ISO 9000 are quality standards when effectively applied, demonstrate as a foundation program. These standards apply to generic product categories such as hardware, software, processed material and service, but are not related to any products technical specifications.
The total quality management is applicable to all company environments. The International Organization for Standardization (ISO) recognized the need for harmonization of various quality standards used worldwide and issued the ISO 9000 series of standards in 1987. They made comprehensive quality management concepts and guidance together with models for external assurance requirements. The ISO 9000 series was revised in 1994 and again in 2000. The purpose of these international standards is not to enforce uniformity of quality systems among various businesses. The requirements are generic and independent of any specific industry or economic sector. These standards are intended to be used in their present form. However, some tailoring may be required to suit individual needs and organizations should adopt the selected system to suit needs, but not change the organization working methods to suit the standard.
The ISO 9000 is a series of international standards. They were developed by quality experts from around the world to be used by companies that either want to implement in house quality systems or ensure that suppliers have appropriate quality systems in place. The standards were developed under the auspices of the International Organization for Standardization (ISO). International standards promote international trade by providing one consistent set of requirements recognized around the world.
Meaning
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9000 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied. Indeed, some companies enter the ISO 9001 certification as a marketing tool. Although the standards originated in manufacturing, they are now employed across several types of organization. A "product", in ISO vocabulary, can mean a physical object, services, or software. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of ISO 9001:2000 certificates - about 31% of the total."
main types of audits 1st, 2nd, and 3rd party audits. An internal audit is a 1st party audit. ISO 9000 encourages (and requires) this type of audit so that an organization can get feedback quickly from those who know the company best. However, this audit process cannot be viewed as impartial. Therefore, 2nd party audits allow for a consumer to evaluate the performance on an organization. As an alternative to a 2nd party audit, many companies choose to become certified with ISO 9000 through a 3rd party audit. In this case, an independent certification body comes into an organization and evaluates it in terms of the ISO 9000 guidelines. If an organization meets the requirements of the standard, it becomes certified in ISO 9000 and carries a seal of quality recognized throughout the world
1. A Customer Focus As stated before, the customer is the primary focus of a business. By understanding and responding to the needs of customers, an organization can correctly targeting key demographics and therefore increase revenue by delivering the products and services that the customer is looking for. With knowledge of customer needs, resources can be allocated appropriately and efficiently. Most importantly, a business's dedication will be recognized by the customer, creating customer loyalty. And customer loyalty is return business. 2. Good Leadership A team of good leaders will establish unity and direction quickly in a business environment. Their goal is to motivate everyone working on the project, and successful leaders will minimize miscommunication within and between departments. Their role is intimately intertwined with the next ISO 9000 principle. 3. Involvement of people The inclusion of everyone on a business team is critical to its success. Involvement of substance will lead to a personal investment in a project and in turn create motivated, committed workers. These people will tend towards innovation and creativity, and utilize their full abilities to complete a project. If people have a vested interest in performance, they will be eager to participate in the continual improvement that ISO 900 facilitates. 4. Process approach to quality management The best results are achieved when activities and resources are managed together. This process approach to quality management can lower costs through the effective use of resources, personnel, and time. If a process is controlled as a whole, management can focus on goals that are important to the big picture, and prioritize objectives to maximize effectiveness. 5. Management system approach Combining management groups may seem like a dangerous clash of titans, but if
done correctly can result in an efficient and effective management system. If leaders are dedicated to the goals of an organization, they will aid each other to achieve improved productivity. Some results include integration and alignment of key processes. Additionally, interested parties will recognize the consistency, effectiveness, and efficiency that come with a management system. Both suppliers and customers will gain confidence in a business's abilities. 6. Continual Improvement The importance of this principle is paramount, and should a permanent objective of every organization. Through increased performance, a company can increase profits and gain an advantage over competitors. If a whole business is dedicated to continual improvement, improvement activities will be aligned, leading to faster and more efficient development. Ready for improvement and change, businesses will have the flexibility to react quickly to new opportunities. 7. Factual approach to decision making Effective decisions are based on the analysis and interpretation of information and data. By making informed decisions, an organization will be more likely to make the right decision. As companies make this a habit, they will be able to demonstrate the effectiveness of past decisions. This will put confidence in current and future decisions. 8. Supplier relationships It is important to establish a mutually beneficial supplier relationship; such a relationship creates value for both parties. A supplier that recognizes a mutually beneficial relationship will be quick to react when a business needs to respond to customer needs or market changes. Through close contact and interaction with a supplier, both organizations will be able to optimize resources and costs.
A good foundation builds a good business, and ISO 9000 is a good foundation for small businesses that want to expand their market. By introducing a quality management system like ISO 9000 to a small business, the quality of processes will increase and costs due to inefficiency will decrease. In addition, a small business will be able to advertise their use of the internationally recognized ISO 9000. This may create business opportunities that were not available before an objectively verified quality management system was in place. Having management systems in place, such as ISO 9000, will also help when selling a business. The integrity and value of a small business will be apparent with well-documented processes and proof of quality. ISO 9000 will ensure the reputation of your business in any situation
However, a broad statistical study of 800 Spanish companies found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration.
