Expanding our Company's AS9100D Registration Scope and Location

J

Jcornett344

#1
Hey guys. I am quite new to this job as my company's ISO Management Representative and this is my first time in this or any related positions.

We are AS9100D certified and our company's scope currently includes the manufacturing of machined parts and the contract manufacturing of custom injection molded parts.

Our surveillance audit is next month but the owners decided they wanted to begin to perform fabrication jobs without even notifying me. They bought an offsite facility a few miles down the road, and a bunch of fabrication equipment (plasma cutter, welders, shear, brake etc.). I never found out until the equipment began to arrive.

With our surveillance audit a few weeks away, this has got me very nervous as I am not sure what changes, if any, this requires us to make to our QMS.

Can anyone advise me as to what those revisions might be? Or any other steps that may be required?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
Your management has to be careful about this. Transfer of work, especially the ones that are not transparent to the customers and CB's, is one of the most frequent reasons for quality escapes. That's why AS9100D stipulates

The organization shall establish, implement, and maintain a process to plan and control the temporary or permanent transfer of work, to ensure the continuing conformity of the work to requirements.

The process shall ensure that work transfer impacts and risks are managed.
From a certification perspective, it also impacts the certification structure. Best thing for you to do: communicate with the CB about the changes, let them know if the products to be manufactured at the second site are part of the scope of certification and when the new site will come on line. Also, check if any of your customers have requirements for informing them of "change of manufacturing facility" or similar. Your management team might not realize the implications of switching manufacturing processes to a second site.

Good luck.
 
Last edited:
#3
If I understand correctly, this is not work transfer, that is work that you currently do in-house or sublet, that is part of the scope of registration.

It sounds like new work, not related to your current scope.

What is the intent of your company? Do they want to bring this into the scope of registration?

If they don't, the only concern is to make sure that any advertising doesn't indicate those activities are included in what is registered.

If they do, your audit needs to include an expansion of scope and that starts with conversations with your certification body.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#4
If I understand correctly, this is not work transfer,
According to the IAQG SCMH

Aviation, Space & Defense companies continuously change the source of supply or manufacturing of a component, a component package or assembly across a company or its external supply chain. Such movement of the work (products and associated activities) from one manufacturing site to another (internal or external) is referred to as “Work Transfer”. Work Transfers often cause On Time / On Quality issues because they are not properly managed.
So, if the new location, "a few miles down the road" (according to the OP), is deemed a new site and the work at the new location is under the current scope of certification, that would be considered work transfer. Obviously, irrespective of that, the new location will bring risks that have to be managed.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#6
It looks to me like this is new work that is outside the scope of the existing certification.
It could be. That's why I mentioned the need for a dialogue with the CB concerning the scope of certification. But the new "fabrication jobs" could be part of the machined parts which are currently in the scope of certification.
 
#7
According to the IAQG SCMH

So, if the new location, "a few miles down the road" (according to the OP), is deemed a new site and the work at the new location is under the current scope of certification, that would be considered work transfer. Obviously, irrespective of that, the new location will bring risks that have to be managed.
Agreed.

That is why I asked if this was current work being transferred or if was completely different work. It appears to be the latter and needs clarification.
 
Thread starter Similar threads Forum Replies Date
F Expanding a Company's Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 4
T CE Certification Strategy - Expanding the validity of certificate EU Medical Device Regulations 1
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
F Business expanding - Campus vs Multi Site Certification Structure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W Substitute for Expanding Arbors General Measurement Device and Calibration Topics 3
K Expanding a Laboratory Calibration Scope General Measurement Device and Calibration Topics 3
J Expanding the c = 0 Small Lot Squeglia Table Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
J Which certificate do we need? - Expanding in the medical product market Other Medical Device Regulations World-Wide 9
C Controlling QMS - We are expanding globally and want to keep our QMS Confidential Quality Manager and Management Related Issues 20
D Expanding the Scope of a Calibration Laboratory General Measurement Device and Calibration Topics 3
Marc Expanding A Registration Overseas ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does any one know if company is allowed to submit appeal for rejected registration file Other Medical Device Related Standards 0
T Company AS9100D External Audit Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
E Device compatibility with other company's devices US Food and Drug Administration (FDA) 0
M An interesting question about import company Other Medical Device Regulations World-Wide 5
T ISO9001:2015 for Work-from-home company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 48
M Role of Quality Manager in a manufacturing company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
R How many process maps are adequate for a company for IATF 16949? Process Maps, Process Mapping and Turtle Diagrams 17
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
Q Training Machinists on Company Processes Training - Internal, External, Online and Distance Learning 6
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
Q Approving distributors as suppliers for automotive company Supplier Quality Assurance and other Supplier Issues 1
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M New Daughter company - ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Accreditations as part of 9001 - Quality checks on your company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L BlipSnip is it Legit Company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Seeking Consultant for Orthopedic Start Up company Other Medical Device and Orthopedic Related Topics 1
R Can PLM be in the OEM position for another company? EU Medical Device Regulations 1
L Acquiring software from 3rd party company IEC 62304 - Medical Device Software Life Cycle Processes 8
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
H Starting my own 3rd party inspection company Service Industry Specific Topics 6
Kevin_Hall Becoming a successful manager of a spacecraft company Human Factors and Ergonomics in Engineering 11
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
J How many majors is one company allowed ? IATF16949 Manufacturing and Related Processes 16
A Outsourcing registration to a local company China Medical Device Regulations 1
D Technical Standard aggregator company suggestions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Transferring a calibrated counting scale to a sister company Calibration Frequency (Interval) 2
A Quality's Authority - Company Moving In ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 10
S Business Number versus Company ID? Canada Medical Device Regulations 3
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom