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ISO 9001:2008 Clause Interpretations and Clarifications

jelly1921

Quite Involved in Discussions
#31
I have a question about 6.2 Human resources

"Personnel performing work" and "personnel performing any task" have the same meaning?
Should the personnel mentioned above have the responsibilities and authorities defined in 5.5.1 Responsibility and authority?
 
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B

Barahir

#33
I have a question relating to clause 0.1 a:
0.1 General

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by

a) its organizational environment, changes in that environment, and the risks associated with that environment,

I think that this may be referencing physical environment and the risks associated with that location (built near an active volcano, inside the arctic circle, microgravity and artificial atmosphere of the moon, "here there be monsters," in Ohio where if you don't like the weather wait an hour and it'll change, etc.).

My boss thinks it is referencing organizational environment from a standpoint of how the management chain works, are we privately held or a mega corporation, etc. I would tend to agree with this but bullet point f) of this same clause references "it's size and organizational structure," so I believe that bullet point f) covers this part.

A third option may be more on the physical side, but more like the risks associated with the internal work environment (working with volatile chemicals that can explode if not handled properly, mining coal a mile under the earth where you can get the black lung if you're not careful, loud noises from machinery can cause hearing loss without proper PPE, etc.).

Anyone know which of these environments this refers to? Is it one of more of these three, or none at all?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#34
Anyone know which of these environments this refers to? Is it one of more of these three, or none at all?
Your boss is the closest one. From ISO 9004:2009, the definition of organization environment:
combination of internal and external factors and conditions that can affect the achievement of an organization's objectives, and its behavior towards its interested parties.
 

Jim Wynne

Staff member
Admin
#36
I have a question relating to clause 0.1 a:
0.1 General

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by

a) its organizational environment, changes in that environment, and the risks associated with that environment,
I think that this may be referencing physical environment and the risks associated with that location (built near an active volcano, inside the arctic circle, microgravity and artificial atmosphere of the moon, "here there be monsters," in Ohio where if you don't like the weather wait an hour and it'll change, etc.).

My boss thinks it is referencing organizational environment from a standpoint of how the management chain works, are we privately held or a mega corporation, etc. I would tend to agree with this but bullet point f) of this same clause references "it's size and organizational structure," so I believe that bullet point f) covers this part.

A third option may be more on the physical side, but more like the risks associated with the internal work environment (working with volatile chemicals that can explode if not handled properly, mining coal a mile under the earth where you can get the black lung if you're not careful, loud noises from machinery can cause hearing loss without proper PPE, etc.).

Anyone know which of these environments this refers to? Is it one of more of these three, or none at all?
What we have to go on is grammar and syntax. The noun environment is modified by the adjective organizational. It doesn't say the organization's..." which could rationally lead to the confusion you're experiencing. Organizational means "of or having to do with organization (or an organization)." Your boss is correct, in other words. :D
 
B

Barahir

#37
Thanks for helping with the clarification guys. I am writing up a quick summary of what the changes mean to present as a part of Management Review for our upgrade. Our auditor gave us a nonconformance at the last surveillance audit because we hadn't done so yet (bad us, I know, but with no real changes I wasn't really focusing on making sure the IATF gets their cash for putting out a document with no real changes that we all have to purchase.) So the corrective action is pretty much:
  1. Buy Copy of Standard
  2. Review against old version to determine what, if any, changes need made to our QMS.
  3. Make any necessary changes.
  4. Summary report on this action at Management Review.
So the bulk of the work I've got ahead of me is changing every document we have that references the previous edition of the standard. I think I'm going to change them all to say "most current edition" rather than call out exactly which edition.
 
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