Is a separate ISO/TS16949 certificate required for an extension site?

M

mr26s

#1
Hello everyone,

I have a question regarding one of those "new rules" in TS16949 4th Edition.
Our registrar keeps emphasizing all of the site extensions will need to transition into single certified site by 4/1/2015.

We had a new building built on our property to fit the higher demand by our customer.
And because of the land the company bought was very big there was a new address assigned to this new building.
Later on we started production in this new building and now our TS registrar is stating we have to get it certified separately because of this new TS rule has required "extensions" have to be single certified.

To me it sounds really silly because the new address was assigned due to the size of the land itself.
However the processes & operations all fall under the same system at the main plant. And all of the employees are on the same payroll as the ones at the main plant as well.
It's not a separate business place, we are all together and I don't see why we do need to get a separate certificate for that place, I mean if the new rule really does require that --- that's ridiculous!

I have consulted one of the well known consultants who I deal before and he suggested us to refuse that proposal by our registrar as ... the same reason I just stated above.

But I also would like to get a second opinion and that's why I'm posting it here where I believe I could get some help from.

Thank you in advance for your comments and suggestions.
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#3
Re: Is a seperate ISO/TS16949 certificate required for an extension site?

It is a bunch of nonsense implemented by a bunch of mindless numbskulls at the IATF.

And if you go thru the previous post, the poor guy had his waiver denied because he dared help people out on the internet.
 
M

mr26s

#4
Re: Is a seperate ISO/TS16949 certificate required for an extension site?

So... does it mean there is no way out of this huge bs???
 
Thread starter Similar threads Forum Replies Date
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 4
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
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
P Separate procedures? ISO 14k System combined with OHSAS 18001 Occupational Health & Safety Management Standards 3
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
M Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures ISO 17025 related Discussions 4
V ISO 14971: 2007 Risk Management File - Separate file required for each product? ISO 14971 - Medical Device Risk Management 3
C Separate procedures for ?identification, collection,..." etc. - ISO 17025 - 4.13.1.1 ISO 17025 related Discussions 4
D Separate or Single Certificate - ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Combined audit - ISO 9001 and ISO 13485 - Why Separate Audits? General Auditing Discussions 5
Raffy Continuous Improvement in ISO 9001:2000 - Separate Procedure Required? Preventive Action and Continuous Improvement 4
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
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 4
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
T Two Separate Businesses - Only Part of Company Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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
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
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
SteveK Separate Medical Device 12V Power Source - What inspection and testing is required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R HVAC Contaminant Test for Two Separate Areas Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
R CNC OTS Software Validation Separate from full IQ/OQ/PQ for 21CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
S Accessing data from separate worksheets in Minitab Using Minitab Software 3

Similar threads

Top Bottom