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What is ISO? What is ISO 9000? What is the role of BIS in ISO 9000?
What is the difference between ISO 9000 standards and IS/ISO 9000 standards? Which IS/ISO 9000 standard is meant for certification? Tell me more about IS/ISO 9004:2000 Where can copies of the IS/ISO 9000 standards be obtained? What is the difference between a certification body and a registration body? I want to be an ISO 9000 auditor: where can I get training? My organization provides services. How are the IS/ISO 9000 standards applicable to us? How to implement the requirements of IS/ISO 9001:2000 in my organization? What are the main benefits of implementing IS/ISO 9001:2000 Quality Management System Requirements? is accreditation? should I obtain IS/ISO 9001:2000 certification?
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What is ISO 14001? Who has formulated ISO 14001:1996 standard? What are the other standards in ISO 14000 family of standards? What is IS/ISO 14004? What are the benefits of implementing IS/ISO 14001:1996? How to implement the requirements of ISO 14001:1996 in my organization? I want to be an ISO 14000 auditor: where can I get training? What is the role of BIS in ISO 14001:1996 certification? Where can copies of IS/ISO 14000 standards be obtained? more details
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(), 15000:1998 - HAZARDS ANALYSIS AND CRITICAL CONTROL POINT (HACCP), IS 15000:1998 - FREQUENTLY ASKED QUESTIONS (FAQs)
1. 2.
3. 4. 5. 6. 7. 8. 9.
Is there any standard published by ISO on HACCP? Tell me more about HACCP. Who can implement HACCP? HACCP - HIGHLIGHTS BENEFITS OF HACCP HACCP CERTIFICATION HOW TO OBTAIN LICENCE? SERVICES OFFERED BY BIS can copy of IS 15000 standard be obtained?
(), 18001:2000 - OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS (OHSMS), IS 18001:2000 FREQUENTLY ASKED QUESTIONS (FAQs)
1. 2. 3. 4. 5.
What is OHSMS? Is there any standard published by ISO on OHSMS? Tell me more about IS 18001:2000. How to obtain certification for OHSMS? I want to be an IS 18001 auditor: where can I get training? Where can copy of IS 18001 standard be obtained? What is the difference between certification, registration and accreditation? For more details
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The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that meet the clients quality requirements. These good practices have been distilled into a set of standardized requirements for a quality management system, regardless of what your organization does, its size, or whether it is in the private, or public sector. The family of ISO 9000 standards have been developed by ISO and it is made up of four core standards: a) b) c) d) ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 Quality Management Systems Requirements ISO 9004:2000 Quality Management Systems Guidelines for performance improvements ISO 19011: 2002 Guidelines for quality and/or environmental management systems auditing
3.
BIS is the National Standards Body of India and is a founder member of ISO. BIS represents India, in ISO. The Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees of ISO are responsible for the
development of ISO 9000 standards. Quality and industry experts from India including BIS officers nominated by BIS participate in the meetings of the Technical Committee ISO/TC 176 and its Sub-committees.
Any organization can apply for certification against IS/ISO 9001:2000. The other standards i.e. IS/ISO 9000:2000; IS/ISO 9004:2000; and IS/ISO 19011:2002 are guidance standards and are not meant for certification. 6. Tell me more about IS/ISO 9004:2000.
The requirements of IS/ISO 9004:2000 should be implemented by the organizations who intend to further improve beyond the requirements of IS/ISO 9001:2000. The standard IS/ISO 9004:2000 has an important element of `self-evaluation and this standard is not amenable to certification. 7. Where can copies of the IS/ISO 9000 standards be obtained?
Copies of the IS/ISO 9000 standards may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website. 8. What is the registration body? difference between a certification body and a
None. The term `certification body is used in some countries, like, India, because BIS as certification body issue certificates (licences). Elsewhere, they prefer to say that they `register organizations complying with ISO 9000. 9. I want to be an ISO 9000 auditor: where can I get training?
Contact National Institute of Training for Standardization (NITS) of Bureau of Indian Standards at the address: Deputy Director General (Training), National Institute of Training for Standardization, A-20&21, Institutional Area, Sector62, Noida 201 307 (Tel: 0120-2402204-07; Fax: 0120-2402203; Email: nits@bis.org.in; Website:www.bis.org.in). Also refer IS/ISO 19011:2002 standard, for auditors qualification, training, experience,etc. 10. My organization provides services. How are the IS/ISO 9000 standards applicable to us? The IS/ISO 9000 standards are applicable to all types of organizations. The definition of the term `product in IS/ISO 9000:2000 also include services and their combination. Therefore, the requirements of IS/ISO 9001:2000 are equally applicable to service sector as it is applicable to product manufacturing company. 11. How to implement the requirements of IS/ISO 9001:2000 in my organization? As a minimum you should familiarize yourself not only with the requirements of IS/ISO 9001:2000 but also with the content and philosophies given in IS/ISO 9000:2000, IS/ISO 9004:2000 and the Quality Management Principles. You have to clearly understand your organizations activities and processes and appropriately interpret the requirements of the standards. Implement the requirements in the various activities and processes adding value to these processes and activities. For training programmes on general awareness on the requirements, content and philosophies of the IS/ISO 9000 standards, our BIS, National Institute of Training for Standardization (NITS) may be contacted. 12. What are the main benefits of implementing IS/ISO 9001:2000 Quality Management System Requirements?
