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Four primary standards and several guides The ISO 9000 series consists of four primary standards supported by several other documents. ISO 9000:2000, Quality management systems– Fundamentals and vocabulary This standard describes the concepts of a quality management system (QMS) and defines the fundamental terms used in the ISO 9000 family. The standard also includes the eight quality management principles which were used to develop ISO 9001 and ISO 9004. This standard replaces ISO 8402:1994 and ISO 9000-1:1994. ISO 9001:2000, Quality management systems – Requirements This standard specifies the requirements for a QMS, whereby an organization needs to assess and demonstrate its ability to provide products that meet customer and applicable regulatory requirements, and thereby enhance customer satisfaction. This standard replaces ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994. ISO 9004:2000, Quality management systems – Guidelines for performance improvements This standard provides guidance for continual improvement and can be used for performance improvement of an organization. While ISO 9001 aims to give quality assurance to the manufacturing processes for products and to enhance customer satisfaction, ISO 9004 takes in a broader perspective of quality management and gives guidance for future improvement. This standard replaces ISO 9004-1:1994. Guidelines for self-assessment have been included in Annex A of ISO 9004:2000. This annex provides a simple, easy-to-use approach to determine the relative degree of maturity of an organization’s QMS and to identify the main areas for improvement. The ISO 9000 standards were first published in 1987, revised for the first time in 1994, and revised for the second time in 2000. Standards are reviewed every five years to ensure that they are current and satisfy the needs of users. ISO 9000 is a starting point for understanding the standards, as it defines the fundamental terms used in the ISO 9000 “family”, or set of standards relating to quality management. ISO 9001 specifies requirements for a quality management system whereby you can demonstrate ability to provide products that fulfil customer requirements as well as applicable regulatory requirements; it also aims to enhance customer satisfaction. ISO 9004 provides you with guidance on continual improvement of your quality management system so that the needs and expectations of all interested parties are met. Management principles ISO 9000 is based on eight management principles (see www.iso.org): Customer focus, resulting in meeting customer requirements and striving to exceed them; Leadership, aiming to create an internal environment in which people are fully
It is necessary to have well-defined processes. Involvement of people who are the essence of an organization. Factual approach to decision-making. and Mutually beneficial supplier relationships. establishment of measurable quality objectives at relevant functions and levels. Top management must take responsibility for leadership. ISO 9000 encourages the adoption of the process approach to manage an organization. to be able to realize the product. operational and support. It should provide adequate resources so that customers get what was mutually agreed. establishment of internal communication processes to ensure effective communication of QMS objectives within the organization. commitment and active involvement for developing and maintaining the quality system. There are five main areas considered for the revised process model in ISO 9000: Quality management system Management responsibility Resource management Product realization Measurement. based on an understanding of their interdependence. consideration of statutory and regulatory requirements. analysis and improvement. based on the analysis of data and information. Continual improvement. understanding and management of interrelated processes.involved. System approach to management. which becomes a permanent objective of the organization. determination of training effectiveness. “customer focus” to ensure “involvement of top management for determining customer requirements”. increased attention on resource availability. leading to improved effectiveness and efficiency through identification. 6 The process model used in the standards is fully compatible with the well-known PLAN-DO-CHECK-ACT cycle. Quality management has to include the processes required to achieve quality and highlight their interaction with each other. monitoring of information on customer satisfaction as a measure of system . The new requirements in ISO 9001:2000 include: increased emphasis on the role of top management. resulting in improved efficiency to obtain desired results. Process approach. by adding separate requirements for “infrastructure” and “work environment”. Customer satisfaction has to be measured and analyzed so that the organization can be improved continually.
