ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices. Control of nonconforming products is a critical aspect of the standard, and ISO 13485 addresses it through various clauses. Here's how ISO 13485 addresses the control of nonconforming products:
Infrastructure: ISO 13485:2016 requires organizations to establish and maintain infrastructure needed for the operation of processes and for the control of nonconforming products. This includes facilities, equipment, and support services to ensure that nonconforming products are properly identified and handled.
Production and Service Provision: This clause specifically addresses the control of nonconforming products during production and service provision. It requires organizations to identify, document, and control nonconforming products to prevent their unintended use or delivery. The standard emphasizes that processes must be in place to ensure that nonconforming products are corrected, segregated, or otherwise dealt with to prevent unintended use.
Control of Nonconforming Products: This is the key clause that directly addresses the control of nonconforming products. According to ISO 13485:
a. Organizations must establish procedures for dealing with nonconforming products.
b. These procedures should define the responsibility and authority for dealing with nonconforming products.
c. The procedures should include the identification, documentation, evaluation, segregation, and disposition of nonconforming products.
d. Nonconforming products should be reviewed and, where necessary, investigated to determine the root cause of the nonconformity.
e. Decisions regarding the disposition of nonconforming products should be documented, and the records should include justification for the chosen action.
Corrective Action: The standard requires organizations to take corrective action to eliminate the causes of nonconformities to prevent their recurrence. This includes addressing nonconforming products, identifying root causes, and implementing corrective actions to prevent similar issues in the future.
Opmerkingen