SBS - The Best Value in QMS software

Advisory Notices - ISO 13485 - applicable to suppliers?

A

amejel

#1
I'd like to extend my gratitude to the founding and contributing members of this forums as this is my first post. Please excuse me if I've posted this in the wrong section.

I work for a small company that offers metal finishing operations namely for knee/joint replacements' polishing. We receive cast-in parts, we polish them and then we send them back to our clients (the manufacturers). One of our client has recently requested our company to be certified ISO 13485 to maintain the continuity of the business.

My question has to do with the advisory notice (7.2.3 d) ). Our company does not design, nor commercialize any products (That is the entire responsibility of the client). We only offer to outsource the polishing phase of the manufacturing.

My understanding that the advisory notices deal with customer communication related to any future modification that might occur to the product when it is out there in the market. Our client does that since it commercializes its knee parts.

So from that, I believe that I can claim an exclusion on 7.2.3 d) and systematically on bits of 8.5.1 (Procedure relating to advisory notices).

I'll be more than happy to supply more information for those who want to help if it makes it any clearer.
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Your understanding is perfectly correct :)

However, there is no exclusion and your role as a subcontractor is to support any investigation that could be required on the medical device and your procedure shall state the responsibility of Advisory Notices rests with the customer who is responsible for placing the device on the market.

I suggest you to take a look at ISO 14969 as well for clarity.

Refer to some threads we have on this subject -

http://elsmar.com/Forums/showthread.php?t=18270

http://elsmar.com/Forums/showthread.php?t=19306

http://elsmar.com/Forums/showthread.php?t=10540
 
#3
We are in a similar situation. We are moving from ISO9001 to ISO 13485, however, we are NOT a medical device company. We manufacture components of medical devices. We were advised by the registrar that we need to have an Advisory Notice procedure in place. I'm struggling with this. Is there anyone out there in a similar situation that can share a procedure/form? With much appreciation in advance of a reply.
 

koulidis

Starting to get Involved
#4
We are in a similar situation. We are moving from ISO9001 to ISO 13485, however, we are NOT a medical device company. We manufacture components of medical devices. We were advised by the registrar that we need to have an Advisory Notice procedure in place. I'm struggling with this. Is there anyone out there in a similar situation that can share a procedure/form? With much appreciation in advance of a reply.
I think that your registrar is wrong. The advisory notice is an obligation for the manufacturer as defined in ISO 13485:
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)

The advisory notice according to ISO 13485 is
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary
information or to advise on action to be taken in the:
— use of a medical device,
— modification of a medical device,
— return of the medical device to the organization that supplied it, or
— destruction of a medical device


In clause 8.2.3 of ISO 13485 it is stated
If applicable regulatory requirements require notification of complaints that meet specified reporting
criteria of adverse events or issuance of advisory notices...


So if you are a component manufacturer you are not required by regulations to issue advisory notices. Therefore this clause in not applicable. However you will have to make this justification for non-applicability in your quality manual.
 

LUFAN

Involved In Discussions
#6
I think that your registrar is wrong.
You quoted the nonapplicable section but left off the applicable one:

8.3.3 Actions in response to nonconforming product detected after delivery When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. Records of actions taken shall be maintained (see 4.2.5).​
The organization shall document procedures for issuing advisory notices in accordance with applicable regulatory requirements. These procedures shall be capable of being put into effect at any time. Records of actions relating to the issuance of advisory notices shall be maintained (see 4.2.5).

From the ISO 13485:2016 Practical Guide:

The procedures for dealing with nonconformities discovered in product which has already been shipped can include taking such actions as:
• withdrawing product from sale,​
• withdrawing product from distribution,​
• giving advice to customers (this can take the form of checks to be carried out before use, providing additional guidance on the use of the product or the replacement of certain product including software or components/assemblies), or
• requesting the physical return or destruction of product.​

Continued... A service organization will likely detect nonconformities while or after the service is provided. It is not possible to correct processes to provide services in the same way a tangible product can be handled. However, it is possible to initiate a corrective action so that the service provision can be revised to reduce the probability of recurrence of the problem.​

If your component has issues, and it makes its way into a finished medical device, depending on your arrangements with the customer will have to issue an advisory notice to report the component issue. 8.3.3 is NOT a clause which you can state is non-applicable @tusher . You MUST have an advisory notice procedure and your NB is correct.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
According to the definition of advisory notice,

Screenshot 2021-06-02 095757.jpg
the supplier of components to a medical device manufacturer would be hard pressed to issue such a document, as the supplier has no formal means of knowing whom to send such advisory to. Further the supplier might might not be able to judge the impact of the nonconforming component onto the final assembly and miscommunicating with potential end users and regulatory agencies could have huge liability implications for the supplier and the legal device manufacturer.

