Adding a New Office Location to an ISO 9001 Certificate (Scope of Registration)

F

fixednfinal

#1
A company has an office in location X in a city. It is granted ISO 9001-2008 certificate mentioning address of location X and listing activities as A, B, C, D and E. After 2 years company opens another office (having the same company name) in location Y in the same city but in this office only activities A and C are carried out. The certification is due for a surveillance audit shortly.The question is this:

  1. Does the second office in location Y need to have another certificate or can it be included in the same certificate?
  2. If the answer to 1 above is No, then what needs to be done in order to bring the second office under the purview of certificate issued for the first office?
  3. Is it required to get the address of the second office mentioned in the certificate ?
  4. Is it required to mention on the certificate that office location X carries out activities A, B, C, D and E and office at location Y carries out activities A and C?
  5. If the first office has not carried out activity E during the last several years but has documented procedures for carrying out this activity if need arises. Does it need to get the activity E removed from the certificate on the grounds of "inactivity"?
 

harry

Super Moderator
#2
Welcome to the Cove.

What you described is not clear enough for anybody to give a good advice.

but in this office only activities A and C are carried out
Requirements would vary depending on what A & C are.

Under the present circumstance, the party that can give you the best advice would be your current CB for they already know your current business and operations. Discuss with them.
 

Paul Simpson

Trusted Information Resource
#3
A company has an office in location X in a city. It is granted ISO 9001-2008 certificate mentioning address of location X and listing activities as A, B, C, D and E. After 2 years company opens another office (having the same company name) in location Y in the same city but in this office only activities A and C are carried out. The certification is due for a surveillance audit shortly.The question is this:

  1. Does the second office in location Y need to have another certificate or can it be included in the same certificate?
  1. It depends on your certification body's (CB) policy but most CBs will allow 2 locations on one certificate.
    [*]If the answer to 1 above is No, then what needs to be done in order to bring the second office under the purview of certificate issued for the first office?
    For it to be included on the same certification it has to be running the same systems.
    [*]Is it required to get the address of the second office mentioned in the certificate ?
    Nt a requirement but the benefit to yo is it avoids a whole bunch of questions from your customers if it is specifically mentioned.
    [*]Is it required to mention on the certificate that office location X carries out activities A, B, C, D and E and office at location Y carries out activities A and C?
    Not necessarily. The idea of a single certification is that the customer comes to you and where the work is carried out is immaterial.
    [*]If the first office has not carried out activity E during the last several years but has documented procedures for carrying out this activity if need arises. Does it need to get the activity E removed from the certificate on the grounds of "inactivity"?
This is the most difficult of your questions. A lot depends on how difficult the capability to carry out activity 'E' is and how different from A - D it is. I presume there are some marketing advantages in retaining the certification and, in principle, there is nothing to stop you from retaining 'E' so long as the CB can periodically check that the capability remains to carry out the work. People and knowledge being more important than documented procedures.:)
 
#4
Have you also considered talking to your CB about this? You do have a point of contact, a Customer Service representative, don't you?

They are, after all, supposed to be providing you with a service, of which answers to these questions are a part...:notme:
 
J

Jason PCSwitches

#5
I recently had a client that expanded and built a new facility adjacent to the original facility. The new facility housed additional molding & machining operations as well as headquarters for sales. It also had a different address (which is key).

So I contacted the CB, which has been suggested, and informed them that we had a new facility that fell under the scope of our current cert. The audit was a re-certification audit so everything was within the scope of the audit. After completion, we received a separate plaque for the new facility under the same certification. Meaning 1 cert. / 2 facilities = no additional cost (notwithstanding the cost of the plaque). After adding the new location in the OASIS database the CB did their thing and the organization was "good-to-go".

Call the CB they will guide you.
 
Last edited by a moderator:
G

Gareth_Mills

#8
I have recently done this exact same thing on my cert renewal. I contacted the CB and informed them of teh second office they asked the exact details of what it did and if it could be audited remotely or if it required a separate day's audit. I said it followed the same QMS procedures and is managed by the main office and this was sufficient. They viewed my audit reports of the second office and issued us with two certificates for the two locations with the same scope.
 
P

prady2581

#9
Hi Gareth,
My case is similar to yours. We have this new site performing same activities as other locations (already certified to ISO9001) and follows the same process, procedures, tools and system. Infact it is more like performing support activities for main sites. Our CB has scheduled for 2 days Audit but it is directly Stage 2 audit.

So my question here what I need to take care before this Stage 2 in terms of any update required in some documentation such as Quality Manual - (eg like adding a location but is it appropriate to add this site before it gets certification). Any other points.

Thanks in Advance.
 

dsanabria

Quite Involved in Discussions
#10
Hi Gareth,
My case is similar to yours. We have this new site performing same activities as other locations (already certified to ISO9001) and follows the same process, procedures, tools and system. Infact it is more like performing support activities for main sites. Our CB has scheduled for 2 days Audit but it is directly Stage 2 audit.

So my question here what I need to take care before this Stage 2 in terms of any update required in some documentation such as Quality Manual - (eg like adding a location but is it appropriate to add this site before it gets certification). Any other points.

Thanks in Advance.
Contact your registrar and let them know exactly what you want to do.

They will schedule a stage 1 (preliminary) audit - usually 1/2 day with the auditor in which they will review and will give you feedback of what is required and what is missing for you to continue to stage 2. Depends what is required, they might need you to complete or fix any areas before they recommend you to go to stage 2.

Yes, that includes adding another site to a single certificate if the scope is the same.
 
Thread starter Similar threads Forum Replies Date
Peter Fraser Our local box office's habit of adding a "booking fee" Customer Complaints 14
U Adding another Subcontractor EU Medical Device Regulations 3
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
D Adding an extra Label on an Ethylene Oxide Sterilized Box ISO 13485:2016 - Medical Device Quality Management Systems 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
A ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
V Option for adding date-time to the copies printed from Adobe Acrobat (pdf) Quality Assurance and Compliance Software Tools and Solutions 1
V What are the Value Adding Quality Assurance Processes and how to measure them? Quality Tools, Improvement and Analysis 3
P Can 'adding a new service' be a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Quality System Manual question - Adding Satellite Facility ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Adding Malicious Operator to FMEA? Quality Manager and Management Related Issues 12

Similar threads

Top Bottom