ISO 13485 - Advisory Notices - Regulations - Quality Manual

Q

QA Tech

#1
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!
 
Elsmar Forum Sponsor
J

Jimmy Olson

#2
Hello and welcome to the cove :bigwave:

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.
 
V

Vincnet

#3
QA Tech said:
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

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
QA Tech said:
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.
 
Last edited:
C

Cathy

#5
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.
http://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.
 
K
#6
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).
 
#7
Kari said:
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

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
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

Involved - Posts
#9
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
 
#10
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
 

Attachments

Thread starter Similar threads Forum Replies Date
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
R ISO 13485 - Advisory Notice Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Advisory Notices - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
C Established procedure for Advisory Notices - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
G Advisory Notices - What is the Requirement in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
D Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 4
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom