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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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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