Without a question, the supplier must communicate with the customer (the medical device legal manufacturer) about the discovery of shipped nonconforming products, but I do not believe that the mechanism for such communication would be in a form of an Advisory Notice.
 

LUFAN

Involved In Discussions
#8
The customer may request (or be outlined in an agreement) the supplier issue an advisory notice which they can help distribute to their own customers. It is unlikely a component manufacturer would actually use such a process, but that said, the process must exist.

I [emphasis myself] would describe difference as what comes down to undeniable truths. For example, if you did not manufacturing sterile products, therefore you can justify saying that sub-clauses related to sterile products are not applicable. Contrast that with saying because you are not a finished device manufacturer, my component could not possible cause an issue with the finished device. That is not an undeniable truth, but wishful thinking. Another one, not having any legal regulatory reporting responsibilities is different than not anticipating future complaints from a customer. One is a truth, one is wishful thinking.

It may never well happen, and you may be in a regulatory jurisdiction that does not use advisory notices, but because it's in the standard, the process and procedure has to exist. This is further evidence by 8.3.3 which states: "These procedures shall be capable of being put into effect at any time," it may just collect dust for eternity.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
Contrast that with saying because you are not a finished device manufacturer, my component could not possible cause an issue with the finished device.
I have no idea of where this is coming from, as no sane person would infer that.

The intent of Advisory Notices is to inform the stakeholders of medical devices about real and potential threats/risks about products placed in the market. A medical device component is not a medical device.

Section 1 of ISO 13485:2016 clearly stipulates the possibility of non-applicability of some of the requirements and it's implications, in terms of conformance with the standard, and for suppliers of components, the second paragraph of ISO 13485:2015 8.3.3 is not applicable.
 

LUFAN

Involved In Discussions
#10
I have no idea of where this is coming from, as no sane person would infer that.

The intent of Advisory Notices is to inform the stakeholders of medical devices about real and potential threats/risks about products placed in the market. A medical device component is not a medical device.
Totally disagree. References to COMPONENTS and return of PRODUCT (not a medical device which is separately defined in section 3) are stated in the ISO 13485:2016 practical guide (written by ISO/TC 210), as I mentioned. A registrar is going to write that up because of the wording of 8.3.3. "These procedures shall be capable of being put into effect at any time." It is not referring to just finished devices. If the intent was just for medical devices, it would have explicitly stated so. If you don't have an advisory notice procedure, you're playing with fire.

From the ISO 13485:2016 Practical Guide:

The procedures for dealing with nonconformities discovered in product which has already been shipped can include taking such actions as:
• withdrawing product from sale,
• withdrawing product from distribution,
• giving advice to customers (this can take the form of checks to be carried out before use, providing additional guidance on the use of the product or the replacement of certain product including software or components/assemblies), or
• requesting the physical return or destruction of product.
[/QUOTE]

Focusing on finished devices in terms of an advisory notice is incorrect.

From ISO 13485:2016:

3.15
product
result of a process

3.11
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
  • — diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • — diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  • — investigation, replacement, modification, or support of the anatomy or of a physiological process;
  • — supporting or sustaining life;
  • — control of conception;
  • — disinfection of medical devices;
  • — providing information by means of in vitro examination of specimens derived from the human body;
 
Thread starter Similar threads Forum Replies Date
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
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 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
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 Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 0
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 4
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
D Lead time to schedule an ISO 13485 audit Auditing Quality and Environmental Management Systems 2
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 9001 Auditing in a Healthcare setting Auditing Quality and Environmental Management Systems 15
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 2
Y How can i integrate ISO 13845 into ISO 27001? ISO 13485:2016 - Medical Device Quality Management Systems 4
vickyva ISO 14155:2020 CIP CIR templates Other Medical Device Related Standards 0
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom