List of Required Procedures as per ISO 13485 & MDD

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

Reference

Cover Page
General Information
Table of Contents
Control of Document
Control of Record
Control of non conforming products
Internal Audit
Corrective Action
Preventive Action
Purchasing Process
Production Process
Customer Related Process
Monitoring and Measurement of Products
Management Review Meeting Process
Maintenance process
Training Process
Preservation of product
Design And Development Process
Risk Management Procedure
Work Environment procedure
Procedure for Validation
Identification and Traceability
Customer Feed back Analysis Procedure
Procedure for Analysis of Data
Vigilance System
Servicing Procedure
Installation Procedure
Control of Monitoring and Measuring Devices
Procedure for Advisory notices
Software development procedure
Testing procedure
Customer property handling procedure
Language translation procedure
Notification Procedure
Out sourcing Procedure
Procedure for Customer Returned products
Procedure for Recall
Procedure for Post Market Surveillance

Re: List of Procedures as per ISO 13485 & MDD

You may want to refer to a related thread and one of the attachments: ISO 13485 documentation requirements.doc

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

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

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.,?

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

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.

mmorgangohandh said:

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.

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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.

Do we need to have separate procedure...

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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.

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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.