Clause 8 Operation
8.7 Control of nonconforming outputs
Clause Criteria
There are two sub-clauses:
Clause 8.7.1 (Action to address nonconforming outputs)
The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services.
This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
Clause 8.7.2 (Documented information)
The organization shall retain documented information that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.
Explanation
Controlling of nonconforming product throughout operations is critical to maintaining ISO 9001. The organization is expected to be able to demonstrate effective management of this aspect to ensure demonstrable control with regard to preventing unintended use of nonconforming products and services.
However the organization treats nonconformities identified during operation of processes is important from the perspective of an ISO auditor. The important thing is to ensure that there is a formal process, with good record keeping, to keep the system auditable.
Enable ISO customers will be familiar with the CAR Register, which can be used to effectively manage this aspect.
Note that this interpretation cannot be specific to particular processes without knowledge of the operations. Please contact us if you need a little help with your preparations for certification.
A wide range of approaches can be taken to manage this requirement. Workflow management systems, kanban, PM tools, software applications, etc., are often employed throughout operations to manage the monitoring and measuring of processes.
Identification of nonconformities can also be automated. Software engineering and customer services environments often use systems such as Jira, ConnectWise, etc. to manage this aspect.
Chief Explainer:
Phil Byrne