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ISO 9001 RequirementsThe ISO 9001 requirements are in clauses 4 through 8 with sub-clauses in each of those primary clauses. We have translated the requirements into plain English. ISO 9001 General Information The 1987 and 1994 editions of ISO 9001 were focused on standardizing processes primarily through extensive documentation. Although the intent was to provide customer satisfaction and improvement those terms never actually appeared in the standard. The ISO 9001 requirements in the 1994 edition, the ISO 9001 edition before the 2000 revision, had one clause with 20 sub-clauses. Each of the sub-clauses focused on a specific type of operation in companies. For example, there was a clause (4.3) titled "Contract Review" that focused on customer order review. Another one was a clause titled "Process Control" (4.9). However, it focused on production processes, not all processes. Each was considered a separate entity and was treated that way when documenting and implementing, as well as being audited. The ISO 9001 requirements in the 2000 edition was completely reformatted and re-focused. This edition contains only five clauses. They are based of the processes most companies have. The new formatting is geared toward the interaction of the processes in companies. All processes in companies rely on others for their input and provide output to other processes. The Process Approach ISO 9001:2008 requires companies to identify the processes in their organization as well as the interaction of these processes in order to enhance customer satisfaction through continual improvement. The process approach starts with customer requirements as the initial input and customer satisfaction and continual improvement as the output. The phrases "customer satisfaction" and "continual improvement" actually appear in this standard. And, requirements have been set for measuring and monitoring activities based on objective measurements. The clauses are: (click on the title of the clause for its plain English translation) 8 - Measurement, analysis and improvement Another of the significant changes from previous editions is there is only one standard opposed to three. The 2000 revision of ISO 9001 includes everything from product design or development to servicing the product after the sale. Speaking of design and development, under the previous edition of the standard companies could simply choose not to include specific operations or processes in the scope of their certification. For example, if they didn’t want to include product design engineering, sometimes referred to as "wild cards" because of the lack of standardization between engineers, they chose certification to ISO 9002. ISO 9002 didn’t include design control. This is no longer possible. You can only exclude a process by justifying that it doesn’t affect customer or regulatory requirements. That's tough to prove when you design and/or develop the product or service what customers buy. This initially resulted in many companies not transitioning from the 1994 edition to the 2000 standard and therefore eventually losing their certification. ISO 9001-2008 The proposed changes for the 2008 revision are editorial in nature. The changes are intended to clarify the intent of the original 2000 requirements and to help in implementing the ISO 9001 Quality Management System. See the ISO 9001-2008 changes... Additional Information Resources What are Quality Management Systems? Online ISO 9000/9001 Overview Course Auditor Training: Online
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