The direct costs include. acquiring relevant national and international standards of the ISO 9000 family and other related books and publications.effectiveness. reorganization of the processes. reduced cost of internal failures following external benefits are generated: customers are more confident that they will receive products conforming to their requirements. including improvements in the house-keeping. an improved image of the company. if required. increased motivation of employees. which in turn results in higher customer satisfaction. more aggressive publicity. if required. benefits of obtaining ISO 9000 certification Implementing a quality management system brings internal benefits to most organizations. as well as opening up opportunities vis-à-vis the outside world. more confidence that the company’s products meet relevant regulatory requirements. the following: time spent by the management and other staff in developing the system. Internal benefits to the company include: improved customer focus and process orientation within the company. organizing in-house training. “continual improvement” of the effectiveness of the QMS Costs and benefits of setting up a quality management system 1. external calibration charges for equipment to ensure national and/or international measurement traceability. Costs… Common implementation costs that companies incur can be broken down into direct and indirect costs. better working conditions for employees. Implementing a quality management system An ISO 9000:2000 quality management system can be implemented by following the steps detailed as follows: . sending personnel for external training. inter alia. inter alia. analysis of collected data to demonstrate the suitability and effectiveness of QMS. as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs. improved management commitment and decision-making. and The indirect costs include. the following: hiring consultants or external trainers.
Supporting information such as quality management principles. and experience in helping other organizations to achieve their stated goals. and on how to audit compliance with the QMS. it is good to check his/her background. knowledge about the product realization processes of your organization. on how to identify and implement improvement processes. greater efficiency and profitability. It is also possible to appoint a consultant only for the training of key staff. 5. and high level of rework or rejection of products or services. Gap analysis Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. which may be requested by an important client or required for enlisting as a supplier to large companies. e.g. The Institute of Quality Assurance (IQA). 4.. guidance on clause 1. on procedures. within the organization. Plan for and provide specific training on how to develop Quality Manuals. Product realization processes Review clause 7 of ISO 9001:2000 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS. Prepare how to bridge these gaps. 13 6. .iso. frequent production hold-ups. delayed deliveries. Awareness and training Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. the latter can then carry out further training and development of the system. 2. high inventories. etc. Before doing so. Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. Another objective in implementing a QMS may be a demonstration of compliance through third party certification.1. frequent warranty returns. At this stage.2 (application) of ISO 9001:2000. improved communications and morale in the organization. increased market share. original equipment manufacturers (OEMs). if necessary If. including certification. including by planning for any additional resources required. etc. you do not have adequate competence to develop a QMS. such as customer satisfaction. guidance on documentation requirements of ISO 9001:2000 and other brochures are available free of charge on the ISO web site at http://www. Gap analysis may be carried out through selfassessment or by the external consultant. on QMS planning. you may appoint a consultant. frequently asked questions (FAQs). the American Society for Quality (ASQ) and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints. Appoint a consultant. Obtain information about the ISO 9000 family The persons identified for initiating the development of an ISO 9000 QMS need to understand the requirements of ISO 9001:2000 as read with ISO 9000:2000 and ISO 9004:2000. identify the goals which you would like to achieve through a QMS.org 3.
Exclude any requirement with justification for doing so as decided in step 6 above. e. 9.1 and 7. Refer to or include documented procedures for QMS. and concerned management should take corrective action on the audit findings without delay. documentation. revise the manuals. Include how the QMS applies to the products. the trained auditors should carry out one or two 14 internal audits covering all activities for the QMS. Describe the interaction between the processes of the QMS. Staffing Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS. measurement and improvement processes. The effective date of implementation should also be decided. 8.1 of ISO 9001:2000 provide information that should be used when developing the plan. and Draft the quality policy and quality objectives for the organization. Carry out internal audits During the phase of implementation of some three to six months after the documentation has been written. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required. implementation and evaluation) depends on the extent of the gaps in your existing QMS. locations and departments of the organization.. Draft a Quality Manual In your Quality Manual. including the appointment of a management representative who will oversee the implementation of the QMS. Wherever required. include activities to be performed. responsibilities and an estimated completion time for each activity. Planning a time frame Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. 7. 10. The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use. In the plan. Clauses 4. After each internal audit. procedures and objectives. processes. you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual. The total time required for each phase (planning. resources required.The processes covered by this clause include: Customer-related processes Design and development Purchasing Production and service provision Control of measuring and monitoring devices Note that if your company is not responsible for preparing the design of your product. the top management should review the effectiveness of the system and provide . the interaction between product realization processes and other management.g.
. including its continual improvement. Apply for certification On satisfactory completion of Step 10. the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. Conduct periodic evaluations After certification. 12. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved. 11. and if your company decides to obtain third party certification. The certification audit process is explained section VII. you can make an application for certification to an accredited certification body..necessary resources for corrective actions and improvements.