List of Required Procedures as per ISO 13485 & MDD

Valli

Involved In Discussions
#1
Can anyone help in listing the mandatory procedures as per ISO 9001, 13485, MDD for medical Device. Do we need to have seperate procudure for trend reporting of Adverse Events?

Clause Reference

Description
Reference

Cover Page
PMT/ISP/A
General Information
PMT/ISP/B
Table of Contents
PMT/ISP/C
4.2.3
Control of Document
PMT/ISP/01
4.2.4
Control of Record
PMT/ISP/02
8.3
Control of non conforming products
PMT/ISP/03
8.2.2
Internal Audit
PMT/ISP/04
8.5.2
Corrective Action
PMT/ISP/05
8.5.3
Preventive Action
PMT/ISP/06
7.4
Purchasing Process
PMT/ISP/07
7.5
Production Process
PMT/ISP/08
7.2
Customer Related Process
PMT/ISP/09
8.2.4
Monitoring and Measurement of Products
PMT/ISP/10
5.6
Management Review Meeting Process
PMT/ISP/11
6.3
Maintenance process
PMT/ISP/12
6.2
Training Process
PMT/ISP/13
7.5.5
Preservation of product
PMT/ISP/14
7.3
Design And Development Process
PMT/ISP/15
7.1
Risk Management Procedure
PMT/ISP/16
6.4
Work Environment procedure
PMT/ISP/17
7.5.2
Procedure for Validation
PMT/ISP/18
7.5.3
Identification and Traceability
PMT/ISP/19
8.2.1,8.5
Customer Feed back Analysis Procedure
PMT/ISP/20
8.4
Procedure for Analysis of Data
PMT/ISP/21
Vigilance System
PMT/ISP/22
7.5.1.2.3
Servicing Procedure
PMT/ISP/23
7.5.1.2.2
Installation Procedure
PMT/ISP/24
7.6
Control of Monitoring and Measuring Devices
PMT/ISP/25
8.5.1
Procedure for Advisory notices
PMT/ISP/26
7.5.2.1
Software development procedure
PMT/ISP/27
8.2.4
Testing procedure
PMT/ISP/28
7.5.4
Customer property handling procedure
PMT/ISP/29
Language translation procedure
PMT/ISP/30
Notification Procedure
PMT/ISP/31
4.1
Out sourcing Procedure
PMT/ISP/32
Procedure for Customer Returned products
PMT/ISP/33
Procedure for Recall
PMT/ISP/34
Procedure for Post Market Surveillance
PMT/ISP/35
 
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Valli

Involved In Discussions
#3
Re: List of Procedures as per ISO 13485 & MDD

Dear Harry,

Thank. What are mandatory procedures for MDD- Full quality system. Like Vigilance, Recall etc.,

Regards,
Valli
 

sagai

Quite Involved in Discussions
#4
Re: List of Procedures as per ISO 13485 & MDD

Hi Valli,
where the standard says "documented procedure", that is the subject you have to cover with procedure.
4.2 ISO13485:2003(E)
Regards, Szabolcs
 

Valli

Involved In Discussions
#5
Re: List of Procedures as per ISO 13485 & MDD

Thanks you. But what are relavent procedures required for MDD Compliance. Do we have to have a procedure seperate Adverse Events , Recall etc.,?
 

sagai

Quite Involved in Discussions
#6
Re: List of Procedures as per ISO 13485 & MDD

You have to have adverse event procedure in general (recalls could be in or in a separate SOP if you like), but there are differences in country regulation for the content of adverse event reporting in the EU (and out of it also).
I would not bet on there is a specific requirement in the MDD (it is my impression only, have2check), but someone may correct me. Regards
 
M

mmorgangohandh

#7
Sounds like you are doing what we are in the process of ourselves. We have our ISO 13485:2003 certification, but we need to upgrade to EN ISO 13485:2012 to attain CE Marking for some of our products. I'm finding the requirements are basically the same, however, the actual procedures will need to be adjusted to the European Market. For instance, labeling procedures and complaint procedures have to be modified to include how we label and respond to the European Market. We also have to include a new SOP on how to write a Technical File.
I am just now starting my research, if I am wrong or if someone can add to it I would appreciate it.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Sounds like you are doing what we are in the process of ourselves. We have our ISO 13485:2003 certification, but we need to upgrade to EN ISO 13485:2012 to attain CE Marking for some of our products. I'm finding the requirements are basically the same, however, the actual procedures will need to be adjusted to the European Market. For instance, labeling procedures and complaint procedures have to be modified to include how we label and respond to the European Market. We also have to include a new SOP on how to write a Technical File.
I am just now starting my research, if I am wrong or if someone can add to it I would appreciate it.
Hi,

If you are compliant with ISO 13485:2003 you are also compliant with EN ISO 13485:2012. What you are probably trying to do is catch up with the MDD. 13485 is only one aspect of MDD compliance.

Cheers,
Ronen.
 

Mark Meer

Trusted Information Resource
#9
Do we need to have separate procedure...
Correct me if I'm wrong, but does any standard or regulation explicitly require "separate procedure(s)"? Usually the term is "documented procedure"...

In otherwords, I believe it is acceptable to just update any procedural documents you already have (e.g. for labelling, vigilance, etc.) to include any additional European requirements. No need to create separate documents.

We also have to include a new SOP on how to write a Technical File.
Is this correct? As above, I think it's acceptable to include this in an already existing document. For example a "Design & Development" SOP may include documentation requirements that cover the contents of Device Master Records (US FDA) as well as technical files (MDD).

Less documents = easier to manage

Just my 2cents. :2cents: :)
 
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