Vi shal Sachdeva Sachdeva et et al. / J our nal of Ph arm acy Rese Research arch 2012,5(8),4108-4112
Review Article ISSN: 0974-6943
Available online through www.jpronline.info
ISO 9000 & its Importance in Pharmacy Vishal Sachdeva*, Vipin Kukkar, Vikram Jeet Singh, Shishir Jha Seth G. L. Bihani S. D. College of Technical Education (Institute of Pharmaceutical Sciences & Drug Research) Gagan Path, Sri Ganganagar (Rajasthan) 335001, INDIA
Received on:14-05-2012; Revised on: 16-06-2012; Accepted on:27-07-2012
ABSTRAC ABSTRACT T ISO 9000 Quality Management System is a structural framework of a business system that specifies, in very broad terms, the necessary components of a quality management system. Subjective studies suggest that ISO 9000 can help organizations improve their management practices. In this paper, the researcher examined the effectiveness of the ISO 90 00 certification, and tested whether earning the ISO 9000 certification leads to improvement in quality management practices, in medication management practices, and in organizational management systems in health care setting. Overall, this study presents ISO 9000 Quality Management System as effective in improving the pharmacy management systems. A well documented and consistent ISO 9000 Quality Management System can contribute significantly to improve performances in health care setting. Key words: ISO, Quality Management, Pharmacy.
INTRODUCTION When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor qu ality, do not fit, are incompatib le with eq uipment that we already ISO is a network of of the national standards institutes of 162 countries , one member per country, with a Central Secretariat in Geneva, Switzerland, have, are unreliable or dangerous. that coordinates the system. When products, systems, machinery and devices wor k well and safely, it is ISO is a non-governmental organization that forms a bridge between often because they meet standards. And the organization responsible for the public and private sectors. On the one hand, many of its member many thousands of the standards which benefit the world is IS O. institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have Who Standards Benefit their roots uniquely in the private sector, having been set up by national ISO standards provide technological, economic and societal benefits. For businesses , the widespread adoption of International Standards means partn ership s of in dustr y assoc iations . that suppliers can develop and offer products and services meeting Therefore, ISO enables a consensus to be reached on solutions that meet specifications that have wide international acceptance in their sectors. Therefore, businesses using International Standards can compete on many both the r equirements of business and the broader needs of society. more markets around the world. ISO’s NAME Because “International Organization for Standardization” would have For innovators of new technologies, International Standards on aspects different acronyms in different languages (“IOS” in English, “OIN” in French like terminology, compatibility and safety speed up the dissemination of for Organisationinternationale de normalisation), normalisation), its founders decided to innovations and their development into manufacturable and marketable give it also a short, all-purpose name. They chose ”ISO”, derived from the prod ucts. Greek isos isos,, meaning “equal”. Whatever the country, whatever the language, the short form of the organization’s name is always ISO. For customers , the worldwide compatibility of technology which is achieved when products and services are based on International Standards gives them Why Standards matter a broad choice of offers. They also benefit from the effects of Standards make an enormous and positive contribution contribution to most aspects of competition among suppliers. our lives. ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards .
Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost.
*Corresponding author. Vi shal Sachdeva Sachdeva 106-A, Setia Setia Col on St. No. 3 Sri Ganganagar (Rajasthan) I ndia, 33500 33500
For governments, International Standards provide the technological and scientific bases underpinning health, safety and environmental legislation. For trade officials, International Standards create ”a level playing field” for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade. International Standards are the technical means by which political trade agreements can be put into practice.
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Vi shal Sachdeva et al. / J our nal of Ph arm acy Research 2012,5(8),4108-4112 For developing countries, International Standards that represent an international consensus on the state of the art are an important source of technological know-how. By defining the characteristics that products and services will be expected to meet on export markets, International Standards give developing countries a basis for makingthe right decisions when investing their scarce resources and thus avoid squandering them. For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability. For everyone, International Standards contribute to the quality of life in general by ensuring that the transpor t, machinery and tools we use are safe. For the planet we inhabit, International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of produc ts can con tribute to efforts to preser ve the en vironmen t. ISO 9000 Origin The story of ISO 9000 is a story of standards, methods and regulation. The brief history that follows is in no w ay co mprehens ive b ut is intended to illustrate four things that standards are an ancient concept that survived several millennia; • that a means of verifying compliance often follows the setting of • standards; that the formalizing of working practices is centuries old and seen • as a means to consistently meet standards; that market regulation (relative to the standard of goods and ser• vices) has been around for centuries for the protection of both craftsmen and traders.
