Standard Operation Procedure (SOP): Complaint Process



Doc Active Date: 06/05/10

Doc Review Date: 06/05/11

Cross Referencing: Customer Service Complaint Process, Quality Systems Regulations, Medical Device Reporting,

Purpose: Problem identification and solution for Honeywell related complaints with equipment/software, or services provided to customer within expected time requirements.

Materials: Honeywell HomMed Quality Policy Manual, Medical Device Incident Reporting – FDA, MDD. CAN, Customer Service Calls Procedure, Customer Complaint Process

Applications and Restrictions:

Complaint Log - Identification of complaint as low, med, high. Complaint is defined as any written, electronic or oral communication that alleges deficiencies related to the identity, quality, reliability, safety, effectiveness or performance of a device (except as defined as routine service).

Procedure Description:

Honeywell HomMed Customer Service is available 24 hours a day, 7 days a week and 365 days a year. Contact Customer Service Department for all software or equipment related issues and/or complaints. Customer Service contact information: Phone: 888-353-5440

1. Complaint (written or oral) can be sent to any Honeywell Employee

2. Complaint if not sent directly to Customer Service will be forwarded to Customer Service including the following information:

• Date and name of service call recipient

• Name of customer, job title and phone number/e-mail address

• Identifying name of device, problem, nature and details of the service issue/complaint.

3. Customer Service receives complaint and responds to the customer. All complaints shall be reviewed as possible reportable incidents for the U.S., Canada, and Europe.

4. If customer service cannot resolve and has to escalate issue he/she contacts customer and gives expected time for resolution.

5. Complaints will be resolved with the customer or investigated further with the internal teams.

6. Once a corrective action is determined customer service contacts customer with resolution.

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