Referencing Standards in Procedures - Current version or actual?

D

DavidG1

#1
What is your preferred way to reference a standard in your procedures? For example, I want to reference a requirement from ISO 13485.

Do I say "current version of ISO 13485" or "ISO 13485:2003"? I don't want to be forced in to revising my library of procedures when we move into 13485:2016.

Thanks for your input.
 
Last edited by a moderator:
Elsmar Forum Sponsor

Michael_M

Trusted Information Resource
#2
Re: Current version or actual

We typically state "....to latest revision", without actually putting the revision requirement in. We would put ISO 13485 to latest revision if we had this requirement.
 
Last edited:

Sidney Vianna

Post Responsibly
Leader
Admin
#3
Re: Current version or actual

Welcome to The Cove.

Certainly referencing the edition of the standard in your procedures will create busy work, when you adequate your documentation to the new edition. So, you DON'T want to do that.

But, going a step further: why reference the (ISO 13485) standard in your command media in the first place? Do you really have to? Consider NOT referencing it at all, as it simplifies your life even more.
 
N

ncwalker

#4
What is your preferred way to reference a standard in your procedures? For example, I want to reference a requirement from ISO 13485.

Do I say "current version of ISO 13485" or "ISO 13485:2003"? I don't want to be forced in to revising my library of procedures when we move into 13485:2016.

Thanks for your input.
Just say ISO 13485. That implies current version. Then, when we go to a new version, you don't have to roll through and change everything.

It is important you also keep a list of what versions you operate to for ALL your standards, because when one changes, you need to see if it DOES affect the text around it.
 

WCHorn

Rubber, Too Glamorous?
Trusted Information Resource
#5
We have a scope statement in the quality manual for our QMS. In the scope statement, I cite the applicable QMS standard(s) with revision. Then I have an explanation that any reference to those standards in subordinate documents implies the revision stated in the scope statement. The only place I cite a QMS standard revision is in the scope statement, so when we transition to a new revision, I just change the scope statement (and exceptions if applicable) and I'm done.
 
B

BoardGuy

#6
[FONT=&quot]Adding to what has already been communicated I would not reference any QMS Standard in procedures or work instructions. Let your quality manual (ISO 9001:2008, Clause 4.2.2) or documented quality management system scope (ISO 9001:2015, Clause 4.3) state the international standards your system complies. All documents created to support this document (manual or scope) are part of the QMS and really don’t need a linked reference.[/FONT]
 
Thread starter Similar threads Forum Replies Date
J Properly referencing ISO standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 10
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
M Referencing Standards in Engineering and Regulatory Documents Other ISO and International Standards and European Regulations 1
A Calling / Referencing National Standards in Quality Manuals Quality Management System (QMS) Manuals 1
S Referencing quote on PO AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Referencing ISO 9001:2015 clause for Audit General Auditing Discussions 10
S Referencing procedures on Control Plans - Best Practices FMEA and Control Plans 3
P Question on First Article Inspection referencing ISO 2768 APQP and PPAP 1
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
Q Referencing EN 63204:2006 instead of EN 62304:2006 AC:2008 IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Referencing a Specification in a Work Instruction as a ?Guidance Document? ISO 13485:2016 - Medical Device Quality Management Systems 1
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Referencing other documents in Control Plans Quality Manager and Management Related Issues 5
P Referencing of Forms in Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Referencing the Regulation in a Design Specification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Referencing or Using a Master Part to take Measurements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q AS9100 and NADCAP - Our QM was told that referencing IPC 620 was acceptable AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Referencing somebody else?s CE Mark and NB Number on an Instruction Leaflet? CE Marking (Conformité Européene) / CB Scheme 7
N Cross-Referencing ISO 9001/ISO 14001/OHSAS 18001 Occupational Health & Safety Management Standards 17
K Question about referencing software - Database Records Document Control Systems, Procedures, Forms and Templates 11
L Surveillance Audit - NC for not referencing requirement of Cl 6.4 in audit plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Work instructions - Referencing other documents including procedures Document Control Systems, Procedures, Forms and Templates 18
optomist1 Hybrid or Pure Electric Aircraft Manufacturing Standards Federal Aviation Administration (FAA) Standards and Requirements 0
K Why are Estonian standards so cheap? Other Medical Device Related Standards 3
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
J Selecting reference standards for calibration General Measurement Device and Calibration Topics 3
M Subscribe to harmonized standards updates EU Medical Device Regulations 5
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
P Harmonised standards story? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
A Common Specifications versus Harmonized Standards EU Medical Device Regulations 3
Sidney Vianna IAQG News Designation of aerospace standards to be modified - from AS91X0 (in the Americas) to IA91X0 (International Aerospace) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Justification of use of non-harmonized standards for MDR conformity Other Medical Device Related Standards 12
I Hold Time studies for Primary Reference standards Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
G How to find applicable standards for a new product? EU Medical Device Regulations 6
A How to find Info about updated Standards EU Medical Device Regulations 2
C Producing to Inactive ASTM and IEC Standards Manufacturing and Related Processes 11
Sidney Vianna Informational Changes to Terms and Definitions in ISO/TC 176 Standards since ISO 9000:2015 was issued. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A How to monitor new versions of external standards in your business Various Other Specifications, Standards, and related Requirements 2
Ajit Basrur Any standards relating to ESG requirements? ISO 14001:2015 Specific Discussions 1
H Regarding confusion of the validity of the European implementation of IEC standards Other Medical Device Related Standards 1
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
C By when should harmonized standards be complied with? EU Medical Device Regulations 5

Similar threads

Top Bottom