To assure ISO 13485:2016 clause 8.2.2 paragraph 2(e) conformity for handling of complaint-related product returned from customers, the following peripheral ISO 13485:2016 clauses also apply, as necessary:
- Clause 7.5.8 (Identification), paragraph 4, to assure that returned medical devices are identified and distinguished from conforming devices;
- Clause 6.4.2 (Contamination control) to assure that returned medical devices will not contaminate the work environment, personnel, or product; and
- Clause 8.3 (Control of nonconforming product) to assure appropriate identification and control of product which does not conform to requirements.
Pursuant to clause 0.1 (paragraphs 5-7), each organization may employ strategic and variable flexibility of the design, implementation, structure, and scope of its quality management system based on various influencing variables. Accordingly, there are a variety of ways to integrate into the QMS such controls for assuring proper handling of complaint-related product returned from customers.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 13-Apr-2018 12:43
From: Anonymous Member
Subject: Handling on complaint-related product
This message was posted by a user wishing to remain anonymous
Hello. ISO 13458:2016, 8.2.2 Complaint Handling states that the procedures for complaint handling shall include handling of complaint-related product. Does anybody know, or have a recommendation of what must be done to comply with this requirement. We request that the customer return the product. Is there anything else that is mandatory? Thank you.