ISO 9000:2000 Standards
The 2000 version of the standard focuses more on management, the customer, and continuous improvement. This version establishes a management system model that is intended to continually improve customer satisfaction and the effectiveness of the management system.
ISO 9000:2000
ISO 9000 describes the basic fundamentals of a quality management system and the definitions of terms used in ISO 9000, 9001, and 9004. The philosophy, intended purpose and general nature of the elements of the quality management system are discussed. As with any requirements document, whether legal, regulatory, or voluntary, the definitions are a very important part of the document. Through these definitions, the scope and intent of the specific requirement are defined.
ISO 9001:2000
The ISO 9001 document establishes the requirements of the quality management system. According to the Introduction to ISO 9001:2000,
"This International Standard may be used by internal and external parties including certification bodies to assess the organization's ability to meet customer, regulatory, and the organization's own requirements."
In other words, this is the requirements document for a company wanting to Register or Certify to ISO 9001.
Notice that the only standard discussed here is ISO 9001. That is because the 2000 revision replaced ISO 9002 and ISO 9003 with ISO 9001. Organizations that are currently registered to ISO 9002 or 9003 may take exception to the non-applicable clauses of ISO 9001 in accordance with section 1.2 of the standard.
For an organization to claim an exception to a clause or element in ISO, the element must truly be not applicable based on the nature of the organization and its product. The exclusions are limited to paragraphs within clause 7 and must not
"affect the organization's ability or responsibility, to provide product that meets the customer and applicable regulatory requirements".
Basically, this means that if you have activities that are necessary in any way to provide your product or service to the customer, these activities must be included in your system. If you outsource any activity that affects product conformity, you are also responsible for ensuring control of these outsourced processes and the controls identified in your quality system.
For instance, a company that was registered to ISO 9002 thereby excluding the Design organization from the scope of its quality management system would no longer be able to exclude design under the 2000 revision. Any exclusions an organization takes must be documented in the Quality Manual.
ISO 9004:2000
ISO 9004 provides guidance on implementing a quality management system and addresses a broader approach than ISO 9001. Objectives related to overall performance and efficiency are included. ISO 9004 should not be viewed as a requirements document, but rather a guidance document for companies wishing to move beyond the requirements of ISO 9001.
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