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Preventive Maintenance Requirements - ISO 9001

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I

ISO 9001 Guy

#32
Re: Seek advice on preventive maintenance under ISO 9001

Amazing. Even with the TC 176 ruling in your face, you are still trying to make up your own rules. TC 176 WROTE THE STANDARD!

Also, you may or may not have noticed that there is no reference to 4.2.4 in element 6.3.
The question posed in your TC 176 ruling is, "Does 6.3 require maintenance records?" The answer from TC 176 is precise and correct: no. Although 6.3 requires maintenance, it does not contain a record requirement. From this we cannot infer that ISO 9001 never requires records of maintenance. (Well, apparently some can . . .)
4.2.4 requires records to provide evidence of conformity to requirements. IF management has established records requirements for maintenance (and many do), then these records must be maintained as evidence to conformity of requirements. That way, management can tell whether maintenance is being done as required.
To more directly address the "in your face" comment, I am fully aware that TC 176 wrote the standard; for you to assert that your cited reference means that TC 176 says records of maintenance are not required is not being precise. All your reference says is that records of maintenance are not required of 6.3. If management requires records--including maintenance records--ISO 9001 requires them to be maintained per 4.2.4 to provide evidence of conformity to requirements. Also, to address your concern that I overlooked the fact, I am keenly aware that there is no reference to 4.2.4 in element 6.3. In fact, that's what I stated in the very quote you took from my posting: "Correct, there is no requirement for records in 6.3". :)
 
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Helmut Jilling

Auditor / Consultant
#33
Re: Seek advice on preventive maintenance under ISO 9001

Can you cite the "shall" for that?
ummm, well, you might want to try 4.2.4:

4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

...:cool:


Note: it does not state records are only required for those clauses where the standard makes a reference that records are required. I don't take that reference to be that exclusive.
 

Big Jim

Super Moderator
#34
Re: Seek advice on preventive maintenance under ISO 9001

ummm, well, you might want to try 4.2.4:

4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

...:cool:


Note: it does not state records are only required for those clauses where the standard makes a reference that records are required. I don't take that reference to be that exclusive.
As long as you are quoting it, you might as well quote it correctly. When quoted correctly the shall just isn't there.

4.2.4 Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

Perhaps you mixed part of the next paragraph in.

The organization shall establish a documented procedure to define the controlls needed for the identification, storage, protection, retrieval, retention and disposition of records.
 

Big Jim

Super Moderator
#35
Re: Seek advice on preventive maintenance under ISO 9001

The question posed in your TC 176 ruling is, "Does 6.3 require maintenance records?" The answer from TC 176 is precise and correct: no. Although 6.3 requires maintenance, it does not contain a record requirement. From this we cannot infer that ISO 9001 never requires records of maintenance. (Well, apparently some can . . .)
4.2.4 requires records to provide evidence of conformity to requirements. IF management has established records requirements for maintenance (and many do), then these records must be maintained as evidence to conformity of requirements. That way, management can tell whether maintenance is being done as required.
To more directly address the "in your face" comment, I am fully aware that TC 176 wrote the standard; for you to assert that your cited reference means that TC 176 says records of maintenance are not required is not being precise. All your reference says is that records of maintenance are not required of 6.3. If management requires records--including maintenance records--ISO 9001 requires them to be maintained per 4.2.4 to provide evidence of conformity to requirements. Also, to address your concern that I overlooked the fact, I am keenly aware that there is no reference to 4.2.4 in element 6.3. In fact, that's what I stated in the very quote you took from my posting: "Correct, there is no requirement for records in 6.3". :)
I am very aware that if an organization says in their documentation that they will keep maintenance records then they need to. That's pretty much true of anything they decide needs to be part of their QMS even if it is above and beyond the requirments of the standard.

If they choose to do maintenance and not keep records they are free to do so unless they say they will keep maintenance records.
 
I

ISO 9001 Guy

#36
Re: Seek advice on preventive maintenance under ISO 9001

Jim, you wrote:

"As long as you are quoting it, you might as well quote it correctly. When quoted correctly the shall just isn't there. [Italics mine.]

4.2.4 Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled."

Come on, now. The shall is clearly there--in your own citation of the requirement! Can't you put your finger on the SHALL in the above requirement?
 
S

samsung

#37
Re: Seek advice on preventive maintenance under ISO 9001

Jim, you wrote:

4.2.4 Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled."
IMO the above sentence does not mandate records to be maintained. I interpret it as emphasizing more on 'control' of records, if established. If it had to emphasize the need for establishing records, the sentence would probably have begun as,
'Records shall be established or maintained to provide............ The records shall be controlled....or like that.

Later, Sorry I failed to see it before. Helmut had already quoted it.
ummm, well, you might want to try 4.2.4:
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.
Just have a look at the attached interpretation of Clause 6.3 (Infrastructure),
 

Attachments

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Helmut Jilling

Auditor / Consultant
#38
Re: Seek advice on preventive maintenance under ISO 9001

As long as you are quoting it, you might as well quote it correctly. When quoted correctly the shall just isn't there.

4.2.4 Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

Perhaps you mixed part of the next paragraph in.

The organization shall establish a documented procedure to define the controlls needed for the identification, storage, protection, retrieval, retention and disposition of records.
Jim, I took it straight from the standard -

4.2.4 Control of records (ISO 9001:2000) -
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

4.2.4 Control of records (ISO 9001:2008) -
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The 2008 version of the standard moved the word "shall" to the back of the sentence, but it does not materially change the meaning of the requirement. The standard requires people to demonstrate conformity to requirements. That is the backboone of the whole auditing program. I guess I don't see how the slight rewording changes the intent.

 

Helmut Jilling

Auditor / Consultant
#39
Re: Seek advice on preventive maintenance under ISO 9001

...If they choose to do maintenance and not keep records they are free to do so unless they say they will keep maintenance records.
Well, somehow they will need to demonstrate that they have a suitable maintenance program. Typically, that includes records. I suppose that could be done without records, but it would be rather unusual. Metrics maybe.
 

Big Jim

Super Moderator
#40
Re: Seek advice on preventive maintenance under ISO 9001

Jim, I took it straight from the standard -

4.2.4 Control of records (ISO 9001:2000) -
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

4.2.4 Control of records (ISO 9001:2008) -
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The 2008 version of the standard moved the word "shall" to the back of the sentence, but it does not materially change the meaning of the requirement. The standard requires people to demonstrate conformity to requirements. That is the backboone of the whole auditing program. I guess I don't see how the slight rewording changes the intent.

Perhaps I see the TC 176 ruling differently than you do. It tells me that records are not required for maintenance. The exception would be when an organization chooses to keep records.

The requirement for keeping records for maintenance does not come from element 6.3.

And it doesn't come from 4.2.4 either. "Records established to provide evidence of conformity . . ." If records are not established they do not need to be controlled. Who gets to determine if records need to be established? Except for the places in the standard where 4.2.4 are cited, THE ORGANIZATION GETS TO DECIDE. Auditors don't have a say it that.
 
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