ISO 9000 is a symptom of practices that were around centuries before anyone coined the term quality management. It is in some respects a natural progres sion tha t will co ntinue to evolv e. The story is told from a British viewpoint.
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 Types of ISO 9000 What is the difference between I SO 9001 / 9002 / 9003? ISO 9001 Is the most complete and demanding standard in the ISO 9000 series. It covers product design, engineering,manufacturing, purchasing, marketing, sales, product storage, shipping and handling and product servicing. ISO 9002 is the next most demanding standard in the ISO 9000 series is designed to assure customers that the quality system is in place from manufacturing to service. ISO 9003 is the least demanding standard in the ISO 9000 series. It addresses only the requirements for detection and control of problems during final inspection and testing of less complex products or services. ISO 9000 Series Quality Management System Principles 1 – CUSTOMER FOCUSED ORGANIZATION 2 – LEADERSHIP 3 -INVOLEMENT OF PEOPLE 4 - PROCESS APPROACH 5 - SYSTEM APPROACH TO MANAGEMENT 6-CONTINUAL IMPROVEMENT 7- ACTUAL APPROACH TO DECISION MAKING 8- MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
How ISO Standars are developed? The national delegations of experts of a technical committee meet to discuss, debate and argue until they reach consensus on a draft agreement. This is circulated as a Draft International Standard (DIS) to ISO’s membership as a whole for comment and balloting.
On September 17, 1999, NASA became the first multi-site government agency in the world to achieve ISO 9001 registration status for all of its sites, fulfilling a goal set by NASA Administrator Daniel Goldin on November 13, 1996.
Many members have public review procedures for making draft standards known and available to interested parties and to the general public. The ISO members then take account of any feedback they receive in formulating their position on the draft standard.
ISO 14000 The ISO 14000 environment management standards exist to help organizations minimize how their operations negatively affect the environment.
If the voting is in favour, the document, with eventual modifications, is circulated to the ISO members as a Final Draft International Standard (FDIS). If that vote is positive, the document is then published as an International Standard.
ISO 14001 ISO 14001 is generic and flexible enough to apply to any organization producing an y product o r service anywher e in the world.
Every working day of the year, an average of eight ISO meetings are taking place somewhere in the world. In between meetings, the experts continue the standards’ development work by correspondence. Increasingly, their contacts are made by electronic means and some ISO technical bodies h ave already gone over entirely toworking electronically, which speeds up the development of standards and cuts travel costs. Popular Standards ISO 9000 Quality Management Systems - Fundamentals And Vocabulary ISO 9001 Quality Management Systems Requirements
ISO 14020 covers labels and declarations. ISO 14030 discusses post-production environmental assessment. ISO 14040 discusses pre-production planning and environment goal setting. ISO 9000 SERIES The ISO, based in Switzerland, first published the ISO 9000 standards in 1987. The series was designed as a means to increase customer confidence
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Vi shal Sachdeva et al. / J our nal of Ph arm acy Research 2012,5(8),4108-4112 in the quality of supplied materials, products, or services. This was especially important for trade between different countries with different languages and cultures. Not surprisingly, the initial emphasis was within the European Economic Community as part of the movement to a unified market. The standard has evolved over several revisions. The initial 1987 version, ISO 9000:1987, although structured like the British Standard BS 5750, included numerous documents then in use around the world. Although the Standard has gone through two more iterations, which have resulted in some radically changed language, all the core, prevention-oriented quality assurance requirements were present in the 1987 docum ent. The language of this first version of the Standard was influenced by existing U.S. and other Defence Military Standards (“MIL SPECS”), so was more accessible to manufacturing, and was well-suited to the demands of a rigorous, stable, factory-floor manufacturing process. With its structure of twenty “elements” of requirements, the emphasis tended to be overly placed on conformance with procedures rather than the overall process of management, which was the actual intent. The 1994 version, ISO 9000:1994 emphasized quality management and quality assurance via preventive actions, and continued to require evidence of compliance with documented procedures. Unfortunately, as with the first edition, companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. Adapting and improving processes could be particularly difficult in this kind of environment. The 2000 version, ISO 9000:2000 that consists of ISO 9001:2000 and ISO 9004:2000, made a significant change by actually placing the concept of process management front and center in the Standard. There was no change in the essential goals of the Standard, which was all about a “documented system,” not a “system of documents.” The goal was always to have management system effectiveness via process