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https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
Mar 21, 2017 · Complaint management is an important part of customer relationship management and like every other quality standard, ISO 13485:2016 emphasizes strong controls over complaint handling. ISO 13485 deals with medical devices, and as the severity of adverse effects of these devices is quite high, the standard emphasizes additional controls for ...
https://www.praxiom.com/iso-13485-definitions.htm
Plain English ISO 13485 2016 definitions: Advisory notice, authorized representative, clinical evaluation, complaint, distributor, implantable medical device ...
https://elsmar.com/elsmarqualityforum/threads/iso-13485-complaints-what-is-a-complaint.68467/
Dec 21, 2017 · My company is working toward getting ISO 13485 certification (we are currently ISO 9001 certified). I'm reviewing and updating our current procedures and found a practice in our complaint handling system that I don't think is acceptable. I'm hoping for …
https://www.orielstat.com/blog/medical-device-complaint-handling-understanding-basics/
Mar 23, 2018 · (The ISO 13485 standard is a copyrighted document so you won’t find the text online, but you can buy it from ISO.) The word “gather” is important because it implies we are proactively seeking feedback. Complaints, unfortunately, come to us, so complaint handling is a reactive procedure. Let’s take quick look at the definition of ...
https://en.wikipedia.org/wiki/ISO_13485
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.This standard supersedes earlier documents such as EN 46001 and …
https://creoquality.com/all/what-is-a-medical-device-complaint/
The ISO 13485 definition is very similar. For reference, FDA complaint regulations are covered in 820.198. ISO 13485 sub-clauses 7.2.3 addresses customer communication and 8.2.1 addresses feedback. It seems like several client engagements in recent years have had some dealings with complaint handling.
https://www.aplyon.com/store/p57/complaint-handling-procedure.html
The ISO 13485 Complaint Handling Procedure provides instruction on sources of complaints, how to receive complaints into the system, required complaint information, complaint investigations, complaint closure and the establishment of complaint files. The ISO 13485 Complaint Handling Procedure provides instruction on the initial review and ...
https://www.iso.org/obp/ui/#!iso:std:59752:en
This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) ... Note 1 to entry: This definition of ?complaint? differs from the definition given in ISO 9000:2015. 3.5. distributor. natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user ...
https://www.iso.org/standard/59752.html
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and ...Category: p
https://www.qualitydigest.com/pdfs/FDA%20Quality%20System%20Regulation%20Webinar.pdf
FDA Complaint handling & “Parts” 803 & 806 The FDA Quality System Regulation was created to align with ISO 9001:1994 and ISO 13485:1996. It contains 20 elements, like the earlier ISO standards. Unlike ISO 9001 or ISO 13485, FDA has very specific requirements for
http://13485quality.com/iso-134852016-standard-8-2-1-feedback/
The ISO 13485 standard requires the evaluation of feedback regarding the use of the medical device; the organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life-cycle:
http://www.asq-seattle.org/sites/default/files/13485-2016%20Overview.pdf
ISO 13485:2016 vs ISO 13485:2003 1. Flexibility Organization can exclude any requirement if they are able to justify the reason for the exclusion or the alternative method taken 2. Regulatory Explicitly expects compliance to any and all other applicable statutory & regulatory …
http://www.qualitywbt.org/FlexTraining/ASP/content/sections/R066/pdfs/13485%20terms-definitions.pdf
13485 terms-definitions.doc Page 1 of 2 ISO 13485, Clause 3 Terms and definitions ... customer complaint written, electronic or oral communication that alleges deficiencies related to the identity, ... NOTE This definition applies to implantable medical devices other …
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/page-4
The inspection should ascertain what files are maintained that meet the definition of a complaint (21 CFR 820.198). By placing complaints in different files, manufacturers may not have noted ...
https://advisera.com/13485academy/documentation/procedure-for-customer-communication-feedback-and-complaints-iso-13485-2016/
ISO 13485 document template: Procedure for Customer Communication, Feedback and Complaints. The purpose of this procedure is to describe the process of communicating with customers, including gathering feedback and handling customer complaints.
https://13485store.com/medical-device-standards/what-is-iso-13485/
ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. Certification to the standard requires an organization’s quality management system to pass a third party Medical Device Single Audit Program, or “MDSAP” Audit.
http://www.redstarcontractmfg.com/sites/default/files/docs/ISO_13485_2016%28en%29.pdf
8.2.2 Complaint handling ... This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009. A summary of …
https://www.nsf.org/newsroom_pdf/md_13485_to_820_alignment_tool.pdf
The definition of “complaint” in 3.4 of ISO 13485:2016 also includes concerns “related to a service that affects the performance of such medical devices” as a potential source of complaints. ISO 13485:2016 defines the term “complaint” as “Written, electronic or oral communication that alleges deficiencies related
https://www.mastercontrol.com/gxp-lifeline/iso_13485_overview_0110/
Apr 17, 2017 · In ISO 13485, meeting requirements includes meeting regulatory requirements. So for devices that will be used in the US, to be compliant with ISO 13485, manufacturers must also meet the QS Reg. As a regulation the QS Reg. is often more specific than ISO 13485, particularly in the areas of complaint handling, labeling control, an d documentation.
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