Controlled information versus defined documents / records

James

Involved In Discussions
#1
Hello all

I'm wondering to what extent I can rely on the existing types and sources of controlled information for my new 13485 system, rather than having to impose document/record templates across 4 departments which will follow the system?

For example, Is it acceptable to say that the information parameters defined on 'form A' must be maintained by all departments. Ideally they would use 'form A' and keep it as a record either electronically or in paper format. If one department translates 'form A' data fields onto a departmental system they are using, this meets the requirements. However, if they fail to record all of the information defined on 'form A', this is a non-conformity.

Essentially I want to define what information must be documented, but allow flexibility in how this is documented for each department because of their existing system differences.

Thoughts appreciated..

James
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
ISO 13485 4.2.4 refers specifically to control of 'documents', not control of 'fields on documents'. You need to have controls in procedures for revisioning, approvals, storage, obsolescence, etc. for documents (i.e., 4.2.4a-h, and 4.2.5 for records). What you propose (specifying the required fields on documents) is merely addressing one small aspect of 4.2.4a ("adequacy").
 

James

Involved In Discussions
#3
ISO 13485 4.2.4 refers specifically to control of 'documents', not control of 'fields on documents'. You need to have controls in procedures for revisioning, approvals, storage, obsolescence, etc. for documents (i.e., 4.2.4a-h, and 4.2.5 for records). What you propose (specifying the required fields on documents) is merely addressing one small aspect of 4.2.4a ("adequacy").
4.2.4 states "documents required by the QMS shall be controlled"... Physical 'documents' dont exist because I'd argue that they aren't required. Information by way of records is required, and is entered into electronic systems, which is a central principle with developing paperless healthcare systems. Creating a physical 'document' to replicate and duplicate electronic system fields doesn't seem a good use of resources to me as it takes us in a backwards direction away from electronic systems.

Having checked ISO 9000, the definition of "document" states "The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof".

I guess I need to work out a way of controlling the combination of electronic sources I'm thinking about


Cheers

James
 

indubioush

Quite Involved in Discussions
#4
However, if they fail to record all of the information defined on 'form A', this is a non-conformity.
Not exactly true. You should allow certain fields to be not applicable if the same form is used for different situations. For these situations, the field will contain an "N/A." Your associated procedure should further clarify.
 
Thread starter Similar threads Forum Replies Date
R Controlled Documents vs. Signage Papers (ie, reminders, general information) Document Control Systems, Procedures, Forms and Templates 1
S Information/Instruction Signs that refer to controlled documents - FDA Environment Records and Data - Quality, Legal and Other Evidence 5
B Controlled Form Font Change - No information is being added or removed - Commments? Document Control Systems, Procedures, Forms and Templates 20
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
C Work Instructions; Controlled/Uncontrolled? Document Control Systems, Procedures, Forms and Templates 5
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
Q Controlled sticker for product identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
S Controlled Document Location Document Control Systems, Procedures, Forms and Templates 3
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Defect codes and process codes need to be controlled AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
M Training template - controlled document? Document Control Systems, Procedures, Forms and Templates 21
D Controlled Documents & Note Making ISO 13485:2016 - Medical Device Quality Management Systems 4
pammesue Controlled Setup Sheets for a production line Document Control Systems, Procedures, Forms and Templates 2
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
M ISO 14644 - Cleanrooms and associated controlled environments -Recovery Test Other ISO and International Standards and European Regulations 0
E Do all Controlled Document copies require a Stamp? Document Control Systems, Procedures, Forms and Templates 3
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
C Leveraging previous results in IQOQs - Environmentally Controlled Room 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FAI (First Article Inspection) on source-controlled parts AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Definition of a controlled document --> is a form a controlled document Document Control Systems, Procedures, Forms and Templates 14
P Employment Application Form - Controlled or Not? Document Control Systems, Procedures, Forms and Templates 3
LeonelAguilar352 Specific Question about Printing Controlled Documents. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Controlled Forms - Centralized or Decentralized? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S CS2 (Controlled Shipping Level) by GM - CB notified. What about other customers? IATF 16949 - Automotive Quality Systems Standard 1
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
N Do Material MSDS's Need To Be Controlled? Document Control Systems, Procedures, Forms and Templates 3
C Need examples for Controlled Shipping I and II (CSL) IATF 16949 - Automotive Quality Systems Standard 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
D Should Customer Drawings be controlled per AS9100 QMS ? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Types of Controlled Documentation - Call Lists of Emergency Contacts Quality Manager and Management Related Issues 5
C Use of white-out or obliterating a portion of a controlled drawing or document Document Control Systems, Procedures, Forms and Templates 7
M Should spreadsheets be controlled? If so, how? Records and Data - Quality, Legal and Other Evidence 8
C Control of Records - Differences between Controlled Documents and Controlled Records Records and Data - Quality, Legal and Other Evidence 18
Q Modification in Controlled Documents AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
A Clean Room as a Controlled Environment - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 12
J Employee Contracts : Controlled and Uncontrolled Documents Document Control Systems, Procedures, Forms and Templates 6
C Controlled Forms Conundrum Document Control Systems, Procedures, Forms and Templates 2
S Cleanliness Requirements for Raw Materials Used in a Controlled Environment Quality Manager and Management Related Issues 4
R Part Prints - Controlled and Uncontrolled Documents (e.g.: The Production Floor) Document Control Systems, Procedures, Forms and Templates 13
L Are ISO/TS Registrars also controlled or governed by ISO17021:2011? IATF 16949 - Automotive Quality Systems Standard 3
N Controlled Document Binders on the Production Floor Document Control Systems, Procedures, Forms and Templates 3
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Similar threads


















































Top Bottom