Reference Document Content and Referenced Documents

E

e006823

#1
Our typical procedure includes 10 or more documents in the referenced document section. Usually these are references to our quality manual, assorted level 2 procedures. I’ve always been of the opinion that if a document is called out in the referenced documents section somewhere in the procedure it should require you to use that document e.g. “All nonconforming material shall be documented in accordance with NCM procedure 12345.” From what I can see ISO has no requirement for me to list the QM and QMP in lower level procedures. I’d like to find out others on the forum handle this situation.

Thanks,
 
Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
Re: Reference Documents

FWIW - My format for procedures and work instructions have a scope, a purpose and then detailed instructions. I do not have a seperate section for "reference documents". My procedures might reference another procedure or work instruction, as in your example.

You are correct, there is no requirement to list the other documents. In fact - I would suggest removing them - making your procedures more "end user" friendly.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#3
Our typical procedure includes 10 or more documents in the referenced document section. Usually these are references to our quality manual, assorted level 2 procedures. I’ve always been of the opinion that if a document is called out in the referenced documents section somewhere in the procedure it should require you to use that document e.g. “All nonconforming material shall be documented in accordance with NCM procedure 12345.” From what I can see ISO has no requirement for me to list the QM and QMP in lower level procedures. I’d like to find out others on the forum handle this situation.

Thanks,
CarolX said:
FWIW - My format for procedures and work instructions have a scope, a purpose and then detailed instructions. I do not have a seperate section for "reference documents". My procedures might reference another procedure or work instruction, as in your example.

You are correct, there is no requirement to list the other documents. In fact - I would suggest removing them - making your procedures more "end user" friendly.
Carol is correct there is no requirement to identify reference procedures. I usually, when I have developed Policy and Procedures, and will under normal circumstances, identify the reference procedures. But that is your choice.
 
Last edited:

E Wall

Just Me!
Super Moderator
#4
While I agree that there is no requirement - the need will depend on the purpose of the document as well as your users familiarity with the upper level procedures. All too often the lowest level document is looked at alone. Unless there is redundancy in your documentation there may be key requirements in upper level documents that should be reviewed depending on the situation.

I've limited reference to the upper level docs to the process outline; documents below this level refer only to the process outline or any associated procedure (like handling/reaction to suspect or known ncm).

It has worked well for us. I also revamped our documents to a process acronym numbering format rather than tie into a 'standard'. My logic is we set up our processes to maximize production and minimize waste and do what we do to stay successful and competitive in business...not because any standard 'says we have to'. Our certifications (9001 & 14001), while voluntary, are maintained as a business need and treated as such.
 
Thread starter Similar threads Forum Replies Date
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Reference Document Training Plan for a Medical Device Company Training - Internal, External, Online and Distance Learning 1
B Guidance Document or Regulation Reference for Scanned Signatures (FDA/EMEA) US Food and Drug Administration (FDA) 4
Q Zero-Based Sampling Plan - Governing document or main reference document Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
E Work Instruction vs. Reference Only document - Computer software use instructions Document Control Systems, Procedures, Forms and Templates 33
K Documentation System Requirements and Document Format procedure - 3.0 Reference Document Control Systems, Procedures, Forms and Templates 7
D Document Control of Pocket / Reference Guides? Document Control Systems, Procedures, Forms and Templates 7
Manix Automotive Headunit Sizes - Standard Numbers - DIN size with No Document Reference Other ISO and International Standards and European Regulations 2
T For Reference Only - Solves document control problems? Document Control Systems, Procedures, Forms and Templates 34
G Posted document/Visual Aid as reference - Must they be controlled? Document Control Systems, Procedures, Forms and Templates 3
S AIAG's Control Plan Reference Manual - GONE from TS 16949 as a referenced document? IATF 16949 - Automotive Quality Systems Standard 9
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 3
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 2
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
E Reference Only on Gage or Visual Aid Calibration Frequency (Interval) 4

Similar threads

Top Bottom