Is there an ISO 13485 requirement to solicit Customer Feedback?

RCW

Quite Involved in Discussions
#1
Afeter a recent audit performed by a customer, my company was issued a finding that we did not solicit feedback from them on a regular basis. This was a finding against ISO 13485 7.2.3 & 8.2.1.

Is my company required to ask for performance data?

Several years ago, an employee at that company used to send my company performance data (on-time delivery, quality / escapes). He left the company and a new guy took over, the same guy who issued this finding. To me it appears the ball was dropped at that company. Nothing was probably written down as to what was being done and when the new guy started - no more data was presented.

The "problem" was found during the audit when management review records were reviewed. There was performance data from other companies in there, data which was provide by but never solicited from them, but there wasn't any in there for his company.

Is there an actual nonconformance here?
 
Elsmar Forum Sponsor
#2
Re: Is there an requirement to solicit feedback?

A very interesting question. Let me begin by stating that I don't believe anything in ISO 13485 (or ISO 9001) is implied. It is either required, or you have flexibility. The standard does require you to have effective arrangements for communicating with your customers, and have a documented procedure for feedback. However, 13485 removed the customer satisfaction requirements that were in ISO 9001, since the focus is more on regulatory issues. The feedback portion of 8.2.1 deals with feedback on product quality rather than on satisfaction.

With that stated... Is the complaint about not soliciting feedback related to product quality issues, or customer satisfaction issues? If product quality, then I think we have a clear demonstrated failure. If they are customer satisfaction, I would say you might have an arguable nonconformity.... but

And this is a BIG but... this is your customer and even if ISO 13485 does not require you to keep that customer happy, business needs may dictate otherwise. If your customer is telling you that you are lacking in listening to them as a customer, you need to pay attention to that! Your customer may not be able to pull your registration, but they are able to pull their business.
 
M

MIREGMGR

#3
Re: Is there a requirement to solicit Customer Feedback?

The applicable ISO 13485 provision is:
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) inquiries, contracts, or order handling, including amendments,
c) customer feedback, including customer complaints (see 8.2.1), and

d) advisory notices (see 8.5.1).

I don't read that to require that a supplier proactively solicit communications from their customers. All that is required is that you have an effective system in place for handling such communications. If they have something to tell you, they should tell you.

If for instance a customer were to notify you that they'd had a significant problem with a product, it would be obligatory for you to record that information in a way that prevents its effective loss, and follow the 8.2.1 requirements in regard to further actions.

Note FYI that US FDA has somewhat different requirements, and in some special contexts within the general category of post-market surveillance, US firms are expected to proactively solicit communications from device users.
 

RCW

Quite Involved in Discussions
#4
Re: Is there a requirement to solicit Customer Feedback?

Note FYI that US FDA has somewhat different requirements, and in some special contexts within the general category of post-market surveillance, US firms are expected to proactively solicit communications from device users.
You wouldn't happen to know what Federal Register or other FDA communique this was in, would you?
 
M

MIREGMGR

#5
Re: Is there a requirement to solicit Customer Feedback?

I'm not referring to a particular singular guidance or regulation. A general "follow" of FDA output over the past few years, though, has made clear that FDA increasingly expects makers of higher risk devices to be pro-active in regard to post-market surveillance.

A search on "post-market" at the FDA site should get you an overview of this evolving expectation.
 
Thread starter Similar threads Forum Replies Date
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Requirement to Identify Changes to record in ISO 13485 : 2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
S Is a Quality Policy Statement a Requirement? (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 7
T Attribute vs Variable Inspection Data ISO 13485 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Rework requirement in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
R ISO 13485 vs FDA Requirement question about when ISO 13485 Certification is Required ISO 13485:2016 - Medical Device Quality Management Systems 4
I Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485:2016 - Medical Device Quality Management Systems 7
R ISO 13485 Clause 4.2.1 - Documentation Requirement question ISO 13485:2016 - Medical Device Quality Management Systems 4
G ISO 13485 Requirement on labeling product in WIP (Work In Process) ISO 13485:2016 - Medical Device Quality Management Systems 4
D Is Process Mapping an ISO 13485 Requirement? Process Maps, Process Mapping and Turtle Diagrams 4
T ISO 13485 Documented Data Protection Procedure Requirement ISO 13485:2016 - Medical Device Quality Management Systems 3
H Material Non-conformance Requirement - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A ISO 13485 - Requirement for Sub-Systems Audited per Year? ISO 13485:2016 - Medical Device Quality Management Systems 13
Q ISO 13485 Quality Manual Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
M Engineering Drawing Number Procedure Requirement - ISO 13485:2003 4.2.1 d)? Document Control Systems, Procedures, Forms and Templates 3
G Advisory Notices - What is the Requirement in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
R Requirement to be registered to ISO 13485 by the end of 2006? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom