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Welcome to the ISO9000Council.org We set up this website for you as a forum for practical information and advice to support a very worthwhile endeavor: your ISO 9000 implementation. Our goal is to promote the global acceptance and utilization of ISO 9000 as a tool for increased quality, customer satisfaction and business/process efficiency. Topics on this page: What is ISO 9000? The new 2008 Revision: ISO 9000 : 2008 Implementation of an ISO 9000 Quality Management System Maintenance and Continuous Improvement of an ISO 9000 Quality Management System What is ISO 9000? ISO 9000 in brief The ISO 9000 standard is one of the best known international standards; it is implemented by countless companies and other organizations in over 150 countries. ISO 9000 addresses "quality management". This means what the organization does to fulfill: their customers' quality requirements, plus any applicable regulatory requirements, while aiming to enhance customer satisfaction, and achieve continual improvement of its performance. What is the Difference between ISO 9000, ISO 9001, and ISO 9001:2000? And what are ISO 9002 and ISO 9003? The quick answer is “none”. These terms are all used to describe the ISO 9001 standard. Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard; without focusing on the technical differences between them, people would just simply refer to each as ISO 9000. In December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the revised standard was then often referred to as ISO 9001:2000 or ISO 9000:2000 (":2000" indicates the year of the revision). The current revision of ISO 9001 is ISO 9001:2008; it was published in November 2008 as successor to ISO 9001:2000. For all practical purposes, ISO 9000 and ISO 9001 mean the same. ► Tip: More detailed information can be found on www.iso.ch. Summary of the ISO 9001 Standard The ISO 9000 standard contains requirements affecting virtually all aspects of any company. Because ISO 9000 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read. The ISO 9001:2008 requirements fall into the following sections: Section 1: Quality Management System This section of the ISO 9001:2008 standard outlines the necessary steps to implement the ISO 9001 quality management system: Identify the process (or activities) needed for the quality management system, Determine the sequence and interaction of these processes, Determine how these processes are effectively operated and controlled, Ensure that all information is available to support the operation and monitoring of these processes, Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement. The ISO 9000 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement. ► Tip: Most companies find the documentation requirements daunting. The use of templates can be of tremendous benefits (see our section on templates). Section 2: Management Responsibility ISO 9001:2008 places great emphasis on top management’s commitment to quality. This section requires a quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements. This ISO 9001 section also requires top management to establish responsibilities and authorities within the company, including the establishment of an ISO 9000 management representative. ► Tip: Use a good standard format for all job descriptions – this will save much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc. Section 3: Resource Management This section of ISO 9001:2008 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements for employee training, as well as for the physical facilities and the work environment. ► Tip: Integrate your company’s HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation. Section 4: Product Realization The ISO 9001:2008 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services. ► Tip: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the outset when writing these documents. Section 5: Measurement, Analysis and Improvement The last section of the ISO 9001:2008 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track. Measurement and monitoring activities also include internal audits and the monitoring of customer perception as to whether the company has fulfilled customer requirements. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess. ► Tip: This is a very important section of the ISO 9001 standard. Depending on how it is implemented, it can add tremendous value or create bureaucracy and waste. We highly recommend placing emphasis on this crucial ISO 9001 section. The ISO 9000 Quality Manual The standard requires companies to write an ISO 9000 quality manual that defines how each requirement of the rather broad ISO 9001:2008 standard is applied at the company. In a sense, the ISO 9000 quality manual is a company specific version of the standard. While writing the quality manual represents a big hurdle for most companies, the ISO 9001:2008 standard requires further details in form of ISO 9000 quality procedures, a quality policy and quality objectives. Most companies make the mistake of creating various different documents to meet these requirements; however, this usually is the beginning of a cumbersome and bureaucratic ISO 9000 quality system. ► Tip: Combine the different documentation requirements (i.e., quality manual, procedures, corporate policy and objectives) as much as possible into one comprehensive manual. This reduces repetition and bureaucracy, and it saves time implementing the quality system. Templates for Quality Manuals and Forms Using templates for ISO 9001 quality manuals, procedures and forms can have huge benefits for an organization. Templates are usually in the form of existing and proven manuals, procedures and forms. Follow the link for more information on the use of Templates. ► Tip: The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system. You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can use as a good example and that you can modify to make it your own quality manual). There are numerous companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual. We urge you to carefully evaluate them before making a purchase decision as we found the majority to be convoluted, bureaucratic and cumbersome. See our Reviews section for suggestions and reviews. What is ISO 9001 Certification? ISO 9001 certification is also known as ISO 9001 registration, ISO 9000 certification (if one is less precise), ISO 9000 registration, ISO 9001:2008 certification (if one specifically refers to the latest version of the ISO 9001 standard), or ISO 9001:2008 registration. All of these refer to an independent certification body attesting that your company’s ISO 9001 quality management system meets all requirements of the ISO 9001 2008 standard. Typically, the certification company sends one or more auditors to perform an initial audit of the quality management system. If no significant gaps to the ISO 9000 requirements are discovered, a certificate is issued. The certificate is typically valid for three years provided that period audits (usually every 6 - 12 months) continue to show compliance. ► Tip: Evaluate your registrar carefully with the goal of finding a registrar whose auditors are flexible (because there are countless ways of fulfilling the ISO 9000 requirements and some may fit better for an individual business) and whose auditors don't mind sharing their experiences (auditors are not allowed to consult but they are allowed to share what they have seen to work for other companies). The Benefits of ISO 9000 The benefits of ISO 9000 certification are: Improvement: ISO 9001 is an excellent tool to develop a strong foundation of good processes and systems. Processes and systems are essential for the performance and expansion of any company. Quality improvements come along with this. Remember, ISO 9001 was developed as a real tool to improve companies. Marketing: ISO 9001 certification can effectively used in marketing as it is a well-recognized standard for quality; it shows your customers that you take quality seriously, that you are proactive and that you put your customers’ satisfaction first. Customer Requirements: if your company provides products or services to other companies, some of those customers may require you to be ISO 9001 certified in order to do business with you. The new 2008 Revision: ISO 9000 : 2008 What is this all about? According to the rules of the International Organization for Standardization (ISO - the publisher of the ISO standards), the ISO 9000 standard undergoes review and revision every 6-8 years. In the past, ISO 9000 was revised in 1994 and then underwent a major revision in 2000. In November 2008, ISO published the current revision, which is called ISO 9000:2008. What are the changes in ISO 9000:2008? The changes in ISO 9000:2008 are relatively minor. ISO 9000:2008 does not contain any new requirements nor does it contain changes to any of the existing requirements in ISO 9000:2000; also, it does not change the intent of ISO 9000:2000. Further, the structure and outline of ISO 9000:2008 is identical to that of ISO 9000:2000. ISO 9000:2008 only introduces clarifications to the existing requirements of ISO 9000:2000 based on eight years of experience of implementing the standard world-wide with about one million certificates issued in 170 countries to date. It also introduces some changes to the wording intended to improve consistency with ISO 14001:2004 The International Organization for Standardization (ISO) explains one of the reasons for the limited changes in the 2008 version as follows: “A key factor in the development of ISO 9001:2008 was to limit the impact of changes on users.” According to ISO, the benefits of the changes to the wording in ISO 9000:2008 are as follows: • Easier to use • Clearer language • Easier to translate into other languages • Better compatibility with the environmental management standard ISO 14001:2004 How does the 2008 Revision affect me? Since the changes in the newest version of ISO 9000 are only minor, the impact of the 2008 revision on you will also be minor: If your company is currently registered to ISO 9001:2000: No changes to the ISO 9001:2000 management system and its documentation are necessary. ISO 9001:2000 certificates remain valid for up to two years from publication of ISO 9001:2008 (until November 13, 2010). You should ask your registrar to issue you an ISO 9001:2008 certificate after your next periodic surveillance audit. If your company has started implementing ISO 9001:2000: You may want to consider purchasing the new ISO 9001:2008 standard because it is easier to read and understand, thus making your ISO 9001 implementation easier. If you are basing your ISO 9000 documentation on templates, you may want to contact your provider and ask for an upgrade to the 2008 version. You should confirm with your registrar that you will be issued an ISO 9001:2008 certificate after your successful certification audit. If you are planning on implementing ISO 9001: If you are planning on using templates for your ISO 9001 documentation (see our section on Templates), you should select a template supplier who has revised and updated their templates to ensure complete ISO 9001:2008 compliance (including the wording). During your selection of your ISO 9001 registrar, please confirm that you will be issued an ISO 9001:2008 certificate after your successful certification audit. ► Tip: See our Reviews section for providers of ISO 9000 quality manual templates, forms and other resources that will offer free ISO 9000:2008 compliance upgrades. Implementation of an ISO 9001 Quality Management System When is the Best Time to start the ISO 9001 Implementation? Ideally you should begin your ISO 9001 2008 implementation when you first start up your company. If you are in the position of starting up a new company, you should be setting up your business processes according to ISO 9001 2008 requirements and start to implement ISO 9001 before hiring your employees. This is the most efficient approach as your company not only immediately reaps the benefits from ISO 9000 but you also don’t have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9000 2008 standard. However, most companies have been long established before they start their ISO 9001:2008 implementation. Since a complete ISO 9001 quality system brings many benefits to a company, it’s always better to start the ISO 9001 implementation sooner rather than later. How do I start the ISO 9000 implementation? As a first step, you should make yourself familiar with the ISO 9001:2008 standard and its requirements. You can find some important information on ISO 9001:2008 and links to organizations selling the standard in our Reviews section. How long does it take to implement ISO 9001? It depends on you and your company. The very fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit. More realistically: if you have a relatively small company (say, less than 20 employees), if your employees are motivated and if they don’t oppose change, if you have the backing of all senior executives, if you and other managers are ready to put some significant time and efforts into this endeavor, and if you use a really good ISO 9001 quality manual template (a sample ISO 9000 quality manual that you can modify to make it your own ISO 9000 quality manual), then you may be able to get certified in as short as 3-4 months; templates for ISO 9000 forms are an additional time-saver. Some companies are significantly slower, with 6-12 months not being unusual. However, companies that write their ISO 9001 quality manual and their ISO 9001 quality procedures from scratch, rather than base them on a proven sample ISO 9001 quality manual, often take up to 2 years or longer. Should we use an ISO 9000 consultant? We found that ISO 9000 consultants can be of great help, and they can also cause great damage, depending on the ISO 9000 consultant and depending on how you use them. Good ISO 9000 consultants can add value as trainers. It may be beneficial if an expert in ISO 9000 matters is used to train the ISO 9000 management representative, or to “sell” the benefits of ISO 9000 to top management. However, since most consultants try to sell their consulting services, pure ISO 9000 trainers are usually a much better choice. We have heard of countless cases in which ISO 9000 consultants purposely made the ISO 9000 requirements appear overly complicated and restrictive only in order to justify the high price of their consulting services. The most common problems that we have encountered are inefficient and bureaucratic ISO 9000 quality management systems. These are typically the result of an ISO 9000 consultant writing and implementing an overly complicated and convoluted ISO 9000 quality manual and procedures. If outside help is desired, we recommend using a pure ISO 9000 trainer (either in-house or in a public class) to teach the management representative and executive management. We further recommend developing the ISO 9000 quality management system in-house as the result is usually more suitable for the individual company. A great help and time-saver is the use of template quality manuals and templates for forms. ISO 9000 Documentation ISO 9001 requires several different documents: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001 standard is very clear that work instructions need only be created where they add value (for example, a trained painter will not find value in instructions on how to paint; on the other hand, brief instructions (possibly in form of pictures), displayed right on a machine, explaining how to replace a filter could be a great time saver). Forms, which must be kept on file after they are filled in, are also part of any ISO 9001 quality management system. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. It is important to note that ISO 9001 does not directly require these forms; however, ISO 9001 calls for recording certain information and a well-designed form not only requires the information but it also walks the user through the process. ► Tip: Always keep the user of the document in mind. Some prefer work instructions in form of pictures, others like flowcharts. Most dislike long, convoluted text. Cost of an ISO 9001 Quality System While operating a good ISO 9001 quality system results in significant cost savings (even after paying the periodic audit fees of about $1,000 - $2,000 per auditor day), the initial implementation of ISO 9001:2008 can be rather expensive. Large companies often spend in excess of hundred thousand dollars, while small companies could get by with a thousand dollars. We found that small to medium size companies can achieve significant savings by implementing the ISO 9001:2008 quality management system internally in-house using a good template or sample for a quality manual and procedures. Maintenance and Continuous Improvement of an ISO 9001 Quality System It is important to recognize that an ISO 9001:2008 quality system is alive and constantly evolving. ISO 9001:2008 includes “continuous improvement” as one of its requirements, and “continuous improvement” not only refers to a company’s products and services but to the ISO 9001:2008 quality management system itself. Achieving Continuous Improvement The ISO 9000 standard incorporates several processes that help a company continuously improve: Goals and Metrics: setting goals on various levels and using metrics to gage performance. Customer Feedback: measuring what customers think about the company and its products or services. Internal Audits: periodical evaluating if the company still meets all ISO 9000 requirements. Corrective Action: systematical identification of underlying causes of existing problems and then correcting these causes. Preventive Action: systematical search for potential problems and correcting their underlying causes before the problems can occur. Management Review: management’s periodical review of key business indicators and planning of improvement initiatives. ► Tip: We recommend keeping all employees involved in the ISO 9000 quality system. A great idea is to periodically send tips to all employees. Revising the ISO 9000 Quality Manual Revising the ISO 9000 quality procedures and the ISO 9000 quality manual should be a normal part of the ever-improving ISO 9000 quality system. These revisions can reach from small corrections to a total makeover of the entire ISO 9000 quality system. If you find your company’s ISO 9000 system to be bureaucratic and cumbersome, if you find your employees completely negative about ISO 9000, and if you end up extensively preparing for each audit, then your ISO 9000 system has plenty of opportunities for improvement and you should consider a complete makeover. Problems related to ISO 9000 It is not uncommon to find employees with negative opinions on ISO 9001. Most of them complain about excessive bureaucracy, much paperwork and extra work before audits. At the same time, they feel that there are no benefits to ISO 9001. These problems are not the fault of ISO 9001 – these problems result from the way the ISO 9001 quality management system was implemented! Typical Problem #1: Management Attitude and Purpose Previously on this page, we talked about the benefits of ISO 9001: internal improvements, marketing and customer requirements. If management desires to implement ISO 9001 solely for marketing reasons or due to customer requirements, the resulting ISO 9001 quality system often lacks the all-important internal improvement component. It is possible to pretend (even to an experienced auditor) to have an effective ISO 9001 system in place that is designed to improve the company, but the costs due to bureaucracy and efficiency could be huge. Typical Problem #2: Implementation by Consultants Frequently management decides to hire ISO 9000 consultants that are tasked with the implementation of ISO 9001. These ISO 9000 consultants promise to write a quality manual, quality procedures and other documents; in many cases, they also provide implementation training. Typical problems with this approach are: The ISO 9000 consultant is unfamiliar with the business, the company and its culture. The resulting ISO 9001 system does not fit the company. The ISO 9000 consultant tries to justify his high fees by setting up an overly complicated and convoluted ISO 9001 quality system. The ISO 9000 consultant does not adjust to the particular company and sets up a standard ISO 9000 system. These “standard” systems are often geared towards large corporations, and they are often far too bureaucratic and labor intensive for small and medium size companies. The ISO 9000 consultant is not flexible. Instead of creatively molding the ISO 9001 system to fit the realities of the company, the ISO 9000 consultant tries to mold the entire company to fit his one-fits-all ISO 9001 quality procedures. Typical Problem #3: ISO 9000 Management Representative Without Power Executive management of some companies erroneously consider ISO 9001:2008 a documentation task rather than the change to an improved and systematic management style. A consequence of this misconception is the appointment of an ISO 9000 Management Representative without the power to make real changes. In these situations, it is very common to find an increasingly disenchanted ISO 9000 management representative who is desperately trying to improve the company while top management pays mere lip service to ISO 9001. Typical Problem #4: Insufficient Resources Unless a company’s management and performance is well above average, the implementation of ISO 9000 usually requires significant resources: the ISO 9001 management representative needs to be trained and guided, top management needs to be convinced of the concept of ISO 9001 and its benefits, an ISO 9001 quality manual, ISO 9001 procedures and other ISO 9001 documentation needs to be written, work processes throughout the company need to be analyzed and streamlined, employees need to be trained, etc. It is crucial to the success of the ISO 9001 implementation that management allocates enough time, as well as financial resources (for example, for ISO 9001 quality manual templates, or for sample ISO 9001 quality manuals, or for employee training, or for internal audits and auditor training, etc). Typical Problem #5: Lack of Improvement It is a common misconception that an ISO 9001 quality management system needs to be implemented, certified and that’s it. In reality, the ISO 9001 system must constantly evolve as the company changes, as the market conditions change, as products change, as technologies improve and as the competition moves forward. Typical Problem #6: Making it Complicated ISO 9001 does not need to be complicated! In fact, the easier to follow and the easier to understand the ISO 9001 quality manual, the better the ISO 9001 system! There are countless reasons for overly complicated and overly bureaucratic systems, including the problems mentioned above, including inflexible auditors, including bad examples, samples or templates, and including bad training. ► Tip: It is interesting to note that the described problems are a direct consequence of management action and management attitude, rather than the often blamed employee resistance to ISO 9000. Ensuring that top management buys into the benefits of ISO 9000 and that top management remains actively involved in ISO 9000 will dramatically improve any ISO 9001:2008 system. An executive overview by a competent trainer prior to the start of ISO 9001:2008 implementation is highly recommended. ► Tip: Implementing ISO 9001:2008 by a company insider as opposed to an external consultant in most cases is not only cheaper but it also results in a more efficient quality management system. We recommend appointing a manager as the ISO 9001 management representative who has sufficient authority to make internal changes, then provide this individual with training in the ISO 9001:2008 standard (there are many good public classes available), then give this individual the resources to acquire a good template or sample for an ISO 9001 quality manual and for ISO 9001 procedures, and ensure that all functions in the company allocate enough time to work with the ISO 9001 management representative. ► Tip: Choose your ISO 9000 registrar carefully! We recommend that you compare different ISO 9001 registrars and pay particular attention towards auditor background (for example, some may consider former military auditors to be rigid and inflexible in their interpretation of the standard) and towards attitude towards sharing ideas (in order to ensure objectivity, auditors are not allowed to consult; however, some registrars permit their auditors to share their experiences). 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