ISO 9001 company now adding Welding to the Scope - What needs to change?

A

AshleyE

#1
We're an ISO 9001:2008 contract manufacturer that previously subcontracted our welding. When we built our QMS in 2009, we had welding equipment in-house (our welder had recently retired and we decided not to replace him) but did not do any welding operations for customer parts.

We've recently hired an in-house welder, what needs to change in our QMS in order to meet the requirements? Process Validation comes to mind but I'm not sure what else we need to add to the system and remain compliant.

Any advice would be appreciated!
 
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N

nukool2001

#2
Hello sir,
For your case you should be review the scope on quality manual, it's covered this process or not.
Then for your welding machine you should be additional to preventive maintance program.
About validation of this process you shall controlled for
- Welder qualification process (GTAW,SMAW, 1G....6G) verify or validate by PT, MT, RT (where applicable)
- Welding condition control standard (Speed, Electric)
- Weld rod control (Baking temp & Holding time before use)
- Acceptance criteria (Under cut, Weld line)
- Where you have a disimilar joint or material you should be verify by special test, such as RT.

Good Luck
 

Richard Regalado

Trusted Information Resource
#3
Hello sir,
For your case you should be review the scope on quality manual, it's covered this process or not.
Then for your welding machine you should be additional to preventive maintance program.
About validation of this process you shall controlled for
- Welder qualification process (GTAW,SMAW, 1G....6G) verify or validate by PT, MT, RT (where applicable)
- Welding condition control standard (Speed, Electric)
- Weld rod control (Baking temp & Holding time before use)
- Acceptance criteria (Under cut, Weld line)
- Where you have a disimilar joint or material you should be verify by special test, such as RT.

Good Luck
I agree with the above post re the requirements of 7.5.2 need to be taken into consideration for the welding process. 8.2.3, 8.2.4 and 8.3 for monitoring the output. 6.2.2 for the competency of welding personnel. Of course 7.5.1 to control the process. Throw in a bit of 5.4.1 if you want.

Preventive maintenance, unless required by the welding machine manufacturer should be there as well. Otherwise, PM is not required by the Standard.
 
#4
We're an ISO 9001:2008 contract manufacturer that previously subcontracted our welding. When we built our QMS in 2009, we had welding equipment in-house (our welder had recently retired and we decided not to replace him) but did not do any welding operations for customer parts.

We've recently hired an in-house welder, what needs to change in our QMS in order to meet the requirements? Process Validation comes to mind but I'm not sure what else we need to add to the system and remain compliant.

Any advice would be appreciated!
I guess it depends on what complexity of jobs/welding you're taking on, Ashley.

I'd suggest, if it is medium to high complexity, that you take a look right the way through your QMS, from quoting a job to final inspection, shipping etc and take a look at how welding requirements are accommodated in those processes. The welder quals are a no-brainer, but welding instructions might need to be developed for some jobs, if they aren't simple MIG types. It could also range to buying specs for consumables and rod conditioning, weld pen die testing etc. etc.
 

Pancho

wikineer
Super Moderator
#5
We're an ISO 9001:2008 contract manufacturer that previously subcontracted our welding. When we built our QMS in 2009, we had welding equipment in-house (our welder had recently retired and we decided not to replace him) but did not do any welding operations for customer parts.

We've recently hired an in-house welder, what needs to change in our QMS in order to meet the requirements? Process Validation comes to mind but I'm not sure what else we need to add to the system and remain compliant.

Any advice would be appreciated!
Hi Ashley!

What welding code does your company weld to? AWS d1.1, ASME BPVC, API, others? Don't forget to review the QC requirements there.

Most codes demand qualification of personnel and procedures, as well as welding procedure specs that fit well with a QMS. Your welder should be very familiar with the requirements.
 

harry

Trusted Information Resource
#6
We're an ISO 9001:2008 contract manufacturer that previously subcontracted our welding. .............................
Technically, you shouldn't need to add anything more if you had properly controlled your outsourced welding process. The extras that you may need to add now are work instructions (if you choose to have it in written format) and records since you are now having welders in-house. But like Andy mentioned, it also depends on what kind of welding you are carrying out?
 
A

AshleyE

#7
Thanks for all the replies, my apologies for asking the question and letting it sit a month!

Most of the work our shop does is for the commercial, scientific instrument, and homeland security industries. Welding has been simple and to my knowledge, non-critical. We inspect welding to customer requirements, usually limited to call outs on drawings, occasionally we'll receive a standard from the customer.

To my knowledge, we had no special welding process controls for our in house welding. The welder retired a year before we began moving towards ISO 9001.

As we're doing quoting for new and potential customers, we're seeing work requirements to AWS standards (d17.1 & D17.2). That work is currently being subcontracted to welders that meet the customer requirements until we can meet those requirements in house.

We're thinking of writing a simple work instruction for welding/validation which is superseded by customer requirements (which would be documented on the job router).
 
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