Complaint Handling policy

Version: AGCH.01.21

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 I. Sources of Complaints

Complaints can come from various sources and may be submitted by customers or from customer service staff, the sales
team or representatives.

We are in Al Noor Gate company receive the complaint through one of the following ways:

• Telephone
• Email
• Social media
• Online product reviews
• Letters

II. Classifying Complaints

The post-market complaints can be classified into two baskets:

• Incident-driven: An incident such as serious harm or death occurred due to malfunction of the device will require
immediate attention.
• Review-driven: When reviewing your data, if a pattern of repeated failures or flaws which qualifies as a complaint
are noticed, it can be categorized as a review driven complaint.

III. Responsibilities:

Executives / technical team are responsible for:

• Reviewing and analyzing trends and recurrences of Nonconformities, complaints and recommending
appropriate remedial action.

• Providing final authority of the disposition of all complaints and other issues arising from customer feedback.

IV. Complaint handling Process

Below the complaint handling process and procedures, we are following in Al Noor Gate Company:

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We shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.

A. These procedures shall include at a minimum requirements and responsibilities for:

B. receiving and recording information;
C. evaluating information to determine if the feedback constitutes a complaint;
D. investigating complaints;
E. determining the need to report the information to the appropriate regulatory authorities;
F. handling of complaint-related product;
G. determining the need to initiate corrections or corrective actions.

If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting from
the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the complaint, relevant information shall
be exchanged between the organization and the external party involved.
Complaint handling records shall be maintained.

The complaint should process:

1- Complaint receiving:

Al Noor Gate receives the complaint from the customer / end user via email, letter or phone call.
The complaint mainly goes under one of the company departments based on how the issue is “technical, admin,
accounts issue”.

2- Complaint evaluation:
The management evaluate the complaint from the technical view to see how it effect on the end user and the company
sales.

3- Investigation:

The management open an investigation to trace the problem and the its affection on the end user / customer.
This investigation contains the item fully description which caused the problem, the batch number, expiry date and the
manufacturer details.
A representative set a meeting with the complaint precentor to discuss and investigate about the complaint in details.

4- Route cause analysis – RCA:

is the process of discovering the root causes of problems in order to identify appropriate solutions. RCA assumes that it
is much more effective to systematically prevent and solve for underlying issues.

5- Corrective action:

The management takes the corrective action based on the complaint evaluation; this action might lead the management
to recall the item in some cases.
If the complaint related to technical issue, it is immediately forwarded to the manufacturer for giving the prompt
advise.

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 6- Problem solving – close the ticket:

After the investigation and taking the suitable corrective action, the problem file will be finalized and the ticket closed.
All the problem history and information are kept in the customer file for the future reference.

Complaint handling system “Affinity”:

We are using Affinity software for managing the complaint handling process and procedures.

The system has the major points for handling the complaint starting from receiving the notification till closing the
ticket, the main points are:

• Medical device name.

• Priority level.
• Device model.
• Manufacturer.
• User details “name, contact”.
• AR details, license number.
• Corrective action details.

Below the Affinity system screenshot for managing the complaint handling process:

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 V. Attachments:

** Complaint handling form – filled by the customer/patient or the end user.

Kingdom of Bahrain
May 15th 2021

Al Noor Gate Medical Equipment

Authorized Signatory

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