Two Separate Businesses - Only Part of Company Certified

T

TigerLilie

In the past my company was divided into 2 separate businesses, an integration business and a services business. Most recently, management has merged the two and our new org chart and processes reflects this change.
However our ISO certification only applies to the integration business. I am struggling to determine the impact of this merging on our certification, even though it is my understanding we can maintain certification for only our integration business. For example, if the auditor asks to see a PO and it is for the services business, he cannot audit it because it's out of scope

Would like to hear your thoughts. Thank you.
 
L

lk2012

Hello,
let's phrase your question the other way round:
What is the impact of the merger on your scope?

Start from there and you'll easily find if both areas need to be audited or not.
By any means, I'd advise to get in touch with your registrar well ahead of your next external audit to avoid any unpleasant surprises.
hope this helps
 
T

TigerLilie

Understood, but isn't it possible to continue to have the same scope which is limited to a specific product range?
 

Big Jim

Admin
Yes.

What I do when I'm writing a manual for a company like yours that has part of the company registered and part of it not registered, is to include a clarification statement with the scope statement to show that there is other business activity in the facility that is outside of the scope of registration. There is no requirement for this, but I do it in the spirit of full disclosure.

You do need to be careful about how you use the certification marks though. You cannot use ISO 9001 terminology or the CB and AB seals in such a way that it appears that the entire company is registered.
 

John Broomfield

Leader
Super Moderator
Consider three scope statements, each smaller than the former:

1. For the enterprise as a whole
2. For the management system
3. From the certified part of the management system

...then it is clear to everyone.
 

somashekar

Leader
Admin
In the past my company was divided into 2 separate businesses, an integration business and a services business. Most recently, management has merged the two and our new org chart and processes reflects this change.
However our ISO certification only applies to the integration business. I am struggling to determine the impact of this merging on our certification, even though it is my understanding we can maintain certification for only our integration business. For example, if the auditor asks to see a PO and it is for the services business, he cannot audit it because it's out of scope

Would like to hear your thoughts. Thank you.
When what you do to meet your customer does not change ...
When your company name is not altered ...
Just see this as a part of change to the QMS as in 5.4.2 b)
Then test the integrity of your QMS when your said change is planned and implemented.
Please do inform your CB about this, when your change is certain, and has begun to happen.
 
Thread starter Similar threads Forum Replies Date
M Display charts on separate monitor? Using SQCpack Software 1
T Should PMS and PMCF plans be 2 separate documents? EU Medical Device Regulations 8
T Combining 2 companies with separate AS9100D certificates! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
J UDI and Labelling hierarchy and requirements for separate device components EU Medical Device Regulations 7
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
S "X-MR charts do not separate piece-to-piece repeatability of the process" Statistical Analysis Tools, Techniques and SPC 2
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
S Do we need separate stand alone procedure for Suspect Unapproved Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 9
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
T Should Testing be a separate operation in the Control Plan? FMEA and Control Plans 5
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
B ISO 9001:2015 8.4 External Providers - If work is transferred to a separate facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Is a separate ISO/TS16949 certificate required for an extension site? IATF 16949 - Automotive Quality Systems Standard 4
D Separate Classifications for Medical Device Accessories EU Medical Device Regulations 2
R One-Time parts separate from QMS? Quality Manager and Management Related Issues 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
cscalise Separate Forms or Procedure Attachments - What's more common? Document Control Systems, Procedures, Forms and Templates 2
C Do separate sites need separate documents? Document Control Systems, Procedures, Forms and Templates 7
A Newly Incorporated Business - Separate Scope and/or Separate Cert? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Should Internal Audit CAPAs be kept separate from "normal" CAPAs? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Separate procedures? ISO 14k System combined with OHSAS 18001 Occupational Health & Safety Management Standards 3
J Device Registration and Listing - Separate for Device and corresponding Instruments? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Q Separate Quality System? Product line of a parent company spins off 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
C What can you do if Quality is treated as a separate function in an organization? Quality Manager and Management Related Issues 24
C Separate Certification - Can I combine documents for ISO14001, OHSAS18001 & AS4801? Miscellaneous Environmental Standards and EMS Related Discussions 3
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
K How do ISO 9001 Requirements apply to 2 sets of specifications to 2 separate vendors? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Include as an attachment or make a separate document? Advise on Document Numbering Document Control Systems, Procedures, Forms and Templates 1
F Multiple Business Lines (Separate Corporations) in one Facility AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Separate Clinical Trials in the US and the EU - When one fails - question US Food and Drug Administration (FDA) 3
M Can I be a legal manufacturer without being a separate legal entity? CE Marking (Conformité Européene) / CB Scheme 6
B Hospital Operating Room Regulations - Separate Entrances for Clean and Dirty Supplies Hospitals, Clinics & other Health Care Providers 4
S Separate Medical Device 12V Power Source - What inspection and testing is required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures ISO 17025 related Discussions 4

Similar threads

Top Bottom