SBS - The best value in QMS software

Can a website be considered a Document of External Origin?

somashekar

Staff member
Super Moderator
#11
I might have misunderstood the original poster, but I don't understand why the they should have control of a computer manufacturer's (e.g. dell) warranty webpage such as this one: http://support.dell.com/support/topics/global.aspx/support/my_systems_info/details?c=us&l=en&s=gen

I can understand if the OP was to create their own webpage which their customers used to check the warranty, but I did not get this impression from the original post

To expand further, and taking your note 3:
If I were to telephone dell and ask when my computer was to go out of warranty, is that conversation a record that requires control? the answer is probably yes however, is it best to record that conversation, or would it be more practical for me to create my own form and write the date given to me down?

Extending this to the website, request the date of warranty expiry, then document!
Dear pkost.
I understand you well and your understanding is perfect. My view on this is that since the OP is using the manufacturer's website to update some information on the systems he purchased, the controls he exercises on his login and password into the manufacturer's site to update the info and the controls he has on the manufacturer's hosting about the maintaining of the website and change information that he needs to keep his uploaded information intact for his future use, must meet his requirement. In a way, it is not purely an external document as intended in the standard.
 
Elsmar Forum Sponsor
A

arios

#12
NOTE 3 The documentation can be in any form or type of medium.
The above is the note in ISO9001:2008, 4.2.1 Documentation requirement, general.
So Website and contents thereof is your document. It is not external to you. It is your document. What controls you exercise in the hosting, updating and maintaining this website must be good enough if they have the activities of the 4.2.3 (Control of documents) mapped and managed well.
As a matter of fact, I have come to an instance of a SOP which included some web site links as part of its content. It happened that some of those links were outdated and did not work anymore, so like Somashekar said it is important to maintain that information accurate, and in such a way demostrate control. :yes:
 
Thread starter Similar threads Forum Replies Date
U Is there any website out there that summarizes all relevant standards? Medical Device and FDA Regulations and Standards News 1
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
N Updating the website of the manufacturer EU Medical Device Regulations 1
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A Contraindication Safety Statement in website - Radiotherapy equipment Other Medical Device and Orthopedic Related Topics 1
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
R Publication of user information in manufacturer website for medical devices Other Medical Device Regulations World-Wide 2
E EU MDR GSPR 23.1 information on website CE Marking (Conformité Européene) / CB Scheme 2
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Trouble with Europa website - Internal Server Error (March 2019) EU Medical Device Regulations 5
J How to look up Failure Modes on FDA website FMEA and Control Plans 4
M Medical Device News EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org Medical Device and FDA Regulations and Standards News 0
Z Does a website needs to comply with Part 11? Qualification and Validation (including 21 CFR Part 11) 6
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
W Website change documentation - Labeling and Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
R The on-line re-certification option on ASQ's website Professional Certifications and Degrees 5
Marc MDD Harmonized List of Standards Website Moved Other Medical Device and Orthopedic Related Topics 1
E Does posting your IFU on your website constitute elabelling? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Can I view listed drug products on FDA website similar to listed medical devices? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
Marc Silent Movie Review Website Coffee Break and Water Cooler Discussions 2
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
L New Website from the FDA concerning UDI Exceptions, Alternatives and Time Extensions Other US Medical Device Regulations 0
R Control of company website and social media Document Control Systems, Procedures, Forms and Templates 8
B New website for AIAO-BAR - Unaccredited Accreditation Body ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 33
Ajit Basrur Google detects fake website ID certificate threat After Work and Weekend Discussion Topics 1
V Is there a Website with OEM Requirements APQP and PPAP 7
A Document Version for Website Help/Training 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Sidney Vianna Discover the new ISO.ORG website - September 2012 Other ISO and International Standards and European Regulations 4
Marc Redesigned ISO Website - June 2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Blood Glucose Monitor & its Logbook Website - Do I need to get 510k for the Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ronen E FDA's enforcement over Website Claims (Medical Device Misbranding) Other US Medical Device Regulations 7
T Can a company's website content be audited? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N ISO 9001 Applicable Requirements for a Company Website? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Sidney Vianna The new IAF Website ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Ajit Basrur Redeveloped TGA (Australia) website Other Medical Device Regulations World-Wide 0
Richard Regalado Free Download of ISO 27000:2009 from the ISO website IEC 27001 - Information Security Management Systems (ISMS) 5
O Website as a Quality Manual? Quality Management System (QMS) Manuals 15
M FMEA Website for Medical Issues FMEA and Control Plans 0
T Apply Job Vacancy directly on company website or via a recruiter? Career and Occupation Discussions 13
H TC 176 Website - Request for an Interpretation Feature ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C How to find the Medical Device Listing Number (MDL Number) from the FDA website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Website Templates After Work and Weekend Discussion Topics 1
Colin Great Website Animation Funny Stuff - Jokes and Humour 6

Similar threads

Top Bottom