Do I need to buy a standard to claim compliance to a standard?

Do you need to buy a standard to claim compliance to that standards ?

  • Yes

    Votes: 16 80.0%
  • No

    Votes: 4 20.0%

  • Total voters
    20
  • Poll closed .

Big Jim

Super Moderator
#11
I agree with Al and Sidney, and would reference one more clause:
It's not just a "should", the standard "shall" be controlled and available. Your organization has no control over a copy at the library, and it may not be available when you need it.
So I guess it come down to an argument of the meanings of "relevant" and "applicable"?

Let's take a look at 4.2.3f since we are talking about an external document.

"to ensure that the documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled."

Would you say that c over rides f? Does c mandate that they don't have the discretion that f provides? Does not the organization have the right to determine which external documents are "relevant" and "applicable"?
 
Last edited:
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Ajit Basrur

Staff member
Admin
#12
A standard such as this would normally fall under the concept of "document of external origin" which should be identified and have it's distribution controlled. As an external auditor, I would be very leery of an organization that claims compliance to a standard, while relying on a public library to access it. If you are going to be that stingy, I would be concerned with what other "expenditure shortcuts" is this organization doing to maximize it's profit.
Absolutely .... no point in cutting costs for buying a standard when thats supposed to be the foundation of the QMS :)
 

howste

Thaumaturge
Super Moderator
#13
So I guess it come down to an argument of the meanings of "relevant" and "applicable"?
It would be an interesting definition that would describe a standard to which a company claims conformity or certification as irrelevant or not applicable.
Let's take a look at 4.2.3f since we are talking about an external document.

"to ensure that the documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled."

Would you say that c over rides f? Does c mandate that they don't have the discretion that f provides? Does not the organization have the right to determine which external documents are "relevant" and "applicable"?
I'm not sure what you're asking here. :confused: C and f complement each other. If the organization has external documents that are applicable, then they should certainly have the proper version of the document identified. If they are claiming conformity to ISO 13485:2003, they shouldn't be basing their system on ISO 13485:1996.

Of course the organization has the right to determine which external documents are relevant and applicable. When they claim conformity to the standard, they are telling me that the document is both relevant and applicable to their system.

The same is true for other external documents used in the system. Last week I audited a company that was using external documents as calibration instructions. They could have taken the information and written their own instructions, but they didn't. By using the documents, they showed that they decided they were necessary and relevant for their system.
 

Big Jim

Super Moderator
#14
It would be an interesting definition that would describe a standard to which a company claims conformity or certification as irrelevant or not applicable.

I'm not sure what you're asking here. :confused: C and f complement each other. If the organization has external documents that are applicable, then they should certainly have the proper version of the document identified. If they are claiming conformity to ISO 13485:2003, they shouldn't be basing their system on ISO 13485:1996.

Of course the organization has the right to determine which external documents are relevant and applicable. When they claim conformity to the standard, they are telling me that the document is both relevant and applicable to their system.

The same is true for other external documents used in the system. Last week I audited a company that was using external documents as calibration instructions. They could have taken the information and written their own instructions, but they didn't. By using the documents, they showed that they decided they were necessary and relevant for their system.
Would not then the same apply to the standard they are using? If they write their quality manual to the standard do they really need a copy of the standard too?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#15
If they write their quality manual to the standard do they really need a copy of the standard too?
:confused: That does not make sense. An organization could comply with the manual requirements of ISO 9001 by addressing the minimum requirements of 4.2.2 only. The rest would not need to be addressed in the manual. Wouldn't they need to have a copy of the standard to know what the requirements are?

Furthermore, the OP talked about a standard, not necessarily a QMS standard. He could be referring to a product standard, a test standard, a material standard, etc...
 

Big Jim

Super Moderator
#16
:confused: That does not make sense. An organization could comply with the manual requirements of ISO 9001 by addressing the minimum requirements of 4.2.2 only. The rest would not need to be addressed in the manual. Wouldn't they need to have a copy of the standard to know what the requirements are?

Furthermore, the OP talked about a standard, not necessarily a QMS standard. He could be referring to a product standard, a test standard, a material standard, etc...
Sidney,

This is what I was refering to.

"The same is true for other external documents used in the system. Last week I audited a company that was using external documents as calibration instructions. They could have taken the information and written their own instructions, but they didn't. By using the documents, they showed that they decided they were necessary and relevant for their system."

If they could have taken the information and written their own document on how to calibrate, why could they not take one of the ISO standards and written their quality manual in such a way that all of the requirements were covered?

Before this get any further out, I'm not trying to say that I think it an ideal situation for a company to not have a copy of the standard they are living to. I'm saying that I don't agree that they necessarily have to, depending on how they handle it. Have you not seen quite a few quality manuals that mimick the standard? I have. I don't like them, but it is part of the universe I audit in, and it is not up to me to write a nonconformance "just because I don't like it".
 
M

Mel Kimsey

#17
If you are a medical company and presumably you are citing Standards for a reason, they (the FDA or CE auditors) are going to want you to have the Standard. They are somewhat lenient on some of the 'minor' standards, but not ISO 14971 (Risk Management). And as a medical company, you must be compliant with 14971 for both the FDA and CE.

They don't much care where you get it from, as long as it's current, and you're compliant. That in itself is a big issue. Good luck!
 

howste

Thaumaturge
Super Moderator
#18
If they could have taken the information and written their own document on how to calibrate, why could they not take one of the ISO standards and written their quality manual in such a way that all of the requirements were covered?
The difference is that they're not certified to the external calibration document. They are not held accountable to the content of that document. If they wrote their own document and changed the calibration methods, there would be no repercussions.

However, if they wrote their manual to regurgitate the requirements of the standard and then used it as the requirements document, it still would need to be verified to ensure that it met the requirements of the standard. This would have to be done by comparing it against the standard. Every time they made a change to the manual, they would have to verify again that it still met the requirements of the standard.
 
U

Umang Vidyarthi

#19
This is an intresting discussion going on here, and a good lot of people are confused over the subject. I hope all the arguments by the experts, for and against, will finally be able to solve the dilemma.

Additionally, I would request the moderators to add a poll.

Umang :D
 

Ajit Basrur

Staff member
Admin
#20
This is an intresting discussion going on here, and a good lot of people are confused over the subject. I hope all the arguments by the experts, for and against, will finally be able to solve the dilemma.

Additionally, I would request the moderators to add a poll.

Umang :D
I have added a poll with "Yes" and "No' and the poll shall close afer 30 days from today.

Request all who had responded in this thread earlier to participate in the poll :)
 
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