Signature Required on Quality Policy?

S

silentrunning

#21
Just to add my experience- On our first audit by a major medical company we got written up because our Quality Policy sign (4 feet by 8 feet) didn't have a signiture. I refused to sign the audit and never heard any more about it.
 
Elsmar Forum Sponsor
C

cogito

#27
If there is any document that should be signed it is the one on display to the workforce. If a signature has any value it is as a visual display of endorsement and commitment.

So the purpose of having the hidden document signed when the displayed version is not frankly baffles me ... :confused:
This illustrates the point perfectly as it is a statement of opinion, not fact. The fact is that the standard doesn't mandate a signature on the Quality Policy. If we (as an industry) allow auditors (me included) to get away with opinion-based auditing, then shame on us.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#28
This illustrates the point perfectly as it is a statement of opinion, not fact. The fact is that the standard doesn't mandate a signature on the Quality Policy. If we (as an industry) allow auditors (me included) to get away with opinion-based auditing, then shame on us.
Cogito, I agree with your underlying point. Auditors, when writing up non-conformities, must stick to requirements and factual evidence at hand. I wholeheartedly support that.

However, it is impossible for auditors not to bring their biases, cultural baggage, expertise, interpretations and opinions into an audit. The same requirement of the standard will be applied differently if I am auditing a nuclear power plant versus a dry cleaning shop. What I find concerning is to see auditors getting distracted and concerned over totally meaningless and valueless issues. It is like when an auditor sees something like the picture below, when conducting a safety management system audit, and his/her main concern is to go to HR to see if the people involved have a forklift driving certificate on record. :frust:
 
Last edited:

Paul Simpson

Trusted Information Resource
#29
Selective quoting

Now please don't take this the wrong way .....

cogito, when you said:
This illustrates the point perfectly as it is a statement of opinion, not fact. The fact is that the standard doesn't mandate a signature on the Quality Policy. If we (as an industry) allow auditors (me included) to get away with opinion-based auditing, then shame on us.
In response to my post here, then you could at least have posted the full quote, otherwise it makes it look as if I am trying to impose my opinion re signatures on the OP. When, if you look at my whole post, you will see I said nothing of the sort.

Please excuse the added emphasis.
Just a comment - their auditors are operating to ISO IEC 17025 - not ISO 9001 - it's not an excuse.

Just that accreditation body assessors operate to a different set of rules (and are a breed apart, IMHO). :lol:
No particular relevance to your post. I've just included it to show I'm not selectively quoting. ;)

I'm not saying your CB auditor was right by any means - I'm just a bit confused about the logic of the argument.
This is where I am saying I do not agree with the OP's auditor querying the fact that the posted policy is not signed.

I then go on to say that the OP's argument to his / her CB auditor is the reason I am confused.

And now the bit you quoted:
If there is any document that should be signed it is the one on display to the workforce. If a signature has any value it is as a visual display of endorsement and commitment.
Added emphasis here, my apologies for shouting. Signatures do have a perceived value - that is why we sign contracts. They demonstrate with our mark that we are the ones who endorse a particular statement or future action. Signatures are one way of demonstrating to others that we support (in this case) a policy.

So the purpose of having the hidden document signed when the displayed version is not frankly baffles me ... :confused:
My summary. But what is the point of signing a document hidden away in a drawer except as a bureaucratic sop to an auditor.

So, I hope you will agree, no shame on me.

I do not care if a policy is signed or not. There are some arguments I do not understand and I feel comfortable questioning in the forum of the cove.

Long may it continue.
 
Thread starter Similar threads Forum Replies Date
R 21 CFR 11 Timeframe of Inactivity after which all Signature Components are Required? Document Control Systems, Procedures, Forms and Templates 11
D Test report requirements - Signature required? ISO 7176-19 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
L MDR 745 - EU Declaration of Conformity - Signature Requirements EU Medical Device Regulations 3
W Customer Signature / Acceptance Service Reports Service Industry Specific Topics 2
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
I Document Signature Software? (Certificate Authorities) Document Control Systems, Procedures, Forms and Templates 15
S Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Signature manifestations - 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 4
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
M Electronic Signature - Certificate Qualification and Validation (including 21 CFR Part 11) 8
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
S Medical Device Servicing - Forms and Signature ISO 13485:2016 - Medical Device Quality Management Systems 1
S Imaged signature is it Ok? Document Control Systems, Procedures, Forms and Templates 11
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
G Auto electronic signature on Calibration Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
S Boss wants customer delivery signature specimen form Customer and Company Specific Requirements 16
M Management Commitment signature issue in same Quality Manual Quality Management System (QMS) Manuals 8
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Test Report - Customer Signature - Customer did not witness test General Measurement Device and Calibration Topics 2
B Requirement to have Customer Signature Profile on File Document Control Systems, Procedures, Forms and Templates 4
L Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
x-files Signature(s) on ?Document control form? and/or on ?Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K AS9102 Field 19 Signature Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
C 21 CFR Part 11 - Electronic Signature Certification Other US Medical Device Regulations 13
H Is this training records signature app FDA compliant? US Food and Drug Administration (FDA) 10
T "Typing name on MS.Word directly" can be "Electronic Approval Signature" Document Control Systems, Procedures, Forms and Templates 3
M Part 11 Compliant Digital Signature Requirements - Sharepoint Qualification and Validation (including 21 CFR Part 11) 1
S Quality Policy without Top Management Signature Quality Manager and Management Related Issues 37
G Signature Missing from Calibration Certificates General Measurement Device and Calibration Topics 6
D E-Signature Compliance Requirements for Training Records Qualification and Validation (including 21 CFR Part 11) 3
S 21 CFR Part 820.198 - Complaint Files & Electronic Signature 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D How to meet AS9100 Electronic Signature Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J How to Link Electronic Records (510k Documents) to Handwritten Signature Other Medical Device Regulations World-Wide 16
L Employee Signature List for Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 8
D Electronic Signature Documents - FDA Requirements for Retention and Hardcopy Records and Data - Quality, Legal and Other Evidence 4
P Part 11 Hybrid System - Partial paper based record but with e-signature Qualification and Validation (including 21 CFR Part 11) 4
Q Physical vs. Digital Signature Requirements Records and Data - Quality, Legal and Other Evidence 7
sagai Automated System's Signature on Electronic Record - PART11 Qualification and Validation (including 21 CFR Part 11) 4
E Approval Signature Record Retention Document Control Systems, Procedures, Forms and Templates 2
E Signature of Records - Microsoft Word forms Records and Data - Quality, Legal and Other Evidence 7
S AMS2750 rev D - para 3.2.6.2 - "Signature of the calibration company representative" Various Other Specifications, Standards, and related Requirements 3
J Electronic Signature Validation Protocol example or template Qualification and Validation (including 21 CFR Part 11) 2
K Question about paperless signature - Electronic signatures in outlook emails ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom