ISO 9001:2008 Mandatory Procedures in Quality Manual

[Sennayagi]

Hi Colin

I agree , as of now most of the consultants advised to prepare 4 tier documentation. i hope that 9K 2015 version will minimise the documentation as you said.


thanks
SEN

 

[lk2012]

Hi,
we've got a similar structure in our company.
There's what I call the 'Top Level Quality Manual' : this is a short document showing overall structure of the company (we have multiple sites so we give an overview of the communication flow), which clauses of TS (ISO) we're under and which are excluded and WHY (this is important). It also gives reference to the further tiers: the procedures (covering the rest of the processes), instructions, and forms.

Next level are the procedures: and that's where your mandatory ones come in. You've got to cover these areas as a minimum:
- document control
- control of records (these 2 can be done together)
- control of non-conforming product
- Internal Audit
- Corrective & Preventive Action
- Training

Any other of your key processes will be covered in additional procedures (for example, my office does Logistics and Distribution so we'd have procedures covering Supplies, Order Processing etc).

under that, you'd have your instructions and then your forms.
Hope this helps:

 

[JaneB]

No, IK2012, a training procedure is not mandatory. (Perhaps you're harking back to the '94 version when it was?)

 

[JaneB]

...as of now most of the consultants advised to prepare 4 tier documentation....

Yikes! 4 tiers of documentation? Really? This consultant wouldn't and doesn't.

Unless you're very large and/or complex and/or working in a highly risky and or regulated environment (Oil & Gas say) I wouldn't. Keep it simple!

 

[lk2012]

hi Jane,
thinking that Training is a mandatory procedure must be from the fact that my company does TS16949. I clearly remember our Auditor listing Training as one of the mandatory ones to cover.
Doesn't hurt having one anyway.

 

[Colin]

Yikes! 4 tiers of documentation? Really? This consultant wouldn't and doesn't. <snip>

I wouldn't like to be the auditor who tried to get that by you Jane!

 

[chiruvuppala]

I completely agree with t.PoN when he says it is up to you where you put the procedures (any of them that is, not just the mandatory ones), clause 4.2.2 states that the manual must include ... or make reference to the procedures.

Just a thought, do consider that sometimes you might be asked to send a copy of the quality manual to customers and if the procedures are in there, you are handing over all of the system virtually. This may or may not be a concern for you.

Dear sir ,

we are maintaining inspection reports in Assembly level , now my question is is there any mandatory requirement in ISO 9001:2008 to maintain inspection report for all components

 

[Colin]

Clause 8.2.4 states that "Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorising release of product".

So there has to be records but as to what form these take, it is up to you.

 

[Big Jim]

Hi,
The consultant was not wrong. As per the Documentation requirements we defined as 4 level of documents like Level 1 for quality manual , Level 2 for Documented procedure manual , Level 3 for Department procedures and work instructions and Level 4 for formats and documents


That?s why the consultant advised to separate the procedures from Quality manual.


Why because the quality manual is 1 level documents but documented procedure is 2 level documents.


So keep it separate.


Hope it will clear your query.


Thanks
SEN

Although the 4 tier thing is a common method of structuring your quality management system, it doesn't come from ISO. It is not a requirement to structure your documents in that manner.

But that wasn't the original concern. The original concern was telling you that the procedures could not be in the quality manual and had to be by themselves. That is wrong as was pointed out before as element 4.2.2 specifically states that either is allowed.

Even if you do adhere to the 4 tier thing, there is nothing to keep you from having tier 1 and tier 2 together.

I have occasionally observed where organizations have defined their own tiers. One of them had five tiers, with the quality policy as the top tier document.

I hope your consultant is providing you with better information for the rest of what he is doing for you. On this topic, he is mistaken. It is especially disturbing that he continues to push that he is correct when his mistake is pointed out.

 

[harry]

............................... He said that they must be separated from the quality manual. ..........................

Did he said 'No' absolutely or was it a discouragement to do so. I know this part of the world quite well - sometimes it is because auditors from the last century or trained in the last century is still in existence.