Y
yzl1018
Hello!MarceloI got a piece of news that the revised ISO 13485 has been registered as DIS.
Does it mean the finalized revision of ISO 13485 will be published before the end of this year?
Thank you!
ISO 13485:2015 Pre-Release News and Discussion
- Thread starter Marcelo
- Start date
Hello!MarceloI got a piece of news that the revised ISO 13485 has been registered as DIS.
Does it mean the finalized revision of ISO 13485 will be published before the end of this year?
Thank you!
Hello, and welcome to the Cove!
The DIS stage is the enquiry stage, where we can still send comments for separate items. It?s followed by the approval stage (FDIS), in which you can only comment on the general document, accepting it or not. So, we have some months to comment on the DIS, there will be another WG 1 meeting to deal with the comments, and then we go into FDIS, and after that, publication. Which will be probably in the first semester of 2015.
The DIS is available for comment in the UK at:-
https://click.bsi-global-email.com/...1067e7d&s=fe221070746c0c7f731c78&jb=ffcf14&t=
and can be purchased at the ISO site:-
https://www.iso.org/iso/home/store/...alogue_tc/catalogue_detail.htm?csnumber=59752
https://click.bsi-global-email.com/...1067e7d&s=fe221070746c0c7f731c78&jb=ffcf14&t=
and can be purchased at the ISO site:-
https://www.iso.org/iso/home/store/...alogue_tc/catalogue_detail.htm?csnumber=59752
SRQAAuditor
Starting to get Involved
Re: News on the ISO 13485 revision
Thank you Marecelo for the update. I would like to know more and be able to review proposed changes if possible.
As usual, the comments here are insightful and thought provoking.
Look forward to continued updates.
Thank you Marecelo for the update. I would like to know more and be able to review proposed changes if possible.
As usual, the comments here are insightful and thought provoking.
Look forward to continued updates.
ISO TC 210 WG 1 will meet on September 8-10, 2014 together with the TC 210 General Meeting) in Stockholm, Sweden, to discuss the comments to the DIS. We will probably have a lot of discussions because the DIS generated a lot of questions (and we will already have at least one negative vote).
xcanals_tecno-med.es
Involved In Discussions
Dear Marcelo
I'm now participating in the Spanish national subcommittee specific for the ISO 13485, the AENOR SC 111/ SC 3 and we have some internal discussions about the scope and application of the new standard.
The introduction of the standard states:
"...
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.
..."
in my understanding the standard scope is clearly extended to distributors (distribution services) but also to servicing performed by the manufacturer or their subcontractor (installation and servicing) and servicing performed by the user (clinical engineering service of the hospital or their subcontractor- i.e. independent servicing companies)
Both independent servicing companies and small distributors refuses the approval of the standard as they consider that they will be obliged by the health authorities when approved.
Also other controversial point is the 1.2 application which estates:
"...
If any requirement(s) in Clauses 6, 7 or 8 of this International Standard is (are) not applicable due to the activities undertaken by the organization or the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
..."
so they extends the possibility to no application to clauses 6 and 8 from the previous edition (I think to allow the new actors as distributors to tailor their requisites)
May you please comment about that? thank you in advance
Xavier
I'm now participating in the Spanish national subcommittee specific for the ISO 13485, the AENOR SC 111/ SC 3 and we have some internal discussions about the scope and application of the new standard.
The introduction of the standard states:
"...
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.
..."
in my understanding the standard scope is clearly extended to distributors (distribution services) but also to servicing performed by the manufacturer or their subcontractor (installation and servicing) and servicing performed by the user (clinical engineering service of the hospital or their subcontractor- i.e. independent servicing companies)
Both independent servicing companies and small distributors refuses the approval of the standard as they consider that they will be obliged by the health authorities when approved.
Also other controversial point is the 1.2 application which estates:
"...
If any requirement(s) in Clauses 6, 7 or 8 of this International Standard is (are) not applicable due to the activities undertaken by the organization or the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
..."
so they extends the possibility to no application to clauses 6 and 8 from the previous edition (I think to allow the new actors as distributors to tailor their requisites)
May you please comment about that? thank you in advance
Xavier
Hello Xavier, it?s great that you are participating on Spanish NC SC, will you be able to be attend the meeting in Stockholm in September?
Regarding your questions:
Yes, the extension will allow that ISO 13485 be applied to anyone that is part of the medical device lifecycle. This is really nothing new, a lot of certification bodies to apply ISO 13485 to entities different from the manufacturer, even with the current version not being applicable to them. This change will only make what already happens "official".
Also, although I understand the fear, the standard itself does not oblige anyone to be in accordance with it. And at least from the discussion of the Medical Device authorities which are part of the WG, there?s no expectation of compliance for the other actors at the moment. But anyway, even without the changes, if an authority would want to require that certain actors be in compliance with some parts of ISO 13485, they could - this change will only make it official if they want to someday.
Exactly, the extension of not applicability to clauses 6 and 8 was done together with the scope extension (however, it?s also true to some manufacturers which do not perform some of the activities, but this is rarer).
Regarding your questions:
Yes, the extension will allow that ISO 13485 be applied to anyone that is part of the medical device lifecycle. This is really nothing new, a lot of certification bodies to apply ISO 13485 to entities different from the manufacturer, even with the current version not being applicable to them. This change will only make what already happens "official".
Also, although I understand the fear, the standard itself does not oblige anyone to be in accordance with it. And at least from the discussion of the Medical Device authorities which are part of the WG, there?s no expectation of compliance for the other actors at the moment. But anyway, even without the changes, if an authority would want to require that certain actors be in compliance with some parts of ISO 13485, they could - this change will only make it official if they want to someday.
Exactly, the extension of not applicability to clauses 6 and 8 was done together with the scope extension (however, it?s also true to some manufacturers which do not perform some of the activities, but this is rarer).
Y
yzl1018
Hello!Marcelo!
I just got a draft EN ISO 13485:2015 from BIS website in this June. I know EN ISO 13485 is equivalent with ISO 13485.
Through reading the entire standard, I found there is no dedicated paragraph to require how to handle complaint. However, a dedicated paragraph (i.e. section 8.5.1) exists for handling complaint in previous draft version that I got in last year.
I would like your answer: could you please explain how you experts consider this change?
Thank you in advance!
I just got a draft EN ISO 13485:2015 from BIS website in this June. I know EN ISO 13485 is equivalent with ISO 13485.
Through reading the entire standard, I found there is no dedicated paragraph to require how to handle complaint. However, a dedicated paragraph (i.e. section 8.5.1) exists for handling complaint in previous draft version that I got in last year.
I would like your answer: could you please explain how you experts consider this change?
Thank you in advance!
Y
yzl1018
[FONT=宋体]Sorry![/FONT]
[FONT=宋体]I made a mistake. Let me further explain.[/FONT]
[FONT=宋体]I got a CD version of ISO 13485:2015 in last year. This draft requires how to handle complaint from its sections 8.5.1.1.1 to 8.5.1.1.6. [/FONT]
[FONT=宋体]This June， I get an updated draft from BIS website. This draft removes sections from 8.5.1.1.1 to 8.5.1.1.6 that are required in last CD version.[/FONT]
[FONT=宋体]You mentioned the complaint handling is required in section 8.2.1.2 of DIS version. However, there is no such section in the draft that I get. [/FONT]
[FONT=宋体]Does it mean my version is not the latest draft? In addition, could you please confirm whether the content of 8.2.1.2 in DIS version is the same as 8.5.1.1 in CD version?[/FONT]
[FONT=宋体]Thank you very much![/FONT]
[FONT=宋体]I made a mistake. Let me further explain.[/FONT]
[FONT=宋体]I got a CD version of ISO 13485:2015 in last year. This draft requires how to handle complaint from its sections 8.5.1.1.1 to 8.5.1.1.6. [/FONT]
[FONT=宋体]This June， I get an updated draft from BIS website. This draft removes sections from 8.5.1.1.1 to 8.5.1.1.6 that are required in last CD version.[/FONT]
[FONT=宋体]You mentioned the complaint handling is required in section 8.2.1.2 of DIS version. However, there is no such section in the draft that I get. [/FONT]
[FONT=宋体]Does it mean my version is not the latest draft? In addition, could you please confirm whether the content of 8.2.1.2 in DIS version is the same as 8.5.1.1 in CD version?[/FONT]
[FONT=宋体]Thank you very much![/FONT]
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