ISO 9001 requirement for Sequencing Operation

[Colin]

There may be a case for excluding purchasing, I know this is one we struggle with but it would depend on whether they were arranging their own transportation or that the customer was also responsible for this. Purchasing can also include the contract for temporary labour.

If the customer is responsible for the design of the finished product then I would think there may be a case for exemption of 7.3

Chrissie

Good points Chrissie - I suspect 7.3 could definitely be excluded. At this rate there won't be much left!

 

[jacko]

Good points Chrissie - I suspect 7.3 could definitely be excluded. At this rate there won't be much left!

I am thinking the same. It really doesn't seem like a lot at all is left. I have never been in a position to exclude items, let alone all of this. May be an easy one.

 

[ChrissieO]

7.5.2. for Process Validation Could likely be excluded as well

I thought it was only possible to be exempt from a clause and not a part clause, i.e. to be exempt from 7.5.2 you would need to demonstrate that you were exempt from all of 7.5 which is highly unlikely for any operation.

Chrissie

 

[Colin]

No, its fine to exclude part of a clause in the case of 7.5.2 or perhaps exclude traceability form 7.5.3 (if it is not a specified requirement of course).

 

[AndyN]

I am thinking the same. It really doesn't seem like a lot at all is left. I have never been in a position to exclude items, let alone all of this. May be an easy one.

The QMS for a sequencing operation is fairly "simple". You don't have to 'buy' anything from suppliers (unless it's the totes of kits etc.), the customer gives you what they want you to kit etc, no design, simple 'production processes'.

It's a bit like a distribution organization, so you may well end up not having to meet many of the ISO 9001 requirements because they just don't 'fit'.

 

[jacko]

The QMS for a sequencing operation is fairly "simple". You don't have to 'buy' anything from suppliers (unless it's the totes of kits etc.), the customer gives you what they want you to kit etc, no design, simple 'production processes'.

It's a bit like a distribution organization, so you may well end up not having to meet many of the ISO 9001 requirements because they just don't 'fit'.

I thought the same thing, but there is a mandate from the owners of the company to be ISO registered. This is a learning experience, since I have only delt with Mfg.... thanks for all of the help.

 

[ChrissieO]

It's a bit like a distribution organization, so you may well end up not having to meet many of the ISO 9001 requirements because they just don't 'fit'.

I wish it were so Andy, it would make my life much easier. We are predominantly distribution operation and we are only exempt from 7.3 and I am experiencing more and more pressure from the CB to bring 7.3 into scope.

If we were to take the phrase for "product" read "service" to the enth degree - are we in fact designing and developing processes?

I think trying to make 7.3 to fit to some service organisations is the proverbial "square peg round hole syndrome"

You also said in your post that they were not purchasing anything, but the questions there are, Do they purchase their own Transportation? and Do they employe temporary labour? Are Plant/Machinery Maintenance, Service Contracts external? All these are purchaisng activities and supplier management is key to all as any of these activities could have an effect on the service the company delivers to their customer.

Chrissie

 

[AndyN]

That's very true, Chrissie! Your organization is a very unique one. Having worked at a car plant where they used sequencing, I was thinking more about that operation, than the very comprehensive distribution services that some companies (like yours) provides to the market place...