Provides an opportunity to increase value to the activities of the organization Improve the performance of processes/activities continually
Satisfaction of customers Attention to resource management Implementation of statutory and regulatory requirements related to product/services Better management control
13.
What is accreditation?
In simple terms, accreditation is like certification of the certification body. `Accreditation should not be used as an interchangeable alternative for certification or registration. BIS Quality Management Systems Certification activity has been accredited by Raad voor Accreditatie (RvA) of Netherlands, to carry out IS/ISO 9001:2000 certification in 23 business sectors. 14. How should I obtain IS/ISO 9001:2000 certification?
The information is available in this BIS website under Management Systems Certification. The application form (Form IV), questionnaire (Form V) and fee structure can also be downloaded from BIS website. A copy of the `Guidelines for Applicants IS/ISO 9001:2000 can be obtained from Regional or Branch Offices of BIS or from Headquarters at New Delhi. 15. For more details
Contact nearby branch office of BIS or any of the Regional Offices of BIS located at Mumbai, Kolkata, Chandigarh, Delhi and Chennai or Head (Management Systems Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi - 110002.
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A family of standards and guidelines for quality in the manufacturing and service industries from the International Organization for Standardization (ISO). ISO 9000 defines the criteria for what should be measured. ISO 9001 covers design and development. ISO 9002 covers production, installation and service, and ISO 9003 covers final testing and inspection. ISO 9000 certification does not guarantee product quality. It ensures that the processes that develop the product are documented and performed in a quality manner. First Popular in Europe Initially popular in Europe, ISO 9000 certification began to increase in the U.S. in the early 1990s. Certification requires exacting documentation and demonstrations in practice over time. The process, which can take up to a year, involves two major players in addition to the company being certified. A consultant provides (and may help implement) a plan for documenting the company's ISO system. Once documented, a registrar interviews the company's management and line staff to make sure that the new system, as documented, has been effectively implemented. Only a few dozen companies worldwide are authorized to conduct such audits for the issuance of ISO 9000 certificates. See ISO and ISO 9000-3. Download Computer Desktop Encyclopedia to your PC, iPhone or Android.
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ISO 9000 is a set of international standards of quality management that have become increasingly popular for large and small companies alike. "ISO is grounded on the 'conformance to specification' definition of quality, " wrote Francis Buttle in the International Journal of Quality and Reliability Management. "The standards specify how management operations shall be conducted. ISO 9000's purpose is to ensure that suppliers design, create, and deliver products and services which meet predetermined standards; in other words, its goal is to prevent non-conformity." Used by both manufacturing and service firms, ISO 9000 had been adopted by more than 100 nations as their national quality management/quality assurance standard by the end of 1997. This quality standard was first introduced in 1987 by the International Organization for Standards (ISO) in hopes of establishing an international definition of the essential characteristics and language of a quality system for all businesses, irrespective of industry or geographic location. Initially, it was used almost exclusively by large companies, but by the mid-1990s, increasing numbers of small-and mid-sized companies had embraced ISO 9000 as well. In fact, small and moderate-sized companies account for much of the growth in ISO 9000 registration over the past several years. The total number of ISO 9000 registrations in the United States increased from a little more than 2, 200 in 1993 to more than 17, 000 in 1998; of those 17, 000 registrations, nearly 60 percent were held by companies with annual sales of $100 million or less. The increased involvement of small and midsized firms in seeking ISO 9000 registration is generally attributed to several factors. Many small businesses have decided to seek ISO 9000 certification because of their corporate customers, who began to insist on it as a method of ensuring that their suppliers were paying adequate attention to quality. Other small business owners, meanwhile, have pursued ISO 9000 certification in order to increase their chances of securing new business or simply as a means of improving the quality of their processes. "The pressure for companies to become ISO 9000-certified is absolutely increasing and will continue to increase, " predicted one management consultant in an interview with Nation's Business. "The question many smaller companies have to ask is when, not if, they [will] get ISO 9000-registered."
