ISO9001:2008 (final con.)

Classified as “medium” impact are:

• Minor additional or reduced requirements for some users.
• Possible impact on understanding by many users.
• Need for limited changes of an organization’s QMS documentation.
• Need for eventual revision of other QMS standards but potential compatibility problems would be tolerable in the interim.
• No significant need for additional education or training for users.
• Creates a minimal requirement for recertification.

Categorized as “low” impact criteria are:

• No increased or reduced requirement.
• No change in intent of requirement.
• No impact on most users.
• No need for additional education or training for users.
• Only need for minimal or marginal changes of an organization’s QMS documentation. In the benefit category, the document lists the following activities as “high” benefit to users:
• Addresses a widely expressed specific user need by improving clarity and eliminating confusion.
• Corrects an error in the existing standard.
• Eliminates inconsistencies within ISO 9001.
• Eliminates inconsistencies within the ISO 9000 family.
• Eliminates major problems of translation.
  

Ranked as “medium” benefits are:

• Improves clarity in regard to a widely expressed user need but may not eliminate confusion and/or translation difficulty.
• Improves clarity in response to needs identified by some users.
• Increases compatibility with ISO 14001.
• Demonstrates willingness to respond to the wish to see improvement in compatibility between ISO 9001 and ISO 14001 even though alignment is not a priority for this amendment.
• Reduces problems of translation.
  

Ranked as “low” benefit are the following:

• Improves clarity only in response to a very low number of requests for improvement.
• Marginal improvement in clarity where benefit may be offset by risk of unintended consequences, e.g. with respect to translation, interpretation.
• Changes not addressing a clear user need.

by QSU Publishing Company (www.qsuonline.com)