ISO 9001:2000

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4.1 General Requirements


Change: ADDITIONAL Requirements
Procedure Required: NO
Record(s) Required: NONE

Comments:
This section is simply a general requirement to comply with all of the requirements that follow it!

Exclusions:
ISO 9001:2000 specifically allows exclusions. This section points to section 1.2 for specific details relating to those exclusions (exclusions are limited to only those requirements specified in section 7).

Outsourcing:
This section states that "where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes."  While this concept should be considered a duplication of the requirements relating to the same concept in section 7.4, "Purchasing", it is curious that the later section does not use the term "outsource".

CAUTION - Phantom Requirement:
This section states that the "organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness" in accordance with the requirements of ISO 9001:2000. Some ISO 9000 registrars and auditors interpret this requirement conservatively to mean that ALL of the requirements in the standard must be documented. However, the vast majority of ISO 9000 registrars and auditors point to section 4.2.1 as providing clarification and interpret this requirement as relating only to those specific sections of the standard requiring a quality manual (section 4.2.2) and documented procedures (4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2 & 8.5.3). Notice that there are no specific requirements for procedures relating to sections 7! Section 7.1b simply states that the organization must determine "the need to establish processes, documents, and provide resources specific to the product".

Guidance:
Generally ignore this section of the standard while ensuring that when addressing section 7.4, "Purchasing", you include the concept of "outsourced processes". I also suggest that your Quality Manual (specifically required in section 4.2.2) address all of the requirements contained in the standard in order to satisfy those ISO 9000 registrars and auditors who interpret section 4.1 conservatively to mean that ALL of the requirements in the standard must be documented.

If there are any elements of section 7 to be excluded, refer back to section 1.2. Exclusions are required by section 4.2.2a to be addressed within the Quality Manual. The most common (and overlooked) exclusion is section 7.5.2 "Validation of processes for production and service provision" (i.e., special processes).




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