Mandatory documents vs shall "something" but without mandatory documents

sistoiv

Involved In Discussions
#1
I had a theoretic discussion with the CB’s auditor on a structural issue of system standard. When there is a reference to the documented information this must be interpreted in a general way (for the clause in object) or only specific for the specific sub-requirement?
Example 4.4 b). There is no reference to documented information for a process map or similar, so it seems that I could simply determine and "tell" it. But 4.4.2 speaks about process documentation so, for the auditor, the obligation for documented processes map is there. Not in my opinion.
Another example. 6.2.1 says that the objectives must be documented but the planning (6.2.2) could also be carried out without having documented the plan for implementing the objectives. The auditor says that however there is 6.2.1.

Another isssue.

4.1, 4.2, 6.1. Standard say “shall” but no document is mandatory. The organization can also show them verbally and in fact, without obligation of documents. If a CB's auditor gives to me a NC I could do reservation to CB, ISO 9001 does not claim documented information about these clauses.

Who's right?
 
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bkirch

Involved In Discussions
#2
I am by no means going to claim to be an expert. My interpretation of all of the requirements are that if they state that a documented process or information is required, then you need to have some documentation. If the requirement states a "shall" but does not mention a requirement for a documented process or information, then you have to be able to demonstrate that you meet the requirement, but it doesn't necessarily have to be documented. However, I have found that sometimes it is a little tricky to demonstrate that you meet a requirement if you don't have some type of documentation, even if it isn't required.
 

sistoiv

Involved In Discussions
#3
Thanks OK, but why does not ISO clarify these ones?, otherwise there will be always discussions and misinterpration.

However, for example, you can ask to me which are my processes, sequence and interactions and I answer to you, where is the matter?
 

Randy

Super Moderator
#4
As long as the standard or something you write down doesn't specifically require documentation, you're right. I'm a CB auditor, that's all I do and I've been doing it 19 years and I'm telling you that it doesn't matter squat what I like or want, it's only about what's required. Now that being said, if I can demonstrate through objective evidence a lack of effectiveness or control without something being documented I might possibly issue a NC but I've only done that on very few occasions.
 

tony s

Information Seeker
Trusted Information Resource
#5
But 4.4.2 speaks about process documentation so, for the auditor, the obligation for documented processes map is there.
Not really. Clause 4.4.2 begins with "To the extent necessary". So, it's left to the organization to determine necessity of maintaining/retaining documented information - unless specifically stated by ISO 9001 (on other clauses).

I'd agree that verbal explanation of the sequence and interactions of the processes can satisfy 4.4.1b without the need of a document. ISO/TS 9002:2016 has this statement as my reference:
"when determining the sequence and interaction of these processes, the links with the inputs and outputs of the previous and subsequent processes should be considered; the methods for providing details of the sequence and interaction of the processes depends on the nature of the organization; different methods can be used, such as retaining or maintaining documented information (e.g. process maps or flow diagrams), or a more simple approach, such as a verbal explanation of the sequence and interaction of the processes"

Randy is right in telling us it doesn't matter what a CB want, it's only about what is required. CB should be guided by the International Accreditation Forum auditing practices guidance in evidence collection (see this link) as specified below:
"Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001".
 

Big Jim

Super Moderator
#6
Imagine trying to document organizational knowledge (7.1.6). It would be an impossible task to try to capture all the collective knowledge pertinent to the organization. The faulty logic of the OPs auditor would have you trying to do that anyway.
 

sistoiv

Involved In Discussions
#7
Thanks to all, suitable (not only adequate) comments.
I'm sorry but for quite some time when a CB's auditor starts to say " ISO Xxxx requires...." but ISO Xxxx doesn't include explicity that requierement, I threatean to claim formally. The proof that the auditor was trying is that it almost always ends suddenly. It is demeaning
 
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John Broomfield

Staff member
Super Moderator
#8
Auditors should never argue but don’t tell them that rule!

...and by sticking to the facts they don’t need to.

In this case just present your copy of the standard and ask “please show me the requirement”.
 
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