Warehouse and shipping/receiving activities need to be part of our scope?

[Stijloor]

I fear ISO 9001:2015...

 

[Roberto Vigo]

Thank for all your responses. It's been a great help.

Brian,
Our Scope reads:

This manual pertains to processes relating to: The manufacturing of fasteners for the fastener industry.

The manual and related quality system documentations are written to comply with the requirements of ISO 9001:2008, and PED 97/23/EC requirements.

 

[insect warfare]

Thank for all your responses. It's been a great help.

Brian,
Our Scope reads:

This manual pertains to processes relating to: The manufacturing of fasteners for the fastener industry.

The manual and related quality system documentations are written to comply with the requirements of ISO 9001:2008, and PED 97/23/EC requirements.

"Manufacturing" (to me) is a pretty generic term, and can encompass many things. However, there are some standard words I do see in a lot of scope statements that could help to drill down what you do (in a line or two) without specifying the processes contained within, like: "distribution", "inspection", "testing", "refurbishment", "repair", and (if they apply) other things like "recycling" and "design and development" (among others). Maybe your CB auditor perceived this and overreacted (incorrectly) by writing up a major NC as some sort of "knee-jerk" response.

Having said that, I do believe that your scope statement could use a little more specificity, but not too much (you know what I mean?)....JMHO

Brian

 

[WCHorn]

Thank for all your responses. It's been a great help.

Our Scope reads:

This manual pertains to processes relating to: The manufacturing of fasteners for the fastener industry.

The manual and related quality system documentations are written to comply with the requirements of ISO 9001:2008, and PED 97/23/EC requirements.

I believe the conversation so far deals with the ISO certificate scope statement. It looks like you're citing a statement in your quality manual. Regardless, I don't think there is a basis for the finding given the information you provided.

 

[AndyN]

Typically, the scope on the certificate and the scope of the quality manual are one and the same. Having said that, once again, the auditor is waaaay off base recording an NC for either situation - since the scope is the scope. Now, if those things activities weren't in the "sequence and interaction of processes", it MIGHT be a minor (this is a surveillance, so what happened before?)

No, however you slice and dice this, the auditor is wrong, the CB should hear about it (because how many other clients have been blindsided by this stupidity and NOT fought it) and they need to get rid of (or take remedial action) with them to stop doing dumb things like raising this as a"major" for one thing, and as a non-conformity for another. This is NOT what CB audits are about...

 

[gavinfb]

"The manufacturing of fasteners for the fastener industry." Is this scope on the certificate (word for word)?

If it is, IMO then the making of fasteners is the core process and you need to show how you ensure the inputs (incl. receiving activities) and the output to the "fasterner industry" (incl. shipping) are under control (i.e. sec 4.1, 7.4, 7.5...)

but...if it is the scope on your certificate, it is quite vague and 10 people will give close to 10 variation of what the scope means

 

[Joe Cruse]

"The manufacturing of fasteners for the fastener industry." Is this scope on the certificate (word for word)?

If it is, IMO then the making of fasteners is the core process and you need to show how you ensure the inputs (incl. receiving activities) and the output to the "fastener industry" (incl. shipping) are under control (i.e. sec 4.1, 7.4, 7.5...)

but...if it is the scope on your certificate, it is quite vague and 10 people will give close to 10 variation of what the scope means

Sounds like his scope is making fasteners for the fastener industry; Does the standard require that the scope list all core processes? I know you must list any exclusions to the standard, and justifications for such.

 

[Randy]

Sounds like his scope is making fasteners for the fastener industry; Does the standard require that the scope list all core processes? I know you must list any exclusions to the standard, and justifications for such.

Pretty much Joe, it's starting to get insane...I pushed back when I was told that everything a client did had to be in the scope....Everything the client did? That could be 12,567 2/3rds things...In a scope statement for a certificate...Utter horse$hit

Anyway the "Scope" is meant to be what the organization intends and has to manage to help it's achieving customer satisfaction...and yes, shipping/warehousing and all that could very possibly be applicable, but to issue a Major, especially after they have already been certified for at least one complete cycle? No way!

If the OP wants to bring this to a screeching halt he can contact ANAB and file a written complaint about the sorry a$$ certification process and auditors that brought this on in the 1st place.

This'll be a reported post by the PC police for sure, but sooner or later honesty and clear language has to start happening or we all should just pack up and go home

 

[Big Jim]

I have seen hundreds of scope statements for companies registered by a variety of certification bodies, and I cannot recall one instance of warehouse, shipping, and receiving being included.

I'm not afraid to write a nonconformance when I find an improper scope statement, but that doesn't look like it requires modification.

Appeal. Appeal it as high as it takes. Start with a phone call to the CB. Don't be afraid to mention this thread and how the preponderance of the comments here are that this is utter BS. Too often the first response for a CB is to back up the auditor if he is right or not, so be prepared to go beyond the first contact. Way beyond if needed.

 

[Big Jim]

I fear ISO 9001:2015...

Please enlighten me. What do you see there to be afraid of?

I have the ISO 9001:2015 DIS open to 4.3 in front of me, and I don't see anything that could justify this sort of finding or anything else to fear about scope.

What might get a bit dicey until more is known is how to handle exclusions since they will no longer be acceptable only if they are part of "operation" (the new term for "product realization").