Management Responsibility Quality System Order Entry Design Control Document and Data Control Purchasing Control of Customer Supplied Products Product Identification and Tractability Process Control Inspection and Testing Control of Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Nonconforming Products Corrective and Preventive Action Handling, Storage, Packaging, and Delivery Control of Quality Records Internal Quality Audits Training Servicing Statistical Techniques
Increased marketabilityNearly all observers agree that ISO 9000 registration provides businesses withmarkedly heightened credibility with current and prospective clients alike. Basically, it proves that the company is dedicated to providing quality to its customers, which is no small advantage whether the company is negotiating with a long-time customer or endeavoring to pry a potentially lucrative customer away from a competitor. This benefit manifests itself not only in increased customer retention, but also in increased customer acquisition and heightened ability to enter into new markets; indeed, ISO 9000 registration has been cited as being of particular value for small and mid-sized businesses hoping to establish a presence in international markets. Reduced operational expensesSometimes lost in the many discussions of ISO 9000's public relations cache is the fact that the rigorous registration process often exposes significant shortcomings in various operational areas. When these problems are brought to light, the company can take the appropriate steps to improve its processes. These improved efficiencies can help companies garner savings in both time and money. "The cost of scrap, rework, returns, and the employee time spent analyzing and troubleshooting various products are all considerably reduced by initiating the discipline of ISO 9000, " confirmed Richard B. Wright in Industrial Distribution. Better management controlThe ISO 9000 registration process requires so much documentation and self-assessment that many businesses that undergo its rigors cite increased understanding of the company's overall direction and processes as a significant benefit. Increased customer satisfactionSince the ISO 9000 certification process almost inevitably uncovers areas in which final product quality can be improved, such efforts often bring about higher levels of customersatisfaction. In addition, by seeking and securing ISO 9000 certification, companies can provide their clients with the opportunity to tout their suppliers' dedication to quality in their own business dealings. Improved internal communicationThe ISO 9000 certification process's emphasis on selfanalysis and operations management issues encourages various internal areas or departments of companies to interact with one another in hopes of gaining a more complete understanding of the needs and desires of their internal customers. Improved customer serviceThe process of securing ISO 9000 registration often serves to refocus company priorities on pleasing their customers in all respects, including customer service areas. It also helps heightenawareness of quality issues among employees. Reduction of product-liability risksMany business experts contend that companies that achieve ISO 9000 certification are less likely to be hit with product liability lawsuits, etc., because of the quality of their processes. Attractiveness to investorsBusiness consultants and small business owners alike agree that ISO-9000 certification can be a potent tool in securing funding from venture capital firms.
Owners and managers do not have an adequate understanding of the ISO 9000 certification process or of the quality standards themselvesSome business owners have been known to direct their company's resources toward ISO 9000 registration, only to find that their incomplete understanding of the process and its requirements results in wasted time and effort. Funding for establishing the quality system is inadequateCritics of ISO 9000 contend that achieving certification can be a very costly process, especially for smaller firms. Indeed, according to a 1996 Quality Systems Update survey, the average cost of ISO certification for small firms (those registering less than $11 million in annual sales) was $71, 000. Heavy emphasis on documentationThe ISO 9000 certification process relies heavily on documentation of internal operating procedures in many areas, and as Meyer stated, "many say ISO's exacting documentation requirements gobble up time. Indeed, there are horror stories about companies losing substantial business because a documentation obsession redirected their priorities." According to Nation's Business, small business owners need to find an appropriate balance between ISO documentation requirements, which are admittedly "one is ISO 9000's hallmarks, " and attending to the fundamental business of running a company: "Strike a balance among obsessively writing down every employee's task, offering training for the work, and letting common sense dictate how a task is to be performed." Length of the processBusiness executives and owners familiar with the ISO 9000 registration process warn that it is a process that takes many months to complete. The 1996 Quality Systems Update survey indicated that it took businesses an average of 15 months to move from the early stages of the process to passage of the final audit, and that processes of 18-20 months or even longer were not that uncommon.
Further Reading:
Buttle, Francis. "ISO 9000: Marketing Motivations and Benefits." International Journal of Quality and Reliability Management. July 1997. Johnson, P.L. ISO 9000: Meeting the New International Standards. McGraw-Hill, 1993.
Kanji, G.K. "An Innovative Approach to Make ISO 9000 Standards More Effective." Total Quality Management. February 1998. Karapetrovic, Stanislav, Divakar Rajamani, and Walter Willborn. "ISO 9000 for Small Business: Do It Yourself."Industrial Management. May-June 1997. Meyer, Harvey R. "Small Firms Flock to Quality System." Nation's Business. March 1998. Rabbit, J.T. The ISO 9000 Book: A Global Competitor's Guide to Compliance and Registration. Quality Resources, 1993. Rayner, P., and L.J. Porter. "BS 5750/ISO 9000: The Experience of Small and Medium-Sized Firms." International Journal of Quality and Reliability Management. Vol. 8, no. 6, 1991. Simmons, Bret L., and Margaret A. White. "The Relationship between ISO 9000 and Business Performance: Does Registration Really Matter?" Journal of Managerial Issues. Fall 1999. Van der Wiele, Tom, et al. "ISO 9000 Series and Excellence Models: Fad to Fashion to Fit." Journal of General Management. Spring 2000. Voehl, F., P. Jackson, and D. Ashton. ISO 9000: An Implementation Guide for Small to Mid-Sized Businesses. St. Lucie Press, 1994. Wilson, L.A. "Eight-Step Process to Successful ISO 9000 Implementation: A Quality Management System Approach."Quality Progress. January 1996. Wright, Richard B. "Why We Need ISO 9000." Industrial Distribution. January 1997. See also: Quality Control; Total Quality Management Ads
A series of international guidelines for quality control. ISO 9000 pertains specifically to the criteria that needs to be met during the manufacturing process. These guidelines do not guarantee product quality, but merely the standards used in the production of goods. Investopedia Says: ISO rules and guidelines were established by the International Organization for Standardization. These rules first gained popularity in Europe, then spread to America in the 1990s. The certification process for this standard takes over a year and requires substantial documentation and demonstration. Related Links: Learn to put the CB data sets to trading use. Each chapter takes you through one of the board's benchmark indicators or surveys, their significance and their applications. Conference Board: Composite Index Of Leading Indicators The economy has a large impact on the market. Learn how to interpret the most important reports. Economic Indicators: Business Outlook Survey The U.S. economy affects many other countries. Find out what this can mean for overseas investments. Overseas Investing No Protection Against Downturn Learn what it means to do your homework on a company's performance and reporting practices before investing.Financial Statements: Earnings
In this feature, we take an in-depth look at the various techniques that determine the value and investment quality of companies from an industry perspective. The Industry Handbook: Automobiles
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A system of procedures, rules, certifications, regulations, and standards first developed in Europe and now being used in other parts of the world. ISO 9000 registration is a costly procedure by which an ISO 9000 consultant develops a program with a company, and then helps register a company for certification. Other systems like HACCP, GMP, and TQM are available and seem to be in wider use in this country today.
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Wikipedia on Answers.com: ISO 9000
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The ISO 9000 family of standards relates to quality management systems and is designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002
[1]
). The standards are published by ISO, the International Organization for Standardization,
and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems
[3] [2]
[2]
requirements that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide
[4]
making ISO 9001 one of the most widely used management tools in the world today. Despite
widespread use, however, the ISO certification process has been criticized[5][6] as being wasteful and not being useful for all organizations.[7][8][9]
Contents
1 Reasons for use 2 Background 3 Global adoption 4 Contents of ISO 9001
4.2 Certification
showed
that certified organizations achieved superior return on assets organizations without certification. Heras et al (2002) performance
[14] [13]
[12]
and demonstrated that this was statistically significant and not a function of
[15]
operating performance and linked this to superior financial performance. Chow-Chua et al (2002)
[18]
showed better overall financial performance was achieved for companies in Denmark. Rajan
and Tamimi (2003)[19] showed that ISO 9001 certification resulted in superior stock market performance
[20]
[21]
ISO 9001 system. While the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al (2005)
[11]
suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification. The mechanism for improving results has also been the subject of much research. Lo et al (2007)
[22]
[24]
process improvements in organizations leading to externally observable improvements. Hendricks and Singhal (2001)
[25]
results indicate that firms outperform their control group during the post-
implementation period and effective implementation of total quality management principles and philosophies leads to significant wealth creation. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment, according to Alcorn.[26]
Background
ISO 9000 was first published in 1987.[27] It was based on the BS 5750 series of standards from BSI[28] that were proposed to ISO in 1979. However, its history can be traced back some twenty years before that, to the publication of the Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 before being submitted to ISO. BSI has been certifying organizations for their quality management systems since 1978. Its first certification
[29]
(FM 00001) is still extant and held by Tarmac, a successor to the original company
which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally.
[30]
The development of the ISO 9000 series is shown in the diagram to the right.
Global adoption
The growth in ISO 9001 certification is shown in the table below. The worldwide total of ISO 9001 certificates can be found in the ISO Survey of 9001 in 2003, 2007, 2008 and 2009.
Dec 2000 Dec 2001 Dec 2002 Dec 2003 Dec 2004 Dec 2005 Dec 2006 Dec 2007 Dec 2008 Dec 2009
1,064,78 5
Source: ISO Survey 2009 In recent years there has been a rapid growth in China, which now accounts for approximately a quarter of the global certifications.
Rank
Country
No. of certificates
China
257,076
Italy
130,066
Japan
68,484
Spain
59,576
Russian Federation
53,152
Germany
47,156
United Kingdom
41,193
India
37,493
USA
28,935
10
Korea, Republic of
23,400
ISO 9001 certification of a fish wholesaler in Tsukiji ISO 9001:2008 Quality management systems Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:
Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
Pages 2 to 14 132 1
Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS. Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards Page 23: Bibliography
The standard specifies six compulsory documents: Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).
Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
The business determines customer requirements. The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.
The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.
The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.
The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).
The business (1) makes sure no one uses a bad product, (2) determines what to do with a bad product, (3) deals with the root cause of problems, and (4) keeps records to use as a tool to improve the system.
Certification
ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2008. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of theAccredited Certification Bodies (CB) are accepted worldwide. The applying organization is assessed based on an extensive sample of its sites, functions, products, services, and processes. A list of problems ("action requests" or "non-compliance") is first made known to management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate. The certificate is limited by a certain scope (e.g. production of golf balls) and names the locations covered. An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the
method and model of quality management described in the standard) or it is not. In this respect, ISO certification contrasts with measurement-based quality systems such as the Capability Maturity Model.
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 9000:1987 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.[citation
needed]
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.[citation needed]
2000 version
ISO 9001:2000 combined the three standards9001, 9002, and 9003into one, called 9001. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process managementfront 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 quality 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 who are implementing the standard.[1] ISO 9001:2008 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.
Auditing
Two types of auditing are required to become registered to the standard: auditing by an external certification body(external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":
Tell me what you do (describe the business process) Show me where it says that (reference the procedure manuals) Prove that this is what happened (exhibit evidence in documented records)
The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote compliance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus: Under the 1994 version, the question was broad: "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the questions are more specific: "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?"
Industry-specific interpretations
The ISO 9001 standard is generalized and abstract; its parts must be carefully interpreted to make sense within a particular organization. Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizationspolice departments (US), professional soccer teams (Mexico) and city councils (UK)have successfully implemented ISO 9001:2000 systems.
Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.
The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100.
PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.
ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.
TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 5.0; unlike ISO 9001 or other sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.
ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000.
ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to computer software.
ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
Effectiveness
The debate on the effectiveness of ISO 9000 commonly centers on the following questions:
1.
Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important; in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994).
2. 3.
Does it help to implement an ISO 9001:2000-compliant quality management system? Does it help to obtain ISO 9001:2000 certification?
Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are: 1. Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits. 2. How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
3. How well the ISO system focuses on improving the customer experience. The broadest
definition of quality is "Whatever the customer perceives good quality to be." This means that a company doesn't necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer's experience. 4. How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.
Advantages
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages: 1. 2. 3. 4. 5. 6. 7. 8. 9. Creates a more efficient, effective operation Increases customer satisfaction and retention Reduces audits Enhances marketing Improves employee motivation, awareness, and morale Promotes international trade Increases profit Reduces waste and increases productivity. common tool for standardization.
Problems
A common criticism of ISO 9001 is the amount of money, time, and paperwork required for registration.[5] According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed."[31] Wilson suggests that ISO standards "... elevate inspection of the correct procedures over broader aspects of quality," and therefore, "the workplace becomes oppressive and quality is not improved."[6] According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[7] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards."
[32]
does not guarantee a successful quality system. While internationally recognized, most consumers are not aware of ISO 9000 and it holds no relevance to them. The added cost to certify and then maintain certification may not be justified if product end users do not require ISO 9000. The cost can actually put a company at a competitive disadvantage when competing against a non-ISO 9000-certified company. The standard is seen as especially prone to failure when a company is interested in certification before quality.[7]Certifications are in fact often based on customer contractual requirements rather
than a desire to actually improve quality.[31][33] "If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost.[33] Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services."
[31]
In fact, ISO itself advises that ISO 9001 can be implemented without certification,
simply for the quality benefits that can be achieved.[34] Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm. Abrahamson[35] argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad.
See also
Conformity assessmentContaining ISO published standards ISO 10006Quality managementGuidelines to quality management in projects ISO 14001Environmental management standards ISO 19011Guidelines for quality management systems auditing and environmental management systems auditing
ISO/IEC 27001Information security management ISO 39001Road traffic safety management AS 9100 - aerospace industry implementation of ISO 9000/1 List of ISO standards Quality management system Test management Verification and Validation
References 1. ^ Poksinska, B.; Dahlgaard, J.J.; Antoni, M. (2002),"The state of ISO 9000 certification:
A study of Swedish organisations", The TQM Magazine 14 (5), retrieved 2010-11-22
2. ^ a b Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002), "An adaptation to ISO 9001:
2000 for certified organisations", Managerial Auditing Journal17 (5), retrieved 2010-1122
3. ^ Beattie, K.R.; Sohal, A.S. (1999), "Implementing ISO 9000: A study of its benefits
among Australian organizations", Total Quality Management 10 (1): 95106, retrieved 2010-11-22
4. ^ ISO Press Release, 25 October 2010. 5. ^ a b "So many standards to follow, so little payoff". Stephanie Clifford. Inc
Magazine, May 2005.