In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability. Disadvantages A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration.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. According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. 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." Paraphrased, Wade's argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. "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. Certification by an independent auditor is often seen as the problem In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. 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.
Step 2. Establish Implementation Team ISO 9000 is implemented by people. The first phase of implementation calls for the commitment of top management - the CEO and perhaps a handful of other key people. The next step is to establish implementation team and appoint a management. Representative (MR) as its coordinator to plan and oversee implementation. Its members should include representatives of all functions of the organization - Marketing, Design and development, Planning, Production, Quality control, etc. In the context of the standard, the MR is the person within the Organization who acts as interface between organization management and the ISO 9000 registrar. His role is, in fact, much broader than that. The MR should also act as the organizations "quality management system champion," and must be a person with: Total backing from the CEO, Genuine and passionate commitment to quality in general and the ISO 9000 quality management system in particular, The dignity - resulting from rank, seniority, or both - to influence managers and others of all levels and functions. Detailed knowledge of quality methods in general and ISO 9000 in particular. The members of the implementation team should also be trained on ISO 9000 quality management systems by a professional training organization. Step 3. Start ISO 9000 Awareness Programs ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the ISO 9000 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. Suppliers of materials and components should also participate in these programs. The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. The program should also stress the higher levels of participation and self-direction that the quality management system renders to employees. Such a focus will go far to enlist employee support and commitment. The programs could be run either by the implementation team or by experts hired to talk to different levels of employees.
Step 4. Provide Training Since the ISO 9000 quality management system affects all the areas and all personnel in the organization, training programs should be structured for different categories of employees - senior managers, middle-level managers, supervisors and workers. The ISO 9000 implementation plan should make provision for this training. The training should cover the basic concepts of quality management systems and the standard and their overall impact on the strategic goals of the organization, the changed processes, and the likely work culture implications of the system. In addition, initial training may also be necessary on writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc. When in-house capacity to carry out such training is not available, it may be necessary to participate in external training courses run by professional training organizations. Alternatively, an external training institution could be invited to conduct in-house training courses. Step 5. Conduct Initial Status Survey ISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organizations existing quality management system, if there is one -- with the requirements of the standard (ISO 9001:2000). For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared. With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place. Unless they are very much out of date, these documents should not be discarded. Rather, they should be incorporated into the new quality management system. Documents requiring modification or elaboration should be identified and listed. This exercise is sometimes referred to as " gap analysis''. During these review processes, wide consultation with executives and representatives of various unions and associations within the organization is required to enlist their active cooperation. In the review process, documents should be collected, studied and
registered for further use, possibly after they have been revised. Before developing new quality management system documentation, you need to consider with which quality requirements or department you should start. The best is to select an area where processes are fairly well organized, running effectively and functioning satisfactorily. The basic approach is to determine and record how a process is currently carried out. We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times. Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2000). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g. inspection/test reports, inspection/test certificates). In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes. Step 6. Create a Documented Implementation Plan Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2000 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organizations quality management system fully in compliance with the standard. The implementation plan should be thorough and specific, detailing: 1. 2. 3. 4. 5. 6. 7. 8. Quality documentation to be developed Objective of the system Pertinent ISO 9001:2000 section Person or team responsible Approval required Training required Resources required Estimated completion date
These elements should be organized into a detailed chart, to be reviewed and approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds Step 7. Develop Quality Management System Documentation Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. Documentation of the quality management system should include: 1. Documented statements of a quality policy and quality objectives, 2. A quality manual, 3. Documented procedures and records required by the standard ISO 9001:2000, and 4. Documents needed by the organization to ensure the effective planning, operation and control of its processes. Step 8: Document Control Once the necessary quality management system documentation has been generated, a documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 9001:2000 requirements and that is all. Document control should include: 1. 2. 3. 4. 5. 6. 7. Approval for adequacy by authorized person (s) before issue, Review, updating and re-approval of documents by authorized person (s), Identification of changes and of the revision status of documents, Availability of relevant versions of documents at points of use, Identification and control of documents of external origin, Assurance of legibility and identifability of documents, and Prevention of unintended use of obsolete documents.
The principle of ISO 9000 document control is that employees should have access to the documentation and records needed to fulfill their responsibilities. Step 9. Implementation It is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented all at once throughout the organization. Where phased implementation takes place, the effectiveness of the system in selected areas can be evaluated. It would be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system. The implementation progress should be monitored to ensure that the quality management system is effective and conforms to the standard. These activities include internal quality audit, formal corrective action and management review. Step 10. Internal Quality Audit As the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system:
1.
Conform to the planned arrangements, to the requirements of the standard (ISO 9001:2000) and to the quality management system requirements established by the organization, and
2. Is effectively implemented and maintained. Even after the system stabilizes and starts functioning, internal audits should be planned and performed as part of an ongoing strategy. A few staff members should be trained to carry out internal auditing.
Step 11. Management Review When the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system. The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. The input to management review should include information on: 1. Results of audits, 2. Customer feedback, 3. Process performance and product conformity, 4. Status of preventive and corrective actions, 5. Follow-up actions from previous management reviews, 6. Changes that could affect the quality management system, and 7. Recommendations for improvements. Management reviews should also address the pitfalls to effective implementation, including lack of CEO commitment, failure to involve everyone in the process, and failure to monitor progress and enforce deadlines. Step 12. Pre-assessment Audit When system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Sometimes certification bodies provide this service for a nominal charge. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for certification. Step 13. Certification and Registration Once the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency. The certification agency first carries out an audit of the documents. If the documents conform to the requirements of the quality standard,
then on-site audit is carried out. If the certification body finds the system to be working satisfactorily, it awards the organization a certificate, generally for a period of three years. During this three-year period, it will carry out periodic surveillance audits to ensure that the system is continuing to operate satisfactorily. Step 14: Continuous Improvement Certification to ISO 9000 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of: 1. 2. 3. 4. 5. 6. Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management review
The process for complying with the ISO 9000 standards and obtaining certification can be complex. From the experience of other companies, there are recommended steps to follow in order to facilitate the process.
Steps to follow
These eight steps--along with their sub-steps--are based on what many major companies have followed to achieve their own ISO 9000 registration. These steps are also useful for companies simple seeking to conform to the ISO 900 standards, but not formally become certified. These steps are a good guide for establishing a timeline, schedule, and potential costs for the process of becoming ISO 9000 certified.
1. Get top management commitment 1. 2. 3. 4. Top management considers ISO 9000 registration Quality steering committee meets to evaluate process Committee informs top management of ISO 9000 costs, schedule, etc. Top management commits to pursue ISO 9000 registration
2. Train personnel 1. Hold basic quality and ISO 9000training for all employees 2. Select and train personnel to be internal auditors 3. Prepare Quality Policy Manual 1. 2. 3. 4. 5. Study and understand ISO 9000 requirements as they apply to your company Write (or re-write) company Vision and Mission statements Write basic Quality Policy Manual outline Complete first draft of Quality Policy Manual Send copy of manual to customer desiring ISO 9000 compliance (if necessary)
1. 2. 3. 4.
Define responsibilities, using Quality Manual as a guide Have those responsible for functions outline their procedures Interview managers and fine-tune procedures Compare Operating Procedures with Quality Manual for consistency
5. Hold internal audit 1. Hold internal audit of ISO 9000 manual vs. ISO 9000 compliance 2. Implement corrective action items from audit 6. Select registrar 1. Research registrars and their cost 2. Qualify possible registrars 3. Select third party registrar 7. Go through registration process 1. 2. 3. 4. 5. 6. 7. 8. Apply for registration and audits Agree to audit process etc. with registrar Hold pre-assessment audit Take any needed corrective action Have ISO 9000 registration audit Take any needed corrective action Re-audit as needed Take any needed corrective action
8. Obtain ISO 9000 registration This verifies that you operate your business in compliance to the ISO 9000 requirements.
International standards specifies requirements for quality management system where a company needs to demonstrate its ability to provide products consistently meeting requirements of customer. Further the systems should be so developed that they will improve the process regularly to exceed the customer satisfaction. For this purpose the standards are generic and not depending on type, size of the company. The latest document reference of the standard. The term supplier replaces the term organization. The term product is replaced by service. For this the organization shall identify the processes required to qualify, sequence of those with criteria and methods needed to control these processes effectively. It should have resources, information to support operation and monitor, measure and analyze them. They should be in position to achieve planned results.
These processes at the factory or at the vendors place should be controlled effectively. The vendors system to be part of organizations quality management system.
The quality policy and objective has to be documented. Quality policy has to clearly spell out the responsibility of organization towards the customer. Management responsibility has to show the commitment to the customers requirement. Quality management system has to be established. Management Representative (MR) has to be appointed to establish quality management process to be established, implemented and maintained. He will report to top management regarding the performance of the system and bring awareness of customer needs in the organization. Management has to review the system periodically as per the following points 1. Customer feedback 2. Process Performance
3. Product Conformity 4. Corrective & Preventive actions 5. Resources required 6. Follow up from last meeting.
ACKNOWLEDGEMENT
As every accomplishment requires backing and support of someone, this project is not an exception. It is our privilege to present the project on Productivity & Quality Management in BMS. The topic for our project is ISO 9000. We would like to thank Prof. Sherley for giving this topic and assisting us in widening our knowledge and experience through this project.
BIBILIOGRAPHY
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Prepared by
Suzanne Dmello Olive Dsouza Viraj Gonsalves Maqbool Khan Cicilia Peter Nikita Parekh Bilal Mashoor 3214 3221 3232 3237 3245 3246 3261