ISO 13485 in Hospital Central Sterilization and Clinical Engineering Services

xcanals_tecno-med.es

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#21
I'm curious about the translators with a 13485 registration, can't see how any of their processes would warrant it rather than 9001...
Is obviously because you see the original version (in english) of the IFU for the devices
:D

if you had seen as an english manual of 200 pages becomes one of 10 pages in its Spanish version ...
Or as a warning of "no use in case of ..." becomes a recommendation on how to use the product

Well, seriously only 2 principal reasons:
1. the ISO 13485 audit needs a expert of the field involved in the audit (which for example knows the annex I paragraphs about doc provided by the manufacturer and standards as EN 980 and EN 1041)

2. please review the new standards about usability: (see the forum discussion group http://elsmar.com/Forums/forumdisplay.php?f=185 )
- EN 62366
- EN 60601-1-6
- AAMI HE 75

Regards

Xavier
 
Last edited:
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R

Roland Cooke

#22
I'm also working with a number of sterile services departments in the UK.

My understanding is that all NHS departments now fall under the scope of the Directive, even if they don't put their product on the market.

The MHRA (who are responsible for implementing the Directive) say in their Medical devices Directive Bulletin 8 that all devices will have to be CE marked (ie comply with the requirements),
I'm a bit out of the loop now, but I was heavily active with all of this in the mid-90s.

Driven by a variety of factors, not least the high profile of nvCJD, the UK MDA (MHRA) was keen to ensure that all SSDs/HSDUs were being appropriately managed and run.

In short, after turning over a few stones, it was clear that it was all a bit of a horror story. Many hospitals were out of control, with several having completely unsuitable facilities and/or an inadequate supply of surgical instruments. Some of this started to hit the national media.

Only about a third of all the UK SSDs were audited by Notified Bodies, (the others being exempt), and while that third were generally better managed, Notified Bodies didn't escape the MDA's wrath either, for having a very variable performance.

SGS actually did very well, but we all acknowledged that SSDs are.....different. If you consider the level of control required to make a sterile disposable - and then consider what you would need to take something that has been inside another person (who has by definition been ill!) - it's kinda mind-boggling.

Eventually things started to sort themselves out; the move to make all UK hospitals come under those standards presumably came out of all that previous harmonisation effort.


I'm not sure of the current situation, but I imagine the national programme is very much improved.
 
B

Bill Marshall

#23
It's part of the manufacturing process for medical devices, and thus needs to be controlled, not least because there is often complex clinical and technical terminology involved.

Thus for medical device companies the translation process usually gets validated, or a competent translation agency is used. ISO13485 provides evidence of control and competency that your best friend's allegedly-bilingual cousin might not readily be able to provide. :)
I'm still a little curious by the inclusion of translation services within the scope of 13485. I've left it for a few days, but it keeps coming back to haunt me !

Perhaps you can help me to understand why translation services need to registered to 13485 and not 9001.

I appreciate that these are critical services that need to be controlled but do not yet see the need for the level of control defined in 13485. Surely these requirements are aimed at manufacturing in a controlled environment ?

Translation services don't seem to warrant the additional requirements and could be more appropriately managed with a system which complies with 9001.

It's obviously critical for a translation service to understand the technical language of the documents in question, but this aspect of the system is managed via the training and document control processes, which are adequately addressed in 9001.

It would help me if you can clarify which of the additional requirements in 13485 are relevant to translation services.

regards
 

xcanals_tecno-med.es

Involved In Discussions
#24
I'm still a little curious by the inclusion of translation services within the scope of 13485. I've left it for a few days, but it keeps coming back to haunt me !

Perhaps you can help me to understand why translation services need to registered to 13485 and not 9001.

I appreciate that these are critical services that need to be controlled but do not yet see the need for the level of control defined in 13485. Surely these requirements are aimed at manufacturing in a controlled environment ?

Translation services don't seem to warrant the additional requirements and could be more appropriately managed with a system which complies with 9001.

It's obviously critical for a translation service to understand the technical language of the documents in question, but this aspect of the system is managed via the training and document control processes, which are adequately addressed in 9001.

It would help me if you can clarify which of the additional requirements in 13485 are relevant to translation services.

regards


we need not only see the "requirements" but also the "review of this requirements"

Please read my previous post. :read:

note that you are talking about a regulated market (as the standard ISO 13485 claims to be devoted)

for more details about to be ISO 13485 certified see for example the page and the ISO 13485 certificate of a IFU translator:

http://www.1-800-translate.com/Medical.php

http://www.1-800-translate.com/images/13485e-certificate.jpg

and note that they have 2 certificates : ISO 9001 and ISO 13485

Regards

Xavier Canals
 

xcanals_tecno-med.es

Involved In Discussions
#25
Just see the issue of the certificate according ISO 13485:2003 to a Clinical Engineering Dept of the Hospital Universitario Miguel Servet from Zaragoza Spain



This certificate is the first issued in Spain to a Hospital department and the consultancy firm which helps them is our company Tecno-med Ingenieros

Regards

Xavier Canals :D
 
B

Bill Marshall

#26
Congratulations.

The department and the consultancy must be very pleased.

Being the first organisation to pursue a registration must feel a little lonely
so I hope you got good support from the certification auditors.
 
R

Roland Cooke

#27
I'm still a little curious by the inclusion of translation services within the scope of 13485. I've left it for a few days, but it keeps coming back to haunt me !

Perhaps you can help me to understand why translation services need to registered to 13485 and not 9001.

I appreciate that these are critical services that need to be controlled but do not yet see the need for the level of control defined in 13485. Surely these requirements are aimed at manufacturing in a controlled environment ?

Translation services don't seem to warrant the additional requirements and could be more appropriately managed with a system which complies with 9001.

It's obviously critical for a translation service to understand the technical language of the documents in question, but this aspect of the system is managed via the training and document control processes, which are adequately addressed in 9001.

It would help me if you can clarify which of the additional requirements in 13485 are relevant to translation services.
You misunderstood me, I never said translation companies needed ISO13485.

I did indicate that ISO13485 could certainly be appropriate (as opposed to an application for certification being rejected). A translation company could simply apply for it, translation is certainly part of the design/manufacturing process, just like any other (outsourced) step.

Where the required translation has e.g. complex clinical content, a customer of that translation company might be more comfortable giving its business to a company that held ISO13485 as opposed to ISO9001.
 

xcanals_tecno-med.es

Involved In Discussions
#28
Dear all
the draft of the ISO 13485:2015 include the following introduction:

0 Introduction
0.1 General
This International Standard specifies requirements for a quality management system that can be used by an organization involved in stages of the life-cycle of a medical device including the design and development, production, storage and distribution, installation or servicing of medical devices, and the design, development, and provision of associated activities (e.g., technical support).
The requirements in this standard may also be used by suppliers or other external parties providing goods and services (e.g., sterilization services, calibration services, distribution services) to medical device organizations. Such a supplier or external party may voluntarily choose to conform to the requirements of this standard or may be required by contract to conform.
 
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