Documents in different languages - Revision and Issue Number

N

nurhakim

#1
Hi :bigwave:,

In the company I am currently working, I have one set of SOP which is only available in our local language. Now I am working on the translation of the SOP into English.

What would be the revision and issue number for the English version? No other changes are made on the content except change the language.

Thanks for help.
 
Elsmar Forum Sponsor
P

PaulJSmith

#3
Re: Document revision and issue number

I agree with Jan. As long as the content and meaning isn't changing (hopefully, nothing changes drastically in translation), there's no reason to complicate things by having different revision numbers for essentially the same document. .
 
D

Dayyana89

#4
Hi!

i want to ask about document number and revision also.

How about my company change the name and company logo. So I have to change all procedures also.

Do I need to change the document number. the document number have a short form of the old company name.

E.g: Old company name : ABC, Doc No: ABC-QP-10
New company name : DEF, can i use the same Doc No? ABC-QP-10.

Thank you!
 
H

hangguanglei

#6
document NO was defined in the ISO9001 clause 4.2 or other place , it base on how you defined the document NO. i guss ABC which should be explain to company name . if like this , you have to change it .
 

John Broomfield

Staff member
Super Moderator
#7
Again, avoid numbering management system documents after any clauses in the management system standard.

Doing this suggests to the employees that the management system exists only to get through audits to get and keep a certificate.

Of course, the management system should exist to help employees to fulfill their employer's mission more effectively and more efficiently.

So, identify your documents for the convenience of your company and its users.

Maintain a single page conformity matrix as necessary act as a memory jogger and to guide an external auditor. BTW, this is the only document maintained especially for the auditor.

John
 
C

Chinese Michale

#8
HI
There have no define how to number the document in ISO9001, but you have to define how to number the document by yourself, include company name, the code of each department, etc. If you define it in your document, you have to follow the rule.
 
Thread starter Similar threads Forum Replies Date
qualprod Controlling documents in two different Applications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
P How to streamline different documents in a multi plant ISO13485 QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
S Document Control - Different documents which must be controlled not identified Document Control Systems, Procedures, Forms and Templates 11
P Document Layout - Different layouts for documents depending upon the author Document Control Systems, Procedures, Forms and Templates 7
A Classifying Documents for Different Document Levels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O What are typical records of different documents required by ISO9001? Records and Data - Quality, Legal and Other Evidence 2
C How do you Manage different Types of Documents? Document Control Systems, Procedures, Forms and Templates 2
K Different "levels" of quality planning and the related documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
M Informational EU – Some documents related to Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
K Mandatory Documents for EU authorized Representative under MDR CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna Interesting Discussion Hello IAF. Are you listening? Please explain the inconsistency in your IAF Mandatory Documents (2019) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
R Do we need to treat local law as external origin documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
shimonv Informational New guidance documents about EUDAMED - April 2019 EU Medical Device Regulations 1
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
L Digitalization of documents - FDA and ISO 13485 Other Medical Device Related Standards 1
G Correction fluid found on documents that are reviewed Qualification and Validation (including 21 CFR Part 11) 11
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L OpEx (Operational Excellence) Documents in QMS? Document Control Systems, Procedures, Forms and Templates 0
I Documents for Manufacturing Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
N IATF 16949 - Mandatory Corporate Documents IATF 16949 - Automotive Quality Systems Standard 10

Similar threads

Top Bottom