6. ^ a b Ian Wilson, Is ISO the way to go? Some say, Not So, June 04, 2010, (accessed 30
Sept 2011)
7. ^ a b c "The 'quality' you can't feel", John Seddon,The Observer, Sunday November 19,
2000.
8. ^ "A Brief History of ISO 9000: Where did we go wrong?" (accessed 30 Sept 2011). John
Seddon. Chapter one of "The Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000. ISBN 1-86076-173-9.
9. ^ Patrick D. T. O'Connor, ISO 9000: Help or Hoax(accessed Sept. 30, 2011) 10. ^ ISO 9001 proven to help win new business. 11. ^ a b Corbett, C.J.; Montes-sancho, M.J.; Kirsch, D.A. (2005), "The financial impact of
ISO 9000 certification in the United States: An empirical analysis", Management Science 51 (7): 10461059, retrieved 2010-11-22
12. ^ Interstate ISO 9000 Case Study. 13. ^ a b Heras, I.; Dick, G.P. M.; Casadesus, M. (2002), "ISO 9000 registration's impact on
sales and profitability - A longitudinal analysis of performance before and after accreditation",International Journal of Quality and Reliability Management 19 (6): 774 791, retrieved 2010-11-22
14. ^ Hardies ISO 9000 Case Study 15. ^ Naveh, E.; Marcus, A. (2007), "Financial performance, ISO 9000 standard and safe
driving practices effects on accident rate in the U.S. motor carrier industry", Accident Analysis & Prevention 39(4): 731742, PMID 17166474
16. ^ DFDS Transport ISO 9000 Case Study 17. ^ Sharma, D.S. (2005), "The association between ISO 9000 certification and financial
performance",The international Journal of Accounting 40: 151172, retrieved 2010-1122
18. ^ Chow-chua, C.; Goh, M.; Wan, T.B. (2002), "Does ISO 9000 certification improve
business performance?", The International Journal of Quality & Reliability Management 20 (8): 936953, retrieved 2010-11-22
19. ^ Rajan, M.; Tamimi, N. (2003), "Payoff to ISO 9000 registration", Journal of
Investing 12 (1), retrieved 2010-11-22
20. ^ Accenture ISO 9000 Case Study 21. ^ British Gas ISO 9000 Case Study 22. ^ Lo, Chris K.Y.; Yeung, Andy C.L.; Cheng, T.C. Edwin (2007), "Impact of ISO 9000 on
time-based performance: An event study", World Academy of Science, Engineering and Technology 30 (7): 3540, retrieved 2010-11-22
23. ^ Buttle, F. (1997), "ISO 9000: marketing motivations and benefits", International
Journal of Quality & Reliability Management 14 (9): 936947, retrieved 2010-11-22
24. ^ Santos, L. (2002), "Benefits of the ISO 9000:1994 system: Some consideration to
reinforce competitive advantage", International Journal of Quality & Reliability Management 19 (3): 321344, retrieved 2010-11-22
25. ^ Hendreicks, K.B.; Singhal, V.R. (2001), "The long-run stock price performance of firms
with effective TQM programs", Management Science 47 (3): 359368, JSTOR 2661504
26. ^ Alcorn, J. E. (1995), "Benefits of ISO 9000 Certification", Ceramic Engineering and
Science Proceedings 16 (2): 1518, retrieved 2010-11-18
27. ^ History of the BSI Group 28. ^ Fast Facts About BSI Group 29. ^ Tarmac Certificate of Registration 30. ^ More About BSI Group. 31. ^ a b c "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes
in Review of Business, Spring 2000.
32. ^ "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems MayJune
2002.
33. ^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001. 34. ^ The ISO Survey 2005 (abridged version, PDF, 3 MB), ISO, 2005. 35. ^ Abrahamson, E. (1996). "Managerial fashion." Academy of Management Review.
21(1):254-285.
Further reading
Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN 0849320631, ISBN 9780849320637
Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard lead to performance improvement?", IEEE Transactions on Engineering Management, 51(3), 352 363.
http://www.iso.org/iso/survey2007.pdf - An abstract of the 2007's ISO survey of certificates. http://www.iso.org/iso/survey2008.pdf - An abstract of the 2008's ISO survey of certificates.
See also
International Organization for Standardization
External links
ISO 9000 at the Open Directory Project. ISO Management and leadership standards. International Organization for Standardization. FAQs on ISO 9000 - General FAQs on ISO 9001 - General ISO's Technical Committee 176 on Quality Management and Quality Assurance.
Technical Committee No. 176, Sub-committee No. 2, which is responsible for developing ISO 9000 standards.
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ISO standards
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ISO 14000 is the general term used for ISO 14000 family of standards. ISO 14001:1996 `Environmental Management Systems Specifications with Guidance for use is a standard published by International Organization for Standardization (ISO) (About ISO, please see ISO 9000 Frequently Asked Questions, Answer to Question No. 1) and adopted by BIS as IS/ISO 14001:1996. IS/ISO 14001:1996 is the exact replica of ISO 14001:1996. This standard provides for the framework for the Management System for an organization to meet its Environmental obligations reliably and consistently. IS/ISO 14001:1996 is the only certification standard in the IS/ISO 14000 family. IS/ISO 14001 is a requirements standard. It contains a set of requirements to define the operation of the Environmental Management System. Since the requirements are expressed in a general form, it has the flexibility to be applied to any organization. 2. Who has formulated ISO 14001:1996 standard?
ISO has published ISO 14000 family of standards including ISO 14001:1996 standard. The Technical Committee of ISO i.e. ISO/TC 207 Environmental Management Systems is responsible for formulation of these standards. BIS represents India as participating member on this Committee. Experts from India including BIS officers are nominated on this Committee to put forth Indias viewpoints on EMS. 3. What are the other standards in ISO 14000 family of standards?
The other standards of ISO 14000 family have also been adopted by BIS as IS/ISO 14000 and are exact replica of ISO 14000 standards. These standards are: IS/ISO 14004:1996 Environmental management systems General guidelines on principles, system and supporting techniques
IS/ISO 14020:1998 Environmental labels and declarations General principles IS/ISO 14021:1999 Environmental labels and declaration Self-declared environmental claims (Type II Environmental labeling)
ISO 14004 has been adopted by BIS as IS/ISO 14004 which is exact replica of ISO 14004 and is the companion standard to IS/ISO 14001. For those organizations implementing the Environmental Management System specified in IS/ISO 14001, IS/ISO 14004 provides guidance and illustrations of `what to do and `how to do it. As this is a guidance standard, it is not meant for certification. 5. What are the benefits of implementing IS/ISO 14001:1996? Following are the benefits to an organization by implementing IS/ISO 14001:1996: Provides framework for
Pollution prevention and waste reduction Compliance with legislative and regulatory requirements
Reduction in liability/risks Competitive advantage for `Green products Globally Creation of an improved community goodwill Improved environmental performance
6. How to implement the requirements of ISO 14001:1996 in my organization? As a minimum you should familiarize yourself not only with the requirements of IS/ISO 14001:1996 but also with the content and philosophies given in : IS/ISO 14050:2002 `Environmental Management - Vocabulary IS/ISO 14004:1996 `Environmental Management Systems General Guidelines on Principles, System and Supporting Techniques IS/ISO 19011: 2002 `Guidelines for quality and/or environmental management systems auditing In addition to the above you may also refer other standards of ISO 14000 family of standards as mentioned at answer to question no 3. You have to clearly understand your organizations obligations towards environment and effect of organizations activities and processes on the environment and appropriately interpret the requirements of the standards. For training programmes on general awareness on the requirements, content and philosophies of the IS/ISO 14000 standards, our BIS, National Institute of Training for Standardization (NITS) may be contacted. 7. I want to be an ISO 14000 auditor: where can I get training?
Contact National Institute of Training for Standardization (NITS) of Bureau of Indian Standards at the address: Deputy Director General (Training), National Institute of Training for Standardization, A-20&21, Institutional Area, Sector62, Noida 201 307 (Tel: 0120-2402204-07; Fax: 0120-2402203; Email: nits@bis.org.in; Website:www.bis.org.in). Also refer IS/ISO 19011:2002 standard, for auditors qualification, training, experience,etc
Copies of the IS/ISO 14000 standards may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website. 10. What is the difference between certification, registration and accreditation? Please refer to Question No. 8 and 13 of ISO 9000 FAQs. 11. For more details
Contact nearby branch office of BIS or any of the Regional Offices of BIS located at Mumbai, Kolkata, Chandigarh, Delhi and Chennai or Head (Management Systems Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi - 110002.
() 15000:1998 - HAZARDS ANALYSIS AND CRITICAL CONTROL POINT (HACCP) IS 15000:1998 - FREQUENTLY ASKED QUESTIONS (FAQs)
1. What is HACCP? Hazard Analysis and Critical Control Point (HACCP) is a process control system designed to identify and prevent microbial and other hazards in food production. It includes steps designed to prevent problems before they occur and to correct deviations as soon as they are detected. Such preventive control system with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food. 2. Why HACCP? India is a signatory to WTO. The WTO Agreement on Sanitary and Phytosanitary (SPS) makes it obligatory to adopt the standards, guidelines and recommendations issued by Codex Alimentarius Commission which advocates the adoption of HACCP. The Indian Standard on Food Hygiene Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for Its Application IS 15000:1998 is technically equivalent to the Codex document on the subject. For food industry in India, adoption of HACCP is becoming imperative to reach global standards, demonstrate compliance to Regulations/Customer requirements besides providing safer food to our millions. 3. Is there any standard published by ISO on HACCP? No. Presently there is no ISO standard available for HACCP certification. 4. Tell me more about HACCP. HACCP involves a system approach to identification of hazards, assessment of chances of occurrence of hazards during each phase, raw material procurement, manufacturing, distribution, usage of food products, and in defining the measures for hazard control. In doing so, the many drawbacks prevalent in the
inspection approach are avoided and HACCP overcomes shortcomings of reliance only on microbial testing.
HACCP enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety. Food inspection too would be more systematic and therefore hassle-free. It would no doubt involve deployment of some additional finances initially but this would be more than compensated in the long run through consistently better quality and hence better prices and returns. 6. HACCP - HIGHLIGHTS Mandatory for export from certain sectors of food industry to some countries Pro-active system for assuring safe production of foods Emphasises prevention rather than inspection Addresses all types of Hazards-Microbiological, Physical and Chemical Can be integrated into a more general quality assurance plan Can be implemented in tiny, small, medium and large scale enterprises
7.
BENEFITS OF HACCP Reduces contamination Reduces recall/product destruction Provides market protection Provides preferred supplier status Demonstrates conformance to international standards and regulations, and requirements of overseas markets Transforms commodities into branded products International acceptance
8.
HACCP CERTIFICATION
Food Safety Certification (HACCP) against IS 15000:1998 HACCP based Quality Management Systems Certification provides for twin Certification through one audit i.e. Certification of Quality Management Systems against IS/ISO 9001:2000 and Certification of HACCP against IS 15000:1998
10.
OTHER SERVICES OFFERED BY BIS General Awareness Programmes on HACCP & QUALITY MANAGEMENT SYSTEM by BIS National Institute of Training for Standardization (NITS). Details on training available in this website
11.
Technical Information Services on Standards and Certification matters Pre-certification services Trial assessment and Survey
Copy of the IS 15000 standard may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website. 12. What is the difference between certification, registration and accreditation? Please refer to Question No. 8 and 13 of ISO 9000 FAQs.
Contact nearby branch office of BIS or any of the Regional Offices of BIS located at Mumbai, Kolkata, Chandigarh, Delhi and Chennai or Head (Management Systems Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi - 110002.
() 18001:2000 -
OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS (OHSMS) IS 18001:2000-FREQUENTLY ASKED QUESTIONS (FAQs)
1. What is OHSMS?
Health and safety are important aspects of an organizations smooth and effective functioning. Good health and safety performance ensures an accident-free industrial environment. This demands adoption of a structured approach for the identification of hazards, their evaluation and control of risks. Bureau of Indian Standards (BIS) has formulated an Indian
Standard on Occupational Health & Safety (OH&S) Management Systems, considering the above in view and a great demand from the industry for a comprehensive framework of OH&S i.e. IS 18001:2000 `Occupational Health and Safety Management Systems Specification with Guidance for use. 2. Is there any standard published by ISO on OHSMS?
No. Presently there is no ISO standard available for OHSMS certification. 3. Tell me more about IS 18001:2000. This standard prescribes requirements for an OH&S Management Systems to enable an organization to formulate a policy and objectives, taking into account legislative requirements and information about significant hazards and risks, which the organization can control and over which it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the organization. All the requirements in this standard are intended to be incorporated into any OH&S management system. This standard also provides imperative guidance on the use of the specification. 4. How to obtain certification for OHSMS?
Organizations interested in obtaining licence for OH&S Management System as per IS 18001 should ensure that they are operating the system according to this standard. The organization should apply on the prescribed proforma (Form IV) at the nearest Regional Office of BIS along with Questionnaire (Form X) and the prescribed application fee as applicable. The form, questionnaire and fee structure can be downloaded from this website Management Systems Certification.
Copy of the IS 18001 standard may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website. 7. What is accreditation? the difference between certification, registration and
Please refer to Question No. 8 and 13 of ISO 9000 FAQs. 8. For more details
Contact nearby branch office of BIS or any of the Regional Offices of BIS located at Mumbai, Kolkata, Chandigarh, Delhi and Chennai or Head (Management Systems Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi - 110002.