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What is the meaning of "define/defined" in ISO 9001?

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kedarg6500

Quite Involved in Discussions
#12
I never met this situation.
1. In some clauses, it clearly asks for “to define …” for example clauses 4.1, 5.5.1. 7.2.2 a), 7.5.2 & 8.2.2
2. Take example clause 5.5.1-Responsibility and authority. It says “Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.”
3. In some clauses it clearly asks for “documented procedure shall be established to define” like 4.2.4, 8.2.2, 8.3 & 8.5.2
4. What I have understood form above discussions, use of “define/defined” means we shall be able to show “objective evidence” as per ISO9000:2005
3.8.1
objective evidence
data supporting the existence or verity of something
NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.

I thank :thanx:all the contributors to give me insight

Kedar
 
S

samsung

#13
1.
2. Take example clause 5.5.1-Responsibility and authority. It says “Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.”

4. What I have understood form above discussions, use of “define/defined” means we shall be able to show “objective evidence” as per ISO9000:2005
What 'objective evidence' would you produce to 'define' Responsibility & Authority where it's not documented?
 

Howard Atkins

Forum Administrator
Staff member
Admin
#14
What 'objective evidence' would you produce to 'define' Responsibility & Authority where it's not documented?
As I posted above ISO 9000
3.9.4
audit evidence
records (3.7.6), statements of fact or other information (3.7.1) which are relevant to the audit criteria (3.9.3) and verifiable
and
3.8.1
objective evidence
data supporting the existence or verity of something
NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.
 
S

samsung

#15
My point is in what way an 'objective evidence' would help someone to prove that someone wasn't responsible for something but somebody else was. e.g. if I did something (and did it wrong) which I wasn't supposed to do but I did it because it had to be done and the one who was supposed to be responsible for doing it, didn't do it.
 
#17
My point is in what way an 'objective evidence' would help someone to prove that someone wasn't responsible for something but somebody else was. e.g. if I did something (and did it wrong) which I wasn't supposed to do but I did it because it had to be done and the one who was supposed to be responsible for doing it, didn't do it.
Simples! You interview those who are responsible (the process owner, for example) and those who do the work! How those people define the process is your objective evidence! End of story!
 
S

samsung

#18
Simples! You interview those who are responsible (the process owner, for example) and those who do the work! How those people define the process is your objective evidence! End of story!
:mg:This is not as simple as it may appear to you. Had it been so, OHSAS 2007 wouldn't have prescribed the requirement of documenting and communicating the responsibilities. (though the question hasn't been put up in OHSAS forum)
 

somashekar

Staff member
Super Moderator
#19
:mg:This is not as simple as it may appear to you. Had it been so, OHSAS 2007 wouldn't have prescribed the requirement of documenting and communicating the responsibilities. (though the question hasn't been put up in OHSAS forum)
Within ISO9001, when the responsibility and authority are defined and communicated, they stand as that. So when you interview those who are responsible (the process owner, for example) and those who do the work, how those people define the process is your objective evidence. If there are other objective evidences noticed that as explained in post # 15 quoted under,
My point is in what way an 'objective evidence' would help someone to prove that someone wasn't responsible for something but somebody else was. e.g. if I did something (and did it wrong) which I wasn't supposed to do but I did it because it had to be done and the one who was supposed to be responsible for doing it, didn't do it.
then it is more a finding on 5.5.3 (The Internal communication) and the only effective and simple way to beat it is to define ... (document) .. communicate; so that ....
appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system., and within that responsibilities and authorities are defined and communicated within the organization.
At places ISO9001 wants a documented procedures by a shall, however at places where it wants the organization to define / define and communicate, the effectiveness of such a defining is best done by controlled documentation, but this is again left to the organizations to determine.
 
Last edited:
#20
:mg:This is not as simple as it may appear to you. Had it been so, OHSAS 2007 wouldn't have prescribed the requirement of documenting and communicating the responsibilities. (though the question hasn't been put up in OHSAS forum)
Apparently, in some countries, when people are arrested by the police, the arresting officer says something along these lines:

"You have the right to remain silent. If you give up this right, anything you say may be used as evidence in a court of law." Surely, if it's been acceptable in this form for many years, as an established form of evidence, why now would a QMS based on ISO 9001 not make it acceptable? (I fail to see what the reference to OHSAS has to do with anything)
 
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