Quality Records - What is classified as a Quality Record?

#1
quality records

Forms or records mention or states in a procedure or instructions are classified as Quality Record?

Situations: (Stated in a Procedure/ Instruction)

1. A document registration (serves as a front page of all types of documents) which contains signature and approval of the creator and his superior/ manager.
2. Forms not related to quality and traceability but it is part of a certain procedure or instruction. E.g. Requisition form, List of schedule, Document Format (used as format in procedures, instructions and standards)

Please help me to classify...

NOTE:
This message was accidentally sent by another user name. Sorry I forgot to press the Clear fields button...
 
Elsmar Forum Sponsor
D

David Mullins

#2
Your "question" is not entirely clear, but my opinion is that procedures and instructions are part of your QMS, and as such the objective evidence (records) prove that you did, or didn't, comply with intended arrangements (what the procedures and instructions say you will do).
Therefore YES forms that are completed, minutes of meetings, etc, etc, are Quality Records - they are the objective evidence.

------------------
 
Thread starter Similar threads Forum Replies Date
L What are Classified as Quality Records? Records and Data - Quality, Legal and Other Evidence 2
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 Quality Records - Should any record be signed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 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

Similar threads

Top Bottom