INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

1. (ISO 9000 SERIES) INTERNATIONAL ORGANIZATION FOR STANDARDIZATION S.RAJESH KUMAR M.Pharmacy 2nd semester Department of Industrial pharmacy University college of pharmaceutical sciences Kakatiya university, warangal - 506009

2. CONTENTS: • INTRODUCTION • DEFINITION • PURPOSE • WHAT STANDARDS MATTER • ISO BRAND • EXAMPLES • ELEMENTS OF THE STANDARDS • THE ISO 9000 SERIES • IMPLEMENTATION OF ISO 9000 QMS • CONCLUSION • REFERENCES

3. Introduction • ISO (International Organization for Standardization) is the largest developer and publisher of international standards. • It is founded on 23 February 1947 and has its head quarters in Geneva, Switzerland . • The organization promulgates world wide proprietary industrial and commercial standards. • The organization adopted ISO based on the Greek word `isos` meaning “equal”. It means it reflects the aim of the organization to equalize and standardize across cultures. • ISO has more than 17500 International Standards and other types of normative documents in the current portfolio.

4. Definition • ISO is a non-governmental organization that forms a bridge between the public and private sectors. • ISO defines itself as a non-governmental organization, its ability to set standards that often become law, either through treaties or national standards, makes it powerful than most non-governmental organizations.

5. Purpose • The purpose of ISO is to promote harmonization of processing, manufacture and quality assurance standards among industrial nations.

6. Why standards matter • Standards make an enormous and positive contribution to most aspects of our lives. • They ensure desirable characteristics of products and services such as quality ,environmental friendliness, safety ,reliability, efficiency and interchangeability - and at an economical cost. What standards do ~ ISO standards - make the development, manufacturing and supply of products and services more efficient, safer and cleaner - facilitate trade between countries and make it fairer. - provide governments with a technical base for health, safety and environmental legislation and conformity assessment.

7. Contd…. • Share technological advances and good management practice • Disseminate innovation • Safe guard consumers and users in general, of products and services • Make life simpler by providing solutions to common problems • ISO standards provide technological, economic and social benefits. • ISO standards are useful to everyone in the world

8. What International standardization means • International standards provide a reference framework, or a common technological language, between suppliers and their customers. • This facilitates trade and the transfer of technology.

9. Elements of the standards • Management responsibility • Resource management • Quality system • Contract review • Design control • Document control • Purchasing • Purchaser-supplied product • Product identification and traceability • Process control • Inspection and testing • Inspection, measuring and test equipment • Inspection and test status • Control of non-conforming product • Corrective action • Quality records • Internal quality audit • Training • Servicing • Statistical techniques

10. The ISO 9000 series • The ISO 9000 series is more systematic in approach and structure. • It is broader since it also encompasses the design stage • The GMP standards can be demonstrated. • It was taken into account during recent revisions of GMPs such as those of excipients by IPEC as well as for the Medical Devices Quality Systems Regulations of U.S.FDA

11. ESSENTIAL STEPS TO IMPLEMENT ISO 9000 QMS • Top management commitment • Establish implementation team • Start ISO 9000 awareness programs • Provide training • Conduct initial status survey • Create a documented implementation plan • Develop QMS documentation • Document control • Implementation • Internal quality audit • Management review • Pre assessment audit • Certification and registration • Continual improvement.

12. Contd… • The three series 9000 documents now are: • 9000:2000 Quality management systems – fundamentals and vocabulary • 9001:2000 Quality management systems – requirements • 9004:2000 Quality management systems – guidelines for performance improvement • It covers full range from design through development, manufacturing ,and production to supply and service. • ISO 9001:2000 • Quality management systems – requirements (required for registration) ~ Management responsibility ~ Resource management ~ product/service realization ~ Measurement ,analysis and improvement

13. Management responsibility • Define a quality policy that describes the organization's attitude towards quality . • Define the organizational structure that you will need in order to manage a quality system # Responsibility and authority * define quality system responsibilities , give quality system personnel the authority to carry out these responsibilities and ensure that the interactions between these personnel are clearly specified. Make sure all of this is well documented. # identify the resources that people needed to perform , manage and verify quality system work and provide them. Make sure that only trained personnel are assigned. # the senior executive is appointed to manage the quality system and ensure that quality system is developed and implemented. A management review is given to senior managers to ensure the effectiveness of the quality system. These reviews should be carried out on regular basis and should be documented and records are maintained.

14. Quality system • Quality system is developed and a manual is prepared which contains quality policy, objectives, overview of the system ,procedures records ,control quality system work practices, guide the implementation of system and explain how the system is audited. • Quality system procedures are developed and implemented that are consistent with quality policy. These procedures need to be documented and keep up to date. • Develop quality plans that show how you intend to fulfill quality system requirements. Quality plans are developed for products ,processes, projects and customer contracts. • Contract review # The contract review procedures should ensure that all contractual requirements are acceptable before agree to provide products to the customers. # Records are maintained and documented the review of customers orders and contracts.

15. Product development and design • The procedures required for the product design and development need to be developed and documented to ensure that all requirements are met. • Create design and development planning procedures • Identify the groups who should be routinely involved in the product design and development process, and ensure that their design input is properly documented, circulated and reviewed. • Develop procedures to ensure that all design input requirements are identified, documented and reviewed and that all design flaws, ambiguities ,contradictions and deficiencies are resolved. • Design outputs are usually documented. These documents are useful for purchasing , production, installation ,inspection, testing and servicing. • These documents should be reviewed and approved before they are distributed • These are accepted only if they meet official acceptance criteria • The procedures are needed to develop to control design out puts • Design review procedures needed to be planned, performed , documented and recorded. • Finally the product development and design should be verified.

