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

kedarg6500

Quite Involved in Discussions
Friends

The word "define/defined" is mentioned in ISO 9001 for 12 times (thanks to MS word:applause:)
What is the meaning?
Does it calls for documenting in black and white?
Shall it be reflected in procedure/ work instruction/ third level documents?

Please express your thoughts

Kedar
 

sagai

Quite Involved in Discussions
Re: what is the meaning of define/defined in ISO 9001

Hi,
I do not think so.
There should be objective evidence (according to ISO9000) for those requirements have been fulfilled.
Regards
Szabolcs

ps.: defined is not identically equivalent with documented and as such its implementation not necessary manifested in a document
 
D

db

I think defined means to know the meaning of. So when the standards says something like responsibilites and authorities shall be defined... it means folks need to know what their responsibilities and authorities are.

As to whether these need to be documented, the standard will tell us. In some standards, such as ISO 13485, it clearly states that responsibilites and authorities have to be documented, in ISO 9001, that requirement is absent. So, we must go back to the default of 4.2.1, specifically d). If the absence of any definition results in loss of effective planning, operation or control of processes, then that definition will have to be documented. The more complex the organization, or processes, the greater need for documentation.
 

Ajit Basrur

Leader
Admin
I do not think there is any ISO specific meaning of "define". It would be the same meaning as offered in dictionary.
 

somashekar

Leader
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In the context of mapping your system to the ISO9001 standard, the define / defined means " to say what something means within your system that must be understood in the same way by everyone."
Obviously for consistancy it needs to be documented.
I guess ISO9001 uses this word(s) at places where it calls for a documented procedure.
Perhaps at 7.2.2 a) product requirements are defined, could be debated about being documented or otherwise, but a wise thought would be product requirement that are documented after being defined for consistancy again.
Shall it be reflected in procedure/ work instruction/ third level documents?
Reflect it whereever it makes meaning to your organization
 
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S

samsung

I would say 'No'. The dictionary meaning of 'define' is "state or describe exactly the nature, scope, or meaning of" but that doesn't mean documenting something. A thing can be defined even verbally.

I agree with db,

In some standards, such as ISO 13485, it clearly states that responsibilities and authorities have to be documented, in ISO 9001, that requirement is absent.

OHSAS too calls for documented responsibilities and authorities.

Similarly there is one more word 'specify' used at several places in the standards. This word too doesn't mean 'documentation' in my opinion.
 
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Howard Atkins

Forum Administrator
Leader
Admin
In ISO 9000:2005 which is stated in ISO 9001 to be
"The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary"

Uses the word define in a number of places.

In none of these places is there any implication that defines means documented

As an auditor in a case where the standard says "defines" I would expect the issue to be at a minimum to be explainable.
If there is no definite requirement for documentation in the standard then this is all that is required

ISO 9000:2005

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
 
N

narupv

Friends

The word "define/defined" is mentioned in ISO 9001 for 12 times (thanks to MS word:applause:)
What is the meaning?
Does it calls for documenting in black and white?
Shall it be reflected in procedure/ work instruction/ third level documents?

Please express your thoughts

Kedar

Dear friend

I think the word define is asking to explain the meaning or describe accurately to avoid ambeguity in perceiving the things by the users of the documents.
 

Randy

Super Moderator
Define[dih-fahyn]
de·fine   /dɪˈfaɪn/ Show Spelled [dih-fahyn] Show IPA verb -fined, -fin·ing.
verb (used with object)
1. to state or set forth the meaning of (a word, phrase, etc.): They disagreed on how to define “liberal.”
2. to explain or identify the nature or essential qualities of; describe: to define judicial functions.
3. to fix or lay down definitely; specify distinctly: to define one's responsibilities.
4. to determine or fix the boundaries or extent of: to define property with stakes.
5. to make clear the outline or form of: The roof was boldly defined against the sky.
 
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