ISO 13485 - Advisory Notices - Regulations - Quality Manual

[QA Tech]

ISO 13485- Advisory Notices/Regulations/Quality manual

We are an electronics manufacturing company that is ISO 9001:2000 and adding ISO 13485:2003 by January of 2005. ISO 14969 explains advisory notices to an extent, however it would be nice to see some examples. Anyone have a model for advisory notice process/procedure?

ISO 13485 constantly referrs to national or regional regulations and typically this is FDA QSR, but are there other regulating bodies for medical devices?

Any tips/suggestions on how to incorperate two quality systems (ISO 9001:2000 and ISO 13485:2003) in one quality manual, quality policy, and one set of procedures?

Thanks!

 

[Jimmy Olson]

Hello and welcome to the cove

I am in the same situation as you. We are an electronic manufacturing company that is looking at adding 13485:2003 (so we can compare notes ) I have a copy of a manual based on the 1996 version of 13485 that is helpful, but I have to clean it up and remove names and references first. I also have some other material that I've gathered that compares the two that I can share, I am on my way out the door, so I will sort through all my stuff tomorrow (just thought I would say hi before taking off).

There are also other people here that have a very good understanding of the medical device field and are very helpful.

 

[Vincnet]

ISO 13485 constantly referrs to national or regional regulations and typically this is FDA QSR, but are there other regulating bodies for medical devices?

Hi QA Tech,

As ISO is an Internationnal standard, regional regulations refers to the EU Directives in Eurpore 93/42/EC and 98/79/EC, regulated by the so called Competent Authorities, and to the Japanese regulation or any other regulations in the world.

Vincnet

 

[Al Rosen]

Any tips/suggestions on how to incorperate two quality systems (ISO 9001:2000 and ISO 13485:2003) in one quality manual, quality policy, and one set of procedures?

Thanks!

QATech:

I wrote my manual using 9k2k, then I made a comparison clause by clause against 13485:2003(FDIS). Where they differed I modified it approriately to incorporate the additional requirements of 13485 and still meet the customer satisfaction requirement of 9001. I haven't been assessed yet to 13485:2003, but I have been assesed and registered to 13485:1996 and CMDCAS. I haven't had any problems.

BTW, you will need more than 6 documented procedures.

 

[Cathy]

Hi QA Tech - don't know if you have found an anwser to your advisory notice question. Here's my input

Advisory notices can be issued from the country's competent authorities or by the manufacturer to the competent authority.

When you (as the manufacturer) issue an advisory notices you need to include detailed information on the following:
1. the type of incident (or potential incident)
2. whether any medical device has been involved that the manufacturer is responsible for
3. whether the incident was caused, wholly or partly, by the medical device
4. if there is any short comings in the information supplier with the product.

To see exmaples of advisory notices check out FDA website or try this link though it is for UK competent authority.
https://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings?Open&count=9999

One thing I will say about the transition from manufacturing to manufacturing medical devices is you need to be very careful in understanding the medical device vigilance. This is built into ISO13485:2003 to some extent but consult the FDA regulations on this area.

 

[Kari]

Advisory Notices

I work for a contract manufacturer that is persuing ISO13485, and builds several different finished devices. I am still confused about Advisory Notices.
Would our customers (i.e., the corporations marketing the devices) be responsible for dealing with them?

(We have never had to deal with adverse event reporting; it is handled by our customer).

 

[db]

I work for a contract manufacturer that is persuing ISO13485, and builds several different finished devices. I am still confused about Advisory Notices.
Would our customers (i.e., the corporations marketing the devices) be responsible for dealing with them?

(We have never had to deal with adverse event reporting; it is handled by our customer).

I would think that advisory notices would be those issued by your company, not your customer. (See Cathy's post). Advisory notices are related to the work your company does.

 

[Al Rosen]

Kari,

Advisory notices are not adverse event reports to the competent authority, they are notices to your customers.

I believe it is the responsibility of the entity that places the device on the market to issue the advisory notices to their customers. But, if you are a contract manufacturer and are to be registered to ISO 13485, it is necesary to address the issue of advisory notices to your customer in accordance with 7.3(d) and 8.5.1.

 

[amjadrana]

Advisory Notices

advisory notices are issued by the manufacturer to the customers in case a device is not functioning as intended. Advisories can be issued by the regualtory bodies as well. For example Health canada posts advisories on its website for medical professionals as well as for general public.

I company should have documented procedures for issuing and implementing advisory notices to customers, regulatory bodies or to general public.

Amjad Rana

 

[Bridget]

Advisory Notice

I have both a procedure and a form that has been through several auditors without any findings. I kept it simple and my form is not sent to our customers. They would be contacted via phone, email, fax, etc more or a personal touch. This form identifies the steps needed to record the problem as well as who to contact if regulatory reporting is needed. Therefore if I am not available anyone can start the recall. The procedure is very simple and echos the form, in fact I made the form first.

If further reporting is needed I have forms for the Competent Authorities which can be used for Canada as well as the FDA.

If it helps at all I am glad I posted it. Of course if anyone sees any gaps in it I welcome the feedback.
Bridget