16. Product identification and tracing • Develop and documented procedures are necessary to identify and track products from start to finish • Process control requirements • Develop procedures to plan ,monitor and control the production, installation and servicing processes. The procedures need to be documented, approved and performed by quality personnel • Develop procedures that allow you or your customers to verify the acceptability of products you have purchased. • Supplier verification at subcontractor's place • Customer verification of subcontracted product. • Protect customer supplied products.

17. Control of inspection equipment • The inspection equipment which is needed to be controlled is to calibrated, maintained and it should be appropriate, effective and secure. • Inspection and test status of products each and every product is identified the test status of each product is documented and respected through out the production, installation and servicing process. # control of nonconforming products procedures are developed to control the nonconforming products and these are reviewed, reworked,regraded,retested,recordedand discussed with the customers # corrective or preventive actions procedures needed to eliminate the causes for nonconformity

18. Handling. storage and delivery • Procedures are developed and documented for handling, storage and deliver of the products. • Develop packaging and marking methods and procedures to protect and control the quality of products and packing materials. • Develop methods and procedures to protect and preserve product quality prior to delivery while the product is till under the organization's supervision and control. • Develop procedures to protect the products after final testing and inspection and during delivery. • Develop a quality control record keeping system • Develop internal audit procedures • Develop training procedures • Develop service procedures which are to be documented • Select the statistical techniques in order to establish, control and verify * process capabilities * product characteristics

19. Difference between ISO 9001and ISO 14001 • The vast majority of ISO standards are highly specific to a particular product, material or processes. • The ISO 9001 (quality) and ISO 14001(environment) are “generic management system standards”. • ISO 9001 contains a set of generic requirements for implementing a quality management system and ISO 14001 for an environmental management system. • Generic standards are applied to any organization. • Today, many products require testing for conformity with specifications or compliance with safety ,or other regulations before they can be put on many markets. • ISO guides and standards for conformity assessment represent an international consensus on best practice.

20. Other ISO series • The ISO 14644 and 14698 series founded by ISO/TC 209 • The ISO 14644 series covering general contamination control topics • The ISO 14698 series on biocontamination control issues • NEWER SERIES: • Energy and nano technology • Nanotechnology cover a wide variety of applied science and technology • International standards contribute at three levels ~ assisting the innovation process ~ addressing the challenges in measurement at the nano scale And ~ helping to alleviate concerns over potential health and environmental impacts.

21. Contd….. • ISO/TR 12885:2008, Health and safety practices in occupational settings relevant to nanotechnologies was developed by ISO/TC 229, Nanotechnologies. • The latest ISO 27000-series international standards for information security management. • ISO/TS 27687:2008 is concerned with the terminology and definitions for the objects at the nano scale, which comes in several shapes (nanoparticle, nanofibre,nanoplate) • ISO 15022 was prepared by technical committee ISO/TC68,banking,securities and related financial services.

22. ISO membership countries • It has 3 membership categories • Member bodies are national bodies that are considered to be most representative standards body in each country. These are the only members of ISO that have voting rights. • Correspondent members are countries that do not have their own standards organization. These members are informed about ISOs work but do not participate in standards promulgation. • Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.

23. ISO international partners • ISO collaborates with the partners in international organization, the International Electrotechnical Commission(IEC) and International Telecommunication union(ITC). The above three are present in Geneva,Switzerland,have formed the World Standards Cooperation (wsc) to act as a strategic focus for collaboration and the promotion of international standardization. • ISO has a close relation ship with the WTO. • It collaborates with the United Nations(UN) organization and its specialized agencies and commissions such as CODEX Alimentarius, on food safety measurement, management and traceability UN Economic Commission for Europe(UN/ECE) WHO, International Maritime Organization(IMO) ,World Tourism Organization etc.

24. CONCLUSION • Many companies see the introduction of a quality management system as a major step forward in controlling and improving their key processes. • Implementation of ISO 9000 affects the entire organization right from the start if pursued with total dedication, it results in cultural transisition to an atmosphere of continuous improvement. • ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader of society.

25. REFERENCES • Robert A. Nash, Alfred H. Watcher ;“Pharmaceutical Process Validation”, third edition • Dale, B. G. and Oakland, J. S., Quality Improvement Through Standards (2nd Edn), Stanley Thornes (Publishers) Ltd. Cheltenham, 1994. • Marquardt, D., Chové, J., Jensen, K. E., Petrick, K., Pyle, J. and Strahle D., ‘Vision 2000: The Strategy for the ISO 9000 Series Standards in the ’90s’, Quality Progress, 24 (5), 1991, pp. 25-31 • Bemowski, K. and Stratton, B., ‘How do People Use the Baldrige Award Criteria?’, Quality Progress, 28 (5), 1995, pp. 43-47. • [4] Gadd, K., Oakland, J. S. and Porter, L. J., ‘Business Self-Assessment and Evaluation of Current European Practice’, Proceedings of the 1996 Learning Edge Conference, Paris, April 24-26, 1996, EFQM, pp. 292-315. • [5] Hesseling, P., Kringloop Van Kennis in Economische Organizaties, Stenfert Kroese, Leiden, 1984. • www.iso.org • www.wikipedia.org • www.osun.org • www.pharmainfo.net

26. THANQ