ISO 13485 Standard - 8.2.1 Feedback E-mail
ISO 13485 customers feedbackThe organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life cycle, and that residual risks are controlled constantly. While the ISO 9001 standard demands the evaluation of customer satisfaction, the ISO 13485 standard does not, but requires the evaluation of feedback regarding the use of the medical device:
  • Does the medical device meet the intended use requirements?
  • Does the medical device meet the regulatory requirements?
  • Are residual risks still controlled and have new risks been identified?

 

The objective is to plan systematical methods that will provide early identification of quality problems and warnings related to the medical device. When such are detected, they will be analyzed, evaluated, and submitted to improvement processes. The idea is to detect the problem before the medical device may harm a patient or a user.

 

The objective of the feedback, simply put, is: to define, document, and implement methods for monitoring and controlling the product using data that were collected in the postproduction phase, or by means of post-market surveillance, in order to detect quality problems. Once quality problems are detected they are handled and submitted to improvement processes.

By measuring feedback, importance is given to the fulfillment of the medical device’s requirements rather than the perception of the customer as to whether the organization has met their requirements. Customer satisfaction is a subjective matter, whereas achieving medical device or regulatory requirements are objective issues that can be assessed and measured. A customer satisfaction survey may turn out to be diverted, and therefore may provide inaccurate results. However, the feedback will indicate the status of the medical device compared to its requirements. Feedback could be positive or suggestive—it need not be only negative regarding the medical device.

Another objective of the feedback is to assist the manufacturer in implementing improvements in the medical device or in the realization processes that, in the end, will allow the product to meet its requirements optimally (and customers’ as regulatory). This will be achieved through four sub-objectives:

  • Early identification of problems concerning quality, performance, functionality, and safety
  • Creating communication channels allowing data to flow
  • Defining and collecting appropriate data that will support the analysis of the root causes
  • Initiating an interface between the problems and related data and the improvement processes for analysis, treatment, and correction
  • Improving quality management system performances

Using defined systematical methods to collect data regarding the use of the medical device, the manufacturer will identify—in advance—quality problems related to its functionality, performance, intended use, and safety, and will submit them to a controlled process for handling. The purpose is to detect these problems before they can cause harm to anyone. The source of these problems may originate in the design of the medical device or the realization processes. In some circles feedback may be referred or compared to post-marketing surveillance (PMS); that is, the search and detection of problems in the medical device that were not identified or recognized before submission for marketing. The methods for conducting and collecting feedback data and information will be defined and documented in a procedure. This will be discussed further later.

How one can measureustomer feedback? Feedback consists of a systematical gathering of information related to the use of the medical device and its affect on users or patients in the postproduction phase; for example, transportation activities, storage, installation, service, and use. The information shall be collected in various ways (which will be detailed later). You are not obligated to implement all methods, but you will be required to justify the exclusion of methods that were not implemented. Bear in mind that the data collected via feedback methods are to be used at later stages as inputs for processes of analysis of data (as required in clause 8.4 (Analysis of Data)). Thus, it is recommended that when you plan the gathering activities and characterizing the types of data to be collected, you should consider future analyses. The objective of the analyses is to demonstrate the suitability and effectiveness of the quality management system, and to evaluate whether improvements of the effectiveness of the quality management system are needed.

Distributors

Before reviewing feedback in detail the following remark regarding distributors should be noted: when a distributor is delivering the medical device to the final customer, the organization will integrate the distributor in any feedback method it has decided upon. You are required to define (and document) to the distributor the communication channel and means of reporting between the dealer and you (e.g., a dealer report).

Service Calls

The organization may use service calls, maintenance activities, and field visits to customers as means to collect data regarding the use of the medical device. The data collected will be analyzed from various aspects: functionality, performance, intended use, and safety. The manufacturer shall evaluate the device’s competence in relation to its requirements through the data. In addition, you may plan that the service technician may perform a technical review of the medical device during the service or maintenance call for an assessment of whether it still meets its requirements.

Published Literature, Journals, and Article Reviews

It may not be the most reliable source of information, but in some cases it may shed light about certain tendencies. The information gathered in such documentation will be brought to the appropriate personnel or employees for verification. For example, say that an article was brought to your attention indicating that a new risk was identified on another medical device, active in the same field as your product. The ISO 13485 standard expects you to evaluate whether this risk is relevant to your product and its scope. The conveying and review of such information is to be systematic or methodic. This means that if you are relying on such reviews from published literature (books, journals, or articles), you must define which ones, what the intervals of review are, and the responsibilities to gather the information.

Recalls of Medical Devices

A recall is an action taken to address a problem that occurred in the medical device that exceeded the norm and accepted tolerances. Such problems can put the patient or manufacturer is to study recalls of medical devices and investigate their occurrence. Usually the manufacturer recalls the devices with the help of distributors or other responsible parties. However, there are cases where a local authority requires the organization to recall its devices. There are three levels of risk where the manufacturer must recall its medical devices:

  • Where there is a reasonable chance that a risk detected in the device is significant and is a threat to the health and safety of the user or patient
  • Where there is a possibility that a risk may pose a significant threat to the user or patient
  • Where the medical device may pose a risk with low severity to the user or patient

 

This webpage contains only a fragment of the chapter 8 Measurement, Analysis, and Improvement from the book: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry published by:

CRC Press

 You may purchase the book through:

 

Amazon

Complete Guide to Quality Management in the Medical Device Industry

 

Feel free to submit any question regarding the standard or its requirements through the Contact Us Page.

 
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