Quality Records - Should any record be signed?

#1
Hi
I have a question about quality records. we are register to ISO 13458 and ISO 9001. Should any record be signed? We don't have an electronic signature.
If I want to save purchase order from the ERP should it be signed? or can I keep it in the computer without signature?

Thanks in advance
 
Elsmar Forum Sponsor

normzone

Trusted Information Resource
#2
I only speak pidgin 13485, but it seems to me that it depends on what your own process requires. In the case of a P.O., completion of the cycle by providing the order to the supplier, then receiving and inspection yields enough record. Signatures are useful where appropriate, but should not be a requirement.

But a 13485 expert should be along shortly to provide an informed opinion.
 

dubrizo

Involved In Discussions
#3
Hi,

ISO13485:2016, section 4.2.5 Control of Records

"The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records."

AKA--this is up to the organization to determine how best to meet the intent of this clause.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Echoing the above - it's really up to you what records need to be retained.
If you don't have a validated electronic signature system and require a signature then you will likely need to keep a signed paper copy (or scan of a signed paper copy). But if your system doesn't require a signature on PO's than keep them however you like... just define how and where you keep them in your Control of Records document.
 
Thread starter Similar threads Forum Replies Date
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q Do hard copies of quality records have to be retained? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
S Retention time requirement for various for quality records Records and Data - Quality, Legal and Other Evidence 1
S Atlassian and Plugins for Quality System/Records? Quality Assurance and Compliance Software Tools and Solutions 1
C Incremental revisions to Quality Manual, and Training Records Document Control Systems, Procedures, Forms and Templates 2
M Contractors with poor Quality Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K Integrating acquired existing product into Quality Management System Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Are all In-Process Quality Records required in final QA Batch Record Review. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
K Quality Records (QR) Control Codes Records and Data - Quality, Legal and Other Evidence 13
J Quality Records Register Requirements - ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 31
H Must I mention "records kept" in the Quality Manual itself ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Storage Cabinets for Quality Documentation (Procedures and Records) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P NQA-1 Requirement 17 Quality Records - Facility Types and Temporary Storage Various Other Specifications, Standards, and related Requirements 5
M Suggestions for Handling Quality Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M What to do about missing Quality Records? Records and Data - Quality, Legal and Other Evidence 11
M Quality Records Matrix Content and Revision Records and Data - Quality, Legal and Other Evidence 6
N Quality Records - Password and Anti-virus Protection Records and Data - Quality, Legal and Other Evidence 3
H Review and Approval in Quality Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Creating a "Records Policy" - Control of Quality Records Records and Data - Quality, Legal and Other Evidence 13
P Obsolete Quality Records - Approval Prior to Disposal Records and Data - Quality, Legal and Other Evidence 15
I Do ALL Quality Records Require Approval? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Quality formats - ISO 13485 Design and development related records and formats ISO 13485:2016 - Medical Device Quality Management Systems 7
S Retention Periods of Quality Records Records and Data - Quality, Legal and Other Evidence 1
A Examples of Quality Records Master List ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Corrective Action for lost project quality records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Are environmental compliance documentation quality records? Document Control Systems, Procedures, Forms and Templates 5
J ISO 9001:2000 4.2.3- Quality Records, Production Travelers Records and Data - Quality, Legal and Other Evidence 9
S Retention time of quality records for parts with Critical (safety) Characteristics? Document Control Systems, Procedures, Forms and Templates 2
C Need a procedure or outline on Good Practices for Completing Quality Records/Document Document Control Systems, Procedures, Forms and Templates 2
Q Signature on Management Review Minutes - Quality Records ISO 13485:2016 - Medical Device Quality Management Systems 5
T Sample Retention Requirements - Quality Records procedure - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A Action on Quality Records - Approve, Update and Carry Out Revision Control Records and Data - Quality, Legal and Other Evidence 10
T Is there a minimum retention time for any of the Quality Records? ISO9001 Records and Data - Quality, Legal and Other Evidence 8
K Records - Are weekly purchasing reports, backlog reports, etc., Quality Records? Records and Data - Quality, Legal and Other Evidence 4
R Procedure does not adequately identify quality records - Audit Minor NC - Why? General Auditing Discussions 8
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Quality records kept "off site", is it ok or not? Records and Data - Quality, Legal and Other Evidence 19
Q Minimum Quality records required by ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
C How often will I update the quality records list? We have about 189 quality records Document Control Systems, Procedures, Forms and Templates 6
M Defined retention time of quality records - ISO 9001:2000 Paragraph 4.2.4 Records and Data - Quality, Legal and Other Evidence 10
N What are the minimum quality records required by QS-9000? Records and Data - Quality, Legal and Other Evidence 1
G Trigger Point - Determining When We Can Dispose of Quality Records Records and Data - Quality, Legal and Other Evidence 11
L Good Documentation (Quality Records) Practices - Dittos? Arrows? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Identification of Quality Records (ISO9001 - 4.2.4) - How? Records and Data - Quality, Legal and Other Evidence 32
C New company - How much quality records history required? Records and Data - Quality, Legal and Other Evidence 3
S Identifying Quality Documents and Records from Non-Quality Records and Data - Quality, Legal and Other Evidence 8
Similar threads


















































Top Bottom