SBS - The best value in QMS software

Which ISO Standard to purchase?

D

dasmann

Registered
#1
#1
We are a small company in Canada looking to obtain our ISO 13485 certification for an EMR software package. We are just starting out and would like to know if the standard from iso.org is fine to purchase or should we purchase the version from BSIgroup? I would happy take other suggestions as well.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Edward Reesor

Edward Reesor

Trusted Information Resource
#2
#2
If it helps, we purchased ISO 13485: 2016 from one source (I believe it was ISo_Org) but recently purchased another ISO standard for one of our products from another source. All we needed was a printable pdf. The second group required some secure software that limits the opening of the document to the device that purchased the document. First it was a pain to access the document (simple solution but it was frustrating). Then we discovered that it was limited to device. I used my aging work laptop. I am confident that my purchase may be transferable but once the laptop dies, it will be another pain. I may be wrong in my frustrations, but you may want to explore this experience when you decide.
 
planB

planB

Super Moderator
#3
#3
dasmann,

ISO 13485:2016 is identical to BS EN ISO 13485:2016 in its normative part. You will find differences in the foreword and in the additional Z-Annexes the latter has.

Hope this helps,
 
blackholequasar

blackholequasar

Involved In Discussions
#4
#4
Edward Reesor said:
The second group required some secure software that limits the opening of the document to the device that purchased the document. First it was a pain to access the document (simple solution but it was frustrating). Then we discovered that it was limited to device.
Click to expand...
This has been an issue that I've encountered as well. When I got BS EN ISO 13485, however, it did watermark the PDF but it did not limit it to a specific user. I understand the need to protect these documents, but they really go out of their way to make it really complicated sometimes!
 
D

dasmann

Registered
#5
#5
Thank's for both of your replies. I have found the ISO standard on CSA's web site - to my dismay I see another version of the standard on the site "CAN/CSA-ISO 13485:16" could anyone comment on this release?

EDIT: Thank's for your reply as well blackholequasar.
 
D

dasmann

Registered
#6
#6
Thanks all. I've figured out which one to buy CAN/CSA. It's published by CSA and would make sense to buy the one made by my regulatory body.
 
P

Philip B

Involved In Discussions
#7
#7
blackholequasar said:
This has been an issue that I've encountered as well. When I got BS EN ISO 13485, however, it did watermark the PDF but it did not limit it to a specific user. I understand the need to protect these documents, but they really go out of their way to make it really complicated sometimes!
Click to expand...
Yes, they watermark them with your name and they are intended for your personal use only. If you want to put them on a shared network or company drive then you are supposed to purchase a network licence. I doubt many people do this but they could raise this during an audit if spotted,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Where can I buy (purchase) copies of the ISO/TS 16949:2002 Standard fast? IATF 16949 - Automotive Quality Systems Standard 3
C The best place to purchase the ISO 9001:2000 standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
M Proper ISO standard for Pressure Testing and Leak Rates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Invalid ISO Standard / Guidelines - ISO 22301 BCMS and a local standard Various Other Specifications, Standards, and related Requirements 1
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
Ashok sunder How to determine the internal and external issues in ISO 45001 standard? Occupational Health & Safety Management Standards 2
E Audited to ISO 13485 standard although customer was aware we're not and have no plans to be ISO 13485:2016 - Medical Device Quality Management Systems 23
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
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
Sidney Vianna ISO 41001:2018 - System Standard for Facility Management Other ISO and International Standards and European Regulations 8
Sidney Vianna ISO 21001:2018 Management System Standard for Educational Organizations Other ISO and International Standards and European Regulations 0
A ISO 14001:2015 transition from the 2004 standard ISO 14001:2015 Specific Discussions 8
qualprod In ISO 9000, Standard vocabulary - Competitors , interested parties? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Proud Liberal Surface finish measurement (roughness) - Rz under the ISO standard vs ANSI standard Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S ISO 9001:2015 - Internal Auditing - Audit to the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T When T&C's (Terms and Conditions) conflict with the ISO standard Manufacturing and Related Processes 8
Paul Simpson ISO TS 22163 - New Rail Industry Standard Other ISO and International Standards and European Regulations 11
A ISO 9000 Standard "standard" definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M I am looking for a copy of the ISO 16232 standard Other ISO and International Standards and European Regulations 2
D When Quoting an ISO Standard should I put the quote in italics? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Where can I buy the ISO 9001:2015 Standard in pdf? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Is there a standard (ISO) to control the use of ISO, IAF and CB logos? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Kronos147 ISO 9001:2015 threads in the standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M ISO 14001 - Should we list the standard itself in clause 4.3.2 ISO 14001:2015 Specific Discussions 8
O Should ISO 9001:2008 be treated as a standalone quality standard alongside AS9120A? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I ISO 26262 standard may apply to automotive IC suppliers IATF 16949 - Automotive Quality Systems Standard 1
T Where in the ISO 9001 standard it asks for process based auditing? Process Audits and Layered Process Audits 6
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 5
M Partial Compliance to an ISO Standard for Medical Device CE Marking EU Medical Device Regulations 13
M Where to buy ISO 3951-1 and ISO 3951-2 standard copy Other ISO and International Standards and European Regulations 1
R Is BS EN ISO 15223-1 a harmonised standard? EU Medical Device Regulations 2
S Quality Manual and ISO TS 16949 Standard IATF 16949 - Automotive Quality Systems Standard 5
D Internal Audit Checklist for the latest ISO/TS 16949 standard IATF 16949 - Automotive Quality Systems Standard 11
0 Standard that is the equivalent to ISO 22000 but for the non-food industry Food Safety - ISO 22000, HACCP (21 CFR 120) 7

Similar threads

Top Bottom