ISO 13485 - Advisory Notice Requirements

#1
My company is 13485 Certified. We do not have a "product" as we are an engineering service company. Recently we had an audit that identified the need for a process for issuing advisory notices.

However, being that our clients are typically the ones who handle this clause, we are uncertain as to how to apply "Advisory Notices" into our QMS. Any insight as to how we could apply this when there is no "actual product" made by our company? Thank you for any thoughts in advance.
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Was it a finding or an OFI?
If it's a finding - Can you provide the wording of the finding from the auditor?
 

QuinnM

Starting to get Involved
#4
Hi RM1967,

First look at the scope consider the definition of “advisory notice” in section 3.1. Would anything in this definition apply to your supplied component/part?

Then consider this:
ISO 13485:2016, Section 1 Scope: “ If any requirement in Clauses 6, 7, or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.”

Quinn
 

Edward Reesor

Trusted Information Resource
#5
Here's a way of looking at it...say your company hired someone and 5 years later it was found that they had falsified their credentials or that their degree didn't come from an accredited school. You would have to deal with somehow in the terms of looking into the projects they were associated with, and how would you notify your clients and the regulatory groups responsible for the project.

So the question is..."What is your process?".
 
#6
I am facing with the same question now in my company, can you tell me if it is enough to have an escalation procedure to our customers only in this case?
 
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
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
Q ISO 13485 - Advisory Notices - Regulations - Quality Manual Quality Management System (QMS) Manuals 13
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 3
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
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16

Similar threads

Top Bottom