Advisory Notices - What is the Requirement in ISO 13485

G

gfux01

#1
Hello all,

I'm just making a gap analysis from our current Management system TS16949 to ISO 13485 and i'm struggling a little bit with the word advisory notice.

Can somebody explain me what the standard understands under advisory notice as Point 8.5.1 states 'The Organization shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time'??

Thank's for your help
:thanx:
 
Elsmar Forum Sponsor

Le Chiffre

Quite Involved in Discussions
#2
Re: Advisory notices

Are you also considering Canadian Medical Device Conformity Assessment System (CMDCAS)? The federal Medical Device Regulations has more on this subject (sections 58 - 61) as well as a Health Canada guidance document on "Mandatory and Voluntary Problem Reporting for Medical Devices".

If your focus is FDA, there are some similar documents on its website.
 
G

gfux01

#5
Thank you very much for your comments!

As we are only supply parts to the Medical Industry, meaning our name is not on the product, we don't consider CMDCAS.

The definition of advisory notes also refers always to medical devices. For my understanding we don't produce medical devices only parts for medical devices as there is no exclusion for this point, has someone any ideas how to cover this point for my purposes??
 

Ajit Basrur

Staff member
Admin
#6
Hi gfux01,

Based on your response, I think your organisation is an injection molding company which makes parts and give to the customer, who ultimately make up a medical devices. Am I right ?

In this scenario, the extent of advisory notices becomes reduced but you can not claim an exclusion.

The advisory notices basically provide supplementary information about the device or specify actions that should be taken. Advisory notices include the following:

discuss the use of medical devices
discuss the modification of medical devices
discuss the destruction of medical devices, and
discuss the return of medical devices

So if your customer has to do the Advisory Notices, he will take the help of your organisation.
 
G

gfux01

#7
Hello Qualityalways,

your are right,

can you specify this reduction a little bit more detailed this would be very helpful. What are the key points of this system I have to cover at least?

Would you suggest to use the vigilance system as a guideline?

Regards,
 
Thread starter Similar threads Forum Replies Date
A Advisory Notices - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
Ajit Basrur What is the German term for "Advisory Notices" ISO 13485:2016 - Medical Device Quality Management Systems 2
J Can I combine Recalls, Advisory notices, and Vigilance systems into one procedure? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Advisory Notices for a Component Supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
Ajit Basrur Anyone having ppt file on Advisory Notices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Who is responsible of Advisory notices ISO 13485:2016 - Medical Device Quality Management Systems 5
C Established procedure for Advisory Notices - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
C Corrections and Removals and Advisory Notices: 21 CFR 806 (Procedure needed) Document Control Systems, Procedures, Forms and Templates 1
Marc Advisory Notices - Who is responsible for dealing with Advisory Notices? ISO 13485:2016 - Medical Device Quality Management Systems 7
G Documented Procedures for the Issue of Advisory Notices and the FDA (Medical Devices) ISO 13485:2016 - Medical Device Quality Management Systems 2
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
M Informational US FDA Patient Engagement Advisory Committee – Cybersecurity in Medical Devices: Communication That Empowers Patients Medical Device and FDA Regulations and Standards News 0
M Informational MHRA Guidance – Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stent Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
W FAA Advisory Circular (AC) Requirements (FAA AC 00-56) - Internal Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R ISO 13485 - Advisory Notice Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
S Nadcap HT Auditor Advisory 17-003 Advice needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Advisory Services - Design and Development requirements per clause 7.3 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
somashekar FDA cGMP on Feedback, Advisory Notice and Customer Property 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Customer Return or Advisory Notice? ISO 13485:2016 - Medical Device Quality Management Systems 6
E Medical Device Advisory Notice Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
K Recall or advisory notice sufficient for software ISO 13485:2016 - Medical Device Quality Management Systems 9
J Location of ANAB Advisory #23 - Nonconformance Classifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Advisory Notice Requirements & Procedure and Form examples ISO 13485:2016 - Medical Device Quality Management Systems 4
H What is a Purchasing "Advisory"? ISO 13485:2016 - Medical Device Quality Management Systems 4
Sidney Vianna ISO 9001 Advisory Group (IAG) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Medical Device News MHRA – Field safety notices – 03 to 07 December 2018 Medical Device and FDA Regulations and Standards News 1
M Medical Device News Medical Device Directives – New templates for Field Safety Notices published Medical Device and FDA Regulations and Standards News 0
N Auto email reminder sent to customer - Calibration Due Notices Calibration and Metrology Software and Hardware 5
smryan SVHC (Substances of Very High Concern) Declaration List Update Notices RoHS, REACH, ELV, IMDS and Restricted Substances 3
T Control of Posted Notices on the Floor - What is considered a "Work Instruction"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
D What is the acceptance criteria/requirement for Stability Study? General Measurement Device and Calibration Topics 2
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0

Similar threads

Top Bottom