Change: ADDITIONAL Requirements
Procedure Required: YES
Record(s) Required: NONE
Comments:
This section clearly specifies the documents (and records) required by
ISO 9001:2000 as being:
a) documented statements of a quality policy and quality objectives,
b) a quality manual, (detailed requirements for the quality manual are contained in section 4.2.2)
c) documented procedures required by ISO 9001:2000 (i.e., sections 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2 & 8.5.3)
d) documents needed by the organization to ensure the effective planning, operation and control of its processes (ref. section 7.1b), and
e) records required by ISO 9001:2000 (ref. see 4.2.4).
Section 4.2.1c specifically requires documented procedures for:
4.2.1d is a general reference to section 7. While there are no
specific requirements to document any procedures contained in section
7,
section 7.1b does state that the
organization must determine "the need to establish processes, documents,
and provide resources specific to the product".
Adding "records required" (4.2.1e) to a listing of documents required
by the standard is confusing. Upon reading further in the standard one
might ask why it was considered appropriate to include records in a
listing of documents and yet have two separate sections differentiating
the control of documents (4.2.3) from
the control of records (4.2.4).
In order to clearly understand the difference between documents and
records, one should reference the definitions provided in ISO
9000:2000,
"Quality management systems—Fundamentals and vocabulary", sections:
3.7.2
document
information (3.7.1)and its supporting medium
3.7.6
record
document (3.7.2) stating results achieved or providing evidence of activities performed
Guidance:
I suggest:
a) stating the quality policy and quality objectives in the Quality Manual (ref. sections 5.3 & 5.4.1 for more detail)
b) that your quality manual paraphrase each section of ISO 9001:2000 (ref. section 4.2.2 for more detail)
c) creating documented procedures as required by section 4.2.1c
d) creating documented procedures for ALL of the applicable elements contained in section 7
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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