Change: ADDITIONAL Requirements
Procedure Required: NO
Record(s) Required: Records of education, training, skills and
experience (Ref. Sec. 6.2.2e).
Comments:
This section essentially requires the organization to qualify and/or
train employees "performing work affecting product quality".
However, no procedure is required.
Guidance:
I suggest paraphrasing the wording of the standard in your Quality
Manual. Be able to describe to your ISO 9000 auditor "how" you qualify
and/or train your workers. Be sure to include part-time and
temporary workers as ISO 9001 does not exclude these workers. Establish
records of education, training, skills and experience (as required by
ISO 9001:2000 Sec. 6.2.2e).
A great deal of emphasis has been placed on the word competent.
Although not entirely consistent with either Webster's Revised
Unabridged Dictionary or The American Heritage®
Dictionary of the English Language, ISO 9000:2000, "Quality
management systems—Fundamentals and vocabulary" provides us with the
following definition:
3.9.12
Competence
demonstrated ability to apply knowledge and skills
CAUTION - Phantom Requirement:
ISO 9001:2000, sec. 6.2.2a requires the organization to "determine the
necessary competence for personnel performing work affecting
product quality". ISO 9000 auditors generally expect to see a
record of worker competence even though ISO 9001:2000, sec. 6.2.2e does
not require it. I suggest either creating a record of competence
for each worker OR referencing periodic performance appraisals (already
utilized by the majority of U.S. organizations) as the record of
demonstrated competence. The periodic performance appraisal may
also be used to demonstrate evidence of compliance with section 6.2.2c
(an evaluation of the effectiveness of the training actions taken).
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |