SBS - The best value in QMS software

Is a Register of Signatures Required by ISO 9001?

I

IMS Manager

#1
Hi folks,

Is there a requirement in the 9001:2008 standard which requires a register of signatures to be established and maintained? I have done it as best practice before as it allows me to see who is signing for goods delivered, works inspected and initialed on the ITP for example.

I was asked about it by an auditor many years ago as well.

Thanks in advance.

Cheers,

IMS Manager
 
Elsmar Forum Sponsor
J

JLang

#2
Re: Registering Signatures

There is nothing in the ISO 9001:2008 standard that specifically requires it. I'm sure that somebody could find a way to read it into the standard somewhere, but no it is not required from my understanding.
 

somashekar

Staff member
Super Moderator
#4
Records shall indicate the person(s) authorizing release of product for delivery to the customer

The above is said in 8.2.4 (Monitoring and measurement of product) of ISO9001, and it is a shall., so a requirement.

Perhaps you are effectively doing this. There could be other ways also.
 
R

Randy Lefferts

#5
Records shall indicate the person(s) authorizing release of product for delivery to the customer

The above is said in 8.2.4 (Monitoring and measurement of product) of ISO9001, and it is a shall., so a requirement.

Perhaps you are effectively doing this. There could be other ways also.
While the requirement is that records shall indicate the person authorizing the release of product, it does not mandate that we maintain a list (or register) of all approved signatures.

The original question was "Is there a requirement in the 9001:2008 standard which requires a register of signatures to be established and maintained?" The answer is no. That is not to say that you can't, just that you aren't required to. Obviously, you do need to make sure your records indicate who approved it. (It doesn't even mandate that your approval take the form of a signature. Now, if your procedures state that you approve by signature then you need to do it.)
 
J

JLang

#6
I agree with Randy. For example, we track all of our inspections/releases in a databse and the inspectors initials are required on each form.

Signatures are not required, but I could see how if you used signatures, some sort of log/register would help in your process.
 

somashekar

Staff member
Super Moderator
#7
I agree with Randy. For example, we track all of our inspections/releases in a databse and the inspectors initials are required on each form.

Signatures are not required, but I could see how if you used signatures, some sort of log/register would help in your process.
Please also note that this is about delivery to customer and this need not be followed for internal deliveries from stage x to stage y in process. Hence a log / register that you will maintain will not be one running into several persons listing. Only a handful perhaps will have the authorization to release products for delivery to the customer, in an organization.
 
#8
Hi folks,

Is there a requirement in the 9001:2008 standard which requires a register of signatures to be established and maintained? I have done it as best practice before as it allows me to see who is signing for goods delivered, works inspected and initialed on the ITP for example.

I was asked about it by an auditor many years ago as well.

Thanks in advance.

Cheers,

IMS Manager
Well, as you know it's not in the standard, so "NO" is the resounding answer. No signatures are required at any time, unless your management culture is such that that's how you hold people accountable. As we know, people sign check/cheques every day, knowing there's nothing in the bank...
 
Y

yeshpal

#9
Hi folks,

Is there a requirement in the 9001:2008 standard which requires a register of signatures to be established and maintained? I have done it as best practice before as it allows me to see who is signing for goods delivered, works inspected and initialed on the ITP for example.

I was asked about it by an auditor many years ago as well.

Thanks in advance.

Cheers,

IMS Manager
As per my understanding, there is no such specific requirement to establish separate record for signatures; but definitely, there has to be a traceability of the signatures elsewhere in other records so as to establish accountability, conformity and adequate system control.

[Ref: 7.3.1 (the review, verification and validation that are appropriate to each design and development stage) & 4.2.4 Control of records & last but not least "statutory and regulatory requirements applicable to the product")]

Hope this helps,
Yeshpal Mathangi
 
I

IMS Manager

#10
Folks thank you very much for your replies.

And I agree that the standards are the standards and if the management choose to go above and beyond well I'm not one to say no.

This is a great forum! I never thought I would be talking about systems like this ever lol

Cheers,

IMS Manager
 
Thread starter Similar threads Forum Replies Date
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
S How long does it take to register a product with MHRA? UK Medical Device Regulations 4
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
S How to register class IIA medical device accessories EU Medical Device Regulations 1
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
L Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
A Do I have to register with the FDA and pay fee? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H REACH Registration Requirements - Who is required to Register REACH and RoHS Conversations 1
Z Do we need a Risk Register for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
T ISO 9001:2015 vs AS9100D - Register to one or both Standards? Manufacturing and Related Processes 10
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Get information into English about medical devices register in Serbia Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risk Register template as per ISO 27001:2013 wanted IEC 27001 - Information Security Management Systems (ISMS) 9
C Should we register to ISO 9001:2008 or ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
A Legislation Register in Dubai (Free Zone) ISO 14001:2015 Specific Discussions 1
I Feedback on an Environmental Aspects and Impacts Register Miscellaneous Environmental Standards and EMS Related Discussions 5
V What is the importance of a Risk Register? FMEA and Control Plans 3
L Examples of a Legal Register - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
S MDR (Master Document Register) for Planning of Documents in Process Engineering Document Control Systems, Procedures, Forms and Templates 2
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
I What information do you place in a "register"? Quality Manager and Management Related Issues 2
R Risk Register, Risk Analysis and Risk Response/Treatment IEC 27001 - Information Security Management Systems (ISMS) 5
T What to include in our Legal Register? Miscellaneous Environmental Standards and EMS Related Discussions 8
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
T Legal Register Guidance - ISO 14001 ISO 14001:2015 Specific Discussions 7

Similar threads

Top Bottom