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Why are the standards being changed? The 2000 revision focuses on the processes within the organization. ISO Quality Standards are periodically revised to satisfy the needs of users worldwide, as per ISO directives. Will my organization have to change its quality management system and all its documentation?Review the requirements set out in the ISO 9001:2000 Standard, to see if your present system complies. If it does not, then you will have to update and document the changes. Ultimately you will have to comply with the published ISO 9001:2000 Standard. In the long run it might be easier to begin to model your documentation after the new standard. What are the main changes to the standards?The main difference is that the 1994 Standard was based on a life-cycle model, and the 9001:2000 Standard is based on a process model. The process model emphasizes managing key processes to continually improve them. Some of the changes to the quality management system standards.
What are the 5 auditable clauses?
Which standard will my organization have to be registered to?The existing ISO 9001/ISO 9002/ISO 9003 standards has been replaced by the revised International Standard (ISO 9001:2000). Now that the ISO 9001:2000 standard has been issued, all registered/certified organizations will have three years to comply with the new standard. My organization provides a service, how does the new standard apply to us?They were changed to accommodate service providers as well as manufactures, and to simplify them and make them user-friendly. Be careful, in servicing companies to take the time to really define your product. Is it information, is it a tangible? Also define what is "nonconforming" or "bad" product? Late delivery? Bad data? It is important to clear up these two items before establishing your quality management system/ What happened to ISO 9002 and ISO 9003?All companies will now register to ISO 9001. You will identify and document requirements that do not apply to your business. For example, if you do not perform design and development functions, you will identify them as permissible exclusions in your quality manual. You may only exclude requirements from section 7 of the standard. What is the Process Model?The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2000 Standard is designed to manage and improve those processes. First, you identify your key processes. Second, you define quality standards for those processes. Third, you decide how process quality will be measured. Fourth, you document your approach to achieving the desired quality, as determined by your measurements. Fifth, you evaluate your quality and continuously improve. Are process flow charts required? Flow charts are not specifically required, but more ht an likely expected by your registrar. The standard requires that you identify your processes and determine the sequence and interaction of the processes. This is most easily accomplished by preparing flow charts of your product realization processes. When do we have to make the changes?Everyone must register to the ISO 9001:2000 standard by December 15, 2003. Most experts recommend that organizations quickly begin the transition. The sooner your organization adopts the new standard, the sooner it will reap the benefits. You will save time and resources by improving our quality systems, having only one quality system to maintain. Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your quality management system by area or department and then auditing all the applicable ISO elements while in that department, you are doing process auditing. If you are auditing your quality system by ISO elements throughout the organization you are not set up currently for process auditing. Process Auditing
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