Addition in the Scope of Quality Manual

S

Shibs

#1
Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!
 
Elsmar Forum Sponsor

somashekar

Leader
Admin
#2
Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!
ISO 9001 is a quality system certification.
It is good that you are adding another product. Have the processes for this product also mapped into your quality system.
Your quality manual scope must not be product specific. That sets you freedom to operate without coming to your quality manual time and again.
So for example., if your scope is to design and build special purpose machines, you can build as many new types of machines as you are capable of.
So you just begin to address such of those new product requirement documents as necessary without making changes into your quality manual.
You keep doing what your business plan is directing. Your auditor will ask you for information of changes prior to the annual assessment, and there you take a call if you have established and turned out any new products.
This activity will not change the scope of your certification as well.
 
#3
Hi,

Our company is adding into its various line of activities another product. The same would be produced in one of our factories.

A procedure for the same would be introduced into our Quality Manual as "Process Control - XXXX" as per Clause 7.5 Production and Service Provision.

My question is: Can I change the scope mentioned in Quality Manual by adding "Supply of XXXX" to the existing scope and wait till the next External Audit to have it added into the ISO Certificate?
Or is it so that I can't add this new procedure into the Quality Manual until the process has been audited by the External Auditors?

The facility hasn't yet started production and would only start in the next couple of months. Can the audit be performed only after production starts?

For your feedback, please.

Thanks!
Be careful about using the word "supply". It doesn't actually describe what you do. If you make stuff you generally "supply" it. If you buy stuff from a supplier and put it in a box, you are also in a "supply" situation, but you don't manufacture. Why are you adding "supply"?

But whatever, make the changes as you wish. When you are preparing for your next CB audit, call your point of contact and tell them you've added to the scope - they will want to know if you have added people or facilities, as a result. An increase in heads will add time. Also, the auditor won't want to have a surprise when they visit.

To have the new activity added to the scope of your certificate, you will have to have evidence that the process(es) are working and meeting the objectives set for it...
 
S

Shibs

#4
Thank you Somashekar and Andy for the feedback!

So, I'd rephrase the sentence as "Production of XXXX..." in the scope.

Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.
 
#5
Thank you Somashekar and Andy for the feedback!

So, I'd rephrase the sentence as "Production of XXXX..." in the scope.

Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.
On the manual change, it's part of the overall changes you'll be making to your QMS - how you plan, implement, audit etc is far more important, don't forget! You can change your manual whenever you wish. The certification scope will be verified at the next visit - whatever that is - and a revised certificate issued after that audit. Don't forget, check with your CB.
 
#6
This is a discussion you should be having with your certification body, and sooner is better than later. They can help you through it. Whatever you do, don't wait until you have an auditor on site and surprise him with this.

They cannot audit your new production until it is in place.

You do not need to wait for a re-certification audit, it can be done with a surveillance audit, however, it will be more than a regular surveillance audit. It would be called a "re-evaluation" and would be triggered by your expansion of scope. Expect there to be a cost increase to accommodate the additional auditing. In some cases the re-evaluation is the same thing as a re-certification somewhat depending on just how much gets changed.

Until they audit to the expanded scope, your scope of registration would continue as is (without the expansion).

After the re-evaluation audit you will get a new certification that includes the scope expansion.

This is not that unusual. Companies grow, shrink, and adjust all the time.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#7
Also, before the facility actually starts production, can I have the scope changed in our Quality Manual? And wait till the next audit happens to have it incorporated into the Certificate?

Will the Certificate's scope be changed after the next Surveillance Audit or would we have to wait till the next Re-certification Audit?

Please advise.
It is very important to keep in mind that the scope of the QMS and the scope of certification can be very different. You are in no obligation to include all of your products in your scope of certification.

Certainly, you can revise your quality manual at any time you desire. IF you want the new product line to be included in the ISO 9001 certification, you communicate with your registrar as early as possible. They can amend the certificate after a surveillance or recertification audit, as well as after a special (using ISO 17021 terminology) audit to allow for this scope expansion.
 
Thread starter Similar threads Forum Replies Date
P Addition of Testing to Our ISO 17025 Scope - How? ISO 17025 related Discussions 1
M Addition of IFU on local language by distributor - Article 16? EU Medical Device Regulations 1
D Distribution Center mandatory addition to Certificate? IATF 16949 - Automotive Quality Systems Standard 3
dgrainger New decision by MHRA on disclaimers - addition of "manner of use as perceived by the consumer" UK Medical Device Regulations 1
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
shrutisancheti Addition of flat panel detector EU Medical Device Regulations 1
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
C Addition of Design & Manufacture - CE Mark Reissue? EU Medical Device Regulations 1
K Addition of a test reader to existing CE marked product. Other ISO and International Standards and European Regulations 2
M CO2 Incubators - Equipment Qualifications in addition to Calibration Qualification and Validation (including 21 CFR Part 11) 5
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
E Addition of Label by Initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Is TGA approval required for a ARTG listed IVD for a sample type addition? Other Medical Device Regulations World-Wide 11
WCHorn Informational How the addition of "Risk" will affect ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 103
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S MDD Technical File CE Mark - Addition of a Device to our Current CE Marked Family EU Medical Device Regulations 4
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
E Addition of French Language (translation) - New 510(k) required? Other US Medical Device Regulations 1
somashekar ISO 13485 & ISO 9001 certified with addition of site. Covegratulations 10
N AS9100 Certification in addition to TS-16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Addition of a Class 1 (Sterile) Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
L CEDAC (Cause and Effect with Addition of Cards) - Sharing Experiences and Form(s) Training - Internal, External, Online and Distance Learning 15
K Differences - ISO17025:1999 vs. ISO17025:2005 - The addition of "Improvement" in 4.10 ISO 17025 related Discussions 16
S Value addition to product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Validation of Processes in addition to Customer Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000 ISO 13485:2016 - Medical Device Quality Management Systems 25
C Is it necessary to have a documented 3 R recycling plan in addition to measures? Miscellaneous Environmental Standards and EMS Related Discussions 10
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9

Similar threads

Top Bottom