performance metrics. The third edition makes this more visible and so reduced the emphasis on having documented procedures if clear evidence could be presented to show that the process was working well. Expectations of continual process improvement and tracking customer satisfaction were made explicit at this revision. ISO 9000 has gained extensive acceptance, having been adopted by over 100 countries. Compliance is voluntary; however, some companies have made certification a condition of doing business. The registration process involv es independent audit and confi rmation that quality systems are in compliance with the standard. A fee is involved and periodic reinspection is required. A certificate of compliance is provided. This is the converse of the U.S. GMP situation, where compliance is assumed unless the FDA states otherwise, and no certificate of compliance is provided. However, a major benefit of ISO 9000 has been to allow and encourage nonregulated industries to introduce a quality management system. Previously, the only widely established systems included regulations such as GMPs aimed at specific industries and award programs such as Deming and Malcolm Baldrige. None of these had universal coverage, although the World Health Organization GMPs do apply to many countries. Since the pharmaceutical indu stryis already su bject to quality r egulations, attaining ISO 9000 or 9001certification is not a goal of pharmaceutical manufacturers. However, suppliers to the pharmaceutical industry have sought it.
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 fina l inspect ion and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:19 87 was also influenced by existing U.S. and other Defense Standards (“MIL SPECS”), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent. 1994 version 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. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system. 2000 version ISO 9001:20 00 combined the three standards—9001, 9002, and 9003— into one, called 9001. Design and development procedures were required only if a company does in fact engag e in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center (“Process management” was the monitoring and optimisation of a company’s tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of qu ality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals w ho are implementing the stand ard. 2008 version ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.
ISO 9000 has eight quality management principles on which the quality management system standards of the revised ISO 9000:2000 series are based. The princ iples are derive d from the collecti ve experi ence and Evolution of ISO 9000 Standards knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, quality management, and QA, which is responsible 1987 version for developing and maintaining the ISO 9000 standards . The eight quality ISO 9000:1987 had the same structure as the UK Standard BS 5750, with management principles are defined in ISO 9000:2000, Quality Management three ‘models’ for quality management systems, the selection of which was Systems Fundamentals and Vocabulary, and in ISO 9004:2000, Quality based on the scope of activities of the organization: Management Systems Guidelines for Performance Improvements. A comparison to U.S. GMP is presented. ISO 9001:1987 Model for qual ity assu rance in design , develo pmen t, production, installation, and servicing was for companies and organizations Principle 1: Customer Focus whose activities included the creation of new products. Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and Jour nal of Pharmacy Research V ol.5 I ssue 8.August 2012
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Vi shal Sachdeva et al. / J our nal of Ph arm acy Research 2012,5(8),4108-4112 strive to exceed customer expectations.Customer focus is a critical business assist organizations improve performance. The standards can be used focus and is not covered in the U.S. GMPs other than the need to have without being linked with certification. produ cts that meet th e standard s and speci fications . All organizations have a quality management system but its formalization is optional. The system enables the organization to achieve its objectives Principle 2: Leadership Leaders establish unity of purpose and direction of the organization. They and therefore exists independently of whether or not ISO 9000 is used and should create and maintain the internal environment in which people can whether or not ISO 9000 Certification is obtained. become fully involved in achieving the organization’s objectives. There is no mention of Leadership in the U.S. GMPs but the concept is included in Remove the two outer pillars and the organization remains stable! The the Quality Systems Approach to Pharmaceutical GMP Regulations final foundation upon which the three pillars stand is the body of knowledge guidance, September, 2006 where providing leadership is the first item in that represents the field of quality manag ement. Most of this knowledge is the management responsibilities section. channelled through the management system, somewhat less is channelled through the standard (ISO 9000) and a particular branch ofthe body of knowledge is channelled through certification. An organizationcould absorb Principle 3: Involvement of People People at all levels are the essence of an organization and their full and apply all relevant knowledge and therefore obtain noadditional support involvement enables their abilities to be used for the organization’s benefit. from ISO 9000 standards or ISO 9000 certification. Anotherorganization Responsibilities of the quality unit and personn el qualifications are covered may absorb and apply some knowledge directly from thefoundation but in the U.S. GMPs and the develop personnel concept is in the Quality require the support of the ISO 9000 standards to helpunderstanding and Systems Approach guidance. application. A third organization may absorb and applylittle knowledge directly from the foundation and require both the support ofthe ISO 9000 standards and ISO 9000 certification to maintain a stable androbust Principle 4: Process Approach A desired result is achieved more efficiently when activities and related management system.(Hoyle D. 2001) resources are managed as a process. Importance of ISO 9000 in Pharmacy Principle 5: System Approach to Management Identifying, understanding, and managing interrelated processes as a system ISO Gives Pharmaceutical industry new management tool to improve contributes to the organization’s effectiveness and efficiency in achieving patient safety its objective. Principles 4 and 5 are not covered in the U.S. GMPs but the The benefits of implementing Good Manufacturing Practices and quality concepts are implied in the Quality Systems Approach guidance. management are henceforth made easier to achieve for the pharmaceutical sector thanks to ISO. Principle 6: Continual Improvement Continual improvement of the organization’s overall performance should “The standard is of vital importance to the pharmaceutical industry and its be a permanent objective of the organization. The closest thing to continual suppliers of pharmaceutical primary packaging materials. For the first time, improvement is the corrective and preventive action (CAPA) GMP practices the principles of Good Manufacturing Practice are specified as part of an that are typically the results of a failure investigation. ISO standard. Principle 7: Factual Approach to Decision Making Effective decisions are based on the analysis of data and information. The basis of science and supporting data is a f undamental expectation o f the U.S. GMPs and quality by design (QBD) initiatives. Principle 8: Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. Control of materials and components is a U.S. GMP requirement and quality agreements and supplier contracts are expected practices but relationships are not a requirement.
Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the cu stomer from purchasin g a product which is ine ffective or even dangerous. Up until now, however, there was no applicable guideline or rule for primary packaging materials, which contain, seal or are used for dose application and have direct contact with the medicinal product. The publication of ISO 15378:2006, Primary packag ing materia ls for medicinal products – Particular requirements for the application of ISO 9001:2000, represents an international consensus on good practice and establishes a benchmark that can be applied for quality improvement, training, auditing and certification.
The Three Pillars of ISO 9000 ISO 9000 Certification is only of any value in markets where it provides the confidence needed for free trade. ISO 9000 as a symbol has become Developed with the participation of pharmaceutical sector experts, ISO synonymous with certification, quality management systems, documentation 15378:2006 incorporates in a single document the quality management and internal audits to such an extent that if one were to dispense with ISO requirements of ISO 9001:2000 together with the Principles of Good 9000 certification, one also ceases to maintain a quality management system, Manufacturing Practice (GMP) for the design, manufacturing and supply ceases to conduct audits and ceases to use documentation. We have to of primary packaging materials for medicinal products. divorce certification from systems and systems from standar ds and correct a few misconceptions. ISO 9000 Certification is optional and whether or In addition, the new standard gives guidance on risk management and not your organization is ISO 9000 certificated, it does not by itself affect validation and – in line with current developments worldwide – contains the performance of an organization. It is a flag of confidence that is visible guidance annexes on both these aspects. to others with whom you trade. Certification is inextricably linked to the standard. ISO 9000 is a series of standards and their use is optional. They The standard is applicable to all p rimary packaging materials (glass, rubber, do not affect the performance of an organization although their use can plastic, aluminum, etc.).
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Vi shal Sachdeva et al. / J our nal of Ph arm acy Research 2012,5(8),4108-4112 ISO 15378:2006 was developed by ISO technical committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical us e. The standard costs 154 Swiss francs and is available from ISO national member institutes and from ISO Central Secretariat.
also requires thorough evaluation of new suppliers before a change is made and/or consistency with respect to how and where orders are placed. 7. Documentation The ISO QMS standard requires documentation of all processes and any changes, errors and discrepancies. This ensures consistency throughout production and accountability of all staff. This also guarantees traceable records are available in case of non-compliant products or raw materials.
