Outsourced Major Processes - Working for Two Sister Companies

kjoberk

Involved In Discussions
#1
Hello again all!

Hope everyone is doing well. I am currently in the middle of making a few big changes to our 9100 system -- the company I work with (the sister company I've talked about in previous posts) is integrating some of their processes into the company I work for...specifically their purchasing/receiving and sales processes.

Those are major ones. To keep a long story short, the company I work for is giving me the authority to document these processes, however, I'm worried about a couple of things:

1- the biggest thing is that I want to keep the line from blurring between companies. They are still working on their AS certification and we have 9110...and we are two different entities, we're mostly just helping them out for a period of time to get some stuff off their plate...they don't do things the same way we do, but it will turn into the same way we do (if that makes sense), but I still don't want to have a "same company" vibe put out.

2- are these processes something that I need to start planning to make exclusions for? I've looked in the standard and their quality manual, but I can't find anything that names those processes outright as "must haves".

Any advice for how to go about this the cleanest way (even if it's a little difficult to begin with) would be wonderful.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
S Outsourced processes how to interact with projects - We are an governmental department with 2 persons ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
K ISO 14001:2015 clause 8.1 on outsourced processes ISO 14001:2015 Specific Discussions 1
Q Control of outsourced processes - drop shipped products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Risk Mitigation Through Outsourced Manufacturing EU Medical Device Regulations 7
Q ISO 9001:2015 Outsourced Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
D Clear definition of Outsourced Processes (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 6
R Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
C ISO 13485:2016 Cl. 6.3 - Infrastructure - Almost Everything is Outsourced ISO 13485:2016 - Medical Device Quality Management Systems 2
J ITAR flow down to Processors (Outsourced Processes) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Non Conformity due to Outsourced Internal Audit Error ISO 14001:2015 Specific Discussions 2
R Outsourced Plating Supplier Responsibilities Service Industry Specific Topics 8
KyloDen Checking Threads - Discrepancy in threads that are machined In-House vs. Outsourced General Measurement Device and Calibration Topics 11
N Neutral Code Requirement - Medical Devices Outsourced from India ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 13485:2016 QMS: Outsourced Processes ISO 13485:2016 - Medical Device Quality Management Systems 11
Y Outsourced aerospace work quality assurance? Supplier Quality Assurance and other Supplier Issues 6
P Records for outsourced special processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
J Outsourced CMM Measurement Inspection Service and ISO 17025 ISO 17025 related Discussions 14
I Vehicles (Outsourced Process) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R When is a new AS9102 report required for Outsourced Processing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Control of Outsourced Process - Shipping ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Company that manages Outsourced Recycling ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
J RA (Regulatory) Requirements for Outsourced Call Centers Supplier Quality Assurance and other Supplier Issues 3
Q Need Outsourced ISO 13485/FDA Internal Auditor for a Medical Device Company Internal Auditing 3
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
M Outsourced Audits - Career Question Career and Occupation Discussions 19
K Supplier or outsourced? Medical Device installation, sales, training Other ISO and International Standards and European Regulations 7
T What is the difference between Supplier and Outsourced Process? Supplier Quality Assurance and other Supplier Issues 8
P Tier 2 Part Approval where Painting is Outsourced APQP and PPAP 2
D Need to include Premise of Outsourced Call Center in ISMS Surveillance Audit? IEC 27001 - Information Security Management Systems (ISMS) 4
N Internal Auditor Selection (Outsourced Internal Audits) Document Control Systems, Procedures, Forms and Templates 3
C 7.2 Customer Related Processes - Everything we do is Outsourced ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
GStough "Outsourced Processes" in a Government Contract Service Provider Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C How to Define and Document Controls of Outsourced Processes Food Safety - ISO 22000, HACCP (21 CFR 120) 5
A Methods for Approval of Internal and Outsourced Manufacturing Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Determining what are, and are not, Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
P Outsourced Manufacturing - Making Subcontractors comply with TL9000 TL 9000 Telecommunications Standard and QuEST 2
D Approved Supplier Control Requirements for Outsourced Special Processes Supplier Quality Assurance and other Supplier Issues 4
Q Outsourced Process also shall be Documented? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
Roberticus Responsibility for Outsourced Process, ALL in-house Mfg/QC done (prior FG PN) ISO 13485:2016 - Medical Device Quality Management Systems 5
A The auditor documented that we did not have control of Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
quality1 Outsourced Process - Why certain "processes" are not included - ISO9001-2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15

Similar threads

Top Bottom