taken to eliminate nonconformity (e) Reverification (f)Notification of changes


Application.. 1. In Management responsibility 2. In Quality systems 3. In Contract review 4. In Purchasing 5. In Process control 6 . In Environmental control 7 . In Packaging 8 . In laboratories testing

PowerPoint Presentation:

ISO 14698… ‘Clean rooms and Associated Controlled Environments–Biocontamination Control’: part 1: General principles and methods Part 2 : Evaluation and interpretation of biocontamination data


Packaging.. What is ISO 15378? This standard is a complete, integrated quality management system standard combining ISO 9001:2000 and Good Manufacturing Practices for Primary Pharmaceutical Packaging Materials. Initially conceived for glass and then expanded to cover all primary packaging materials for pharmaceuticals, the next development is to extend the standard to include secondary packaging materials.


ISO 11418-1:2005 Containers and accessories for pharmaceutical preparations –bottles, transfusion, blood processing equipment, etc… CONTAINERS AND ACCESSORIES


ISO-11737: Bioburden testing for non-sterile products. BIOBURDEN TESTING


REFERENCES The state of ISO-9000 certification – A study of Swedish organization. Poksinska B., Kahlgarad J., Antoni M. 2. APV/IKEV Seminar on Good Manufacturing Practice: Compliance and Inspection, Istanbul, June 10/11, 2004. 3. Steinborn Leonard , GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers,Vol-2 ,6 th edition.

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