ISO 9000 IN R&D Process driven quality system much as ISO 9001 are potentially • of great value to control the quality of the R&D process ISO 9001: 2000 provides an “ideal” opportunity for R&D man• agers to achieve the benefits of total quality management and 8. Consistency One of the foundations of ISO; All processes from research and development, thus improvement in various key performance. Within the R&D context, ISO 900 1 is becoming more popular as to production, to shipping, are defined, outlined and documented, minimizing • a way of making people think and plan ahead and as providing room for error. Even the process of making changes to a process is documented, ensuring that changes are well planned and implemented in the a disciplined way of capturing the R&D. best possible way to maximize efficiency. Recommendations in the biotech The revised version of ISO 9001 look into the dynamic character • industry to use XML authoring or similar software formatting for data of organisations in which issues such as leadership, people incollection, reports, and product labelling, minimizes the risk of obsolete volvement, system approach to management, continuous , documents/labels being mistakenly used. improvernent and a fact -based approach to decision-making for example receive special attention. The need for more dynamic 9. Customer Satifaction approach To R&D management has been emphasized for years. Client confidence is gained because of the universal acceptance of the ISO ISO 9001 addresses both the issues of better control and continu• standards. Customer satisfaction is ensured because of the benefits of ISO ously raising the R&D standards 9001:2000 QMS to company efficiency, consistency and dedication to • ISO 9001 is a good means of providing a framework for developquality service. ing a quality system in R&D. It outlines the organizational structural management responsibilities, procedures and processes 10. Improvement Processes required to set the base for a “holistic quality management sys- The ISO 9001:2000 QMS outlines audit processes, management review tem. and improvement processes based on collected data. Improvements are carefully planned and implemented based on facts, using a system of Other Applications of ISO 9000 Iin Pharmacy documentation and analysis, to ensure the best decisions are made for your 1. Increased Efficiency company. Companies that go through the ISO 9001:2000 Quality Management Standards certification process have given a lot of thought to their processes REFERENCES and how to maximize quality and efficiency. Once certified for QMS, the 1. Hoyle D. (2001) “ Iso 9000 Quality Systems Handbook” Fourth processes are established and guidelines in place for anyone to follow Edition butterworth-Heinemann, Linacre House, Jordan Hill, easily, making training, transitions, and trouble-shooting easier Oxford Woburn 83-90 2. Nally J. (2007) “ Good Manufacturing Practices For 2. Increased Revenue Pharmaceuticals” sixth edition by Informa Healthcare USA, Inc. Studies have shown that ISO QMS certified companies experience increased New York, ny 100 16 350-352 productivity and improved financial performance, compared to uncertified 3. Leonard S. (2003) Gmp/Iso Quality Audit Manual for Healthcare companies. Manufacturers and Their Suppliers sixth edition volume 1 by CRC Press United States of America 07 3. Employee Morale 4. Macey S. (2001) An Integrated Model For Performance Defined roles and responsibilities, accountability of management, established Management Based On Iso 9000 And Business Excellence Models training systems and a clear picture of how their roles affect quality and the 2001 National Library Of Canada. 51 overall success of the company, all contribute to more satisfied an d motivated 5. Other Application of ISO at www.biotech.about.com/od/ staff. isocertification/tp/ISOQMS/.htm accessed on 22 march 2012 6. Kenkel J. 2000 ” A Primer on Quality In The Analytical 4. International Recognition Laboratory” Published By Crc Press Llc , United States Of The International Organization for Standardization (ISO) is recognized America 1-2 worldwide as the authority on quality management. 7. Sharma D. (2005). “The association between ISO 9000 5. Factual Approach to Decision Making
The ISO 9001:2000 QMS standard sets out clear instructions for audits and process reviews that facilitate information gathering and decision making based on the data. 6. Supplier Relationships Mutually beneficial supplier relationships are one of the key attractions to ISO certification. Following the processes for documentation and testing ensure quality raw materials go into your production system. The process
certification and financial performance”. The International Journal of Accounting 40. 8. Introduction to ISO Available at http://www.iso.org/iso/about.htm 9. Types of ISO 9000 Available at http://www.pharmainfo.net/ reviews/international-organization-standardization 10. Iso Gives Pharmaceutical Industry New Management Tool To Improve Patient Safety available at http://www.iso.org/iso/ pressrelease.htm?refid=Ref998
Source of support: Nil, Conflict of interest: None Declared
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